Why the FDA’s new e-cigarette regulations are a gift to Big Tobacco (and could actually harm public health)

The FDA begins evaluating the risks and benefits offered by cigarette alternatives

IN 2009, Congress gave the Food and Drug Administration wide authority to oversee tobacco products. The agency has moved cautiously in flexing that power. On Thursday, for the first time, the FDA “deemed” several tobacco products to be under its watch, including cigars, pipe tobacco, nicotine gels, hookahs and e-cigarettes. This move is welcome, if overdue. The FDA now has to conduct the tricky work of figuring out when further restrictions, particularly on e-cigarettes, help and when they might actually harm public health. As long as the FDA steers clear of direct regulation of products other than cigarettes, smokeless tobacco and roll-your-own tobacco, public health advocates rightly worry that potential smokers — particularly children and teenagers — will find it easier or more appealing to use unregulated products with varying or unknown public health effects. The agency says that expanding its oversight, which Congress gave it the power to do, is the first, “foundational” step toward broad regulation of these alternatives to cigarettes. The FDA is demanding some concrete steps of manufacturers upfront. They will have to register their products with the agency and reveal their ingredients. They will have to attach warning labels. Many vending machines will become off-limits. And the federal government will ban e-cigarette sales to minors. Once regulators gather more information on the harm various products can cause and on how people are obtaining and using them, they can do more in the interest of public health, such as consider bans on Internet sales, candy-like flavorings or certain kinds of marketing. The FDA is also accepting feedback on whether to exempt “premium” cigars from regulation, since people often do not smoke them habitually. That strikes us as unnecessary, because cigars, too, can do harm. If regulators determine that premium cigars do not pose the same public health risks as other products, they can keep the demands on their manufacturers relatively light. But for one product there is good reason for caution. E-cigarettes, which deliver a nicotine-laced vapor that presumably contains many fewer harmful ingredients than tobacco smoke, could help addicted, lifetime smokers to reduce their consumption or quit. On the other hand, e-cigarette use among young people is soaring, and there is concern that it might be a gateway to conventional smoking. In addition, some adult smokers may use e-cigarettes to augment their traditional cigarette habit when they otherwise might have kicked it. Unlike with many other nicotine-containing products, the FDA has to determine how to keep e-cigarettes available to those who might benefit from them while minimizing their capacity to hook young people or encourage continued smoking. Thursday’s announcement is just the beginning of that process. **Read more about this topic:** The Post’s View: Higher taxes on cigarettes make good sense The Post’s View: E-cigarettes have risks but they also offer public health benefits The Post’s View: CVS’s smart shift away from tobacco

‘Baptists, Bootleggers & Electronic Cigarettes’: A response to Professor Berman

In short, Big Tobacco would like to use regulation to do for e-cigarette markets what has already been done to cigarette markets. In these efforts, Big Tobacco (which was the Big Four, then the Big Three and now the Big Two) has often joined forces with public health groups to support greater regulation, forming a “bootlegger and Baptist” coalition. So, for example, tobacco giant Altria joined forces with some anti-smoking groups to draft and then lobby for the Family Smoking Prevention and Tobacco Control Act. This law helped suppress competition in cigarette markets and is the source of the FDA’s purported authority to regulate e-cigs — authority that both Big Tobacco and many anti-smoking groups encouraged the FDA to use.     Whether or not one thinks the FDA deeming rule is a good idea, that Big Tobacco companies and other economic interests supported the rule should be beyond dispute. As some public health groups supported the rule as well, the claim that tobacco “bootleggers” joined pro-regulatory “Baptists” in pushing for greater e-cig regulation should be beyond dispute.     There’s lots more to take issue with in Professor Berman’s post, but the above should suffice to explain why we claim that Big Tobacco has played the role of the “bootleggers” in a “Baptist and bootlegger” coalition supporting greater regulation of e-cigarettes. This fact alone is not enough to demonstrate the the FDA’s regulations are ill-advised, but it does place the FDA’s regulatory initiative in context.  DISCLOSURE: In 2014, I co-authored a white paper on the political economy of e-cigarette regulation for which my co-authors and I received compensation from NJOY, an e-cigarette manufacturer. NJOY exercised no control over the conclusions of that white paper, and I have not maintained any relationship, economic or otherwise, with NJOY since completing that work. All of my conclusions about e-cigarette regulation are my own.

The FDA’s new plans could just switch one form of nicotine addiction with another

As a physician who treats patients devastated by tobacco-caused lung disease, I was concerned by the Aug. 5 editorial “Breaking nicotine’s grip,” which embraced Food and Drug Administration Commissioner Scott Gottlieb’s plan for regulating tobacco products. The commissioner seems unconcerned about switching one form of nicotine addiction with another. Nicotine in any form is bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that nicotine can be a gateway drug. Flavoring agents and other chemicals in e-cigarettes, when vaporized, are harmful. Mr. Gottlieb appears willing to risk future generations of young people to nicotine addiction by granting Big Tobacco free rein to hook children on e-cigarettes and cigars. By going easy on the e-cigarette and cigar makers — giving them at least a four-year hiatus from new product applications and action on flavors and potentially exempting “premium” cigars — Mr. Gottlieb is effectively greenlighting continued peddling of addiction to youth. The FDA’s job is to protect youths from all types of tobacco and nicotine addiction, not to negotiate which types of nicotine addiction it will allow. ****Enid R. Neptune** , Baltimore** _The writer is vice chair of the American Thoracic Society’s Tobacco Action Committee._

The FDA finally steps up on e-cigarettes

OVER THE past several years, the e-cigarette business has boomed, tying public-health experts in knots. On one hand, the devices are far less dangerous than conventional cigarettes. It would be a public-health victory if every smoker stopped lighting up and chose to vape instead. On the other hand, e-cigarettes seem designed to appeal to children and teenagers. E-cigarette liquids come in a variety of candylike flavors that, according to federal health officials, have driven interest among young users. Some young people — it is unclear how many — would not have gotten hooked on nicotine without e-cigarettes. As youth e-cigarette use jumped — 900 percent between 2011 and 2015, according to federal officials — the federal government hardly reacted. Astonishingly, there has been no ban on selling e-cigarettes and vaping liquids to minors, let alone consistent regulations on packaging, labeling and advertising or professional review of the ingredients that vaping companies put in their products. Though these products doubtless are less harmful than conventional cigarettes, they certainly contain nicotine, which may harm adolescent brains, and they might contain other chemicals that pose health dangers. The risks associated with inhaling secondhand vapor are also unknown. This regulatory vacuum has been unnecessary. Under the Tobacco Control Act, the Food and Drug Administration has wide-ranging power to regulate tobacco products. The agency finally has decided to begin using it more fully, announcing a final rule on e-cigarettes, cigars and hookahs. The rule bans e-cigarette sales to minors and requires sellers to check buyers’ ages but stops short of cracking down as hard as the FDA could, by banning certain flavorings, for example. The most controversial part of the rule requires e-cigarette and e-liquid makers to submit their products to extensive FDA review before sale, providing ingredient lists and any data they have on health effects. Critics castigated the agency for cracking down on a young industry filled with small operators. The result, they say, will be more expensive and less desirable e-cigarette products, which will drive up conventional smoking and reward big tobacco companies that can afford to navigate the FDA process. This view neglects the danger that e-cigarette use will become increasingly common among youths, who without regulation would assume the products were safe, addicting a generation of children and teens to nicotine. E-cigarette businesses, whether small or large, are mixing highly addictive batches of chemicals and selling them with almost no federal oversight. Figuring out what is in these products is necessary for figuring out how dangerous they are — and how to make safer nicotine delivery devices for those trying to quit conventional smoking. The FDA’s e-cigarette rules do not overreach. They are long overdue. **Read more on this topic:** The Post’s View: How to regulate e-cigarettes Jonathan Adler: Why the FDA’s new e-cigarette regulations are a gift to Big Tobacco

FDA outlines plan to regulate e-cigarettes

The Food and Drug Administration said Thursday that it intends for the first time regulate the booming market of electronic cigarettes, as well as an array of other products such as cigars, pipe tobacco and hookahs. The move would begin to place restrictions on e-cigarettes, a nearly $2 billion industry that for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes also would be banned from making health-related claims without scientific evidence. The FDA’s proposal stops short of broader restrictions sought by many tobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda and piña colada — all tactics that critics say are aimed at attracting young smokers and that have been banned for traditional cigarettes. Those restrictions might come eventually, FDA officials said, but not before more rigorous research can establish a scientific basis for tougher rules. “Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. He said Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, adding, “It creates the framework. We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate- keeping function.” E-cigarettes vary from brand to brand, but they generally resemble the size and shape of traditional cigarettes. Instead of burning tobacco, the battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” Supporters say that makes e-cigarettes an attractive alternative to their cancer-causing tobacco counterparts. Congress passed a law in 2009 giving the FDA broad power to regulate cigarettes, including requirements for new warning labels, restrictions on ads and explicit approval of new products. The law also gave the FDA the authority to broaden its jurisdiction over other tobacco-related products. While the agency has indicated for years that it planned to do just that, action has been slow in coming. Reactions to Thursday’s announcement from the e-cigarette industry, public health officials and consumer advocates was swift — and mixed. Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the FDA’s action an important step but said that it is “inexcusable” that the agency had taken so long to act. “In the absence of any meaningful regulation, the e-cigarette manufacturers have acted as if it’s the wild, wild West, with no rules and no restraints,” Myers said. “Their advertising is exactly the same type of advertising that made cigarettes so appealing to young people” decades ago. He said FDA needs to move quickly to finalize Thursday’s proposal and conduct the scientific research it will need to put more stringent rules in place down the road on marketing practices and flavors. “They can’t move forward at the same pace that they have been moving and do their job protecting public health,” Myers said. “We can’t waste another five years; this cannot take that long. There is a moral and public health imperative for them to treat this with the urgency it deserves.” Still, whatever changes are coming won’t happen overnight. The public will have 75 days to comment on the proposal. After the FDA sorts through a likely tidal wave of responses and finalizes its regulations, companies will have to begin complying almost immediately with the proposed age and identification restrictions. But they will have two years to submit applications to the FDA to approve their products, which can remain on the market in the meantime. The FDA’s effort to begin overseeing the sprawling e-cigarette market comes at a critical time. Sales have doubled year after year, with no signs of slowing, according to some industry analysts. That pales in comparison with the estimated $80 billion-a-year U.S. market for conventional tobacco products, but the gap is shrinking steadily. In addition, tobacco giants such as Lorillard, Reynolds and Altria have entered the e-cigarette market in recent years, joining hundreds of smaller manufacturers. Some industry advocates worried Thursday that federal regulation will benefit only a handful of those large companies, who have established distribution channels and the money and manpower needed to file the streams of paperwork that will now be required to seek FDA approval of all e-cigarette products. “This is worse than I expected,” said Greg Conley, a board member of the American Vaping Association, who said he welcomed the age-restriction rules but had hoped the FDA would grandfather in existing products, rather than force e-cigarette makers to file lengthy applications for any product on the market dating to early 2007. “A lot of these companies, they are supporting several employees, investing any profits back into their buisness ... They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers.” Not everyone in the e-cigarette industry bristled at Thursday's proposal. Indeed, some of the larger players in the e-cigarette market praised FDA for committing to a science-based regulatory process, which they hope will allow them to make a strong case that e-cigarettes have the potential to reduce tobacco-related harm and be an overall positive for public health. “What they did today was very encouraging ... We’ve already done many things to prepare ourselves and act responsibly,” said Miguel Martin, president of Logic Technology Development one of the nation’s leading e-cigarette companies. “At least speaking for my company, this will not be the tobacco wars of the 80s and 90s.” The move toward federal regulation comes amid an impassioned debate over simple questions that so far have no simple answer: Will e-cigarettes eventually cause more people or fewer to smoke? Will the devices emerge as a healthier alternative that makes cigarettes obsolete, or will they act as a gateway to smoking and undermine a half-century of efforts to reduce tobacco-related deaths, which still kill an estimated 480,000 Americans annually? “There’s such a huge debate over whether e-cigarettes are a good thing or a bad thing for public health,” said Kenneth Warner, a tobacco researcher and professor of public health at the University of Michigan. “But we’re in a kind of factual vacuum. There are not that many [reliable] studies. . . . We really don’t know the right answer.” Warner said the FDA will have to walk a fine line in the way it treats e-cigarettes. On one hand, the agency must set reasonable restrictions, such as keeping nicotine-delivery devices out of the hands of minors and creating safe manufacturing standards. On the other hand, if e-cigarettes do hold the potential to help some people quit smoking, the agency doesn’t want to stymie innovation and crush an industry that’s quickly evolving. “It’s a tricky balance,” Warner said. “Even in an environment devoid of politics and lawsuits, it would be a challenge to come up with the right mix of regulations. . . . Figuring out how to do this is going to be hard, and it isn’t going to happen quickly.” The cigar and e-cigarette industries have long been preparing for the inevitability of federal regulation — and working hard to try to shape it. For example, makers of “premium cigars” have been lobbying intensely not to be lumped in with the fruit-flavored corner-store varieties that public health experts say target kids — a distinction FDA officials have said they are willing to consider. E-cigarette executives have been every bit as aggressive, making their case over the past year in meetings with FDA regulators, members of Congress, and state and local officials, seeking to avoid some of the stringent rules that govern conventional cigarettes. In essence, they have argued that e-cigarettes vapor is far less harmful than cigarette smoke, with its cancer- causing toxins, and can actually help smokers kick the habit. Therefore, the manufacturers say, they should be subject to kinder, gentler oversight — and lower taxes — than traditional cigarettes. At the same time, manufacturers have been fighting growing regulation in cities and states. Numerous cities, from Los Angeles to Chicago to Boston, have banned e-cigarettes in public places, and dozens of state attorneys general have urged federal regulators to speed up restrictions on marketing the devices to young people. The e-cigarette industry also has faced questions about the safety and accessibility of its products. The Centers for Disease Control and Prevention reported this month that calls to poison centers involving e-cigarettes have surged in recent years as the products have gained in popularity, with most of the incidents involving children younger than 6 who have accidentally ingested the liquid nicotine. Last year, the CDC reported a dramatic increase in the number of high school students who said they had tried e-cigarettes, including some who had never smoked. That fueled concerns among some public health officials that the devices could lead users toward traditional smoking. E-cigarette advocates argue there’s little evidence to support such a claim. According to the FDA, hard evidence will be key from now on. People on every side of the argument agreed that reliable research should dictate how the FDA regulates e-cigarettes going forward, even as what that research will show remains a source of disagreement. “It will move from theory and conjecture and gut feelings to a science-based regulatory framework,” said Jason Healy, founder and president of blu eCigs, which was acquired by Lorillard in 2012. “Both sides have to now be accountable for their statements. You’re going to have to put science behind it.” However that ends up shaping the industry, Healy said, that approach ultimately could prove positive for consumers. “There’s been so much uncertainty,” he said. “Now, everyone will know where we stand.” More from The Washington Post: Seven things about e-cigarettes Consider this before you ‘vape’ Big Tobacco tries to hook a new generation The Post’s View: E-cigarettes have risks but offer benefits

FDA regulation of e-cigarettes draws mixed reaction

Reggae music poured from the speakers Thursday afternoon inside the DC Vape Joint, a basement shop that opened last month in Adams Morgan. Display cases held dozens of electronic cigarettes and a seemingly endless array of nicotine liquids, in far-flung flavors such as Mojito and Moon Pie, Swedish Fish and Scooby Snacks. On a nearby couch, shop co-owner Erik Miller and store manager Ryan Bixby took drags off their own e-cigarettes, filling the tiny space with apple- and vanilla-scented vapors. They hardly sounded troubled by Thursday’s announcement that the Food and Drug Administration intends to start regulating the rapidly expanding e-cigarette market. “We’re excited,” said Bixby, 30. “With regulation comes standardization. The quality is going to improve.” If approved, the FDA’s proposal would quickly put curbs on sales to minors, require health warning labels and disclosure of ingredients, and prohibit manufacturers from making unverified health-related claims — ideas that most e-cigarette producers and retailers say they embrace. What comes after that might prove far more delicate and divisive. For now, the FDA isn’t seeking to halt online sales of e-cigarettes, forbid television advertising, or ban the dizzying array of flavorings, from mango to margarita to mocha, which tobacco control advocates say are aimed at luring young smokers and which have been banned in traditional cigarettes. Those rules eventually could come, FDA officials say, but only after there is a scientific basis for broader regulations. The FDA’s long-awaited move to begin regulating e-cigarettes — as well as cigars, pipe tobacco, hookah tobacco and other products — drew swift and mixed reactions Thursday from public health officials, consumer advocates and manufacturers. But almost everyone agreed that the details of how __the agency eventually regulates the rapidly evolving, $2 billion-a-year e-cigarette industry will shape it dramatically and could have profound effects on public health. The public has 75 days to comment on the FDA’s proposal, and manufacturers will have two years after the current rules are finalized to submit applications to the FDA to approve their products, which can remain on the market in the meantime. Matthew Myers, president of the Campaign for Tobacco-Free Kids, called Thursday’s action an important step but said that it is “inexcusable” that the FDA had taken years to act. He said the agency must move quickly to conduct the research it will need to crack down on the flavorings and marketing aimed at minors. “They can’t move forward at the same pace that they have been moving and do their job protecting public health,” Myers said. “We can’t waste another five years; this cannot take that long. There is a moral and public health imperative for them to treat this with the urgency it deserves.” Some industry advocates worry that federal regulation will benefit only a handful of large e-cigarette companies that have the money and staffing needed to file the mountain of paperwork required to seek FDA approval for every e-cigarette product. “This is worse than I expected,” said Greg Conley, a board member of the American Vaping Association, who had hoped that the FDA would grandfather in existing products, rather than force e-cigarette makers to file lengthy applications for any product on the market dating to early 2007. “A lot of these companies, they are supporting several employees, investing any profits back into their business. . . . They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers.” Not everyone agrees. Some of the largest players in the e-cigarette market praised the FDA for committing to a science-based decision-making process, which they hope will allow them to make a case that e-cigarettes have the potential to reduce tobacco-related harm. “What they did today was very encouraging,” said Miguel Martin, president of Logic Technology Development, one of the nation’s leading e-cigarette companies. “At least speaking for my company, this will not be the tobacco wars of the ’80s and ’90s.” The market for e-cigarettes — battery-powered devices that heat up a liquid and deliver nicotine-laced vapor to users — still pales in comparison to the $80 billion in annual tobacco sales, but that gap is narrowing, and some analysts think e-cigarettes could eclipse conventional cigarettes in popularity within a decade. The FDA’s move comes at a time when many questions remain about whether e-cigarettes actually help people kick the smoking habit or put more people on a path toward smoking. It comes as cities and states are putting in place public bans on e-cigarettes over the objections of advocates who say they should be embraced as a welcome replacement to toxic, burning tobacco. As the federal government enters the fray, it faces a balancing act of setting sensible restrictions that will ensure safe products while restricting access to minors, but won’t crush an industry that has the potential to reduce the number of tobacco smokers in America. In the end, the FDA insists, the data will dictate which direction regulators take. That’s fine by Jason Healy, founder and president of blu eCigs, which was acquired by Lorillard in 2012. “It will move from theory and conjecture and gut feelings to a science-based regulatory framework,” Healy said. “Both sides have to now be accountable for their statements. You’re going to have to put science behind it.” However that pans out, he said, it’s likely to be good for customers visiting the vape shop in Adams Morgan, and thousands of others like it around the country. “There’s been so much uncertainty,” Healy said. “Now, everyone will know where we stand.”

E-cigarettes’ peril and opportunity

IS THE rising popularity of electronic cigarettes a public health problem or a way for smokers to get their nicotine in a safer form? Right now, e-cigarettes appear to be both. The Centers for Disease Control and Prevention (CDC) last week announced that the number of youth who have tried e-cigarettes doubled between 2011 and 2012. One-tenth of high school students inhaled the devices’ vapor last year. About three-quarters of those who admitted using e-cigarettes currently also smoked traditional cigarettes. But roughly 160,000 students in the National Youth Tobacco Survey last year said they had tried only e-cigarettes. E-cigarettes contain small amounts of liquid that an atomizer vaporizes for inhalation. They aren’t regulated heavily, so there isn’t much public information available on what’s in them, and the contents probably vary widely by brand. But they clearly contain nicotine, which is highly addictive. Public health advocates warn that e-cigarette makers are using the same strategies that tobacco companies employed to attract young people to start smoking — candy flavorings such as “Atomic Fireball,” for example. Lax state-level regulations also make it easy for young people to buy them. If flavorings, advertising and easy access result in lots of students committing to a lifetime of addiction to nicotine products — and the CDC’s latest results suggest that might be happening — e-cigarettes could serve as a dangerous gateway drug. The Food and Drug Administration (FDA) has the power to demand information from companies on e-cigarettes’ ingredients, regulate their contents and control their sale, and it has expressed interest in doing all that. But the agency has taken its time. It should get going. Yet public health advocates also should appreciate the other side of e-cigarettes — their potential value to those already struggling with addiction. For those who are unwilling or unable to give up nicotine, e-cigarettes offer something akin to the experience of smoking a real cigarette without the same profusion and concentration of toxins. This point, too, argues for more government oversight. If the FDA asserts its authority over e-cigarettes, it can ensure that they are a less unhealthy tobacco alternative, at least as far as that’s possible. We would be the last ones to hope that any tobacco product succeeds. Nicotine addiction is not be wished on anyone. But if the FDA can get more addicted smokers onto e-cigarettes without encouraging children and teenagers to take up smoking, it would do some good. **Read more on this topic:** The Post’s View: FDA should do more with its authority over tobacco products The Post’s View: Snuffing out tobacco with taxes? The Post’s View: Stubbing out secondhand smoke in the District Doug Fine: Five myths about legalizing marijuana

When the FDA said it would regulate e-cigarettes, the reaction was swift.

Twitter never sleeps. So when the news broke in the dead of night that the Food and Drug Administration wants to regulate e-cigarettes, the response was swift.  E-cigarettes are battery operated devices that contain nicotine, but not tobacco, and produce vapor instead of smoke. Some claim they are safer than regular cigarettes; others say they are dangerous for different reasons and a gateway to smoking the real thing. For the first time since e-cigarettes appeared in the U.S. in 2006, the FDA said Thursday that it will impose restrictions. The Post’s Brady Dennis has details:    *[WSU]: Wayne State University The new rules will also regulate cigars, pipe tobacco and hookahs. But it’s e-cigarettes that are getting all the attention. You can tell from headlines how controversial this is going to be. This New York Times headline from Wednesday – Selling a Poison by the Barrel: Liquid Nicotine for E-Cigarettes – prompted this one from the tech Web site Digital Trends – The NY Times is blowing smoke: Toothpaste poisons more people than vaping liquid. Earlier this week, a patient on oxygen at a Syracuse hospital caught on fire while puffing on an e-cigarette. Earlier this month, a study from the Centers for Disease Control showed a dramatic increase in calls to poison centers related to exposure to nicotine-laced liquid in e-cigarettes. Both sides are armed with statistics and studies but solid data on the subject is scarce and sometimes conflicting:    *[WSU]: Wayne State University And there’s plenty of snark to go around: Want more? Here are seven things you should know about e-cigarettes from the Post’s Lenny Bernstein.    *[WSU]: Wayne State University

FDA ‘deeming rule’ survives first court challenge

The Tobacco Act, by its terms, authorized FDA regulation of cigarettes, cigarette tobacco and smokeless tobacco. It further authorized the FDA to “deem” other “tobacco products” subject to its regulation, too. Under the act, a “tobacco product” is: With its deeming rule, the FDA declared e-cigarettes and other forms of electronic nicotine delivery systems (ENDS), in addition to their parts and components, to be subject to regulation under the Tobacco Act.   The most interesting — and in my view problematic — portions of Jackson’s opinion are those concerning the challengers’ First Amendment claims. Nicopure and its allies raised two separate First Amendment claims: one against the prohibition on distributing free product samples, the other against the prohibition on “modified-risk” claims about tobacco products.   Jackson is too quick to reject the challengers’ objection to the Tobacco Act’s modified-risk product provisions. Her analysis is quite cursory — occupying a fraction of the space taken up by her analysis of the ban on free samples — and inconsistent. In the opening portion of the opinion, Jackson characterizes the relevant prohibition as nothing more than a requirement that manufacturers “tell the truth when making any claims about their [products’] health benefits,” even though later in the same opinion she acknowledges that the law, in fact, prohibits making truthful, fact-based claims. It is, she later notes, “a clear restriction on truthful and non-misleading speech.”   Writing for himself and Judge Kavanaugh, Judge Randolph concluded that the department’s regulation represented a permissible application of the statutory prohibition on smoking on airplanes. Judge Ginsburg dissented, arguing that smoking and vaping are not the same thing. His dissent begins:

FDA should do more with its authority over tobacco products

IN 2009, PRESIDENT Obama signed the Tobacco Control Act, which gave the Food and Drug Administration (FDA) authority over tobacco products. It was a signal moment in the fight against smoking. Tobacco use is the leading cause of preventable death in the country, racking up 400,000 premature deaths in America every year and holding 40 million Americans in the grip of addiction. After decades of education campaigns, cessation programs and increasing taxes, the U.S. smoking rate is stuck at about a fifth of the adult population. And after a string of headline-worthy achievements, the FDA’s tobacco program has been a little quiet lately. The act prodded the safety agency to do a few things immediately, such as finalizing a rule on marketing and promotion to children. The FDA barred the sale of fruit-, candy- or clove-flavored cigarettes. It began studying the prevalence and effects of menthol cigarettes, another flavoring that encourages children to start lighting up. It created the Center for Tobacco Products, under which it would continue to assert its new authority. But, the American Lung Association says in a new report, the FDA’s anti- tobacco work in 2012 didn’t proceed at the heady pace of the previous two years, perhaps because of a broader regulatory hiatus during last year’s presidential election. So far, the agency has asserted authority over only cigarettes and smokeless tobacco, not products such as cigars, pipe tobacco or e-cigarettes. Until it claims broader jurisdiction, it can’t compel the examination of ingredients and assess their relative lethality, let alone regulate more aggressively. Flavored cigarettes have been banned, but tobacco companies still flavor cigars to taste like grape or cola, and the vaporous chemical mixture inhaled from e-cigarettes now comes in flavors such as “cherry limeade” and “Atomic Fireball.” The lung association sees upticks in the use of non-cigarette tobacco products and worries that the industry will hook children with new, less-regulated products. Menthol cigarettes, meanwhile, are still on sale. Lawrence Deyton, the FDA’s chief tobacco regulator, says the agency has been busy enforcing all the rules it enacted in its first years, building a regulatory body from scratch and informing tobacco companies what it will expect of them. In order to take steps such as dialing back the amount of nicotine in tobacco products, the agency must undertake exhaustive scientific research demonstrating that its decisions are not “arbitrary and capricious.” Mr. Deyton says the public can expect more progress in 2013. Meanwhile, the FDA isn’t the only body that needs to act. Congress should raise national tobacco taxes, especially for products that currently enjoy preferential tax treatment relative to cigarettes, such as large cigars and pipe tobacco. States, too, can raise excises and devote more of the money to anti-tobacco programs. These sorts of policies have saved many lives over decades of effort, and there’s reason to think that old tools can still help. **Read more on this issue:** The Post’s View: Snuffing out tobacco with taxes? The Post’s View: Justifiably harsh cigarette warnings

Don’t let Big Tobacco hook a new generation on nicotine with alluring ads for e-cigarettes

The tobacco industry is sharply raising spending on advertisements and other marketing for electronic cigarettes to try to make smoking glamorous again and hook a new generation of Americans on nicotine. We shouldn’t let them get away with it. If adults choose to “vape” — inhale nicotine-laced vapor from battery-powered e-cigarettes — then they should be free to do so. But that doesn’t mean the public should allow Big Tobacco to use its billions to build a new mass market for a consumer product scientifically proved to be very addictive. The Food and Drug Administration says it intends to extend its regulatory authority to include e-cigarettes and might recommend banning television and radio advertising. It should do so quickly, before a halfcentury of progress in combating smoking is undone. I was only vaguely aware of the debate over vaping when I recently saw a TV ad for Blu brand e-cigarettes that made me gasp. It showed a slim, jeans-wearing “tough guy” puffing while appearing shirtless before an urban skyline, attending a concert and strolling through Inca ruins in Peru. “For us smokers, times have changed,” the actor, B-list celebrity Stephen Dorff, says. “But a few things remain the same. Our desire to explore. To adventure. To roam without boundaries. With Blu, we can still be ourselves. After all, this country was founded on free will. Embrace it. Chase it.” How’s that for combining manliness, style and individualism? I was dumbfounded to see again the psychological pitch of cigarette ads that I grew up watching before a 1970 law forced them off the airwaves. The similarity is no coincidence. Lorillard Tobacco, which makes Blu, also manufactures Newport and Kent. Another Blu ad wields equally familiar sex appeal. Actress and former Playboy centerfold Jenny McCarthy, wearing a low-cut dress, vapes Blus while flirting with a man in a bar. Public health authorities are especially worried about such ads’ effect on teens. The Centers for Disease Control and Prevention reports that from 2011 to 2012, the percentage of high school students who had tried e-cigarettes more than doubled to 10 percent. “It is frankly appalling,” said CDC Director Tom Frieden. “Nicotine is highly addictive. If kids have more access to nicotine, they are quite likely to have a lifetime addiction to tobacco products, including cigarettes.” Six of the largest e-cigarette manufacturers spent $59 million on advertising and other promotion in 2013, with five of them increasing their ad spending by 164 percent during the year, according to a congressional report released Monday. “The second coming of tobacco marketing is pouring millions into adland,” Advertising Age reported. E-cigarette defenders argue that vaping is a less harmful alternative to traditional cigarettes, or “combustibles.” With the electronic version, users don’t inhale tar and smoke. But too little research has been conducted to say for sure that vaping is entirely safe. Promoting e-cigarettes also risks encouraging smoking, in general. Some current smokers will be less inclined to quit if they can vape in places where combustibles are banned. Furthermore, the CDC was unhappy to find that many former smokers are now using e-cigarettes. “We are very concerned that under the guise of reducing harm, [e-cigarettes] will actually increase smoking,” Frieden said. Still, the biggest concern about e-cigarettes is the young. Research suggests that nicotine damages adolescent brain development and that teens are more vulnerable than adults to getting addicted. The FDA should impose a nationwide ban on selling e-cigarettes to people younger than 18. More than half the states, including Maryland and Virginia, have some form of age limit already. But other states and the District do not. The FDA also should prevent advertising that will lure the young to vape. E-cigarette manufacturers insist they’re not targeting teens, but some of their marketing techniques suggest otherwise. They promote e-cigarettes in sweet flavors such as “cherry crush” and “vivid vanilla.” Their ads use cartoon characters such as “Mr. Cool” and “eJuice monkey.” “E-cigarette makers are using a broad range of marketing techniques previously employed by traditional cigarette companies to entice young people to use their products,” said the new congressional report, called “Gateway to Addiction?” The report, prepared by the staffs of 11 Democratic senators and representatives, urged the FDA to regulate e-cigarettes. Vape if you want. That’s your business. But don’t give tobacco companies free rein to profit by manipulating the public’s mind and jeopardizing its health.

How to regulate e-cigarettes

ARE ELECTRONIC cigarettes a public health problem or a public health tool? They’re both, and the government must treat them that way. The latest news on e-cigarettes, electronic sticks that vaporize concentrated, nicotine-laced liquid, is that teen use of the devices is up — way up. The percentage of middle and high school-age minors using e-cigarettes tripled between 2013 and 2014, according to the National Youth Tobacco Survey, from 4.5 percent to 13.4 percent. That equates to 2.5 million kids vaping at least once in the month before they were surveyed. Unsurprisingly, this astounding spike in teen use has some public health advocates very worried. Though e-cigarettes don’t deliver conventional cigarettes’ uniquely toxic cocktail of tar and other nasty chemicals, they certainly deliver nicotine, which affects teenage brain development, Centers for Disease Control and Prevention (CDC) Director Thomas Frieden warns. They also contain flavoring chemicals that might present some health risk. Another major worry is how e-cigarettes will interact with conventional tobacco use. They could hook kids who go on to smoke them in conjunction with traditional cigarettes and other sorts of tobacco products. Or kids could graduate to smoking deadly conventional cigarettes exclusively. Public health researchers are still figuring out how these dynamics will play out. But there’s an upside visible in the numbers, too. Overall teen tobacco use is flat, and kids are smoking a lot fewer conventional cigarettes: Combustible cigarette use dropped 3.5 percentage points in a single year. That’s great news. These figures suggest that some teenagers are starting up electronic cigarettes instead of lighting up old-school ones. The Food and Drug Administration and many states are moving to regulate e-cigarettes. Top on the list must be figuring out how harmful various types of e-cigarettes are. From there, regulators should ensure that any risks vaping liquid chemicals pose are minimized. Firm restrictions on sales to minors are also needed. Ideally, the FDA would then draw a fine regulatory line. Cracking down on candy-style flavors transparently aimed toward teenagers — “unicorn puke” is one of many examples — makes sense. But regulators must also avoid rendering the product unattractive to smokers who want to reduce the risks of their habit but are wary of an electronic aftertaste. The FDA needs to restrict marketing to teenagers without sending inaccurate messages about e-cigarettes’ risks. And the agency needs to find a way to encourage those who would never quit smoking to transition fully from combustible tobacco products without discouraging them from conquering their addiction, or never getting hooked to begin with. What the FDA can’t do is nothing. While the e-cigarette industry is burgeoning under light or no regulation, federal officials have yet to finalize their claim of regulatory authority over the devices. Once that’s in place, the agency has a formal process for considering whether e-cigarettes can be considered less-harmful “modified risk tobacco products.” The sooner the FDA sorts this out, the better. **Read more:** The Post’s View: The FDA begins evaluating the risks and benefits offered by cigarette alternatives Sally Satel: How e-cigarettes could save lives Steven C. Weiss: Ban e-cigarettes for kids

Ban e-cigarettes for kids

Are electronic cigarettes “safer” than traditional cigarettes? That question is before the Montgomery County Council, which is considering a bill to regulate the class of battery-powered nicotine-delivery devices known as electronic cigarettes. Public health groups say more research must be done to determine the health effects of e-cigarettes on their users and on those exposed to the aerosol they emit. But plenty of evidence indicates that e-cigarettes pose health risks. For example, a recent study described in the New England Journal of Medicine found that e-cigarette users can be exposed to far higher concentrations of formaldehyde — which is commonly used as an industrial fungicide, germicide and disinfectant — than traditional cigarette users. The potential for harm should be reason enough to keep electronic cigarettes away from children. But e-cigarette companies, some of which are owned by large tobacco manufacturers, including Altria and R.J. Reynolds, have been accused of marketing their products to kids. The companies claim their products are intended for adults, yet they feature flavors such as cotton candy, gummy bear and bubble gum, and advertisements air during television shows popular among teens. A study in the journal Pediatrics last year found 12- to 17-year-olds were exposed to nearly three times as many TV ads for e-cigarettes in 2013 as they were in 2011. E-cigarettes are sold in shopping malls in Montgomery County and throughout the region, and the aggressiveness of the sales staff can be appalling. I was with my two elementary school-age children at Westfield Wheaton mall recently when we saw a salesperson taking deep drags from an e-cigarette and exhaling large plumes of aerosol. His kiosk, situated in the middle of the mall, caught the attention of numerous kids and adults doing their shopping. No wonder the Centers for Disease Control and Prevention have reported sharp increases in e-cigarette use among youth, many of whom never used traditional cigarettes. The number of teenagers using e-cigarettes now exceeds that of those using traditional cigarettes. In the absence of federal oversight of e-cigarettes, states and communities nationwide are taking action to protect children’s health. Virginia’s law banning the sale of e-cigarettes to minors and regulating e-cigarettes in a manner similar to cigarettes went into effect July 1. It’s time for Montgomery County to enact its own strong prohibitions on the use, sale and marketing of e-cigarettes. Maryland already bans e-cigarette sales to kids, but the bill before the council, co-sponsored by council members Nancy Floreen (D-At Large), George L. Leventhal (D-At Large), Cherri Branson (D-Eastern County) and Nancy Navarro (D-Mid County), would go further by prohibiting minors from using e-cigarettes and banning the products in all places where the county forbids tobacco use. The bill, which is supported by groups including the American Cancer Society Cancer Action Network, should be quickly adopted to stop e-cigarette companies from targeting their next generation of users. **Read more about this issue:** Sally Satel: How e-cigarettes could save lives The Post’s View: E-ciagrettes have risks but they offer public health benefits The Post’s View: E-ciagrettes’ peril and opportunity

Awaiting FDA, states pursue their own e-cigarette rules

The decades-long battle between big tobacco companies and the health-care community has evolved from a debate over stinky bars and second-hand smoke to a debate over vapor flavored like Fruit Loops and gummy bears. Those are just two of the flavors available to consumers of electronic cigarettes. The product looks like a cigarette, but it delivers nicotine in the form of water vapor. They are different enough from regular cigarettes that existing federal and state laws didn’t cover them, setting up a race to impose new regulations — and they’re becoming big business for tobacco companies that have seen sales flag elsewhere. Legislators in dozens of states are facing three questions when they consider regulations: Who should be able to use the product? How should the product be taxed? And what, exactly, is it in the first place? The last question is the most vexing, to industry advocates and health activists alike. Whether state legislatures decide they should be viewed as tobacco products or as something separate will determine how they are taxed, and if they are subject to the same indoor bans most states have imposed on regular smoking materials. Health advocates want e-cigarettes classified in the same category as regular cigarettes. Doing so, they say, would allow states to treat e-cigarettes under existing law. “We want them included in the definition of tobacco product. It’s really one of the easiest ways to handle them,” said Thomas Carr, director of national policy at the American Lung Association. “Nothing else has to change, really.” But the industry says that unfairly stigmatizes their product as a tobacco product. They hope to position e-cigarettes as a safer alternative to cigarettes, even as a step toward quitting smoking altogether. “Our goal as an industry is to distinguish ourselves from cigarettes, and there’s a very important reason that we want to be defined at the state level not as a tobacco product,” said Eric Criss, president and chief executive of the Electronic Cigarette Industry Group. “We believe the product is a good alternative, and the goal should be to move people down the risk ladder from cigarettes.” Four states — Utah, North Dakota, Arkansas and New Jersey, plus the District — have already sided with the American Lung Association by including e-cigarettes in indoor smoking bans. California, Connecticut and Massachusetts are considering following suit. And nine other states, ranging from New York and Colorado to Tennessee and Wyoming, have lumped e-cigarettes into the tobacco product category. California also restricts e-cigarette advertising online. Seven other states have passed measures advanced by the e-cigarette industry that defines them as something other than tobacco products. Some states have followed Alabama’s lead in labeling e-cigarettes as “alternative nicotine product.” Other states, like North Carolina, more explicitly define them as “vapor products.” While it’s no surprise that the tobacco companies that have cornered the market on e-cigarettes are pushing bills in many states, in an odd twist of legislative strategy, the bills those companies favor impose restrictions on their own products. Since 2009, when the first e-cigarette bills were introduced, 25 states and the District of Columbia have passed measures defining and regulating them. Those states all restrict sales of e-cigarettes to minors, and most require purchasers to provide identification for both in person and online transactions. “This is a product intended for adult consumers. It’s marketed toward adult smokers,” said Cynthia Cabrera, executive director of the Smoke Free Alternatives Trade Association. “It’s not intended to be a gateway.” Health advocates charge that e-cigarettes are marketed toward children, given the flavored vapors in many products. Electronic cigarettes are becoming assets to corporate bottom lines. There are more than 200 e-cigarette companies in the U.S., according to industry analysts, but only five make up a little more than 80 percent of the market. Lorillard, the maker of the Blu line of products and the driving force behind legislation in many states, said last week that e-cigarettes accounted for $63 million in sales during the third quarter of 2013, or a little less than 4 percent of its total sales. Wells Fargo estimated the e-cigarette market stands at about $2 billion. That market  — which the bank said will hit $10 billion by 2017 — is another driver in the push to define e-cigarettes independently of tobacco products. After all, most states tax tobacco at very high rates. New York levies a $4.35 surcharge on each pack of cigarettes, while fourteen other states charge at least $2 per pack. Therefore, if e-cigarettes are classified as tobacco products, they will qualify for those high taxes. If they are characterized in a different category, they won’t be subject to the same taxes. Several states that took up e-cigarette legislation have already moved to tax them in specific ways. Minnesota, which defines e-cigarettes as an “other tobacco product,” requires them to be subject to a tax equal to 95 percent of their wholesale price, making the taxes paid on an e-cigarette in Minnesota greater than the taxes on a pack of regular cigarettes, according to Darryl Jayson, an industry analyst at the Tobacco Merchants Association. Legislators in Oklahoma and Utah tried to levy a tax on e-cigarettes equal to 10 percent of cigarette taxes, but those measures failed. “The typical rationale for tax policy in the tobacco realm is to recover the social costs of those products,” said Bryan Haynes, a lawyer who represents tobacco industry clients at Troutman Sanders in Richmond. “If anything, there should be a different category that speaks to the fact that e-cigarettes are fundamentally different from tobacco products.” Haynes said a number of other states are expected to take up legislation dealing with e-cigarettes in 2014 — especially focusing on the tax question. The rush to define e-cigarettes at the state level comes as the Food and Drug Administration mulls its own rules and definitions. The proposed rule, which isn’t public, has been sent to the Office of Management and Budget and the White House’s Office of Information and Regulatory Affairs for review, said Jennifer Haliski, an FDA spokeswoman. And there’s a possibility that an adverse federal rule could create a silver lining for the industry: If e-cigarettes are defined as tobacco products by the federal government, but explicitly defined in other categories under state law, the conflict would mean states would have to pass new tax rules, or redefine e-cigarettes, before they could earn revenue off sales. But industry insiders think the FDA rule will lump e-cigarettes in with regular tobacco products. Cabrera, of the Smoke Free Alternatives Trade Association, said her group would file a Freedom of Information Act request to see the proposed rule. “At the federal level, the battle might be over. But at the state level, it’s not,” Criss said.

Is the surgeon general endangering America’s youth?

E-cigarettes are not risk-free. Most contain nicotine, which is highly addictive. Vaping aerosol also contains potentially harmful constituents (albeit at far lower levels than are found in cigarette smoke). While I would recommend vaping as an alternative to smoking, it’s not a habit I would otherwise encourage.  Although the surgeon general’s report acknowledges some of the evidence showing e-cigarettes to be less harmful than tobacco cigarettes — and that smokers would reduce their health risks “substantially” were they to switch to vaping products — the report largely glosses over evidence that vaping products often serve as a substitute for tobacco products, such that restrictions on vaping products can increase smoking, including among young people.   Whatever the reason, the surgeon general’s report ignores relevant research on the effect of e-cig regulations on teen smoking rates, and the result is a report that does not grapple with real public health questions and has the potential to do more harm than good. Indeed, if policymakers follow the surgeon general’s recommendations, they may actually make public health worse by increasing smoking rates among children.  Let me close on a personal note. I have two daughters.  I hope that neither of them chooses to smoke or vape. But if they were going to do one or the other, there is no question which I would choose. Indeed, if I had a choice between one of them smoking and both of them vaping, the latter is still an easy call. And precisely because I care about my children’s health, I would not mislead them about what we know about the relative risks between e-cigs and actual tobacco products.

E-cigarette makers lobbying hard to shape rules for fast-growing industry

The giants of the tobacco industry know what it’s like to face heavy government regulation. So as the makers of Marlboro, Newport and Camel enter the booming market for electronic cigarettes, they are pressing to keep their new products free of such strict oversight. With the consumption of e-cigarettes projected by some analysts to surpass that of traditional cigarettes within the next decade, exactly how e-cigarettes are defined — and what kinds of regulations and taxes they will face — are critical to the industry’s future. At the moment, that future looks very bright, with sales roughly doubling every year and projected to approach $2 billion this year. The Food and Drug Administration has said it intends to start regulating the sprawling e-cigarette industry for the first time this month, under the 2009 tobacco-control law. Industry executives have been making their case in high-level meetings at the FDA’s Center for Tobacco Products in Rockville and with members of Congress who oversee the agency. Their main pitch: The battery-powered devices, which deliver nicotine, flavor and other chemicals in the form of a vapor, are essentially harmless, especially compared with the cancer-causing toxins in regular cigarette smoke, and therefore should get friendlier treatment. E-cigarette makers large and small also have been lobbying across the country as cities and state legislatures debate how steeply to tax e-cigarettes and where people should be allowed to use them. Late last month, attorneys general from nearly 40 states wrote to the FDA, urging the agency to treat e-cigarettes like traditional cigarettes and impose restrictions on marketing them to young people. Around the same time, top Democrats on the House Energy and Commerce Committee wrote to Margaret Hamburg, head of the FDA, asking that the agency move quickly to regulate e-cigarettes. The letter cited a recent report from the Centers for Disease Control and Prevention that said e-cigarette use among middle and high school students has been rising rapidly. The lawmakers also asked the Republican chairman of the committee to schedule a hearing on the health effects of e-cigarettes and other tobacco products. Since September 2012, the FDA’s tobacco center has held at least a dozen meetings with representatives of the e-cigarette industry, according to agency records and multiple participants. These “listening sessions” have been held at the companies’ request, the FDA said, and those who have participated describe them as a “one-way conversation,” with agency officials providing few clues to their thinking about e-cigarettes. While e-cigarettes vary from brand to brand, they generally look like cigarettes but do not burn tobacco. Instead, when a user pulls air from the end, an atomizer converts liquid inside the device into a vapor. A starter kit, which typically includes two e-cigarettes, extra batteries and various nicotine cartridges, can cost anywhere from $20 to $200. Regulators say too little research exists to understand how much nicotine or other potentially harmful chemicals are inhaled during e-cigarette use, or whether they might act as a stepping stone to getting children and nonsmokers hooked on conventional cigarettes. In the meantime, many anti-smoking activists complain that the industry is spending lavishly on advertising to glamorize e-cigarettes, potentially undermining decades of work to reduce smoking rates. After the FDA formally declares that e-cigarettes fall under its regulatory umbrella — a decision that, before the government shutdown, had been expected this month — the agency eventually could make an array of other moves. E-cigarettes could in time face restrictions on how they are marketed, where they are sold and who can buy them. Manufacturers could be subject to FDA inspections, and they could be forced to turn over detailed ingredient information to the agency and seek its approval before putting any new products on the market. As they await specific FDA proposals, lobbyists for the industry say they are contacting lawmakers and their staffs, with a focus on those who sit on committees with jurisdiction over the FDA — the Senate Health, Education, Labor and Pensions Committee and the Energy and Commerce Committee in the House. “Our current approach is to make a few friends in Congress, educate them on a product they’re probably not too familiar with, lay out the industry’s best practices and relay some concerns about potential regulatory hurdles,” said John Scofield, whose firm began lobbying for NJOY, an e-cigarette maker, in the spring. Those registered to lobby on behalf of NJOY include Scofield and Jeff Shockey, both former top House Appropriations Committee aides, as well as a former top adviser to House Majority Leader Eric Cantor (R-Va.). Federal disclosure records show their firm was paid $40,000 for its lobbying for NJOY in the second quarter of this year. The firm, Shockey Scofield Solutions, also lobbies on behalf of National Tobacco, which distributes V2 e-cigarettes. National Tobacco paid the firm $60,000 over the first six months of the year. Lorillard Tobacco — best known for its Newport cigarettes — entered the e-cigarette market in 2012 with its purchase of blu eCigs and has started to lend some of its lobbying might to the cause. The company spent $2.35 million last year on lobbying, according to federal disclosure filings, and is on track to exceed that this year. The company’s lobbying team at Dickstein Shapiro includes former House speaker J. Dennis Hastert and several other former members of Congress. This year, Dickstein Shapiro began to list “all federal and legislative action related to e-cigarettes” among its lobbying issues. Lorillard officials say they try to educate members of Congress, their staffs and other policymakers about the product. “We always have an e-cigarette on hand so they can see it,” said Michael Shannon, vice president of external affairs at Lorillard. While Lorillard, NJOY and other e-cigarette makers say they welcome FDA regulation, Shannon said, “We just want to make sure that regulation is appropriate and recognizes the differences between e-cigarettes and traditional cigarettes.” In the traditional cigarette business, new products must be approved by federal officials, television ads aren’t permitted and packages must carry warning labels about the health risks of tobacco. E-cigarettes have only become widely available in recent years, but their rapid growth contrasts sharply with the steadily declining sales of traditional cigarettes. The question of how to regulate e-cigarettes has lingered for years. In 2010, a federal judge sided with manufacturers who had challenged the FDA’s authority to regulate e-cigarettes as a drug delivery device, which could have meant a strict set of regulations. Ray Story, the e-cigarette company owner who prompted the lawsuit, now heads the Tobacco Vapor Electronic Cigarette Association. He is trying to convince regulators on both sides of the Atlantic to adopt a uniform set of what he calls “common-sense regulations,” such as safe manufacturing standards, tight restrictions on sales to minors and limits on marketing, steps that many industry executives also say they support. “All these different regulatory bodies are doing their own thing,” he said in a call from the Netherlands. “They all dance to their own beat.” Greg Conley, legislative director for the Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group, has spent much of the past couple of years crisscrossing the country, from Maryland to Connecticut to California, fighting local usage bans on e-cigarettes, pushing state legislators to impose far lower taxes than on normal cigarettes and trying to sway federal regulators. “It’s an incredibly important time, because so much could go either way,” he said. Conley’s group makes weekly “calls to action” to its thousands of members. A potential e-cigarette usage ban in Duluth, Minn., the possibility of a prohibition on e-cigarette stores in Seal Beach, Calif., an ordinance in New York that could outlaw flavored e-cigarettes — each has been met with an e-mail blast asking members to contact local officials or show up en masse at public meetings. Mitch Zeller, director of the FDA’s tobacco center, has expressed concern about young people smoking e-cigarettes but left open the possibility that the devices could help existing smokers wean themselves off conventional cigarettes. “There is promise with e-cigarettes. But to date, the evidence is anecdotal,” he said this summer on “The Diane Rehm Show” on NPR. “Right now, we have far more questions than answers.” Conley said the e-cigarette industry’s future will depend heavily on how the FDA interprets those answers in coming years. “FDA is in the position to either foster a new market that’s helping smokers to quit, or decimate it and drive much of it underground,” he said. “We’re cautiously optimistic.”

Judge blocks rules requiring graphic images on cigarette packs

A federal judge formally blocked new rules that would have forced tobacco companies to display graphic images on packs of cigarettes that were designed to shock consumers and deter them from smoking. The Wednesday ruling, which was presaged by a temporary injunction issued by the same judge in November, strikes a blow to one of the government’s most aggressive efforts to prevent deaths linked to cigarettes. At issue were regulations published by the Food and Drug Administration last year in response to congressional legislation. The rules required tobacco firms to affix large warning labels to cigarette packages, cartons and advertising. The warnings were to include such images as a bare-chested cadaver and a man exhaling cigarette smoke through a tracheotomy hole. The Justice Department, which appealed the temporary restraining order, is also expected to appeal Wednesday’s ruling. Some of the country’s largest cigarette makers, including R. J. Reynolds Tobacco and Lorillard, sued to block the requirements, arguing that they were too broad and violated the companies’ First Amendment rights. The Justice Department, which represented the FDA, countered in court papers that the images were effective in conveying the dangers of cigarette smoking. The White House called the labels “common sense measures that will help prevent children from smoking.” U.S. District Judge Richard J. Leon of the District’s federal court initially sided with the tobacco firms in issuing the temporary restraining order that blocked the new rules. In his 19-page Wednesday opinion, Leon reiterated that analysis. The government may compel companies to issue warnings that convey facts to consumers, Leon wrote, but the new requirements went too far because they were “neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” “Although an interest in informing or educating the public about the dangers of smoking might be compelling, an interest in simply advocating that the public not purchase a legal product is not,” Leon wrote. Floyd Abrams, a First Amendment lawyer who represents Lorillard, said the ruling “makes clear that the government cannot compel speech except in very rare circumstances and certainly cannot do so in ones in which it is telling the seller of a lawful product to urge them not to buy it.” An FDA spokeswoman declined to comment. Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the ruling “inconsistent with the scientific evidence, the health effects of smoking and the impact of warning labels.” Warnings on cigarette packs and in advertising began in 1966, and smoking rates fell steadily for decades. One in five American adults and teens still smokes, however, and smoking kills hundreds of thousands each year. ** browndm@washpost.com browndm@washpost.com **

The federal government is about to begin regulating the booming e-cigarette market

The federal government on Thursday banned the sale of e-cigarettes to anyone under the age of 18 and required manufacturers to disclose their ingredients and submit their products to the government for approval. The Food and Drug Administration’s action, which represents the first time the government has regulated the booming market of e-cigarettes, seeks to clamp down on devices that have become increasingly popular, especially among young people, even as they have been subject to almost no oversight. The agency, which first said it intended to regulate e-cigarettes in 2014, also imposed the regulations on cigars, hookahs and pipe tobacco. The effort is a response to long-standing concerns about what health experts call a “Wild West” atmosphere involving the multibillion-dollar e-cigarette industry. The battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or "vapes." Easily carried and offering flavors from bubble gum to mocha to margarita, the devices are used by many Americans, but most notably by middle and high schoolers. The number of young people using e-cigarettes now exceeds the number who smoke traditional cigarettes, according to the Centers for Disease Control and Prevention. About 5.3 percent of middle school students reported in 2015 that they had used e-cigarettes in the previous 30 days. For high schoolers, the figure has risen to 16 percent. In 2015, 3 million middle- and high-school students reported using e-cigarettes, according to the FDA and the CDC. "As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” said Sylvia Mathews Burwell, secretary of health and human services, in announcing the rules on Thursday. “All of this is creating a new generation of Americans who are at risk of addiction." She said, “As a nation, we have agreed for several years that nicotine does not belong in the hands of children.” Industry officials reacted angrily to many of the rules, warning that requiring pre-market approval could decimate the many small businesses that produce e-cigarettes and could ultimately deprive consumers of what they say is a less harmful alternative to conventional cigarettes. Public health experts largely welcomed the rules, saying they were long overdue. Some said the FDA should have gone much further, banning the use of e-cigarette flavors and placing curbs on advertising. “FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy,” said Benard Dreyer, president of the American Academy of Pediatrics. But despite the landmark nature of the effort, the FDA action is unlikely to settle an intensifying debate over whether e-cigarettes are a gateway to traditional tar-laden, chemical-filled cigarettes or an effective way to help the long-addicted quit smoking. David Levy, a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center, argued there is “strong evidence” that e-cigarettes could help people stop smoking, so the agency should be cautious about derailing the industry. But many experts, including the FDA’s top tobacco official, Mitch Zeller, said there isn’t enough scientific evidence about the long-term health effects of e-cigarettes and also about whether they are effective as smoke-cessation tools. The new regulations generally require manufacturers whose products went on sale after Feb. 15, 2007, to get approval from the agency to continue selling their products. These reviews will allow the FDA to scrutinize ingredients, product design and health risks, the agency said. It added that it will allow the companies to keep selling their products for two years while they submit their applications and then for an additional year while the FDA reviews the submissions. Zeller told reporters that it would initially cost companies “several hundred thousand dollars” to apply for FDA approval, but that could change over time. Representatives of the e-cigarette industry have supported bans on sales to minors but argued Thursday that some of the rules put forward by the agency will endanger the market for products that have the potential to help people move away from traditional tobacco. "These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers,” Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, the largest industry trade group, said in a statement .“It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar, job-creating industry, the majority of which are made of small businesses." The FDA’s new youth-access restrictions, which take effect in 90 days, compel retailers to verify the age of purchasers by photo identification, to put health warnings on their labels and to bar sales of the products in vending machines that are accessible to minors. Many states have such restrictions, but federal officials said enforcement wasn't always consistent. The rules also ban the distribution of free samples. Officials suggested they might eventually consider banning flavors in cigars and e-cigarettes, but said the topic needs more research. Thursday’s regulations also bring a range of other products under federal regulation, including hookahs and regular and the more expensive, premium cigars. The International Premium Cigar & Pipe Retailers Association, a trade group, said on its website Thursday that “the FDA’s regulation of premium cigars, if left unchecked, would have a devastating impact on retailers and manufacturers alike.” It added that consumers would “have less choice.” And they said the rule could hurt the thousands of Americans who work in the industry. But Chris Hansen, president of the American Cancer Society Cancer Action Network, praised the FDA for including a wide range of cigars, including premium cigars, saying "these products pose no less a health risk than other cigars." In recent weeks, the e-cigarette industry has gotten support from some public health experts. In late April, a group of tobacco-control experts, writing in the journal Addiction, urged the FDA to be "open-minded" about e-cigarettes, saying that the products can result in a reduction in traditional smoking. And recently, the Royal College of Physicians concluded that e-cigarettes were likely to be beneficial to public health in Britain. But many anti-smoking advocates disagree. They say that e-cigarettes could be harmful, that the long-term health risks are unknown and that companies are marketing their products to younger and younger teens. They say the companies are using the same tactics and themes that the traditional cigarette makers used years ago. "It’s about time that we stem the tide of these e-cigarettes,” said Roy Herbst, chief of oncology at Yale Cancer Center and Smilow Cancer Hospital. “The momentum has been so much in favor of their use." The FDA's authority to regulate the products stems from a 2009 law that gave the agency broad power over traditional cigarettes, as well as jurisdiction over other tobacco-related products. In the years since, states and municipalities have taken it upon themselves to limit the use of e-cigarettes, including banning them in public places and prohibiting sales to minors. Just this week, California Gov. Jerry Brown banned “vaping” in public places such as theaters and restaurants as part of a package of bills that raised the state’s legal smoking age to 21.

E-cigarettes have risks but they also offer public health benefits

IF ELECTRONIC cigarettes, known as e-cigarettes, live up to their potential, millions of nicotine addicts in the United States will use them. To some public health advocates, that sounds terrible. People should kick nicotine rather than cultivate their dependence with a barely regulated product that seems designed to addict children. The concentrated, nicotine-laced liquid that these devices vaporize is also toxic when inappropriately consumed. The Centers for Disease Control and Prevention just reported that, with the rise in the use of e-cigarettes over the past several years, the number of calls to poison control centers stemming from misuse of e-cigarette liquid also has increased, from about one a month in 2010 to 215 a month now. “These poisonings will continue,” CDC Director Tom Frieden ominously warned. But, in the fight against the profound misery and death that conventional cigarette smoking causes, even an imperfect tool is worth welcoming if it can reduce smoking. The CDC news does not disqualify e-cigarettes from helping — as long as the government regulates them. The  CDC also has reported that nearly half a million Americans die of illnesses caused by conventional cigarette smoking every year. Some 8.5 million Americans live with serious smoking-related illnesses. Nonsmokers who reside in states that lack public smoking bans have to endure roomfuls of noxious fumes simply to go out on a Saturday night. Decades of effort have pushed the national smoking rate far down, but 42.1 million Americans still light up despite clear evidence of the risks. E-cigarettes offer smokers a reliable nicotine-delivery mechanism that simulates the act of smoking without exposing users and bystanders to the toxin-filled cloud conventional cigarettes produce. But there are a variety of potential problems, aside from poisonings caused by mishandled e-cigarette liquid. Some people might replace a cigarette or two but not all of their daily smokes with vapor. The CDC recently found that e-cigarettes were becoming more popular with middle school and high school students, perhaps because the vapor comes in candy-like flavorings. Nicotine can harm adolescent brains, and some children and teenagers might move on to more dangerous drugs. Though e-cigarette vapor is almost certainly less toxic than cigarette smoke, the government also does not have comprehensive information on what it contains. Good thing, then, that several years ago Congress gave the Food and Drug Administration wide latitude to regulate the production and sale of products made of or derived from tobacco. Once the agency begins regulating — and it soon will, it said — it can make e-cigarettes less attractive to teenagers, require childproof containers on e-cigarette liquid, demand appropriate warning labels on packaging and figure out what is in e-cigarette vapor. More serious regulation of combustible cigarettes — from the FDA and from the states — is also necessary to maximize the potential public health benefits and minimize the drawbacks. **Read more about this issue:** The Post’s View: E-cigarettes’ peril — and opportunity The Post’s View: Maryland should hike tobacco taxes again Sally Satel: How e-cigarettes could save lives The Post’s View: The war on smoking is working — and should continue The Post’s View: CVS’s smart shift away from tobacco The Post’s View: The FDA should do more with its authority over tobacco products

The FDA just unveiled one of the most important public-health initiatives of the century

THE FOOD and Drug Administration unveiled last week what may be one of the most important public-health initiatives of this century: an ambitious long- term strategy to finally end tobacco’s cycle of addiction and death, a scourge that has taken the lives of millions of Americans over centuries of cultivation and consumption. The FDA should move quickly to make this vision a reality — more quickly than it did under the Obama administration. Though smoking rates are at historic lows, the habit still kills roughly half a million people every year. Meanwhile, some 2,500 youths light up for the first time every day, representing a new generation of smokers who, absent intervention, will refill the ranks of those destined to die prematurely due to their nicotine dependence. Nicotine is astonishingly addictive, working its calming effects on users with incredible speed when combusted along with everything else in tobacco leaves — including a range of toxins. Public-health authorities have encouraged people for years to get their nicotine fix some other way, including by chewing gum or wearing a patch. More recently, e-cigarettes have become popular as an alternative nicotine delivery mechanism. But millions continue to smoke. So the FDA is proposing to lower nicotine levels in combustible cigarettes to minimally addictive or nonaddictive levels. Commissioner Scott Gottlieb explained that allowing nicotine levels to remain the same in gums, patches and e-cigarettes will encourage smokers to move toward “products capable of delivering nicotine without having to set tobacco on fire,” which is by far the riskiest way to obtain the drug. There is a risk that addicts would simply take deeper puffs or hold smoke in their lungs longer, seeking to maximize their nicotine hit. But these behaviors would be minimized if nicotine levels were not tapered down slowly but cut dramatically all at once, spurring smokers accustomed to a certain level of nicotine intake to switch immediately to non-tobacco alternatives. The most profound gains, however, would take time to see. Nearly all habitual smokers get hooked in their teens. No public-health authority can stop all young people from experimenting with cigarettes. But by making cigarettes far less addictive, the FDA can minimize the number of lifelong smokers that teen experimentation produces. The role of e-cigarettes in this initiative is still controversial. Anti-smoking activists are wary of the devices, which vaporize nicotine-laced liquid for inhalation, because they can still hook people on nicotine, their various flavorings seem to appeal to teens and it is not entirely clear how safe “vaping” is. Ideally, smokers who cannot quit would move to e-cigarettes, and teen use would be limited. The FDA has begun to regulate the e-cigarette industry, but the agency also announced last week a slight relaxation of its timeline on enforcing some rules. The sooner the FDA makes good on its long-term vision — low-nicotine cigarettes along with a well-regulated e-cigarette industry — the better. Congress gave the agency wide authority over tobacco products nearly a decade ago. The FDA should move with determination now. **Read more here:** The Post’s View: A promising decline in teen smoking The Post’s View: The FDA finally steps up on e-cigarettes Sally Satel: How e-cigarettes could save lives The Post’s View: How to regulate e-cigarettes

Federal court smacks down new tobacco labels

About a year ago, the Food and Drug Administration rolled out nine new cigarette warnings, the first packaging update in 25 years. The images would be significantly more graphic, as you can see above, than what we have now. The new labels were meant to hit cigarette boxes next month, but don't hold your breath. A federal appeals court for the District of Columbia ruled today that these labels are unconstitutional. The reason: There is not enough evidence that these labels will actually reduce smoking rates to justify infringing on tobacco companies' First Amendment right to free speech. Here's the relevant passage from the opinion of Judge Janice Rogers Brown, courtesy of the Incidental Economist. I did a quick search through the academic literature and there do indeed appear to be numerous studies making the connection between graphic cigarette labels and higher rates of smoking cessation. One Canadian study found that a fifth of adult smokers smoked less after the country rolled out new labels. The court does acknowledge the large body of knowledge making this link. It says, however, that isn't good enough, that this correlation isn't necessarily a causal relationship. The FDA, Judge Brown writes, "offers no evidence showing that such warnings have directly caused a material decrease in smoking rates." And that explains why these new tobacco labels won't hit shelves anytime soon.

Big Tobacco’s new cigarette is sleek, smokeless — but is it any better for you?

Philip Morris International says it has created a **** less toxic cigarette — an innovation it claims could save lives and eliminate smoking in America. The new technology, called IQOS, consists of a tube that gently heats up sticks of tobacco instead of burning them. By using heat instead of flame, the company says, IQOS eradicates 90 to 95 percent of toxic compounds in cigarette smoke. The Food and Drug Administration is expected to decide in the next two months whether to allow IQOS into the U.S. market. And that has triggered heated debate and worries among health experts about whether IQOS will help or hurt public health in this country. Among their most pressing concerns: whether the new device will lower tobacco-related deaths, or if it is just substituting one harmful product for another. Fueling such doubts is that many of America’s leading health organizations and experts remain deeply suspicious of Philip Morris. This is the company, they point out, that makes Marlboro — the world’s best-selling cigarette — and misled the public for years about the hazards of smoking. “They are masterful liars. That’s not an exaggeration — that’s a fact proven by decades of evidence,” said Matthew L. Myers, longtime president of the Campaign for Tobacco-Free Kids. “So the question we’re all asking ourselves is: What’s their ultimate game plan with this thing?” Only one independent study so far has examined the risks of IQOS and found higher levels of several toxic compounds produced by the device than Philip Morris has claimed. The company’s response to the study was so forceful that the independent researchers have now gone silent, refusing to talk publicly about their work. Even if Philip Morris’s health claims turn out to be true, health officials warn, IQOS could be a Trojan horse. Smoking in America has dropped to an all-time low. Some health advocates worry Philip Morris — which spent $3 billion to develop IQOS — wants to use its new machine to halt that progress. If IQOS attracts new smokers, it could hook a new generation on nicotine. “The skepticism is not surprising for us,” said one of Philip Morris’s chief scientists, Moira Gilchrist. “You don’t have to trust or believe us. You don’t have to take our word for it. But what we ask is that people have an open mind. Look at the science we’ve done on this and base your decision on that.” But even the harshest skeptics acknowledge that there is a chance Philip Morris is right and IQOS could save lives. “If we’re being honest, we’re dealing with a big unknown here,” said Myers, who has fought for three decades to keep tobacco products away from kids. “One thing’s for sure: The stakes here are huge.” On a recent sunny day, standing outside Philip Morris’s Washington office — just two blocks from the White House — Gilchrist clicked open a smooth, sleek battery pack. With two fingers, she pulled out what looked like a hollowed-out electronic cigar — the latest IQOS prototype. To use it, she explained, you push into its hollow end a short modified cigarette, called a HeatStick. A heating blade inside the IQOS pierces the HeatStick and gently warms the tobacco inside. Gilchrist lifted the IQOS and took a long drag. As she exhaled, a slight musty-sweet smell permeated the air. “Because there’s no combustion involved, there’s no smoke,” she said. Unlike vaping machines, which use a liquid solution to deliver nicotine, the IQOS deliberately uses tobacco. Many smokers have trouble quitting cigarettes even after trying vaping, studies have shown. Philip Morris scientists argue that for smokers to quit, you need to offer something with the same buzz and taste of tobacco. “You have to give them that satisfying experience,” Gilchrist said. “You have to deliver nicotine at roughly the same speed and amount.” The first thing that now greets customers on Philip Morris’s home page is this question: “How long will the world’s leading cigarette company be in the cigarette business?” Philip Morris chief executive André Calantzopoulos predicts that smokeless products like IQOS will one day be so common that his company stops selling all regular cigarettes. In a recent interview with the BBC, he said, “I hope this time will come soon.” The company — which makes the world’s best-selling cigarette — has built a new $120 million research center in Switzerland to focus entirely on smokeless products. The gleaming glass-enclosed facility, called the Cube, consists of three wings — dubbed Earth, Wind and Air. (There is, notably, no section named Fire.) Of all the Cube’s new products, IQOS is the most advanced. It is now sold in 25 countries. But the clearest sign of its potential has been Japan. Last spring, IQOS became available nationwide there, and in the brief time since, IQOS has grabbed 10 percent of Japan’s tobacco market — a feat that has investors salivating over its U.S. prospects. Philip Morris says 72 percent of users in Japan quit cigarettes entirely and converted to IQOS. That’s significantly higher than the 7 percent quit rate among those who tried vaping and 6 percent quit rate of nicotine patch users in a trial published by the journal Lancet. Japanese demand has so outstripped capacity that Philip Morris can’t produce HeatSticks fast enough. It had to limit the number of IQOS devices sold in Japan. And last month, it began converting two cigarette plants in Europe into HeatStick factories and announced plans for a new plant. This year, the company plans to more than triple its manufacturing capacity, from 15 billion HeatSticks to 50 billion. By the end of 2018, it plans to produce 100 billion. Two months ago, three Swiss researchers published the only independent study so far on IQOS’s health risks. When contacted by a Washington Post reporter, however, the researchers refused to talk. A spokeswoman for the University of Lausanne (where one of them works) explained in an email that after their study published, the bosses of all three received an alarming letter from Philip Morris. The letter was personally addressed to the heads of the University of Bern, Lausanne University Hospital and University of Lausanne, accusing their employees of faulty methodology. Such a letter is almost unheard of in the scientific community, University of Lausanne spokeswoman Francine Zambano noted. Usually, if someone disagrees with a study, they contact the journal where it appeared or challenge its findings by publishing their own evidence. When informed of Philip Morris’s unusual letter to the researchers’ bosses, Mitchell Katz, deputy editor of the journal JAMA Internal Medicine, which published the study, said: “That certainly smacks of intimidation. I’ve been deputy editor here eight years, and I’ve never seen that happen before.” The Swiss study compared the harmful compounds in the air generated by IQOS with those of regular cigarettes. The study found that although IQOS generated many toxic chemicals at lower rates, some were much higher than Philip Morris claimed. It also found that IQOS produced 295 percent more of one hazardous compound than traditional cigarettes. In their study, the scientists accused Philip Morris of “dancing around the definition of smoke” and argued that “there can be smoke without fire.” Philip Morris has posted an academic rebuttal online, questioning the Swiss study’s methodology and interpretation. Company officials would not discuss in detail their letter to the Swiss bosses but defended their actions. “When a study like that picks up so much media interest, smokers who have already converted to IQOS and been helped by it have the potential to be misled,” spokesman Corey Henry said. This isn’t the first time tobacco companies have trumpeted the arrival of a healthier cigarette. In the 1950s, they marketed filtered cigarettes as much safer, but that proved an exaggeration. In the 1970s, they came out with “light” and “low-tar” cigarettes, and it took health experts decades to prove those weren’t safer at all. Internal documents showed tobacco manufacturers deliberately designed their light cigarettes to fool government smoke-testing machines. At his office at the Campaign for Tobacco Free-Kids, Myers keeps a museum on his bookshelf of all the ways tobacco companies have tried to fool the public over the years. There are strawberry-shortcake-flavored products aimed at kids and tobacco embedded into dissolvable breath mint strips. Myers worries IQOS — with its sleek, sexy design — could be used to attract younger consumers. Brian King, a deputy director at the Centers for Disease Control and Prevention’s Office on Smoking and Health, worries IQOS could make tobacco acceptable again. “We’re finally at a place where smoking isn’t accepted as normal and isn’t allowed in public places. We’re making progress on the smoking rate. All that could easily be reversed.” Stanton Glantz, a tobacco researcher at the University of California at San Francisco, says that even if IQOS reduces carcinogens, it could still cause serious heart problems because of nicotine and ultrafine particles. “It probably isn’t as bad as a cigarette, but that’s like saying jumping out of a 10-story building isn’t as bad as jumping out a 50-story building.” A few health researchers, however, support Philip Morris’s effort. “If you have a company willing to shift to a less harmful product, is that something we should be getting in the way of?” said Jonathan Foulds, a smoking cessation expert at Penn State University. Ultimately, the FDA will have the final word on science and health concerns over IQOS. Last month, Philip Morris’s case for IQOS got a boost when the FDA’s commissioner stressed the need for innovation and alternatives to cigarettes in a speech. The agency is expected to decide in the next two months whether IQOS can be sold here, but it won’t rule on its health claims until the beginning of next year. If the FDA approves those health claims, IQOS would be the first tobacco product to carry the U.S. government’s stamp as a less harmful alternative to cigarettes — a marketing coup for Philip Morris. And competitors are already racing to catch up in other countries by rushing out prototypes of their own. Included in Philip Morris’s FDA application are more than 2 million pages of scientific data. Health organizations — such as the American Lung Association and the American Cancer Society — are just beginning to sift through them to make their recommendations to the FDA. But even if health groups don’t trust Philip Morris’s moral reasons or scientific claims on IQOS, there are compelling business reasons to believe it really wants to save smokers’ lives, industry analyst Michael Lavery said. “If you can find a way to keep your consumer alive longer,” he said, “you’ll make more money off them. It’s a better business model.”

These top scientists want the FDA to have an open mind about e-cigs

While at least 55 countries have prohibited or restricted the sale of e-cigarettes, they have remained largely unregulated in the United States. That is slated to change this year, as the Food and Drug Administration plans to begin regulating “vaporized nicotine products,” or VNPs —by taking such steps as preventing manufacturers from luring kids with edgy ads or flavored e-cigs. But seven prominent tobacco experts writing in Addiction, a journal of the Society for the Study of Addiction, are trying to get ahead of the rules, urging regulators to keep a more open mind and take a restrained approach to e-cig regulation. The lengthy article — labeled “For Debate” — was written by top researchers from five universities in the United States, Canada and Australia, plus the Truth Initiative (the tobacco-control nonprofit formerly called the American Legacy Foundation). They present a detailed analysis of who uses e-cigs, how people start using e-cigs and how long they do it, along with a framework for using such data to carefully structure targeted legislation. The tone is measured and cautious: “The evidence suggests a strong potential for VNP use to improve population health by reducing or displacing cigarette use in countries where cigarette prevalence is high and smokers are interested in quitting” is about as strong as the article gets. But the lead author, David. T. Levy of the Lombardi Comprehensive Cancer Center at Georgetown University, spoke more directly about vaping in a university press release. “We believe that the discussion to date has been slanted against e-cigarettes,” Levy says in a press release about the journal piece. “We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as a gateway to cigarette use,” Levy says. This is unfortunate, he continues, because “these products appear to be used mostly by people who already are or who are likely to become cigarette smokers.” Several days after the Addiction article appeared online, a major British medical organization chimed in: The Royal College of Physicians issued a paper that said, “Large-scale substitution of e-cigarettes, or other non-tobacco nicotine products, for tobacco smoking has the potential to prevent almost all the harm from smoking in society.”

Montgomery County Council votes to ban e-cigarettes in public places

The Montgomery County Council on Tuesday passed a bill banning the use of electronic cigarettes in all places where traditional tobacco smoking is now prohibited, including county buildings, bars, restaurants and other businesses open to the public. If signed into law by County Executive Isiah Leggett (D), who supports it, it would be the first such ban in the Washington area. The council also voted to bar pet stores from selling kittens or puppies from commercial breeding “mills” and authorized the hiring of a development ombudsman to help businesses and individuals through the often-complicated county approval process. All three measures were approved unanimously and are expected to become law. The ban on e-cigarettes also covers e-cigars, e-hookahs, e-pipes and vape pens, which are devices that are shaped like pens but function as smoking devices and vaporize herbs, oil or wax. About a dozen states and numerous cities have some form of prohibition on such devices. Last year, the Food and Drug Administration announced its intention to regulate e-cigarettes, a process that could take several years. Research into the health effects of e-cigarettes and similar devices is limited, but studies do show that many e-cigarettes use a tobacco solution that contains several cancer-causing chemicals. Council member Nancy Floreen (D-At Large), the bill’s sponsor, said the county should not wait for the federal government to act. People — including teens — could be drawn to e-cigarettes if they believe that the devices are safer than traditional tobacco, she said. Maryland already bans the sale of e-cigarettes to minors. But the Montgomery bill also restricts the sale of liquid nicotine containers, used in e-cigarettes, unless they have childproof packaging. Many of the liquid products come in flavors designed to appeal to minors, including cherry and chocolate. “It’s like they were designed by Ben and Jerry’s,” Floreen said. Council President George L. Leventhal (D-At Large) said it was important for the county’s e-cigarette regulation to be consistent with rules governing tobacco so restaurant proprietors and owners of other businesses don’t have to determine on their own exactly what kind of product a patron is using. The pet store bill requires that shops selling dogs or cats obtain them from a shelter or nonprofit rescue organization — an effort to keep stores from doing business with large-scale commercial breeding operations. The measure does not prohibit private individuals from making transactions with breeders. Animal rights activists, who overwhelming supported the bill, say cats and dogs from mills often suffer from health or behavioral problems that new owners don’t discover until after they take the animals home. What’s unusual about the bill, which was sponsored by Leventhal, is that there are no pet stores in the county’s jurisdiction that sell puppies or kitttens. Leventhal, who owns a parrot, said he intended the new law as a preventive measure — and has been surprised by its popularity. “I’ve been an elected official for 12 years, and it took me this long to realize that people love their puppies,” he said at a recent news conference. “Where have I been?” According to the Humane Society of the United States, 70 localities nationwide — including Chicago and Los Angeles — have similar restrictions. The council also voted Tuesday to approve Leggett’s request to establish the position of development ombudsman. The official, who would report to Leggett, would serve as a high-level contact to guide developers through an approval process that involves multiple county agencies as well the county planning board. Officials stressed that the ombudsman, who will be paid about $200,000 a year, will not have the authority to exempt projects from required scrutiny or maneuver them around laws or regulations. The idea is for “a person who can help all the players, not just developers, navigate the shoals of the regulatory environment,” said Floreen, head of the council’s planning and housing committee. Creating the position of ombudsman is one of a series of initiatives Leggett has launched in an effort to help improve the county’s reputation in the business community. Relations have been frayed, he has said, by a combination of regulatory delays and a steady stream of progressive legislation, including minimum-wage increases as well as new health and environmental laws. Leggett has also floated the idea of creating an independent economic development authority, patterned after one in Fairfax County. Earlier Tuesday, the council set aside plans to renovate its aging office building. The action followed protests from the school board president that the $31 million proposal sends the wrong message as the county attempts to secure more school construction money from Annapolis. Leventhal said Tuesday that the matter has been pulled from the agenda of a government operations committee meeting scheduled for Thursday. He added that the item was removed not because of school board opposition but because there is no council consensus on how to proceed.

FDA aims to lower nicotine in cigarettes to get smokers to quit

The Food and Drug Administration said Friday it wants to reduce the nicotine in cigarettes to make them less addictive. The unexpected announcement sent shares of tobacco companies plummeting and sparked praise among some public health advocates. If successful, the effort would be the first time the government has tried to get the Americans to quit cigarettes by reaching beyond warning labels or taxes to attacking the actual addictive substance inside.  “The only actual thing that is happening right away is the delay,” said Dave Dobbins, chief operating officer at the tobacco-control group Truth Initiative. Not only is FDA delaying the timetable for e-cigarettes, he noted, but also the one for cigars, cigarillos and hookah — currently sold in convenient stores in kid-friendly flavors like grape and tropical punch flavors. “There’s no excuse for not regulating those products as quickly as possible,” he said.  By tying the two issues — lowering nicotine in traditional cigarettes and regulating e-cigarettes — Gottlieb hoped to unite all sides who are opposed to conventional cigarettes while also allaying their fears on e-cigs. In an interview with The Washington Post, he said he told staff from the moment he took the job as FDA commissioner that he wanted to find a way to help smokers quit. In his first agencywide speech, he told staffers that nothing they could accomplish in the next few years would be as important as reducing the smoking rate in America — and the 480,000 deaths every year it causes. “I told them I wanted to do something to dramatically change that … I wanted to do something to bend the curve,” Gottlieb said. The idea of reducing nicotine in cigarettes has existed for at least two decades, but the FDA did not have the authority to do so until a 2009 law gave it regulatory power over tobacco. Since then the FDA has slowly been laying the groundwork to wield that new authority. Because it is such a drastic move, lowering the nicotine could have unintended consequences, a concern FDA officials acknowledged Friday and said they would be studying. It could create a black market for higher nicotine cigarettes. Depending on how the plan is implemented, it could cause smokers to smoke more deeply or in greater amounts to compensate, warned some researchers. Others in the past have expressed concerns that the withdrawal it could imbalance smokers with mental illnesses — who make up a huge proportion of the people still smoking in the United States. One of the most important decision for FDA will be whether it lowers nicotine gradually over several years or reduces it sharply to a much less addictive level, said Eric Donny, one of country’s foremost researchers on low-nicotine cigarettes. For the past six years at the University of Pittsburgh, Donny has run experiments — funded by the National Institutes of Health and the FDA — on low-nicotine cigarettes.   The announcement comes on the heels of furious lobbying by the e-cigarette industry to roll back hefty FDA regulations, issued last year, that would have affected e-cigarette products that came on market after Feb. 15, 2007. Nearly all the e-cig products sold today would be required to go through rigorous review, industry officials said. Greg Conley, president of the pro-vaping American Vaping Association, said he was relieved by Gottlieb’s announcement, saying that without it, 99 percent of vaping products would have been banned.

The e-cigarette quandary: helping smokers quit while enticing new addictsThe e-cigarette dilemma

E-cigarettes pose a public policy conundrum. They are a gateway drug — but it’s not, or hasn’t been, entirely clear in which direction most traffic through that gateway flows. For some existing smokers, particularly those for whom other efforts to quit have failed, electronic cigarettes offer the advantage of a nicotine delivery device without risking the health consequences of smoking tobacco. Meantime, for those not yet hooked, e-cigarettes present the risk of an alluring on-ramp to the real thing. The question is whether the potential public health benefit of helping smokers quit outweighs the public health cost of enticing a new generation of addicts. On the benefit side, the evidence is disappointingly inconclusive. The largest trial found that e-cigarettes were “modestly effective” in helping existing smokers quit, with verified quit rates of 7.3 percent vs. 5.8 percent for the nicotine patch. Indeed, even the e-cigarette industry is careful to emphasize reducing tobacco use rather than eliminating it. E-cigarettes are “probably the most effective tool right now in curbing the most preventable form of death we have in our society,” said Phil Daman, president of the Smoke-Free Alternatives Trade Association, an e-cigarette industry group. But, he added, “I am not saying this helps you stop smoking at all.” On the cost side of the equation is the galloping growth of the market, particularly among youth, enticed by televised advertising that portrays e-cigarettes as an emblem of glamorous independence, with flavors such as cotton candy and banana split. Whatever the precise balance, it has become increasingly clear that e-cigarettes require far tighter oversight and regulation than are now in place — especially as the Big Three tobacco companies have moved into the e-cigarette market. “There is currently an enormous gap between what people hoped would be the public health potential of these products and the reality of what has gone on in the marketplace,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. The numbers help explain Myers’s concern. E-cigarettes have been around for just over a decade, and they currently account for a tiny sliver of the market, just 1 percent. But as total cigarette volume has declined 3 percent to 4 percent a year, according to Wells Fargo Securities analyst Bonnie Herzog, e-cigarettes have been growing at 20 percent annually. She predicts that e-cigarette consumption could pass conventional cigarettes within 10 years. This could be good news, except for two unfortunate developments. First, many adults who use e-cigarettes continue to smoke regular cigarettes. Although tobacco consumption may drop for these dual-use smokers, the duration of tobacco use, not the amount of it, appears to be of greater concern when it comes to both heart disease and cancer. More troubling, the Centers for Disease Control and Prevention reported recently that more than 260,000 youth _who had never smoked a cigarette_ tried e-cigarettes — triple the number just two years earlier. The youth numbers would be troubling even if none of the middle- or high-schoolers went on to tobacco products because of nicotine’s addictive properties and its particular impact on the still-developing adolescent brain. That makes the current regulatory void all the more alarming. In about 10 states and the District of Columbia, there are no restrictions on minors buying e-cigarettes. Rules against such purchases are toothless in many other states. The Food and Drug Administration, importantly if belatedly, has proposed extending the federal ban on sales of tobacco products to minors to e-cigarettes. But the FDA held off acting in two other areas: advertising and flavors. While cigarette advertising has been banned from television since 1971, in large part to diminish cigarettes’ allure to children, the FDA declined to restrict e-cigarette advertising. As the American Heart Association observed last month: “Many of these advertisements have themes that promote rebelliousness and glamorize e-cigarette use. . . . Such marketing practices are likely to recruit a new generation of nicotine addicts.” Similarly, while Congress banned flavored cigarettes (other than menthol) in 2009, again in an effort to reduce smoking among children and young adults, the FDA opted against regulating flavored e-cigarettes. “The last thing that anybody in this industry wants is to indoctrinate youth or new ‘vapers,’ ” Daman said, referring to those who use e-cigarette vaporizers to inhale. “This is an adult consumer product for smokers.” That’s a welcome sentiment but one that will require vigilance to ensure that it reflects reality. _Read more fromRuth Marcus’s archive, follow her on Twitter or subscribe to her updates on Facebook._ **Read more about this topic:** The Post’s View: E-cigarettes have risks but they also offer public health benefits The Post’s View: E-cigarettes’ peril and opportunity Sally Satel: How e-cigarettes could save lives

E-cigarettes raise new questions about smoking

When a friend sitting at my kitchen table pulled out what looked like a cigarette, I was about to direct her to the front porch. But then I realized that what she was blowing was an odorless vapor, not smoke. It was an electronic cigarette. Electronic cigarettes come in a variety of shapes and models, but most consist of a battery, a heating element, and a liquid that contains nicotine, propylene glycol and flavorings. The heating element warms and aerosolizes the liquid, turning it into a vapor the user inhales. Smoking an e-cigarette (called “vaping”), gives users a nicotine hit without exposing them, or those around them, to tobacco smoke. The lack of odor is one of the biggest selling points, says Craig Weiss, chief executive of NJoy electronic cigarettes. Though e-cigarette makers do not make safety or health claims, many users assume that eliminating the smoke of burning tobacco also eliminates the harm. “There’s no question that e-cigarettes deliver fewer [toxic substances] than conventional cigarettes, but the question of how much less is still not clear,” says Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California at San Francisco. Though sales of e-cigarettes are expected to reach $1 billion this year, with many different brands available. vaping is new enough that there haven’t been many studies done yet — certainly none of the large-scale, randomized trials that would be necessary to offer conclusive answers about the safety of e-cigarettes, Glantz says. While there’s little doubt that electronic cigarettes expose users to far fewer carcinogens and irritants than conventional cigarettes, the ingredients found in the liquids can vary greatly from product to product, says behavioral scientist Alexander Prokhorov at the University of Texas MD Anderson Cancer Center. “The companies improvise to come up with new flavorings and every time they introduce a new flavor, you don’t really know what’s in it,” he says. An analysis by researchers at the FDA found very low levels of nitrosamines, ethylene glycol and diethylene glycol — chemicals associated with cancer and other health risks — in some electronic cigarette products, but the levels were a tiny fraction of what a smoker would get from a tobacco cigarette. Unlike tobacco cigarettes, electronic cigarettes aren’t currently subject to regulation in the United States, which means their ingredients aren’t standardized. The FDA is working on a proposed rule to regulate the devices, wrote agency spokesperson Jenny Haliski in a prepared statement. Though the FDA did not provide a timeline for regulation, Glantz suspects political pressure makes regulation unlikely to happen anytime soon. For now, researchers are trying to get a handle on the risks and benefits of e-cigarettes. “It’s a new product, and there’s still a lot we don’t know,” says Pallav Pokhrel, a public health scientist at the University of Hawaii Cancer Center. For instance, it’s unclear what effects electronic cigarettes may have on smoking initiation among youth or cessation among current smokers. Some electronic cigarettes allow users to adjust the amount of nicotine they’re getting, and even adjust it down to zero over time, and it seems plausible that a device that lets people reduce the amount of nicotine they’re consuming could help them cut their dependence, Prokhorov says. However, right now there aren’t good studies to show that they outperform existing nicotine cessation products, nor are they FDA-approved for this purpose. Lauren Odum, a pharmacist at the University of Missouri at Kansas City, recently published a review of the scientific literature on using e-cigarettes to quit smoking. “We came up with a lot of anecdotal evidence from patients saying that these are very helpful, but it’s mostly surveys and the data is skewed, because people who have a positive experience are more likely to report back,” she says. “The ones who weren’t able to quit smoking were probably less likely to respond these surveys.” Odum works at a smoking cessation clinic and says that patients have told her that e-cigarettes helped them quit or cut back on regular cigarettes. “One of the reasons that people like them is that they don’t have to stop the smoking habit,” she says. “They still get the hand-to-mouth motion and they still get the nicotine, which is the addictive component.” Nick Capodice never wanted to stop smoking: “I really loved smoking. I loved the act of it, the taste of it — everything” says the Brooklynite. He had no intention of quitting. But after his father was diagnosed with cancer, Capodice spent three “miserable” months attempting to give up cigarettes, before giving up. He didn’t try vaping in hopes of quitting smoking altogether, but after a few e-cigarettes, he lost his urge for tobacco. He hasn’t smoked in more than 16 months and has tapered down the amount of nicotine he’s using in his e-cigarettes to zero. But not everyone who uses e-cigarettes stops smoking — NJoy’s Weiss says that most of his company’s customers also use tobacco cigarettes — and some public health researchers worry that vaping may actually prevent some people from kicking their nicotine habit if it allows them to get their fix in circumstances where they can’t smoke. Another concern is that e-cigarettes might be a gateway to traditional cigarettes for kids, getting them hooked on nicotine, Prokhorov says. (A report last week by the Centers for Disease and Control found that use of e-cigarettes among middle and high schoolers doubled between 2011 and 2012, with about 1.78 million students having tried them, among whom 160,000 had never used conventional cigarettes.) Finally, people who would never smoke a regular cigarette might take up the habit if they think that electronic cigarettes are safe, says Odum. But Richard Carmona, who crusaded against tobacco during his term as U.S. surgeon general from 2002 to 2006, views e-cigarettes as a potential tool for improving public health. About 20 percent of Americans smoke, and the number of smokers has hit a plateau, Carmona says. “We still need to do more research,” he says, but “this is the first thing I’ve seen in years that has promise for decreasing tobacco use in our country.” Carmona, who recently joined the NJoy board (it’s a paid position), says that the company is committed to conducting and publishing the research necessary to answer the important scientific questions that remain about e-cigarettes.

What’s in e-cigarettes, and are they safe? A few issues to consider before you ‘vape.’

Maybe a friend or family member uses one. Maybe you’ve seen one being fired up in a place where you thought smoking was banned, such as a restaurant or sporting arena. Or maybe you’re using one yourself to try to kick a tobacco habit. Whatever your experience is with electronic cigarettes, it appears that the battery-powered devices, which deliver a form of nicotine and mimic the feel of traditional cigarettes, are here to stay. Sales grew from about $500 million in 2012 to an estimated $1.5 billion in 2013. That’s a fraction of the tobacco cigarette market — roughly $100 billion per year — but it reflects rapid growth, in contrast to the steady decline in tobacco cigarette sales. E-cigarettes are marketed as a more socially acceptable alternative to smoking. But what exactly are users — and the people around them — breathing in? Are the cigarettes safe? And with kid- friendly flavors such as Cherry Crush, Peach Schnapps and Vivid Vanilla, who are they really being marketed to? Here are answers to some key questions about electronic cigarettes. The main component is a refillable or replaceable cartridge of liquid “juice” that contains nicotine, solvents and flavors. When users draw on the device, it causes the battery to heat the liquid solution, which is then atomized into an inhalable vapor. The claimed levels of nicotine vary. The Blu brand of e-cigs, for example, offers cartridges of varying strengths, from no nicotine to approximately 13 to 16 milligrams, with each cartridge containing enough for 250 or more “puffs.” Some other brands list nicotine as a percentage of volume. Less clear is what’s used to create the piña colada, vanilla, bubblegum and other flavors. At the moment, they aren’t. The Food and Drug Administration is expected soon to release a proposed rule that would allow the agency to regulate them as they do other tobacco products. That could result in restrictions on advertising or sale to minors and would probably require companies to disclose ingredients and conform to certain manufacturing standards. In the meantime, some states and municipalities have enacted bans on e-cigarettes in public parks and indoor venues where cigarette smoking isn’t allowed. We don’t know yet. They expose users and people around them to fewer toxins than tobacco cigarettes, but that doesn’t mean they’re risk-free. Nicotine is very addictive, so e-cigs — especially the fruit- and candy-flavored ones, health officials warn — could hook kids and teens on the stimulant or serve as a gateway to real cigarettes. And because they’re unregulated, you don’t necessarily know what’s in them. In 2009, the FDA detected diethylene glycol, a toxic chemical used in antifreeze, in some e-cig samples and carcinogens called nitrosamines in others. Questions also linger over secondhand “vapor.” A December 2013 study compared exhaled vapor from three e-cigarette brands with exhaled tobacco smoke and found that the e-cig vapor contained about one-tenth the level found in tobacco smoke. But the researchers didn’t test for some of the other potentially unsafe components of vapor that earlier studies had found, including formaldehyde and metal particles. They might, though they’re not approved for that by the FDA. And as with approved quitting methods, the results aren’t that impressive. In a study of 657 smokers published last fall, e-cigs were about as effective as nicotine patches and were slightly better than placebo e-cigarettes, which contained no nicotine. But the differences were minor, and the overall number of people who quit with any method was low. After six months, about 7 percent of those in the e-cigarettes group and 6 percent of those who used nicotine patches stopped smoking, vs. 4 percent of those who used placebo e-cigs. The main reason it’s so hard to say whether e-cigarettes are safe is that they haven’t been around long enough to know. It took decades for the risks of tobacco cigarettes to emerge, and nobody knows yet what the long-term effects of “vaping” will be. If you’re trying to give up real cigarettes, stick with better-studied methods: nicotine gum, patches and counseling. And if you don’t smoke, don’t start with e-cigs just for fun. Copyright 2014.  Consumers Union  of United States Inc. For further guidance, go to www.ConsumerReports.org/Health, where more detailed information, including CR’s ratings of prescription drugs, treatments, hospitals and healthy-living products, is available to subscribers.

Government quits legal battle over graphic cigarette warnings

The federal government, facing a court-imposed deadline and fierce opposition from the tobacco industry, has decided to abandon its legal fight to require cigarette makers to place large, graphic labels on their products warning of the dangers of smoking. The decision marks a setback for the Food and Drug Administration, which two years ago announced that it would require tobacco manufacturers to include ghastly images on all cigarette packages. The proposed labels included pictures of disease-ridden lungs, the corpse of a smoker and a man exhaling smoke through a tracheotomy hole. They also included the number of a stop- smoking hotline, 1-800-QUIT-NOW. The FDA said in a statement Tuesday that it will go back to the drawing board and “undertake research to support a new rulemaking consistent with the Tobacco Control Act,” the 2009 law that requires the agency to find ways to reduce the estimated 440,000 annual deaths attributable to tobacco use. Shortly after the FDA rolled out the new requirements in 2011, some of the country’s largest cigarette makers, including R.J. Reynolds Tobacco and Lorillard, sued the agency, arguing that the labels were too broad and violated the companies’ First Amendment rights. The Justice Department countered that the images merely contained factual information about the health risks of smoking. Richard J. Leon, a federal district court judge, granted a temporary injunction in late 2011, and in February 2012 he ruled in favor of the tobacco companies, a group that did not include Richmond-based Altria, parent company of the nation’s largest cigarette maker, Philip Morris USA. In a 19-page opinion, Leon ruled that the proposed requirements went too far because they were “neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks.” Rather, he wrote, they were intended to evoke emotional responses that would provoke people to quit smoking or never start. “Although an interest in informing or educating the public about the dangers of smoking _might_ be compelling,” Leon wrote, “an interest in simply advocating that the public not purchase a legal product is not.” Last August, the U.S. Court of Appeals for the D.C. Circuit upheld the D.C. District Court’s decision, finding that the requirement indeed ran afoul of the First Amendment. Facing a deadline to appeal to the Supreme Court, the Justice Department declined, Attorney General Eric H. Holder Jr. said in a letter to House Speaker John A. Boehner (R-Ohio) dated March 15. “In these circumstances, the Solicitor General has determined, after consultation with [the Department of Health and Human Services] and FDA, not to seek Supreme Court review of the First Amendment issues at the present time,” the letter said. Warnings on cigarette packs and in advertising first appeared in the mid-1960s, and smoking rates fell steadily for decades. Since 2004, the numbers have largely stayed level at about 45 million U.S. adult smokers. Dozens of countries already require graphic warning labels similar to those proposed by the FDA, and a survey by the World Health Organization found that they were more effective than text-only labels in deterring smoking.

Snuffing out tobacco with taxes

AMERICA’S DECADES-LONG anti-tobacco effort has yielded massive benefits, cutting the smoking rate in half since 1964 and saving untold millions of lives. But the smoking rate has plateaued in recent years, at around a fifth of U.S. adults. Has policy reached its limit? Will there always be a chunk of the population that cannot resist lighting up or chewing? Federal, state and local governments have not given up. Congress in 2009 gave the Food and Drug Administration authority to regulate tobacco; the agency could eventually require reductions of addictive chemicals and carcinogens in tobacco products. Federal rules now prohibit flavored cigarettes and misleading terms on packaging such as “low,” “light” and “mild.” Many — but not all — states have adopted smoke-free policies in bars, restaurants and workplaces. And some states have continued to crank up their most effective weapon: tobacco taxes, which encourage quitting and which have a particularly good record at preventing teen smoking. But raising taxes can also spur the development of a black market, as shown by tobacco smuggling — where cigarettes are taken from states with low tobacco taxes into those with higher ones. No doubt much of this problem could be solved by raising the federal tobacco tax with an eye toward harmonizing state policies. But how far even the federal government can increase its excise without inviting international smuggling or other illicit commerce is an open question. New Zealand may help provide an answer. The Pacific nation announced last week a pathbreaking plan to eliminate smoking by 2025. Among other things, shops selling cigarettes will have to conceal them from view. New Zealand will increase its already high tobacco tax by 40 percent, bringing the price of a pack to about $15 (U.S.). That’s a few bucks higher than packs in New York City, which has the highest cigarette taxes in the United States. But New Zealand’s is also a national policy, so criminals will find it harder to supply illicit tobacco there than they do in America’s high-tax areas. There is a point beyond which raising national cigarette taxes stops being useful, or becomes a prohibition policy in all but name. New Zealand considered and rejected the idea of raising the price to $75 a pack. But $15 a pack may discourage use further without eliminating individual choice. After 2016, when the country’s new policy phases in fully, public-health advocates will have additional evidence one way or another. ****

California labels e-cigarettes a public health threat

The California Department of Public Health on Wednesday issued a warning about the dangers of e-cigarettes, as states across the country consider new regulations for the booming industry. In a report issued Wednesday, the department urged legislators to regulate e-cigarettes like tobacco products. The growing popularity of the new devices presents a particular risk to children and teenagers, who increasingly report using them, the department said. Department of Public Health Director Ron Chapman told reporters Wednesday the department will begin a public education campaign warning of the dangers posed by e-cigarettes.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Chapman said he is particularly concerned about the variety of flavors in which the nicotine-containing liquid used in e-cigarettes is available. “The availability of e-cigarettes in a variety of candy and fruit flavors such as cotton candy, gummy bear, chocolate mint and grape makes these products highly appealing to young children and teens,” Chapman wrote. Electronic cigarettes, which vaporize liquid that contains nicotine, are different enough from regular cigarettes that existing laws do not regulate them. Dozens of states are considering new regulations, some backed by the e-cigarette industry itself and others pushed by health advocates. The product also represents a major growth opportunity for tobacco companies, whose sales have slid as smoking rates of tobacco smoking have dropped. More than 200 e-cigarette companies operate in the United States, according to industry analysts, but five of them account for a little more than 80 percent of the market. Industry analysts at Wells Fargo estimated in 2013 that the e-cigarette market is likely to grow to $10 billion annually by 2017. And while scientists have studied the health effects of regular cigarettes for decades, studies on the impacts of e-cigarettes are just beginning. The California report cited studies that show the vapor produced by e-cigarettes contains at least 10 chemicals known to cause cancer or birth defects. The report also cited preliminary studies that suggest e-cigarettes cause lung irritation and inflammation similar to that caused by tobacco cigarettes. Industry advocates say e-cigarettes are much safer than traditional cigarettes, and they back restrictions on sales to minors. For regular smokers, the industry has positioned the product as a cessation tool, similar to  nicotine gum or patches. They also criticized the California report for omitting studies that reached different conclusions. “It’s an overly alarming piece of propaganda that uses cherry-picked studies and turns what is a complex public health topic into a black-and-white issue,” said Greg Conley, president of the American Vaping Association. “What’s most disgraceful is that they are telling California smokers that if they’ve tried the gum and the lozenge and the patch and it hasn’t worked for them, they might as well keep smoking.” Conley pointed to three clinical trials that measured the effectiveness of e-cigarettes in helping smokers give up traditional cigarettes, none of which was cited in the California report. Health officials cited their own reports that show e-cigarette users are less likely to quit smoking. They are alarmed by the growing use of e-cigarettes by young adults and those under legal smoking age. More eighth-graders, 10th-graders and 12th-graders are using e-cigarettes than traditional cigarettes, according to state and federal surveys, and about 20 percent of e-cigarette users have never smoked traditional cigarettes. California also has seen a marked rise in the number of reports to poison control centers of children having consumed e-cigarette vapor or liquid. The number of cases involving children 5 and younger tripled in just a year. Officials pointed to television and radio advertisements promoting e-cigarettes, four decades after traditional cigarette advertisements were banned from the airwaves. In 2013, Kantar Media Intelligence estimated the e-cigarette industry spent more than $80 million promoting its products. The federal Food and Drug Administration has proposed adding warning labels and ingredient lists to e-cigarette packaging, although new rules could be years away. Health departments in Arkansas, Oklahoma and Tennessee have issued warnings similar to California’s, and more than half of all U.S. states have passed some level of regulation of e-cigarettes.

The FDA didn’t go far enough in regulating e-cigarettes

Regarding the May 6 front-page article “FDA launches rules for hot e-cigarette industry”: Ah, yes! Quicker than a geologic second but slower than it takes to get millions of high schoolers addicted to nicotine, the Food and Drug Administration stepped forward to slow the speeding e-cigarette train by several miles per hour. Just about a decade after its arrival from China and after numerous studies demonstrating e-cigarettes’ multifarious dangers, the government has moved to stem the conflagration of new drug aficionados — that is, in about three years from now — which will add a couple of million victims. Just 13 years from the inception of a danger to the children of the future to the mitigation of its threat. But what can be expected from a giant governmental sloth? Immediately, complaints and wailing by purveyors of e-cigarettes accost the air. They speak of jobs that will be lost — a prolific political argument that seems to imply that jobs are worth just about any consequence, however detrimental — neglecting in their reasoning the tiny fraction so affected next to the countless millions who will be prevented from a habit that brings only misery and death. In the final analysis, this measure by the FDA is more than nothing, equal to some effect, and certainly inadequate as a solution to nicotine addiction and the many who transition to conventional tobacco. ****Michael E. White** , Oxford, Mass.**

Senators have a bone to pick with Leonardo DiCaprio, Julia Louis-Dreyfus

Some senators are burned up over the use of e-cigarettes during the Golden Globes awards, and they’ve written to the shows execs asking them to stamp them out of the next ceremony. Seems the Democratic lawmakers, Sens. Dick Durbin of Illinois, Richard Blumenthal of Connecticut, Sherrod Brown of Ohio, and Edward Markey of Massachusetts, think the fake smokes glamorize a bad habit to impressionable young fans. Though we should note that there was plenty of bad behavior on display at the Globes, aside from the e-toking by Julia Louis-Dreyfus and Leonardo DiCaprio, that the kiddos at home probably shouldn’t try to emulate. (Oh, hey there, Emma Thompson and martini! And looking at you, Elisabeth Moss’ middle finger).    *[WSU]: Wayne State University Here’s the text of the letter: January 14, 2014 Theo Kingma   President   Hollywood Foreign Press Association   646 N. Robertson Blvd.   West Hollywood, CA 90069    *[WSU]: Wayne State University Stephen B. Burke   Chief Executive Officer   NBC Universal   30 Rockefeller Plaza   New York, NY 10112    *[WSU]: Wayne State University Dear Mr. Kingma/Mr. Burke: We write to express concern regarding the prominent display of electronic cigarettes at Sunday night’s Golden Globe Awards. Each year, the Hollywood Foreign Press Association recognizes excellence in film and television at the Golden Globe Awards. Throughout the country and the world, people tune in to watch fashionable actors on the red carpet, enjoy the show, and root for their favorite films and actors. Unfortunately, this year, many young viewers saw notable displays of e-cigarette use throughout the awards show, including the opening monologue and repeated shots of celebrities smoking e-cigarettes. In light of studies showing that exposure to on-screen smoking is a major contributor to smoking initiation among youth, we are troubled that these images glamorize smoking and serve as celebrity endorsements that could encourage young fans to begin smoking traditional cigarettes or e-cigarettes. Electronic cigarettes, also called e-cigarettes, are battery-operated devices that simulate traditional tobacco cigarettes. E-cigarettes contain cartridges filled with flavors, chemicals, and the highly addictive substance, nicotine, which are vaporized and inhaled by the user. According to the Centers for Disease Control and Prevention (CDC), e-cigarette use is growing rapidly. Between 2010 and 2011, the number of U.S. adults who have tried e-cigarettes doubled.  Further, a CDC study released in September 2013 found that in just one year, from 2011 to 2012, the percentage of high school students who have ever used e-cigarettes more than doubled from 4.7 percent to 10 percent. In spite of the growing popularity of e-cigarettes and limited research on their long-term health effects and risk for increasing use of traditional cigarettes, e-cigarettes are currently not required to be submitted to the Food and Drug Administration (FDA) for evaluation or approval. In 2009, FDA conducted a limited analysis of a sample of e-cigarettes. The analysis found significant quality control issues such as the presence of carcinogens and toxic chemicals, variation in the dose of nicotine in each inhalation, and the presence of nicotine in products claiming to be nicotine-free.  The study raises concerns regarding the safety of these products, the levels of nicotine and other potentially harmful chemicals, and the marketing of e-cigarettes to children and teens. Unlike traditional tobacco products, e-cigarettes can be legally sold to children and are currently not subject to federal age verification laws. E-cigarettes marketed to appeal to kids in candy and fruit flavors, like bubblegum and strawberry, are readily available to youth in shopping malls and online. These products risk addicting children to nicotine, which could be a pathway to cigarettes and other tobacco products. The Golden Globes celebrates entertainers who are an influence on young fans. We ask the Hollywood Foreign Press Association and NBC Universal to take actions to ensure that future broadcasts of the Golden Globes do not intentionally feature images of e-cigarettes. Such action would help to avoid the glamorization of smoking and protect the health of young fans.

FDA delays enforcement of stricter standards for e-cigarette, cigar industry

The Trump administration has delayed enforcement of a rule finalized last year that imposed strict oversight over electronic cigarettes and cigars for the first time. The move, which the Justice Department revealed in court filings Monday night in both the District and Alabama, comes as the vaping and tobacco industries are launching a concerted effort to roll back the Food and Drug Administration regulation through both legislation and litigation. A bipartisan group of lawmakers had tried over the weekend to insert language into a must-pass funding bill that would have exempted thousands of products from FDA scrutiny. In the motions, Justice Department attorneys joined with industry groups challenging the rule to ask for an additional three-month delay in two different cases to give “new leadership personnel” at the Health and Human Services “additional time to more fully consider the Rule and issues raised in this case.” According to FDA officials, the agency is postponing any deadline established under the rule — which extends the FDA’s regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco — set for May 10 or later. As a result, as of next week, cigar manufacturers will not have to submit their plans for putting addictiveness warnings on their products. Information on what ingredients are contained in e-cigarettes and cigars will not have to be submitted starting Aug. 8, and interstate commerce of products including the label of “light,” “low” or “mild” will not be banned as of that date. Aspects of the rule that went into effect last summer, including provisions that bar the sale of these products to anyone under 18 or the distribution of free samples, are still in effect. Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said the legal and legislative jockeying shows how “the cigar and e-cigarette industry have waged a war to alter, gut and basically repeal” what public health advocates see as “critical.” “From a pure public-health standpoint, there’s been no factual change from the overwhelming public record that prompted promulgation of the rule,” Myers said. “The administration’s decision yesterday means that the public will continue to lack the information about what products are on the market, what effect they’re having and what’s in them.” While the administration has not indicated what it will ultimately do about the 2016 rule, the decision to side with the industry in delaying the rule represents a sharp policy shift from the previous administration. Industry officials are optimistic that they will get a favorable hearing from the administration, especially considering that a large number of lawmakers are on their side. “What we’ve got to do is rein it back in,” said Tobacco Vapor Electronic Cigarette Association president Ray Story, referring to the 2016 rule. When it came to the administration, he added, “I certainly think that they are going to curb regulation, just to curb regulation, because it’s bad for business.” But he added, “I certainly don’t think they’re going to lift the veil and say, ‘Here you go, e-cigarettes, you can do whatever you want to do.’ ” Several senior Trump administration officials have ties to the tobacco and vaping industries. Chad A. Readler, the acting assistant attorney general for the civil division — whose name was on a March 1 brief asking the U.S. District Court for the Middle District of Alabama Northern Division for an extension in a case involving the rule — represented R.J. Reynolds at the law firm Jones Day before joining the Justice Department. And Scott Gottlieb, who’s in line to become the next FDA commissioner, served on the board of the e-cigarette firm Kure until May 2016 and retained stock in the company even after he was nominated to his post. He pledged to sell his stock if he won Senate confirmation, which is expected this month. He also said he would not weigh in on matters involving Kure for a year following his resignation from the board, which means this recusal period ends sometime this month. The Justice Department said in a filing that Readler’s name appeared in filings “as a matter of course,” but he had not participated in the case. An FDA spokesman referred any questions related to Gottlieb to the White House, which did not respond immediately. Sen. Jeff Merkley of Oregon, the top Democrat on the appropriations panel overseeing the FDA, said Gottlieb’s one-year recusal “does not solve the conflict of interest at all.” The Obama administration vigorously defended what is known as the “deeming” rule, which got its name because the Tobacco Control Act of 2009 gave the FDA jurisdiction over cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco and “any other tobacco products that the [HHS] Secretary by regulation deems to be subject to this chapter.” It was finalized a year ago, and challenged by the Cigar Association of America and multiple e-cigarette companies. Vaping proponents argue that their products can help wean smokers off combustible cigarettes, while critics argue that nicotine remains highly addictive and many e-cigarettes appeal to young people because of their combinations of candy and fruit flavors. From 2011 to 2014, according to a brief the FDA filed in August, use of e-cigarettes among high school students rose from 1.5 to 13.4 percent. “Vaping has evolved into an industry that’s targeted at our children,” Merkley said, adding that becoming addicted to nicotine “can have lifelong health impacts.” Keith Nelson, the TVECA’s chief political officer, said that when it comes to the health impacts of electronic cigarettes, “most of it is somewhat premature, because this is a nascent industry.” But he noted that two major e-cigarette companies — NJOY and Electronic Cigarettes International Group Ltd. — have gone bankrupt since the rule went into effect. And he added that the rule, which applies to any e-cigarettes introduced since Feb. 15, 2007, requires firms to conduct “not just health-based research but behavioral research and psychological research on the impact of your product and all the combinations of these products. “The numbers start to add up,” Nelson said. “The industry needs some relief.” While major tobacco companies such as R.J. Reynolds and Altria, which contributed $1 million and $500,000, respectively, to Trump’s inauguration, have not sued the federal government over the rule, they have pressed lawmakers to curtail it. Both firms have subsidiaries that manufacture electronic cigarettes. “You can’t simply apply antiquated regulations on a category that did not exist when those regulations were passed,” said David Howard, a spokesman for Reynolds American Services Company, in a statement. “We do support, however, a regulatory framework based on level of risk, one that enables responsible innovation of products that may present less risk compared to cigarettes.” The companies back language that Reps. Tom Cole (R-Okla.) and Sanford D. Bishop Jr. (D-Ga.) sought to attach to this week’s continuing resolution, which would have given the FDA oversight only over vaping products introduced as of Aug. 8, 2016. That provision was blocked by Senate Democrats. A separate bill, which Rep. Duncan D. Hunter (R-Calif.), introduced last week, would change the FDA classification so that e-cigarettes would no longer be classified as tobacco products. _Correction: A previous version of this story incorrectly said Scott Gottlieb was already confirmed as FDA commissioner._ Matt Zapotosky contributed to this report.

When bootleggers and Baptists converge

Smoking, said England’s King James I in 1604, is “loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lungs.” Three years later he planted a colony in Jamestown. Its tobacco enhanced the royal treasury until Virginia produced a bumper crop of revolutionaries, including the tobacco farmer George Washington. King James might have been less censorious about “vaping,” which almost certainly is less harmful than inhaling chemicals produced by the combustion of tobacco. Users of e-cigarettes inhale vapors from electronic sticks containing a  liquid with nicotine , which is addictive and perhaps particularly unhealthy for adolescent brains. Between 2013 and 2014 the use of e-cigarettes by middle and high school students tripled, and now it exceeds that cohort’s use of traditional cigarettes. E-cigarettes, sometimes flavored to tempt the immature (“Unicorn Puke,” “Stoned Smurf,” “German Chocolate Beefcake”), might be “gateway drugs,” leading to tobacco cigarettes. Currently, however, e-cigarettes often are substitutes for them. So, prepare for regulations combining high-mindedness and low cunning. E-cigarettes raise public health issues but also illustrate the unhealthy process by which public policy often is made. They illustrate a familiar phenomenon, the cooperation between “bootleggers and Baptists,” meaning merchants and moralists — those motivated by profits and those motivated by social improvement. In 1983, Bruce Yandle, then a Clemson University economist who now is at George Mason University’s Mercatus Center, had an epiphany: Regulations often come from a counterintuitive convergence of pressures from two groups, the earnestness of one providing cover for the other’s avarice. In his example, Baptists wanted laws closing liquor stores on Sundays to promote piety, and bootleggers wanted such laws to create an unserved market. Today, New York has the highest state cigarette tax ($4.35 per pack — plus a $1.50 New York City tax) and North Carolina has the sixth-lowest (45 cents), so naturally Interstate 95 is a corridor for smuggled cigarettes, which in 2013 were nearly 60 percent of New York’s cigarette market. Proclaiming morality while practicing cupidity, states have tried to hit the sweet spot of cigarette taxes — high enough to maximize revenue without excessively discouraging smoking. States addicted to tobacco taxes need a large and renewable supply of smokers, so they wince whenever an e-cigarette displaces a traditional cigarette. As Yandle and three colleagues explain in the current issue of Regulation magazine, state governments are now bootleggers masquerading as Baptists, and many are in a bind. In 1998, acting on the dubious proposition that smoking costs governments substantial sums (actually, cigarettes are one of the most heavily taxed consumer products, and one in three smokers who begin the habit in childhood dies prematurely, before fully collecting government medical, pension and nursing home entitlements), the tobacco companies agreed to pay 46 states $206 billion over 25 years. Some states, impatient to spend their windfall, securitized the future revenue in tobacco bonds. Now, as vaping supplants some smoking, there is a new cadre of bootleggers — the holders of tobacco bonds. They are supposed to be paid from a revenue stream from smokers (disproportionately low-income and low-information people), so they will urge regulations that discourage e-cigarettes. Or that bring e-cigarettes under the 1998 agreement, perhaps by declaring them “tobacco products” because the nicotine can come from tobacco. In exchange for the big cigarette companies’ payments, the 1998 agreement gave them tobacco marketing restrictions, which they welcomed. The restrictions impede the entrance of new competitors into the field and hinder smaller companies from using cigarette advertising for its primary purpose, which is not to create new smokers but to capture a larger market share of existing smokers. E-cigarettes can expect similar bootlegging regulations, couched in moralistic cadences. Also, manufacturers of nicotine-replacement therapies (e.g., nicotine patches and gum) will be bootleggers seeking regulations that will discourage people from thinking e-cigarettes are a relatively safe way to enjoy nicotine. Yandle’s “bootleggers and Baptists” hypothesis is given many illustrations, from environmental regulations to Obamacare, in a new book of that title, co- authored with his economist grandson, Adam Smith. Yandle’s hypothesis expands “public choice” theory, which demystifies and de-romanticizes government by applying economic analysis — how incentives influence behavior — to politicians and bureaucrats. It rebuts the fiction that such officials are more disinterested than actors in the private sector. Yandle does the same thing regarding many of those who seek regulations. Life would be sweeter if people would forgo the pleasures of inhaling smoke and vapors that do not improve the air, which is plentiful and untaxed. And government would be better if more people were clear-eyed about how Baptists and bootleggers collaborate. _Read more fromGeorge F. Will’s archive or follow him on Facebook._ **Read more on this topic:** The Post’s View: How to regulate e-cigarettes The Post’s View: E-cigarettes have risks but they also offer public health benefits Sally Satel: How e-cigarettes could save lives George Will: An amendment to bind the spenders

Here’s what you need to know about new e-cig regulations

The federal government has now moved to regulate the booming e-cigarette industry, by banning electronic cigarette sales to minors and requiring all tobacco products, including the liquids used in e-cigarettes, to undergo government review. E-cigarettes, along with similarly categorized devices such as vaporizers and vape pens, will be regulated as tobacco products because they use a liquid containing nicotine. Here are some questions and answers about how the Food and Drug Administration’s new rule will affect consumers: The FDA will now regulate all tobacco products including e-cigarettes, cigars, hookah tobacco and pipe tobacco. The agency already oversees cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products. The rule bans sale of all types of tobacco products to people younger than 18, requires photo identification for buyers younger than 26, prohibits sales in vending machines (except those in an adult-only facility) and prohibits the distribution of free samples. The rule also requires that all products carry warnings that they have nicotine, an addictive chemical. Virtually all e-cigarettes and any new tobacco products will have to seek marketing authorization from the FDA. Products sold before Feb. 15, 2007, are exempt. In stages. The ban on the sale to minors takes effect Aug. 8. That will primarily affect only Michigan and Pennsylvania. The other 48 states already ban sales of e-cigarettes to people younger than 18. Coincidentally, California Gov. Jerry Brown this week signed legislation that will raise the legal smoking age in his state from 18 to 21, prohibit the use of e-cigarettes in many public places and ban the marketing of e-cigarettes to children. The law takes effect June 9, making California the second state to raise the legal smoking age to 21, following Hawaii. the prohibitions on distributing free samples and vending machine sales will also take effect Aug. 8, and retailers will be required to ask consumers to show photo identification. The warning-label requirements will take effect in May 2018. Products already on the market could remain so for up to three more years. That’s because manufacturers have two years to submit product applications to the FDA for review, and the FDA has an additional year to finish the evaluation. While the rate of cigarette smoking has declined in the past decade among adults and youth, the use of other tobacco products, including e-cigarettes, continues to climb. A survey supported by the FDA and the Centers for Disease Control and Prevention shows that in 2014, 1 in 4 high school students and 1 in 13 middle school students reported being tobacco users, meaning they had consumed one or more tobacco products in the previous 30 days. That’s 4.6 million youths. The survey also indicated that current e-cigarette use among high school students surged from 1.5 percent in 2011 to 13.4 percent in 2014. Meanwhile, hookah use rose significantly, from 4.1 percent to 7.2 percent. According to the rule, the FDA intends to target flavored cigars for regulation next. Consumer advocates have long wanted the FDA to ban flavored e-cigarettes and cigars. Research has not provided a full answer yet. The e-cigarette consists of a battery, a heating element and a cartridge that contains a liquid suspension containing nicotine. When a user inhales from the cartridge, the liquid is heated and a vapor is emitted. The nicotine is obtained from tobacco plants. In 2009, an FDA test on a small number of e-cigarette samples found “detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.” However, in 2010, a court ruled that “the FDA had cited no evidence to show that electronic cigarettes harmed anyone.” Research is still being conducted to determine whether e-cigarettes lead people to start using traditional tobacco products or help them quit smoking. Recent research found that teens who used e-cigarettes were more than three times as likely as other to smoke traditional cigarettes a year later. ** — Kaiser Health News **

Democrats accuse GOP of siding with tobacco industry over children’s health

Seems the tobacco wars will never end on the Hill. This week, Democrats accused Republicans of “tucking a special interest giveaway to the tobacco industry” in an agriculture appropriations bill. The White House scolded them that spending bills should be “free of ideological provisions.” Public health groups warned they’re putting children at risk. But Republicans stood fast Wednesday to vote down a Democratic amendment to strip out language exempting tobacco products, like e-cigarettes, which are already on the market, from a retroactive review by the federal government. The FDA, given authority to regulate a host of new tobacco items like e-cigs, cigars and hookahs, wanted to review any of those products that came on the market since February 2007. Republicans rejected that, saying the review date should begin from whenever the FDA finalizes its rule on regulating the new tobacco products. Otherwise, they said, it would be unfair to force products that have been on the market for at most eight years to go through an onerous review process and risk being pulled off the market. And, some argued, e-cigarettes are healthier than regular ones anyway. But Rep. Nita Lowey (D-N.Y.) said that meant letting untested items, many fruit-flavored to attract young smokers, remain on the market without knowing their impact on public health. The Centers for Disease Control in April 2015 released a study that e-cigarette use among middle schoolers tripled from about 120,000 students in 2013 to 450,000 students in 2014. CDC Director Tom Frieden warned that “nicotine is dangerous for kids at any age.”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The tobacco industry, 45 years after Congress required the surgeon general’s warning be put on tobacco products, still has a powerful hold on Capitol Hill. It spent $22 million lobbying in 2014 and contributed $2.8 million to candidates, according to Opensecrets.org. Of that, $2.2 million went to Republicans.

The real reason Big Tobacco is getting even bigger

British American Tobacco said on Friday that it has offered to buy U.S. tobacco giant Reynolds American in a $47 billion deal that would create the world’s largest publicly traded tobacco company.   The proposal values Reynolds at $56.50 per share, a premium of 20 percent over the stock's closing price on October 20. Vivian Azer, an analyst with the Cowen Group, said that tobacco companies are currently in a strong position. In the US, “tobacco profits have accelerated for three consecutive years,” she said. She attributes that primarily to the ability of tobacco companies to raise prices in order to compensate for a diminishing number of customers. The deal also would help the combined company capitalize on a growing customer base. British American Tobacco said that the merger would also create “a world class pipeline of vapour and tobacco heating products,” such as e-cigarettes. That product pipeline has become increasingly important for tobacco companies. A smaller share of adults smoke traditional cigarettes today than at any point in the past half-century. As the market for traditional cigarettes in developed countries has shrunk rapidly, e-cigarettes are becoming more popular.  “Global tobacco demand is subject to a number of potential headwinds,” Cowen Group analysts Vivian Azer and Aaron Grey wrote Friday in a research note on the merger, pointing to “increased awareness of the risks associated with traditional tobacco use, and resultant regulatory actions (e.g., indoor smoking bans, enlarged textual or graphic warnings, and / or plain packaging).”     A merger between Reynolds American and British American Tobacco would allow the companies to consolidate their work on e-cigarettes, potentially leading to new products that are more attractive to consumers. "With the U.S. representing one of the best profit pools in global tobacco (industry profits were up 10% last year), BAT will not only gain access to this attractive market, but also to RAI’s intellecutal property pipeline" on new technology, Azer and Grey write in their research note. It would also give the new tobacco giant a larger global footprint, enabling it to better tap into foreign markets where tobacco use is increasing. According to the World Health Organization, 1.1 billion humans — 14 percent of the world’s population — smoked tobacco last year.

Big Tobacco is cool with scary e-cigarette warnings because no one reads them anyway

In a drastic, and decidedly uncharacteristic move, tobacco companies are independently slapping stark warnings onto e-cigarette packages.The labels, which are similar to the kind big tobacco companies have historically battled to keep from off traditional cigarette packs, are also often far more foreboding. Altria, for instance, which makes Marlboros, now sells its e-cigarettes with a label that warns Nicotine is "very toxic by inhalation, in contact with the skin, or if swallowed." And Reynolds American, which makes Camels, includes a cautionary note that people with "a heart condition, high blood pressure, or diabetes," as well as those "who are at the risk for heart disease" or "are taking medicine for depression or asthma" should avoid using them. As the New York Times, which wrote about the puzzling trend this morning, explains, the cautionary labels are raising a few eyebrows:    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico But while large tobacco companies claim to be including warnings that read more like essays than caveats for the sole purpose of communicating health risks inherent in tobacco use, there's actually a clever business strategy at work here. To begin with, cigarette warnings are less important than one might think, because people don't actually read them, let alone even notice them. A 2007 study by the Centers for Disease Control and Prevention found that smokers, in particular, pay no mind to the warnings. A separate report by the Annenberg Public Policy Center notes that the effect of warning labels has "drastically weakened" since they were first mandated in 1984, to the point that they are "virtually meaningless," because people no longer even see them.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Since the new e-cigarette warnings will likely to go unnoticed by consumers, the labels aren't as risky or costly for the industry as they might seem. Which makes them a perfect voluntary compromise. The Food and Drug Administration (FDA) is currently mulling how to try e-cigarettes, and could levy a number of restrictions on the product, including the sort of marketing bans and heavy taxes that normal cigarettes are subject to. By slapping low-risk warnings onto e-cigarette packages, the industry might calm the FDA's response at a deceivingly low cost. Here's the New York Times: Tobacco companies might also earn a bit of public goodwill in the name of altruism. If Big Tobacco were actually serious about Americans' health, the industry might move to promote warnings the size and seriousness of those mandating in the European Union, which cover 65 percent of the surface of each cigarette pack, or agree to uniform, unbranded packs, which have been proven to stem smoking rates. Heck, if health were its main concern, it would stop selling cigarettes, which kill some 500,000 Americans annually, altogether. "They do everything for legal reasons," Robert N. Proctor, a Stanford history professor who studies the tobacco industry, told the New York Times. "Otherwise they’d [tobacco companies would] stop making the world’s deadliest consumer products."

Do e-cigarettes help people quit smoking? New study raises doubts

A new study suggests that e-cigarettes don’t actually help people to quit smoking, but its authors have raised doubts about their own research. Nothing quite divides anti-tobacco advocates these days like the debate on whether e-cigarettes can actually help people quit. So a study like this one from the Center for Tobacco Control Research and Education is bound to draw attention. The science on e-cigarettes is still young, adding to the confusion around the burgeoning $1.5 billion industry that the FDA will soon regulate. Absent federal oversight so far, some states and cities have enacted their own bans on the products, which deliver nicotine through a vaporized liquid instead of burning tobacco. Researchers writing in JAMA Internal Medicine found that use of e-cigarettes was not associated with “greater rates of quitting cigarettes or reduced cigarette consumption” after one year. The authors reached the conclusion based on self-reported data from 949 smokers, which included 88 who used e-cigarettes. Still, they’re the first to admit that their findings should be viewed with some caution. The study’s small sample size could have hurt their ability to draw a relationship between e-cigarettes and quitting smoking, they wrote. They also didn’t collect information on characteristics of use, such as motivation and frequency. “Nonetheless, our data add to the current evidence that e-cigarettes may not increase rates of smoking cessation,” wrote authors Rachel Grana, Lucy Popova and Pamela Ling. Mitchell Katz, editor of the research journal, acknowledges that the evidence on whether e-cigarettes help to stop smoking is “contradictory and inconclusive.” Still, he argues, there’s not enough evidence to claim that e-cigarettes do help people to quit. “I agree with Grana and colleagues that sellers of e-cigarettes should not be able to advertise them as smoking cessation devices without sufficient evidence that they are effective for this indication,” Katz wrote. Tom Glynn of the American Cancer Society, whose advocacy arm has lobbied for strict e-cigarette regulation, said he’s worried about the strong conclusion drawn by the study authors given the sample size and their own hedging. “This study has problems,” said Glynn, ACS director of Cancer Science and Trends. “What’s interesting is even the authors talk about the limitations.” There hasn't been much previous research on this topic. A September study out of New Zealand found that e-cigarettes were "modestly effective" at helping people to quit smoking, about on par with nicotine patches.    *[WSU]: Wayne State University Other recent studies have been bearish on e-cigarettes’ potential as a smoking cessation tool. A study published earlier this month in JAMA Pediatrics found that middle and high school students who smoked e-cigarettes were also more likely to smoke cigarettes. But experts were also split on the meaning of those findings, the New York Times reported.    *[WSU]: Wayne State University Ultimately, the FDA is expected to soon issue regulations on how the products may be marketed and sold. The fierce lobbying battle that’s played out in recent months shows just how high the stakes are for the industry’s future.    *[WSU]: Wayne State University

Lobbyists clash over proposed e-cigarette restrictions in D.C.

Tobacco industry lobbyists and public health advocates battled it out Thursday in a D.C. Council committee chamber over whether the city should restrict electronic cigarettes from all of the same places that it bans those rolled with tobacco. In the absence of any federal guidelines on the increasingly popular devices,states and cities have scrambled to decide how to treat them. On Thursday, those for and against a bill to create “parity” with tobacco cigarettes, restricting them from all indoor areas, patios and bus stops, presented wildly different views of the battery-operated inhalers. To hear anti-smoking groups tell it, the vapor they emit contains traces of chemicals found in anti-freeze; are dangerously popular with middle school and high school students as a means to experiment with drugs; and could prove carcinogenic to those who inhale and those subject to secondhand exposure to the vapor. Industry lobbyists, chiefly Bruce Bereano, a college fraternity brother of Mayor Vincent C. Gray (D), called such descriptions reckless and said restricting the use of e-cigarettes would be “grossly premature” without further research. Bereano pulled out a pen-like e-cigarette from his blazer and waved it around at the witness table. “This is an e-cigarette, and there are absolutely no chemicals that come out of here — no chemicals,” he said. “There is no carcinogen, there are no toxics. All there is is nicotine and a liquid . . . and there’s no credible evidence that nicotine in and of itself causes any harmful and fatal diseases,” he said. E-cigarettes can resemble a cigarette or a pen. They contain nicotine cartridges and often artificial flavoring such as mint, chocolate or strawberry. When a user draws on an e-cigarette, a light-emitting diode causes the tip to glow, and the inhaled nicotine vapor is exhaled in a way that resembles cigarette smoke but dissipates more quickly. The Food and Drug Administration has said it intends to start regulating e-cigarettes, and the industry is scrambling to lobby Congress to shape those restrictions. Bereano said that there is no risk of secondhand smoke and that using e-cigarettes “is something that adults can and should be allowed to use,” although he also suggested that he was skeptical of claims about traditional secondhand smoke. “Secondhand smoke — allegedly, and it’s supposedly confirmed that secondhand smoke is harmful to those who are not smoking around you,” he said. With e-cigarettes, “this is not that,” Bereano said. “It doesn’t even come close to it. So the premise of equating it has no basis.” Angela Bradbery, a founder of Smokefree D.C., said the prudent course would be to limit the use of e-cigarettes until there is more research. “The tobacco industry says, ‘Oh trust us,’ but we certainly have heard that before,” she said. Council member Yvette M. Alexander (D-Ward 7), who introduced the bill to restrict e-cigarettes, is also chairwoman of the council’s health committee. Her bill, co-introduced by council member David Grosso (I-At Large), would also ban sales of e-cigarettes to minors, as Maryland did last year. During Thursday’s hearing, Alexander called e-cigarettes the “wild, wild West of smoking devices” and said clarity is needed on where e-cigarretes can be used. “Businesses may not even be aware — I have seen people smoke in restaurants, and really, the restaurant staff, they don’t know what to say when you tell them it’s not a cigarette or it’s not a tobacco product,” she said.

Big Smoke Screen

“Addiction Incorporated” is more than a PSA about how cigarettes are bad for you. The documentary, now playing at the E Street Cinema, also has an element of “All the President’s Men,” with journalists struggling to tell a story that those in power don’t want told. The story here is about the addictiveness of cigarettes — a story multiple news outlets uncovered in the mid-’90s but chose not to report, despite the information given them by whistle-blowers. “Think about it,” says director Charles Evans Jr. “A man has delivered documents on par with the Pentagon Papers, only it’s an ongoing crime, and [a reporter] is told he can’t report on it.” The documentary’s focus is Victor DeNoble, a scientist who starts working with Phillip Morris in the 1980s to make a cigarette that, as he puts it, “was equally addictive but killed less people.” DeNoble was successful, manipulating other chemicals to lower the amount of nicotine while keeping cigarettes crave-worthy. But as he prepared to present a paper on his findings at a scientific conference, Phillip Morris suddenly pulled him from the event and shut down his lab — after all, if their in-house lab had proved that not only are cigarettes addictive but that their addictive quality is kind of the point, they couldn’t pretend that they weren’t in the addiction business. While many would like to believe that everyone who works for Big Tobacco is a mustache-twirling villain, DeNoble is no bad guy. “This was a man who wanted to do good with science,” Evans says. “That’s the story I wanted to tell, along with the story of the cigarette industry and their behavior and all of the drama of their disgrace and decline.” DeNoble — who now spends his time educating kids about the dangers of cigarettes, with funding provided, ironically, by the tobacco companies as part of a government settlement — is the moral center of “Addiction Incorporated.” “It’s not a ‘pound the tobacco industry’ story. In the end, it’s an educational message, a ‘Can you find the Victor in yourself?’ message.”

Teenagers’ tobacco use hits a record low, with a sharp drop in e-cigarettes

Teenagers' use of e-cigarettes fell sharply last year, while overall tobacco use declined to a new low, according to data that some antismoking advocates said could signal a turning point in the decades-long effort against youth smoking.  In addition, just 8 percent of high-schoolers smoked cigarettes last year, while a little over 20 percent reported using “any tobacco product,” which includes cigars, hookahs, pipes, smokeless tobacco and small, leaf-wrapped cigarettes called bidis, as well as regular and e-cigarettes. Both those numbers are the lowest on record, the agency said. “This is unimaginable, extraordinary progress,” said Matthew Myers, president of the nonprofit Campaign for Tobacco-Free Kids, noting that almost 30 percent of young people smoked cigarettes in 2000. “This is a change of a cosmic nature that has the potential to dramatically impact lung cancer, heart disease, asthma and other problems.” At the same time, he and other anti-tobacco advocates warned that the number of young people using tobacco products — 3.9 million high school and middle school students — was still much too high. They warn that progress could be derailed, especially if the Trump administration weakens the regulation of e-cigarettes and certain other tobacco products. It has already delayed enforcement of some tobacco regulations. Robin Koval, president and chief executive of Truth Initiative, a nonprofit that focuses on tobacco use by young people, said the report suggests that the United States could be “well on our way to finishing smoking for good.” But she cautioned that the picture was very uneven among subgroups, with the high school smoking rate in West Virginia more than double the rate in California, for example. She also said that the rapid decline in e-cigarettes among high schoolers suggests much of that use “has been experimental and that the current offering of products may be less appealing” than had once been feared. But she added that the rapid innovation in the e-cigarette industry “underscores the urgency for full implementation of FDA regulation” of the products. The Food and Drug Administration asserted its authority to regulate e-cigarettes and some other products in 2016. But in early May, it delayed for three months the enforcement of some regulations that were to be imposed for the first time on e-cigarettes and cigars. The delay came as the vaping and tobacco industries have launched a concerted effort to roll back the FDA regulations through both legislation and litigation. The e-cigarette industry, which includes small vaping businesses as well as the large tobacco companies, has said that the rules are onerous and will drive them out of business. They say that e-cigarettes are safer than conventional cigarettes and should not be targeted. (Some aspects of the rules, including a ban on the sale of e-cigarettes and cigars to minors, went into effect last year.) The three-month delay was announced a week before Scott Gottlieb was confirmed as FDA commissioner. In a statement Thursday about the new CDC data, Gottlieb said that while the latest numbers “are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products.” He said the agency has issued more than 4,000 warning letters to brick-and-mortar and online retailers for selling newly-regulated tobacco products, such as e-cigarettes and cigars, to minors. Myers, of Tobacco-Free Kids, said that the report's good news “is balanced by the fact that the very regulatory structure and programs that have helped bring it about are now being threatened.” Referring to Gottlieb, he added, “he comes in at a critical time. If he delays or weakens the rules over e-cigarettes he threatens the progress we are making with kids. If however, he vigorously implements them even while exploring whether e-cigarettes can help adults quit, he has the potential to turn the current trend into an irreversible movement.” To determine how many young people are using tobacco products, the CDC asks them whether they have used it in the past 30 days. Brian King, the senior author of the CDC report, said the decrease in e-cigarette use is likely a result of several factors, including efforts by the government and public health groups to educate young people about possible hazards of the products. While they don't contain some of the harmful substances in conventional cigarettes, he said, the inhaled vapor usually contains nicotine, which is highly addictive and can harm the adolescent brain, as well as ultrafine particulates and heavy metals. King also said that declines in tobacco use also are partly due to increases in state and local tobacco taxes, as well as the inclusion of e-cigarettes in antismoking ordinances barring smoking in restaurants, bars and other sites. The federal government and some nonprofits have also mounted campaigns warning about the dangers of smoking.

The U.S. Chamber of Commerce should quit lobbying for tobacco abroad

THE FACTS about tobacco’s dangers are stark. The World Health Organization says tobacco kills nearly 6 million people each year. More than 5 million die from smoking and the rest from exposure to second-hand smoke. Eight in 10 of the world’s 1 billion smokers are in low- and middle-income countries. Tobacco use is the leading preventable cause of death in high-income countries and increasingly in low- and middle-income countries, too. Some 180 nations have backed the WHO Framework Convention on Tobacco Control, a treaty that offers a road map for reducing tobacco use around the world, focusing on both supply and demand. The United States, which has made huge gains in cutting back on smoking since the landmark 1964 surgeon general’s report, has signed but not ratified the treaty, which entered into force in 2005. There are promising signs that the tide is turning against tobacco. The pharmacy chain and retailer CVS Caremark last year phased out tobacco sales at its more than 7,600 stores, saying selling tobacco products was inconsistent with its mission of helping people improve their health. The surgeon general, in an update last year to the 1964 report, found that research has shown “what works” and “what steps must be taken if we truly want to bring to a close one of our nation’s most tragic battles — one that has killed ten times the number of Americans who died in all of our nation’s wars combined.” Apparently, the U.S. Chamber of Commerce has not heard, or deliberately chooses to ignore this. According to an account in the New York Times, the chamber, which describes itself as representing the interests of more than 3 million businesses, is quietly supporting efforts around the world to resist tighter controls on tobacco use. The Times published e-mails and documents showing how the chamber has lobbied to curtail anti-smoking measures outside the United States. How does advancing a product that kills people prematurely serve the interests of businesses? The chamber ought to be the first organization to grasp that smoking puts a terrible burden on societies, draining their public health and medical resources and stealing away lives that could be productive for years to come. Is it wise to represent the narrow and harmful interests of one industry — tobacco — at the expense of the broader public good? More and more, that harm is caused to women and to people in low- and moderate-income countries. Is that an exemplar of U.S. corporate vision? A chamber spokesman told us that the organization “is not an advocate for cigarette smoking and we know that smoking carries obvious health risks” but that the group is opposing encroachment on business rights. Does a health warning on a pack encroach on intellectual property of a cigarette company? We doubt it. In the United States, decades of efforts to stop the tobacco scourge are showing results. The smoking rate has declined by more than half, from 42.7 percent in 1965 to 18 percent in 2012. This ought to be duplicated, not subverted elsewhere. The Chamber of Commerce should quit its global advocacy for tobacco and stand up for what really helps business: healthy workers and healthy people. **Read more about this topic:** Samuel T. Wilkinson: The marijuana industry is following the trail blazed by Big Tobacco The Post’s View: Raise the smoking age to 21

The FDA should regulate cigars

The March 24 news article “Cigar aficionados smoldering over possible rules” reported that the cigar industry is pushing legislation to exempt “traditional large and premium” cigars from Food and Drug Administration regulation. Unmentioned was that the legislation would exempt hundreds of millions of cigars from regulation, including machine-made cigars that are mass-produced at a rate of 10 per minute. It would also prevent the Food and Drug Administration (FDA) from taking any action to ban the use of candy flavoring in traditional large and premium cigars. Youth cigar use is on the rise. Recent data from the Centers for Disease Control and Prevention show that nearly as many high school males smoke cigars (15.7 percent) as cigarettes (17.7 percent). Among black high school males, cigar use exceeds cigarette use. Candy-flavored cigars are a big part of this rise. Just like cigarettes, cigars are bad for anyone’s health, causing cancer and respiratory and heart disease, and the FDA must be allowed to require basic protections such as warning labels. ****Monica Kraft,** New York ** The writer is president of the American Thoracic Society.

No more puffing on e-cigs on commercial flights

The U.S. Department of Transportation has banned the use of electronic cigarettes on commercial flights. Transportation Secretary Anthony Foxx announced the new rule Wednesday, calling it an effort to prevent vulnerable passengers from being exposed to harmful chemicals. The measure applies to flights into and out of the United States, along with domestic and international carriers. Previously, passengers were prohibited from packing the devices in their checked bags, but were allowed to bring them in carry-ons as long as the devices and batteries were not charged aboard the aircraft. It was unclear whether the previous rules prohibited inhaling from the vaporizers on flights, something DOT sought to clear up with Wednesday’s ‘final rule’.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The new rule effectively treats electronic cigarettes the same as traditional tobacco cigarettes, which are banned from use on U.S. flights. “This final rule is important because it protects airline passengers from unwanted exposure to aerosol fumes that occur when electronic cigarettes are used onboard airplanes,” Foxx said in a statement. “The Department took a practical approach to eliminate any confusion between tobacco cigarettes and e-cigarettes by applying the same restrictions to both.” DOT said the devices are a concern because they contain a number of harmful chemicals, potentially exposing children, older passengers and those with respiratory issues to aerosol in an enclosed space. The department said the new rule eliminates any confusion over whether previous regulations applied to e-cigarettes, and it applies to all forms of electronic cigarettes including: electronic cigars, pipes and “devices designed to look like everyday products such as pens.”

States don’t wait for feds on e-cigarette restrictions

A group of Democratic senators called on federal regulators Monday to restrict e-cigarettes and pushed them to act immediately to curb how the devices are advertised.    *[WSU]: Wayne State University The effort comes as a growing number of states, cities and municipalities have passed legislation limiting the use of e-cigarettes in public spaces, with more bills brought up every day to bring the devices closer in line with traditional cigarettes. While senators acknowledged the FDA was “working to regulate” e-cigarettes, they asked the agency to work to thwart e-cigarette companies from claiming their products help people to quit smoking traditional cigarettes. “However, the FDA’s Center for Drug Evaluation and Research does not need this regulation or any new authority in order to investigate companies making unsubstantiated and potentially false therapeutic claims,” six senators wrote in a letter to Food and Drug Administration Commissioner Margaret Hamburg. Democratic Sens. Barbara Boxer (Calif.), Richard Durbin (Ill.), Richard Blumenthal (Conn.), Edward Markey (Mass.), Sherrod Brown (Ohio) and Tom Harkin (Iowa) signed the letter. A second letter was sent to the Federal Trade Commission requesting that it take action on how e-cigarettes are marketed. The lawmakers also raised concerns about a new report from the Centers for Disease Control and Prevention that reveals that about half – 41.7 percent – of the cigarette and e-cigarette exposure calls to poison control centers are now due to e-cigarettes.    *[WSU]: Wayne State University “Given the rapid increase in e-cigarette-related exposures, of which 51.1 percent were among young children, developing strategies to monitor and prevent future poisonings is critical,” the April 4  report said. E-cig advocates have pushed back, saying the products help smokers quit the real thing and they are in no way marketed to the underage. Several major producers of  e-cigarettes have said they welcome laws preventing sales to minors. So what now? While both sides of the debate wait for Office of Management and Budget to finish their review to grant the FDA authority to regulate e-cigarettes, states have taken action. Here’s a run-down of where e-cigarettes stand around the country: **Federal:**    *[WSU]: Wayne State University Hamburg told the Senate Budget Committee last week that she expects a ruling on whether e-cigarettes can be regulated “very soon.” The rule granting this authority has been under review for five months in the Office of Management and Budget – a fact Sen. Mark Begich (D-Alaska) called “ridiculous” at the hearing. **State bans in public places:**    *[WSU]: Wayne State University As of April 1, North Dakota, New Jersey and Utah have banned e-cigarettes in workplaces, bars and restaurants, according to a list compiled by the American Non-Smokers’ Rights Foundation. Ten other states have some level of prohibition in place. For example, Maryland has banned use of e-cigarettes on the MARC commuter rail system. **Local bans:**    *[WSU]: Wayne State University In addition to cities such as Chicago, New York and Los Angeles, 139 local governments have passed laws to restrict e-cigarette  use in “smoke-free” areas. Check out the full list of the bans here.    *[WSU]: Wayne State University

The facts behind e-cigarettes and their health risks

Chances are good that you’ve seen people “smoking” e-cigarettes: inhaling from cigarette-shaped devices, then puffing out clouds of odorless fog. E-cigarettes, also known as e-cigs or electronic nicotine delivery systems, have been on the market for about a decade and are surging in popularity. But there’s widespread disagreement about their safety or any benefits they may have. Proponents say that e-cigs, a $2.8 billion market in the United States, are potentially less harmful than conventional cigarettes and can help smokers quit. Critics say that their safety hasn’t been proved and that it’s too soon to know what the long-term effects of “vaping” (inhaling the vapor) may be. Consumer Reports spoke with medical experts and reviewed more than 50 scientific studies to find out what’s known. A typical battery-operated e-cigarette contains a cartridge of e-cig liquid, or juice, which usually contains nicotine and the chemical propylene glycol. The juices come in an array of flavors including cola and watermelon, which some say are meant to attract younger users. When used, the battery powers an atomizer that vaporizes the liquid in the cartridge for the user to inhale. Aside from those basics, e-cigarettes vary widely in terms of ingredients, construction and factors such as battery voltage. The Food and Drug Administration, which regulates regular cigarettes, has proposed regulating e-cigarettes more tightly, but some politicians and many in the industry oppose the FDA’s plan. Juice from e-cigarettes has different amounts of the addictive stimulant nicotine, from zero to about 72 milligrams per milliliter of liquid. (A traditional cigarette has 10 to 15 milligrams.) “Nicotine has short-term negative health effects, like increasing your heart rate and blood pressure, so it can aggravate heart conditions,” says Marvin M. Lipman, Consumer Reports’ chief medical adviser. “It also interferes with fetal development, making it unsafe in pregnancy regardless of its source.” Larger doses of nicotine can be more harmful, especially to children, who may be attracted by the sweet flavors and brightly colored packages. And in 2014, poison-control centers responded to 3,783 e-cigarette and liquid nicotine exposure cases. More than half of those involved children younger than 6 who might have ingested or inhaled liquid nicotine or gotten it on their skin or in their eyes. In 2015, those centers received 3,067 nicotine-exposure reports across all age groups. When propylene glycol is heated, it can degrade into formaldehyde, a chemical linked to nose and eye irritation, and an increased risk of asthma and cancer. The Center for Environmental Health recently tested 97 e-cig products and found formaldehyde and the chemical acetaldehyde in more than half of them. E-cig vapor can also contain lead, cadmium, nickel, tin and other metals, which can cause nervous-system or respiratory problems. And some flavoring chemicals, such as those used to create cinnamon flavor, can be toxic. But unlike conventional cigarettes, e-cigs don’t burn tobacco. So they don’t produce the tar that clogs the lungs, or carbon monoxide, which is linked to heart disease. Overall, experts say more research is needed. But given what we know now, vaping is less harmful than smoking tobacco. “If a patient switches from smoking two packs a day to only using e-cigs, it’s not as good as quitting, but it’s undeniably better,” says Douglas Kamerow, a former assistant surgeon general and a professor of family medicine at Georgetown University. “But if a nonsmoker starts vaping and gets hooked on nicotine, especially if it leads to tobacco smoking, that’s a problem.” A recent clinical trial found no real difference between e-cigs and nicotine patches in helping people stop smoking: Neither were very effective. Another study found that teenagers who smoke and vape tend to smoke more conventional cigarettes than those who smoke but don’t use e-cigs. Last fall, the U.S. Preventive Services Task Force said the evidence was insufficient to recommend e-cigs as a smoking-cessation device. For more information about e-cigs, go to consumerreports.org/cro/health/e-cigarette-guide/index.htm. Copyright 2015. Consumers Union of United States Inc. For further guidance, go to www.ConsumerReports.org/Health, where more detailed information, including CR’s ratings of prescription drugs, treatments, hospitals and healthy-living products, is available to subscribers.

FDA approves two new cigarette brands

The Food and Drug Administration on Tuesday began using one of the key powers Congress gave it under the landmark 2009 tobacco-control law: Final say over which new tobacco products can be marketed and sold to consumers. The Family Smoking Prevention and Tobacco Control Act gave the FDA broad authority to regulate everything from cigarettes to smokeless tobacco. Before its passage, companies could introduce new products without the blessing of any federal regulator. Since the law’s enactment, the FDA has received roughly 4,000 applications for products that companies claimed were “substantially equivalent” to ones already on the market, but the agency had not acted on any of them. Until Tuesday. The FDA said it had approved applications for two types of non-menthol cigarettes made by Lorillard after determining that the cigarettes, while slightly different than previous products, wouldn’t pose new public health worries. The FDA rejected four other applications, citing potential new health concerns raised by some ingredients and a lack of detail about product designs. It said companies had withdrawn another 136 applications. The agency declined to name the specific companies or products. Tuesday’s move put hardly a dent in the backlog of tobacco-product applications before the FDA. Some have been awaiting a ruling for more than two years. But it does mark a turning point in the long-running fight over tobacco regulation. “This is an historic step forward,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Today is the first day that a regulatory agency anywhere in the world has made a science-based determination, on a pre-market basis, that a product either can or cannot be marketed.” FDA Commissioner Margaret Hamburg told reporters that the announcement represents an “important step toward the FDA’s goal of reducing preventable disease and death caused by tobacco.” She added, “For the first time, the federal government is bringing science-based regulation to the manufacturing, marketing and distribution of tobacco products.” The law allowed thousands of products introduced between February 2007 and March 2011 to remain on the market, pending review by the FDA. About 500 products submitted for review after March 2011 cannot be sold until the FDA approves them. Zeller emphasized that Tuesday’s approvals do not mean that the FDA considers the products “safe” or “FDA-approved” — only that they don’t raise new health concerns. He also said he expects the agency to pick up the pace of its decisions. “We are proud to be the first company in the industry to receive authorization to begin marketing these new products in the U.S. through the FDA’s substantial equivalence pathway,” Lorillard’s chief executive, Murray Kessler, said in a statement. He added, “[We] believe that the FDA has carried out its evaluation process in a deliberate manner reflecting sound science.” Tobacco-control advocates reacted with cautious optimism, praising the FDA for its apparent rigor in examining the potential dangers of new tobacco products. But they also urged the agency to provide more details about the criteria it is using to decide whether to approve products and what information tobacco companies have provided. “It is an important milestone,” said Matthew Myers, president of the nonprofit Campaign for Tobacco-Free Kids. “But the information disclosed leaves many unanswered questions. . . . Without that information, it is impossible to assess the impact of these decisions.”

How regulators can make smart devices more secure against hackers

These kinds of privacy breaches are increasingly common as billions of devices now become part of the “Internet of Things” (I.o.T.). Whether it be our TV sets, cars, bathroom scales, children’s toys or medical devices, we are already surrounded by everyday objects equipped with sensors and computers. And the companies that make them can get away with being careless with consumer security — and with stealing customer data.   Regulations and consumer protections are desperately needed. One option would be to hold the manufacturers strictly liable for these hacks, to financially motivate them to improve product security. In the same way that seat belt manufacturers are responsible for the safety of their products, I.o.T. device makers would be presumed to be liable unless they could prove that they had taken all reasonable precautions. The penalties could be high enough to put a company out of business. But this would be inequitable. One of the factors enabling such hacking is that users don’t use sufficiently complex passwords and thus leave the front door unlocked. It could also stifle innovation, with the big players avoiding the possibility of extreme penalties by becoming averse to innovations, and small players avoiding entering the market because they lack the resources to handle possible litigation. Duke School of Law researcher Jeremy Muhlfelder says that copyright law has a history of Supreme Court cases that have ruled on this exact principle, of not wanting to curb the “next big thing” by holding innovators liable for their innovations. Innovators themselves wouldn’t, and shouldn’t, be liable for how carelessly their innovations are incorporated into new products. But imposing strict liabilities on manufacturers, since it would lead indirectly to canceling the rewards of innovation, might not be legally realistic either.   As Wheeler also noted, addressing I.o.T. threats is a national imperative and must not be stalled by the transition to a new president. This is beyond politics. It is a matter of national security and consumer safety.

Don’t tax e-cigarettes out of smokers’ wallets

The D.C. Council appears poised to vote Tuesday for an objectionable tax: a massive increase on electronic cigarettes and vaping products. The April 19 editorial “Smoke signals” recommended that the Food and Drug Administration “avoid rendering the product unattractive to smokers.” While the editorial focused on regulatory issues broader than taxation, the point still applies to the potential planned increase from a 5.75 percent sales tax to 70 percent for wholesale vapor products. The proposed tax hike threatens to make these products unaffordable for low- income smokers looking for an effective way to quit. And, while more than 40 states have banned the sale of these products to minors, the District is more concerned about taxing them. Only four states have placed an excise tax on e-cigarettes. Recent cigarette and cigar tax increases resulted in collections that were millions of dollars short of projections as a result of declining sales. History repeats itself. This tax will harm small businesses (including my vape shop) and smokers in the District without making up budget shortfalls. At hearings on the topic, testimony was unanimous in opposition to this proposal. The council should listen to D.C. residents on this matter. ****Sean Robinson** , Washington**

Big Tobacco admits defeat, will develop e-cigarettes

A couple days ago, the tobacco giant Philip Morris International announced a decision it didn't think it would have to make: It was finally getting into the e-cigarette business, after pooh-poohing the product as recently as July. That is, it would start selling a product that _directly competes_ with the tobacco-stuffed sticks it's always flacked, since nicotine vapor in cigarette form is seen as a decent substitute for the real thing for the 69 percent of American smokers trying to quit.    *[WSU]: Wayne State University Why would the world's biggest tobacco company spend $100 million to accelerate the availability of a product that could destroy the business it's been in for 160 years? The basic answer is, it's already happening. And self-disruption is big tobacco's best chance to survive, even in a different form, for much further down the road. There are three main reasons why. **1\. Competitors are already making electronic cigarettes.**    *[WSU]: Wayne State University Many small companies already have e-cigs on the market, and a few of Philip Morris's competitors — Lorillard and Reynolds American — have either bought e-cig startups or are developing their own. They're still less than 1 percent of the overall market but growing fast, as Philip Morris illustrated at its investor presentation Wednesday:    *[WSU]: Wayne State University What's more, it could be growing faster. In its presentation, Philip Morris outlined e-cigarettes' limitations. "Given high awareness and distribution, lower prices, adult consumer understanding of potential reduced-risk benefits, lack of regulation and significant marketing freedoms, e-cigarette repeat purchases remain surprisingly low," read one slide. "Slower nicotine delivery profile and weak taste explain limited user satisfaction." With a huge budget available for research, Philip Morris figures it's better positioned to develop a more appealing product than its less well-resourced competitors. That may also be why it's happy to see the Food and Drug Administration regulate e-cigarettes, while the independent producers oppose it; large companies are always better equipped to deal with government oversight than smaller ones.    *[WSU]: Wayne State University **2\. The domestic cigarette market is already disappearing.**    *[WSU]: Wayne State University Philip Morris USA — the division that Altria kept after spinning off Philip Morris International in 2008 — also dragged its feet on introducing e-cigarettes. But it's facing a pretty cold reality: Fewer Americans are smoking than ever before, according to Gallup, and those who still do are smoking less. Cigarette companies have never diversified into other businesses, like PepsiCo and Coca Cola did with healthier snacks and drinks, because tobacco products have been so lucrative. But with their core product in such a structural, long-term decline, they have little choice.    *[WSU]: Wayne State University Philip Morris USA dipped its toe in the e-cig market this summer.    *[WSU]: Wayne State University **3\. Even the rest of the world might be slowing down.**    *[WSU]: Wayne State University Philip Morris International has been thought best positioned for the long term out of the big American tobacco companies, with nearly 30 percent market share in countries outside the United States and China — especially Southeast Asia, where about a third of adults smoke.    *[WSU]: Wayne State University But those gigantic markets are also starting to slow down. Philip Morris expects cigarette volume in Russia to decline by as much as 11 percent in 2014, as President Vladimir Putin introduces restrictions. The Philippines slapped a high excise tax on cigarettes earlier this year, which led to a 40 percent drop in Philip Morris's sales in the country, according to the research firm Trefis. Australia recently introduced a plain packaging law that erases the brand loyalty advantage for iconic names like Marlboro and Virginia Slims. The World Health Organization is aggressively pushing restrictions on advertising around the world, which could help do to emerging markets what antismoking campaigns, taxes and surgeon general warnings did in the United States. And meanwhile, counterfeit and discount cigarette makers are stealing market share from Philip Morris's premium products, especially as it raises prices even higher.    *[WSU]: Wayne State University Analysts have long loved Philip Morris because of its international exposure, strong name recognition, deep market penetration and the addictive nature of its products — it's a "cash-generating machine," as Morningstar put it. But that love has started to fade, with Goldman Sachs downgrading the stock to neutral in light of the international headwinds, and Nomura Securities rating it a sell because of slowing growth in Asia.    *[WSU]: Wayne State University At the moment, e-cigarettes face none of those challenges, and could mitigate the erosion of big tobacco's traditional product. And hey — they're still really addictive. **4\. [UPDATE] It's also possible that people will smoke e-cigarettes in addition to regular ones.**    *[WSU]: Wayne State University A reader writes in to point out that Philip Morris is hardly giving up on cigarette manufacturing, having put $200 million into its manufacturing facility in Richmond, Va. Studies on the efficacy of e-cigarettes as smoking cessation tools have been inconclusive; one recent study recently showed that people who tried e-cigarettes as a way to quit smoking were less successful than those who didn't, while another showed the opposite. And whether or not using e-cigarettes as a harm-reduction tool serves public health generally is a matter of considerable debate. But it's quite possible that, if carefully marketed, e-cigarettes could be used as supplements to the real thing, rather than always a substitute.    *[WSU]: Wayne State University

Surgeon general calls youth e-cigarette smoking ‘a major public health concern’

The surgeon general on Thursday called the skyrocketing use of e-cigarettes among youth “a major public health concern,” saying that while more research needs to be done on its potential harms, policymakers should take strong action to keep the products out of the hands of the nation's young people. “We know enough right now to say that youth and young adults should not be using e-cigarettes or any other tobacco product, for that matter,” Surgeon General Vivek H. Murthy said in an interview. “The key bottom line here is that the science tells us the use of nicotine-containing products by youth, including e-cigarettes, is unsafe.” E-cigarettes are now the most commonly used form of tobacco among young people in the United States, having surpassed conventional cigarettes in 2014. During the past five years, the number of middle school and high school students who report having used e-cigarettes has tripled. Among young adults ages 18 to 24, the number has doubled. Public health officials say that the sharp rise is troubling, in part, because of how much researchers still don't know about the long-term effects of “vaping.”     “Companies are promoting their products through television and radio advertisements that use celebrities, sexual content, and claims of independence to glamorize these addictive products,” Tom Frieden, director of the Centers for Disease Control and Prevention, wrote in a forward to Thursday's report.  “Although electronic cigarette uptake has skyrocketed among youth, cigarette smoking has fallen at historic rates. This would be nearly impossible to explain if electronic cigarettes were causing a substantial number of youths to start smoking,” Siegel, who had not yet seen Thursday's report, said in an email. “While the surgeon general is rightfully concerned about the emergence of a vaping culture among young people, the truth is that this vaping culture is helping to displace a smoking culture. All in all, this is a good thing.” Siegel said he agreed with the goal of keeping young people off e-cigarettes, as well as traditional cigarettes. “But it is important that people understand the actual public health implications of the emergence of vaping,” he said, “and it is nothing close to what the surgeon general has suggested.” Thursday's report focuses exclusively on youth use of e-cigarettes and steers clear of the broader, public health questions surrounding what has become a $3.5 billion industry: Will vaping prove to be a healthier alternative that helps adults quite cigarette smoking and reduce overall tobacco-related deaths? Are e-cigarettes unequivocally less harmful than tar-laden, chemical-filled cigarettes, as a growing body of research seems to suggest? Should they be regulated exactly the same way as traditional tobacco products? Such questions have raged for years, with no resolution in sight. Murthy said Thursday's report didn't aim to address those larger questions. Its primary purpose, he said, was to detail the clear risks of e-cigarettes to youth and to give parents, teachers and other adults guidance on how to prevent young people from using them. “In order to address tobacco in America, we need a multipronged approach,” he said. “What’s at stake here is really protecting the next generation from nicotine addiction and tobacco-related disease.” This spring, the federal government for the first time began regulating the booming e-cigarette market two years after it first said it intended to do so. The regulations include a ban on the sale of e-cigarettes to anyone under age 18. They also require manufacturers to disclose their ingredients and submit their products to the government for approval.

Zeller takes reins at FDA’s Center for Tobacco Products

When Mitch Zeller takes over Monday as the nation’s top tobacco regulator, it will mark a homecoming of sorts. Zeller spent much of the 1990s at the Food and Drug Administration spearheading its burgeoning tobacco-control efforts — including pressing Congress to give the agency broader regulatory powers and designing the first nationwide program to keep tobacco out of the hands of minors. David Kessler, who as FDA commissioner first tackled the tobacco issue in the early 1990s, recalled the day he asked Zeller to become the point man for that undertaking. “I said, ‘I need you for two weeks to work on tobacco, then you can go back to doing what you were doing,’ ” Kessler said. “Those two weeks turned into two years, turned into two decades. . . . Mitch cares deeply about this issue.” So deeply, in fact, that he once proclaimed, “After my family, tobacco control is my first love.” Now, as Zeller returns as director of the FDA’s Center for Tobacco Products, created by Congress three years ago to regulate tobacco for the first time, there won’t be much space on his schedule for welcome parties. The agency this year is expected to make a long-awaited decision on whether to ban menthol cigarettes, which studies show have boosted the number of smokers — particularly among African Americans, teens and low-income people — and make it harder to quit. It faces pressure from public health advocates and industry officials over the backlog of 3,500 applications that tobacco companies have submitted for new products and changes to existing ones. Regulators have yet to rule on any of them, citing “significant deficiencies” in many applications. At the same time, the center is assembling what will become a multi-year, multimillion-dollar anti-smoking campaign, targeted at young people and at-risk demographic groups such as African Americans, Native Americans and Hispanics. There are ongoing legal battles with the industry over whether the FDA can force cigarette makers to put graphic warning labels on packages that show the consequences of smoking — such as images of a man exhaling smoke through a tracheotomy hole and a picture of cancer-ridden lungs. In addition, the center faces an April 1 deadline to update Congress on the range of its efforts to rein in the tobacco industry. It also has said it will soon assert its authority to regulate a broader range of products, including cigars, pipe tobacco and electronic cigarettes. On nearly every front, Zeller will face impatience from all directions. Tobacco companies — unaccustomed to federal oversight, wary of restrictions that could shrink their bottom lines and willing to wage legal battles — have maintained at best a tense relationship with their new regulator and have looked for ways around existing regulations. The waiting game over product applications encapsulates that uneasy relationship. FDA officials have said they are taking extra care in determining how best to evaluate products that have proved to be addictive and deadly. Tobacco companies such as industry giant Lorillard and others have argued that most of the changes are minor and insignificant and question why an office with 420 employees and a $505 million budget — funded by the industry — has refused to act. “As a general rule, there has been no substantive response at all” to the applications, said Richmond attorney Bryan Haynes, whose firm Troutman Sanders represents multiple tobacco firms. “That presents a serious operational concern. . . . It’s absolutely stifling innovation.” Tobacco control advocates and anti-smoking activists would like such “innovation” stifled indefinitely, particularly if it would lead to increased tobacco sales. They are eager for the new center to prove itself as a forceful regulator and to more rapidly use its powers to curtail smoking, the leading preventable cause of death in the United States. “So far, they’ve been pretty toothless,” said Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California at San Francisco. Glantz praised the FDA tobacco center’s inaugural director, Lawrence Deyton, who is leaving for a post at George Washington University’s School of Medicine, for assembling a smart team of experts and laying the groundwork for meaningful regulation. He also said he has high hopes for Zeller. But he said he worries that the FDA, which is not allowed to ban nicotine or cigarettes outright, has been too willing to accommodate the concerns of the industry. “The tobacco companies are not stakeholders,” Glantz said. “They are the opposition.” Zeller, who could not be reached for comment, has shown impatience in the past. In an article last year in the journal Tobacco Control, he wrote that “action is sometimes sacrificed to process” at the FDA and that leaders there must instill a sense of urgency. Tobacco industry representatives have reacted to Zeller’s appointment with skepticism. “Somebody from a tobacco control background, you want to understand whether they’re going to regulate the industry in a reasonable way or not,” Haynes said. Meanwhile, tobacco control advocates have welcomed Zeller with open arms, not only because of his decades-long history of fighting alongside them, but also because of his experience navigating the massive FDA bureaucracy. “He understands the agency. He’s absolutely dedicated to using the agency’s authority aggressively. He’s knowledgeable about tobacco products and tobacco marketing, and he’s well-respected in the public health community,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids, adding, “[He] has an opportunity to bring about important and fundamental change.”

CDC: Roughly tenfold increase in use of e-cigarettes by teens in just 4 years

That shakes out to around 4.7 million children and teenagers who use tobacco.   In 2015, with all the overwhelming scientific evidence of the inherent health risks, those numbers might seem strange — until one considers e-cigarettes.   The rise isn’t new.       And, of course, they contain nicotine.

Should e-cigarettes be banned indoors in D.C.?

Two D.C. Council members are proposing to add electronic cigarettes to the city’s indoor smoking ban, arguing that the products may be a health risk and are an annoyance to non-smokers. Commonly referred to as e-cigarettes or e-cigs, electronic cigarettes have grown popular and are often used to help a smoker transition off tobacco. The products come in a variety of flavors and do not burn tobacco. Instead, battery-operated inhalers heat nicotine into a vapor, which apparently has some of the same stimulant effect of cigarettes. In recent years, celebrities such as Leonardo DiCaprio have been photographed with the products. And because they do not produce smoke, e-cigarettes generally have escaped regulation from states and cities. In the District, it has become common to see people puffing on e-cigarettes in restaurants, office buildings, bars and even Metrobuses. But council members Yvette M. Alexander (D-Ward 7) and David Grosso (I-At Large) introduced a bill at Tuesday’s council session to change that. If approved, e-cigarettes would be classified as cigarettes under the city’s indoor smoking ban. The law prohibits smoking in all public places and allows business owners to ban smoking on the sidewalk in front of their property. In an interview, Alexander said e-cigarettes are being “used to usurp the smoking ban.” “It is smoking, is an inhalant and it’s similar to smoking,” said Alexander, chairwoman of the Health Committee. “We don’t know what the ill effects of this are, and it’s still a bother to some people.” Numerous states, including Connecticut, are considering adding e-cigarettes to their indoor smoking ban. In 2011, the Food and Drug Administration announced it would regulate e-cigarettes as it does tobacco, a less restrictive stance than some had advocated. But the FDA is continuing to review the products. “Further research is needed to assess the potential public health benefits and risks of electronic cigarettes and other novel tobacco products,” an agency spokeswoman said. But manufacturers say e-cigarettes result in neither secondhand smoke nor proven health risks to the users. Cigarettes, they say, contain more than a thousand chemicals that are not present in e-cigarettes. Blu Cigs, one of the largest e-cigarettes manufacturers in the United States, recently alleged in a statement that the tobacco industry was behind efforts to crack down on the industry. “From misinformed lawmakers to scared big tobacco companies, actions are being made to limit the sale and use of electronic cigarettes,” the company said. Alexander said she’s not worried that her bill could make it more difficult for tobacco smokers to give up the habit. Instead, she said, the products “may encourage more people to start smoking.” “You are getting that same nicotine derivative, and it’s just attracting more, younger people,” Alexander said.

The war on smoking is working — and should continue

FIFTY YEARS on, the war on smoking can look back and claim a huge victory. Nearly half of the country used to smoke. Now less than a fifth of the country does. Some say that public health advocates have done enough; let those who still choose to light up, disproportionately from poor and vulnerable communities, smoke away their lives in peace. We disagree. It’s time for more taxes, more regulation and more outreach. “Cigarette smoking is causally related to lung cancer in men; the magnitude of the effect of cigarette smoking outweighs all other factors; and the risk of developing lung cancer increases with the duration of smoking and number of cigarettes smoked per day, and diminishes by discontinuing smoking.” Today, these lines seem obvious. Fifty years ago, when they appeared in the surgeon general’s first report on smoking’s health effects, they were revolutionary. Today, we know that smoking and secondhand smoke cause so many health problems across so much of the body that the benefits from the drop in use, accumulated across so many lives, are incalculable. Millions who quit or never started smoking breathe easier, suffer fewer strokes, get fewer cases of lung cancer, pass on fewer birth defects and take fewer sick days. A new study in the Journal of the American Medical Association attempts at least to calculate the number of premature deaths prevented since 1964 by changing the public’s view of the habit. Based on the assumption that smoking patterns would have continued without a decades-long public health push, the researchers estimated that tobacco-control programs have saved 8 million lives in the past five decades. Should the country forgo the opportunity to save millions more? Of course not. Plenty of sensible measures that stop short of banning cigarettes but effectively discourage their use are not consistently applied in the United States. The most obvious is taxing cigarettes. Rates vary drastically by state , leading to interstate smuggling. The federal government should raise its excise tax, bringing laggard states closer to those that do the right thing, reducing the opportunity for criminals and increasing incentives not to smoke. If Congress doesn’t act, individual states with low taxes, such as Virginia, should. Similarly, states and localities without strong indoor smoking restrictions should bring them in line with others’ stronger rules. The Food and Drug Administration, meanwhile, has a range of authorities over tobacco products that it should exercise with ambition. Perhaps the most promising is the possibility that requiring tobacco companies to reduce the amount of nicotine in their products will usefully cut their addictive quality. Consumer choice might help, too. Electronic cigarettes appear to offer the hopelessly addicted a safer alternative to combustible tobacco products, and smokers’ increasing use of these indicates significant demand for this sort of product. If federal regulation, public education and other efforts combine smartly with smokers’ desire to stop lighting up, e-cigarettes might be a useful tool to reduce harm rather than a gateway to a life of smoking. **Read more about this issue:** The Post’s View: Tax the smokers — again The Post’s View: Stubbing out secondhand smoke in the District The Post’s View: Health premiums for smokers should be tweaked

Snuffing out a tobacco exemption in Trans-Pacific Partnership trade deal

T obacco sickens and, eventually, can kill if consumed as intended. Every country, the United States included, should be taking every effective step to prevent smoking. The costs and benefits of free trade are clear, but, as recent presidents, Republican and Democratic, have recognized, the long-term gains to society outweigh the short-term losses to particular groups. Thus, the United States has wisely pursued pacts to expand free trade with partners around the world. What to do, however, when free trade and tobacco control seem to be in tension? The question arises in the context of the Trans-Pacific Partnership (TPP), a proposed trade agreement that would link the United States, Canada, Mexico, Japan, Australia, South Korea, Vietnam and five other countries as never before — spurring global growth and bolstering the United States geopolitically. Initially, the Obama administration favored a TPP provision exempting individual nations’ tobacco regulations — such as those banning advertising or requiring warning labels — from legal attack as “non-tariff barriers” to the free flow of goods. The idea was that, when it comes to controlling a uniquely dangerous product, there’s no such thing as “protectionism.” Alas, the United States softened its position at a public meeting of TPP negotiators last month. The new proposal simply specifies that tobacco is included in an existing exemption for policies necessary to protect human life or health, and requires governments to consult before challenging each other’s tobacco rules. While better than the status quo, in that it might constrain governments from going to bat for domestic tobacco producers, this suggestion would leave tobacco companies free to mount legal challenges to various nations’ policies. The office of U.S. Trade Representative Michael Froman explained the new stance reflected “consultations with Congress and with a wide range of American stakeholders” — a polite reference to pushback from farm-state legislators, farm lobbies and other interest groups that feared a tobacco exception would expand to a health-related excuse for protectionism against many other products. Though Asian countries have, in the past, discriminated against U.S. beef on trumped-up health grounds, U.S. agriculture’s fears this time are overblown. Tobacco is unique, and everyone knows it. Surely that can be enshrined in an enforceable agreement — which would be easier if all “stakeholders” worked toward an effective compromise instead of attacking Mr. Froman’s attempt as insufficiently protective of U.S. interests, as business interests continue to do. Tom Bollyky of the Council on Foreign Relations suggests that the office of the trade representative could formally reassure U.S. businesses that supporting tobacco control in the TPP cannot serve as precedent under other circumstances. It could also make an exemption from legal challenge for tobacco-control measures applicable only to those measures that treat domestic and imported products equally. All concerned should strive for a TPP that addresses legitimate concerns of U.S. business — but reflects the unique dangers of smoking both here and abroad. **Read more about this issue:** Lee Hamilton and David Williams: Trade deal could open door for constitutional change The Post’s View: Time for EURAFTA? Mitt Romney: China must respect the free-trade system David F. Gordon: A trade opportunity Washington shouldn’t pass up Harold Meyerson: Go slower on free trade

Officials in India are really sick and tired of their country’s tobacco habit

Delhi joins a roster of Indian states that have implemented bans, and the Supreme Court recommended a nationwide ban of a kind of chewing tobacco called gutka, though not all states have complied.  Delhi officials are hoping that the new ban and greater enforcement will stop tobacco vendors from rampant circumvention. A 2011 federal law, the Food Safety and Standards Act, classified combinations of tobacco and "flavorants" as "food," which made the products illegal by default because "food" was not allowed to contain tobacco. Retailers sidestepped the law simply by selling tobacco and flavorants in separate sachets.

Whistleblowers are protected

In response to the report that the federal government was tracking the personal e-mails of staffers at the Food and Drug Administration [front page, Jan. 30], some have suggested that the whistleblowers targeted should have “known better” than to use FDA laptops to blow the whistle to Congress. The problem is that the FDA’s program was not routine monitoring. The scientists were targeted for surveillance only after reporting the approval of unsafe medical devices to President-elect Obama. The FDA illegally intercepted e-mails to retaliate against the whistleblowers. Just as your employer cannot spy on you just because of your race, religion or gender, it is illegal for the FDA to target employees based on their constitutional right to blow the whistle. ****Lindsey M. Williams,** Washington** The writer is director of advocacy and development at the National Whistleblowers Center, which supports the FDA whistleblowers.

How e-cigarettes could save lives

_Sally Satel is a resident scholar at the American Enterprise Institute and a psychiatrist specializing in addiction. She has served as an expert witness in tobacco litigation._ Should electronic cigarettes be regulated like tobacco products, emblazoned with warnings and subject to tight marketing restrictions? Those are among the questions before the Food and Drug Administration as it decides in the coming weeks how to handle the battery-powered cigarette mimics that have become a $1.5 billion business in the United States. Groups promoting intensive regulation include the American Lung Association and the Campaign for Tobacco-Free Kids. They worry that the health risks haven’t been fully established and that e-cigarettes will make smoking commonplace again, especially among teens. They are quick to push back in response to anything that might make e-cigarettes more attractive, such as the NJOY King ad that aired during the Super Bowl or when actors Leonardo DiCaprio and Julia Louis-Dreyfus were shown “vaping” at the Golden Globes. A surgeon general’s report released last month, on the 50th anniversary of the office’s first warning about the dangers of smoking, had little to say about e-cigarettes. Its suggestions for further reducing tobacco use were familiar, including: increase taxes on cigarettes, prohibit indoor smoking, launch media campaigns and reduce the nicotine content of cigarettes. E-cigarettes, however, could be what we need to knock the U.S. smoking rate from a stubborn 18 percent to the government’s goal of 12 percent by 2020. We should not only tolerate them but encourage their use. Although critics stress the need for more research, we can say with high confidence that e-cigarettes are far safer than smoking. No tobacco leaves are combusted, so they don’t release the tars and gases that lead to cancer and other smoking-related diseases. Instead, a heating element converts a liquid solution into an aerosol that users exhale as a white plume. The solution comes in varying concentrations of nicotine — from high (36 mg per milliliter of liquid) to zero — to help people wean themselves off cigarettes, as well as e-cigarettes, and the addictive stimulant in them. But even if people continue using electronic cigarettes with some nicotine, regular exposure has generally benign effects in healthy people, and the FDA has approved the extended use of nicotine gums, patches and lozenges. The other main ingredients in e-cigarettes are propylene glycol and glycerin. These are generally regarded as harmless — they’re found in toothpaste, hand sanitizer, asthma inhalers, and many other FDA-approved foods, cosmetics and pharmaceuticals. There are also traces of nitrosamines, known carcinogens, but they are present at levels comparable to the patch and at far lower concentrations than in regular cigarettes — 500- to 1,400-fold lower. Cadmium, lead and nickel may be there, too, but in amounts and forms considered nontoxic. “Few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns,” a 2011 study in the Journal of Health Policy determined. “A preponderance of the available evidence shows [e-cigarettes] to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.” The potential for e-cigarettes to help people quit smoking is encouraging. Yet so far there has been little research on their effectiveness. A study published in the Lancet in November concluded that e-cigarettes, with or without nicotine, were as effective as nicotine patches for helping smokers quit. Granted, patches have had a disappointing record in helping people stay off cigarettes for more than a few months. But there are reasons to think that e-cigarettes would be even more effective outside the laboratory. Participants in the Lancet study were randomly assigned to nicotine e-cigarettes, patches or placebo e-cigarettes. In the real world, of course, people get to choose. And e-cigarettes have several advantages over patches and gums. For one, they provide a quicker fix, because the pulmonary route is the fastest practical way to deliver nicotine to the brain. They also offer visual, tactile and gestural similiarities to traditional cigarettes. Reporter Megan McArdle tested the comparison for a Bloomberg Businessweek article this month: “After I’d put it together, I had something surprisingly close to one of the cigarettes I used to smoke. The mentholated tobacco flavor rolled sinuously over my tongue, hit the back of my throat in an unctuously familiar cloud, and rushed through my capillaries, buzzing along my dormant nicotine receptors. The only thing missing was the unpleasant clawing feeling in my chest as my lungs begged me not to pollute them with tar and soot.” This is where anti-smoking advocates get worried about e-cigarettes being too attractive and encouraging people — especially young people — to become addicted to nicotine and, in some cases, to progress to smoking. The Centers for Disease Control and Prevention stoked concerns with data released in September showing that 1.78 million middle and high school students had tried e-cigarettes and that one in five middle school students who reported trying them said they hadn’t tried traditional cigarettes. “This raises concern that there may be young people for whom e-cigarettes could be an entry point to use of conventional tobacco products, including cigarettes,” the CDC concluded. According to that same CDC study, however, an extremely small percentage of teenagers use e-cigarettes regularly — only 2.8 percent of high school students reported using one in the previous 30 days in 2012. And while that number is rising — it was 1.5 percent in 2011 — teenage cigarette smoking rates are at record lows. That might suggest that increased exposure to e-cigarettes isn’t encouraging more people to smoke. But the numbers are so small that it’s too early to make definitive claims about the relationship between teen vaping and smoking. Yes, we still need research on the long-term health and behavioral impacts of e-cigarettes. Brad Rodu, a pathologist at the University of Louisville, offers an apt analogy between electronic cigarettes and cellphones. When cellphones became popular in the late ’90s, there were no data on their long-term safety. As it turns out, the risk of a brain tumor with prolonged cellphone use is not zero, but it is very small and of uncertain health significance. In the case of e-cigarettes, Rodu says that “at least a decade of continued use by thousands of users would need to transpire before confident assessments could be conducted.” Were the FDA to ban e-cigarette marketing until then, the promise of vaping would be put on hold. Meanwhile, millions of smokers who might otherwise switch would keep buying tobacco products. “We can’t say that decades of e-cigarette use will be perfectly safe,” Rodu told me, “but for cigarette users, we are sure that smoke is thousands of times worse.” The FDA should call for reliable, informative labeling and safe manufacturing standards for e-cigarettes. It should also allay concerns about potential gateway use and youth addiction to nicotine by banning the marketing and sale of e-cigarettes to minors. It should not be heavyhanded in restricting marketing and sales to adults. Instead, promoting electronic cigarettes to smokers should be a public health priority. Given that the direct medical costs of smoking are estimated to be more than $130 billion per year, along with $150 billion annually in productivity losses from premature deaths, getting more smokers to switch would result in significant cost savings — as well as almost half a million lives saved each year. We should make e-cigarettes accessible to smokers by eschewing hefty taxes, if we tax them at all, and offering free samples and starter kits. Those kits, which contain a battery, a charger and nicotine-liquid cartridges, typically run between $30 and $90. To reduce the hurdle to initiation, any payer of smoking-related costs — health insurers, Veterans Affairs medical centers, companies that offer smoking-cessation programs for their employees, Medicare, Medicaid — should make the starter kits available gratis. Users should have to pay for their own replacement cartridges, but those are much cheaper than cigarette packs. Also, we should allow and welcome public vaping in adult environments such as bars, restaurants and workplaces. Vapers would serve as visual prompts for smokers to ask about vaping and, ideally, ditch traditional cigarettes and take up electronic ones instead. It may be hard for anti-smoking activists to feel at ease with e-cigarettes in light of their view that traditional cigarette makers have long downplayed the health dangers of their product. This perception has generated distrust of anything remotely resembling the act of smoking. It doesn’t help that major tobacco companies are now investing in e-cigarettes. But if we embrace electronic cigarettes as a way for smokers to either kick their nicotine addictions or, at least, obtain nicotine in a safer way, they could help instigate the wave of smoking cessation that anti-smoking activists — and all of us — are hoping for.

Big tobacco companies are putting big warning labels on their e-cigarettes

MarkTen e-cigarette packages feature a 117-word warning: "Nicotine is addictive and habit forming, and is very toxic by inhalation, in contact with the skin, or if swallowed," the warning reads. The product, the warning says, is unsuitable for children and people with diabetes, high blood pressure and heart disease. For the health conscious, those warnings might make sense. But the New York Times discovered something kind of weird about them: MarkTen, along with the other e-cigarette brands produced by Big Tobacco companies, feature warnings that are sometimes several degrees more severe than those on the same corporations' traditional cigarettes.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico MarkTen is produced by Nu Mark, which is owned by Altria. The parent company makes Marlboros, Parliament, Virginia Slims and several other recognized traditional brands and is the parent company of Phillip Morris. According to MarkTen's Web site, the full product warning label reads:    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Currently, traditional cigarettes feature one of several shorter warnings required by the Food and Drug Administration. A plan to require larger, graphic warnings in compliance with a 2009 law failed after a successful court challenge from many large corporations in the tobacco industry -- but not, it should be noted, Altria.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico A spokesperson for Altria told the Times that the longer labels on the new e-cigarette products are part of "a goal to openly and honestly communicate about health effects," and that the labels are based on "previously developed warnings” for tobacco products. Speaking to The Post, Bill Phelps, a Nu Mark spokesman, said that the company supports "the FDA developing a national warning" for e-cigarette products, adding that Nu Mark "looks to a variety of sources" to develop its current warnings "in the absence of a government-mandated warning."    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Traditional cigarettes produced Nu Mark's parent company Altria use the shorter, federally-mandated language from the FDA. When asked whether the company could add more text to the mandated label warning on its tobacco cigarette packets, the spokesman noted that there's more information on the health effects of cigarettes on the company's website. R.J. Reynolds Vapor Co., which makes Vuse and puts a similar warning on its e-cigarette products, had less to say to the paper on the subject. But a spokesman but did say that its warnings note that e-cigarettes aren't "combustion" based. R.J. Reynolds was part of the lawsuit challenging the new tobacco cigarette labels.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico So why is this happening? The Times explains one educated guess: Large tobacco companies now own some of the biggest e-cigarette brands, including Blu, which was acquired by Lorillard and later purchased  by Imperial after Lorillard merged with the even larger R.J. Reynolds company.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico But Big Tobacco shares the market with smaller companies, including those who sell "vape" pens. And all of them are trying to grab consumers from the traditional cigarette industry -- not to mention those who haven't previously smoked. Although both traditional cigarettes and e-cigarettes are basically methods for users to inhale the addictive drug nicotine, they work in different ways. Instead of burning tobacco leaves to produce smoke, e-cigarettes heat up a nicotine-containing liquid, producing vapor.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico This side-steps the production of tar and other carcinogens inhaled by traditional cigarette smokers. "E-cigarettes appear to have far fewer of the toxins found in smoke compared to traditional cigarettes," the CDC wrote this year. But the safety of e-cigarettes is still being debated.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Also empirically unsettled? Whether the products help traditional smokers quit the habit altogether, as many e-cigarette proponents allege.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico In April, the FDA proposed a new rule that would allow the agency to start regulating the $2 billion dollar industry just like many other tobacco product.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The World Health Organization has also called for greater regulation of the products, among other things, to "prohibit unproven health claims about e-cigarettes" and to "impede e-cigarette promotion to non-smokers and young people."    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

The marijuana industry is following the trail blazed by Big Tobacco

_Samuel Wilkinson is a resident physician at the Yale School of Medicine._ Last month, people voted to legalize recreational use of marijuana in Oregon, Alaska and the District. As the movement toward marijuana legalization continues, lawmakers and policy experts are looking to the experiments in Colorado and Washington for guidance. We should not overlook, however, valuable lessons from our experience with another legal drug: tobacco. In the late 19th century, the landscape of tobacco consumption was very different than it is today. Tobacco use was much less prevalent, and cigarettes accounted for a tiny portion of consumption. Yet by the mid-20th century almost half of U.S. adults smoked, with major consequences for public health. Despite important health policy achievements since, cigarette smoking remains a major contributor to the top causes of death in the United States, including cardiovascular and lung diseases, as well as cancer. This drastic rise in the prevalence of smoking can be attributed to a number of successful business strategies. Hand-rolling of cigarettes, a technique that limited production potential, was supplanted by machine manufacturing. Changes in the chemical composition and curing process of cigarettes made them more flavorful as well as more addictive. Aggressive marketing techniques sought to build a larger consumer base. Advertisements often featured doctors in an effort to quell public fear over smoking-related health concerns; other campaigns targeted children or adolescents, who represented potential lifetime customers. Finally, the industry created powerful lobbying groups to protect their profits from regulations aimed at curbing consumption. Alarmingly, marijuana businesses are now mimicking many of Big Tobacco’s successful strategies. New methods of consuming marijuana (such as vaporization) are said to represent a healthier way to get high — though little research supports this claim — encouraging individuals to consume more marijuana in one sitting. The percentage of tetrahydrocannabinol (the euphoria-inducing compound associated with many adverse health effects) in marijuana is much higher than it was a few decades ago. Just as tobacco companies featured doctors in advertisement campaigns, marijuana advocates have appealed to medical authority by successfully lobbying in many places for the approval of “medical marijuana” for a plethora of conditions, even when little or no scientific evidence supports its use. While it is laudable that Colorado has placed restrictions on marijuana advertising, it is also disturbing that the marijuana industry quickly mounted powerful legal efforts to challenge these restrictions in court. The formula for success in profiting from a legal drug is simple and has been clearly outlined by Big Tobacco: Identify a product with addictive potential, aggressively market it to as large an audience as possible, develop technical innovations to allow for and promote increased consumption, and deny or minimize potential costs to human health. The marijuana industry is poised to copy this formula, with dire consequences. Important lessons can also be drawn from the Netherlands , where marijuana has been decriminalized since 1976. Following decriminalization, the Dutch government strictly enforced guidelines prohibiting advertising and transactions above a certain quantity (to discourage mass production and distribution). For about a decade, marijuana consumption rates remained stable. However, in the mid-1980s, waning enforcement of these guidelines coincided with a drastic increase in both the commercialization of marijuana and rates of consumption. The overriding lesson from the Netherlands is that it was commercialization, not decriminalization itself, that led to sharp increases in use. If we are intent on legalizing marijuana for recreational use, lessons from the tobacco industry and the Dutch marijuana experiment suggest that we do so in a way that does not pit corporate incentives against the interests of public health. Similar to efforts in Uruguay, production and distribution should be done solely by the government so as to ensure that there is no corporate incentive to entice more people to consume marijuana in larger quantities. Advertisements in all media venues should be banned, or as stringently regulated as allowed by law. While the health effects of marijuana are generally not as severe as those of cigarette smoking, the consequences — including addiction, psychosis and impaired cognitive abilities — are nonetheless real. Notably, these effects are most pronounced in children and adolescents. Claims that marijuana legalization will make it easier to prevent use by minors are not backed by scientific or historical evidence. The most prevalent drugs consumed by teenagers are those that are legal: alcohol and tobacco. This should give us pause to consider the optimal way to legalize marijuana — and indeed whether other states should consider legalization at all. **Read more:** Charles Lane: Colorado’s marijuana experiment has a bitter aftertaste E.J. Dionne: Marijuana injustices The Post’s View: Congress should allow D.C.’s marijuana legalization to stand Paul Steinberg: The downside of legal marijuana

Teen vaping soars

The number of middle and high school students using electronic cigarettes tripled between 2013 and 2014, according to government figures released Thursday, a startling increase that public health officials fear could reverse decades of efforts combating the scourge of smoking. The use of e-cigarettes among teenagers has eclipsed the use of traditional cigarettes and all other tobacco products, a development that Tom Frieden, director of the Centers for Disease Control and Prevention, called “alarming” and “shocking.” “What’s most surprising is how incredibly rapid the use of products other than cigarettes has increased,” Frieden said in an interview, adding that some e-cigarette smokers would undoubtedly go on to use traditional cigarettes. “It is subjecting another generation of our children to an addictive substance.” The results, based on an annual survey of 22,000 students around the country and published Thursday by the CDC, detail a quickly evolving landscape of tobacco products that appeal to teenagers.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Anti-smoking advocates argue that the rise in the popularity of e-cigarettes stems in part from aggressive, largely unregulated marketing campaigns that Frieden said are “straight out of the playbook” of cigarette ads that targeted young people in earlier generations. “These are the same images, the same themes and the same role models that the cigarette industry used 50 years ago,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. “It’s the Marlboro Man reborn. It’s the Virginia Slims woman recreated, with the exact same effect. ... This is not an accident.” But advocates of e-cigarettes -- small devices that heat up flavored, nicotine-laced liquid into a vapor that is inhaled -- say the worries expressed by public health officials are premature and not backed up by data. Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, an industry group, said her organization has long supported age restrictions and other measures to keep e-cigarettes out of the hands of minors. But at the same time, she said there’s no definitive evidence e-cigarettes are a “gateway” to using traditional cigarettes and other tobacco products. On the contrary, she said, many teens have tried e-cigarettes in the past already were smokers. “We need to not lose perspective about the potential these products have to eliminate harm from combusted tobacco,” she said. “I suspect teens experiment with a lot of things. And I suspect anytime someone is not smoking a cigarette, that’s a good thing.” “The CDC should really be jumping for joy at the fact that smoking rates are declining. This is a huge success,” added Michael Siegel, a professor and tobacco control specialist at Boston University’s School of Public Health. “Instead, they are using this as another opportunity to demonize e-cigarettes.” Siegel said he agrees that minors shouldn’t have access to any tobacco product. But he said the CDC numbers suggest that rather than serving as a gateway to cigarette smoking, e-cigarette use might be diverting teens from traditional cigarettes, which still kill hundreds of thousands of Americans each year. “That’s a good thing,” he said. While tobacco giants such as Lorillard and Altria have indeed purchased e-cigarette companies in recent years, Cabrera disputed that those marketing campaigns target underage smokers. And she said the bulk of e-cigarette marketing is still done by hundreds of small companies whose ads on the internet and other platforms target only adults. “If you’re thinking this is Big Tobacco redux, that’s the wrong thinking," she said. This much seems certain: Teens are experimenting as much as ever. Roughly a quarter of high school students and near 8 percent of middle school students still report using a tobacco product at least once during the past 30 days. But between 2013 and 2014, the findings show, e-cigarette use among high school students had increased from 4.5 percent to 13.4 percent. Usage also more than tripled among middle school students, according to the findings. Only  among black students was another tobacco product, cigars, more popular than e-cigarettes, the CDC said. During that same period, the use of hookahs — water pipes that are used to smoke specially made tobacco — roughly doubled for middle and high school students, also eclipsing the use of regular cigarettes. Meanwhile, use of conventional cigarettes sank to the lowest levels in years. According to the CDC, 9.2 percent of high school students and 2.5 percent of middle school students reported smoking a cigarette over the past month. On the surface, that might seems like good news, given the hundreds of thousands of Americans that still die from smoking each year. And it might be. “The drop in cigarette use is historic, with enormous public health significance,” Myers said. But, he was quick to add, “the explosion of e-cigarette use among kids means these products are being taken up in record numbers with totally unknown long-term consequences that could potentially undermine all the progress we’ve made.” Last April, the Food and Drug Administration announced that for the first time it would begin to regulate e-cigarettes, which has grown into a multibillion- dollar industry in the United States. The agency said its plan would force manufacturers to curb sales to minors, place health warning labels on their products and disclose the ingredients in e-cigarettes. The initial proposals stopped short of halting online sales of e-cigarettes, restricting television advertising or banning the use of candy and fruit flavorings that critics say are intended to appeal to young smokers.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico A year later, the FDA has not finalized any new regulations involving e-cigarettes, though its top tobacco officials said in a statement Thursday the agency still plans to oversee the burgeoning market. “In today’s rapidly evolving tobacco marketplace, the surge in youth use of novel products like e-cigarettes forces us to confront the reality that the progress we have made in reducing youth cigarette smoking rates is being threatened,” said Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products. “These staggering increases in such a short time underscore why FDA intends to regulate these additional products to protect public health.” Myers said such action can't come soon enough. "The failure of the FDA to move more quickly means we have an urgent crisis that needs to be addressed," he said. "In the absence of strong governmental action, these numbers will only keep going up."

Take menthol out of cigarettes

The Post’s Feb. 5 editorial “Holding our breath,” on the Food and Drug Administration’s inaction on tobacco-related issues, noted that “flavored cigarettes have been banned” and “menthol cigarettes . . . are still on sale.” Menthol is the most deadly tobacco flavoring. The 2009 Tobacco Control Act banned the use of all flavorings in cigarettes except menthol, which was to be studied by the Tobacco Products Scientific Advisory Committee. In March 2011, that committee recommended that the FDA ban menthol cigarettes to “benefit public health in the United States.” Two years later the FDA has yet to act. Because menthol reduces the harshness of smoke and the irritation from nicotine, menthol cigarettes are a powerful starter product. Almost half of 12- to 17-year-old smokers choose menthol cigarettes and more than 80 percent of adolescent African American smokers use them. More than 90 percent of adult smokers are hooked as teens. Menthol flavorings not only lure youth to start smoking, they also make it harder for menthol smokers to quit. Now is the time for the FDA to ban menthol flavoring in cigarettes to help reduce health-care costs and protect the health and save the lives of more Americans. ****Joseph A. Califano Jr.,** Westport, Conn.** ****Louis W. Sullivan,** Atlanta** The writers, former secretaries of what is now known as the Department of Health & Human Services, are, respectively, the chairman and vice chairman of the Citizens’ Commission to Protect the Truth, which works to reduce teenage smoking.

Booming e-cigarette market in need of greater oversight, studies say

The electronic cigarette market is booming both online and in brick-and-mortar retail outlets in ways hardly imaginable half a decade ago, and the growth continues to be largely unregulated, according to a series of studies published Monday in the journal Tobacco Control. “It’s exploding,” said Shu-Hong Zhu, a professor in the Department of Family and Preventive Medicine at the University of California at San Diego, who co- authored one of nine studies funded by the National Cancer Institute. “There’s no sign of slowing down.” Zhu and other researchers found a “staggering” proliferation of e-cigarette brands and flavors on the Internet in the past two years alone, with roughly 10 new brands and 240 new flavors arriving on the market every month. As of January, researchers trawling English-language Web sites identified 466 e-cigarette brands and 7,764 flavors, from peppermint to piña colada. But e-cigarettes have gained traction far beyond the Internet. Other researchers found that nearly a third of U.S. convenience stores, pharmacies and other retailers near schools sell e-cigarettes — a statistic that raises concern among some anti-smoking advocates who say there are too few barriers to youth access to the products. “There’s this really rapid growth happening,” said Frank Chaloupka, director of the Health Policy Center at the University of Illinois at Chicago and author of several of Monday’s studies. “They are becoming available all over the place, they are being marketed aggressively, and they are cheap compared to normal cigarettes. But in terms of policy, there’s been very little done to control [the market] to this point.” The increasing popularity of e-cigarettes — devices that generally resemble traditional cigarettes but, instead of burning tobacco, heat nicotine-laced liquid into a vapor that the user inhales — has been well documented in recent years. But as the ever-changing and vast $2 billion market continues to expand, researchers involved in Monday’s studies said the feverish growth underscores the need for more oversight and more research into the potential impact on public health. At the least, Zhu and Chaloupka said, lawmakers should act quickly to pass measures to limit sales and marketing of e-cigarettes to minors and to ensure sound manufacturing practices. “That’s the most important regulation that needs to be done, and it should be done quickly,” Zhu said. Dozens of states have put in place some regulations for e-cigarettes, but so far the rules are neither uniform nor comprehensive. More than three dozen states currently prohibit the sale of e-cigarettes to minors, and that number is likely to climb. About a dozen states have enacted some form of usage ban in public places such as schools and government buildings, though only three — New Jersey, North Dakota and Utah — forbid the use of e-cigarettes everywhere that smoking is banned. Numerous municipalities also have instituted usage restrictions. Meanwhile, Minnesota remains the only state that taxes e-cigarettes at the high rate that also applies to traditional tobacco products. North Carolina recently put in place a much more modest tax of 5 cents for each milliliter of the nicotine liquid. In April, after years of speculation, the Food and Drug Administration said it would for the first time begin regulating e-cigarettes, as well as cigars, pipe tobacco and hookahs. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes would be banned from making health-related claims without scientific evidence. But the FDA’s proposal would not seek to restrict online sales of e-cigarettes, curb television advertising or ban the widespread use of exotic flavors, which tobacco-control advocates have argued helps to attract young smokers and which have been banned for traditional cigarettes. Given the sluggish nature of the federal rule-writing process and the prospect of litigation over the proposed rules, any final regulations are probably years away. “The industry has no problem with regulation. The industry has a problem with inappropriate regulation,” said Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, who had not yet seen the details of Monday’s studies. “If you have regulation that stifles this market, that’s not a good thing.” Cabrera said her group supports a national age restriction on e-cigarettes and the majority of companies have been diligent in putting strict age-verification checks in place, both online and in retail outlets. She added that reputable e-cigarette makers adhere to stringent manufacturing practices. Cabrera also said that many e-cigarette users are cigarette smokers who are trying to kick tobacco habits. “If current smokers are switching over to vaporizing products, then great,” she said. Zhu, the UC-San Diego researcher, agreed that e-cigarettes could end up providing a net benefit if they lessen use of tobacco. But he said that what’s missing is basic regulation of the industry and more reliable research into e-cigarettes’ long-term impact on health. “We want to regulate e-cigarettes in such a way that we help reduce cigarette smoking as much as possible,” he said. Another study released Monday offered an additional glimpse at who seems to be attracted to e-cigarettes, at least in Europe. Researchers there analyzed nearly 27,000 e-cigarette users from 27 countries in the European Union. The results showed that users were more likely to be young, between 15 and 24. They also were more likely to be cigarette smokers who have made at least one attempt to quit in the past year. Related: FDA outlines plan to regulate e-cigarettes E-cigarette regulation draws mixed reactions Seven things you need to know about e-cigarettes E-cigarette use grows rapidly among middle, high schoolers

Big Pharma in the living room

Regarding the March 29 Wonkblog excerpt, “Big drug companies bet you’re tuning in” [Business]: Through most of my 50 years as a physician, it was unethical for doctors and pharmaceutical companies to advertise. It is still illegal in almost all other countries, where, unlike in the United States, parents don’t have to explain to 8-year-olds about “an erection that lasts more than four hours.” Our major medical societies seem to be ethically numb and/or corrupted by money, and new drugs are too easily approved by the Food and Drug Administration — before safety and efficacy are well established. The FDA is no match for Big Pharma. Dozens of countries have better health-care results, and at much lower costs, than the United States. ****E. James Lieberman** , Potomac**

High school, middle school kids now use more e-cigs than tobacco: CDC

The number of middle and high school students using electronic cigarettes tripled between 2013 and 2014, according to government figures released Thursday, a startling increase that public health officials fear could reverse decades of efforts combating the scourge of smoking. The use of e-cigarettes among teenagers has eclipsed the use of traditional cigarettes and all other tobacco products, a development that Tom Frieden, director of the Centers for Disease Control and Prevention, called “alarming” and “shocking.” “What’s most surprising is how incredibly rapid the use of products other than cigarettes has increased,” Frieden said in an interview, adding that some e-cigarette smokers would undoubtedly go on to use traditional cigarettes. “It is subjecting another generation of our children to an addictive substance.” The results, based on an annual survey of 22,000 students around the country and published Thursday by the CDC, detail a quickly evolving landscape of tobacco products that appeal to teenagers.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Anti-smoking advocates argue that the rise in the popularity of e-cigarettes stems in part from aggressive, largely unregulated marketing campaigns that Frieden said are “straight out of the playbook” of cigarette ads that targeted young people in earlier generations. [ _FDA outlines plan to regulate e-cigarettes_]    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico “These are the same images, the same themes and the same role models that the cigarette industry used 50 years ago,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. “It’s the Marlboro Man reborn. It’s the Virginia Slims woman recreated, with the exact same effect. ... This is not an accident.” But advocates of e-cigarettes -- small devices that heat up flavored, nicotine-laced liquid into a vapor that is inhaled -- say the worries expressed by public health officials are premature and not backed up by data. Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, an industry group, said her organization has long supported age restrictions and other measures to keep e-cigarettes out of the hands of minors. But at the same time, she said there’s no definitive evidence e-cigarettes are a “gateway” to using traditional cigarettes and other tobacco products. On the contrary, she said, many teens have tried e-cigarettes in the past already were smokers. “We need to not lose perspective about the potential these products have to eliminate harm from combusted tobacco,” she said. “I suspect teens experiment with a lot of things. And I suspect anytime someone is not smoking a cigarette, that’s a good thing.” “The CDC should really be jumping for joy at the fact that smoking rates are declining. This is a huge success,” added Michael Siegel, a professor and tobacco control specialist at Boston University’s School of Public Health. “Instead, they are using this as another opportunity to demonize e-cigarettes.” Siegel said he agrees that minors shouldn’t have access to any tobacco product. But he said the CDC numbers suggest that rather than serving as a gateway to cigarette smoking, e-cigarette use might be diverting teens from traditional cigarettes, which still kill hundreds of thousands of Americans each year. “That’s a good thing,” he said. [ _CDC ads target vaping for first time_]    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico While tobacco giants such as Lorillard and Altria have indeed purchased e-cigarette companies in recent years, Cabrera disputed that those marketing campaigns target underage smokers. And she said the bulk of e-cigarette marketing is still done by hundreds of small companies whose ads on the internet and other platforms target only adults. “If you’re thinking this is Big Tobacco redux, that’s the wrong thinking," she said. This much seems certain: Teens are experimenting as much as ever. Roughly a quarter of high school students and near 8 percent of middle school students still report using a tobacco product at least once during the past 30 days. But between 2013 and 2014, the findings show, e-cigarette use among high school students had increased from 4.5 percent to 13.4 percent. Usage also more than tripled among middle school students, according to the findings. Only  among black students was another tobacco product, cigars, more popular than e-cigarettes, the CDC said. During that same period, the use of hookahs — water pipes that are used to smoke specially made tobacco — roughly doubled for middle and high school students, also eclipsing the use of regular cigarettes. [ _Seven things to know about e-cigarettes_]    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Meanwhile, use of conventional cigarettes sank to the lowest levels in years. According to the CDC, 9.2 percent of high school students and 2.5 percent of middle school students reported smoking a cigarette over the past month. On the surface, that might seems like good news, given the hundreds of thousands of Americans that still die from smoking each year. And it might be. “The drop in cigarette use is historic, with enormous public health significance,” Myers said. But, he was quick to add, “the explosion of e-cigarette use among kids means these products are being taken up in record numbers with totally unknown long-term consequences that could potentially undermine all the progress we’ve made.” Last April, the Food and Drug Administration announced that for the first time it would begin to regulate e-cigarettes, which has grown into a multibillion- dollar industry in the United States. The agency said its plan would force manufacturers to curb sales to minors, place health warning labels on their products and disclose the ingredients in e-cigarettes. The initial proposals stopped short of halting online sales of e-cigarettes, restricting television advertising or banning the use of candy and fruit flavorings that critics say are intended to appeal to young smokers.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico A year later, the FDA has not finalized any new regulations involving e-cigarettes, though its top tobacco officials said in a statement Thursday the agency still plans to oversee the burgeoning market. “In today’s rapidly evolving tobacco marketplace, the surge in youth use of novel products like e-cigarettes forces us to confront the reality that the progress we have made in reducing youth cigarette smoking rates is being threatened,” said Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products. “These staggering increases in such a short time underscore why FDA intends to regulate these additional products to protect public health.” Myers said such action can't come soon enough. "The failure of the FDA to move more quickly means we have an urgent crisis that needs to be addressed," he said. "In the absence of strong governmental action, these numbers will only keep going up."

The number of high schoolers using e-cigarettes has tripled since 2011

Another year, another uptick in the number of youth puffing on vaporized tobacco. A new study by the Centers for Disease Control and Prevention (CDC) found that e-cigarettes are becoming increasingly popular among high school students, a trend the agency warns could undermine some of the progress made in reducing tobacco use among adolescents. "We've seen continued declines in tobacco use, but e-cigarette use is rising and that's troubling," said Brian King, senior adviser with the office on smoking and health at the CDC. "Any use is hazardous to the health of youths." The percentage of high school students who said they had used an e-cigarette in the past 30 days rose to 4.5 percent in 2013, a more than 60 percent jump from 2012 and roughly triple the number in 2011. The percentage of high school students who said they had ever tried an e-cigarette rose, too. Twelve percent said they had used an e-cigarette at some point, compared to 10 percent in 2012. The prevalence of use might seem insignificant in percentage terms, but it's quite the opposite, warns King. "In terms of ever-use, we're talking about several million high school kids," he said. "Even in terms of regular use we're still talking about several hundred thousand." Part of the reason e-cigarette use is climbing among adolescents is that the industry has pitched it as a less harmful alternative to traditional cigarettes. The idea, according to e-cigarette makers, is that the devices might help smokers quit, but the result has been that many teenagers who might not have taken up smoking traditional cigarettes are trying their electronic counterparts. The other, arguably more problematic reason is that e-cigarettes are still largely unregulated. The U.S. Food and Drug Administration is working on legislation that will ban the sale of e-cigarettes to anyone under the age of 18. But as of today, only 36 states restrict the sale of e-cigarette to minors—meaning that in 14 others, it's perfectly legal for children to buy the vaporized tobacco devices. E-cigarettes can also be legally sold on the Internet, though regular cigarettes cannot. The ways in which the industry markets the devices has been a point of contention, too. E-cigarette makers contend that they don't target adolescents with their advertising. Some of them, for instance, including Lorillard Inc., buy television placements only for programming aimed at adults; others do the same for radio spots. But there's reason to believe the industry might be pandering to younger users. Especially considering the range of flavors offered by e-cigarette makers. "The availability of these products in different flavors is a problem," said King. "Kid-friendly flavors, like fruit and candy, are particularly attractive to youth, because they mask the flavor of the tobacco." There are also more subtle ways in which the marketing tactics could be be luring younger users. The prevalence of prominent celebrity endorsements is among the most contentious. But a number of other strategies, including free samples, promotions, and sponsored events are likely glamorizing the products, too. Anti-smoking advocates have noted the eerie similarity between modern day e-cigarette marketing and latter day traditional cigarette advertising. "It is beyond troubling that e-cigarettes are using the exact same marketing tactics we saw the tobacco industry use in the ’50s, ’60s and ’70s, which made it so effective for tobacco products to reach youth,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, told the New York Times last year.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

More than 16 million children live in states where they can buy e-cigs legally

More than 16 million children age 17 and under live in the District of Columbia and 10 states that allow them to buy e-cigarettes legally, according to a report released Thursday by the Centers for Disease Control and Prevention. The 10 states are Maine, Massachusetts, Michigan, Montana, Nevada, New Mexico, North Dakota, Oregon, Pennsylvania and Texas. The 40 other states have laws banning the sale of e-cigarettes and other devices, such as electronic cigars, to minors. Public health officials have warned about the dangers of e-cigarettes for youths. CDC officials have said that calls to poison centers involving e-cigarettes have surged in recent years. Last year, the CDC reported a dramatic increase in the number of high school students who said they had tried e-cigarettes, including some who had never smoked.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The latest data from the National Youth Tobacco Survey showed 4.5 percent of all high school students and 1.1 percent of all middle school students had used e-cigarettes within the past 30 days in 2013. "We know e-cigarettes are not safe for youth," said Tim McAfee, director of the CDC's Office on Smoking and Health. The CDC data is based on information obtained from its tobacco tracking system as of Nov. 30, 2014. The Food and Drug Administration announced in April that it intended for the first time to regulate the booming market of electronic cigarettes, as well as an array of other products such as cigars, pipe tobacco and hookahs. The move would begin to place restrictions on e-cigarettes, a nearly $2 billion industry that for years has operated outside the reach of federal regulators. If adopted, the government’s plan would force manufacturers to curb sales to minors, stop handing out free samples, place health warning labels on their products and disclose the ingredients. Makers of e-cigarettes also would be banned from making health-related claims without scientific evidence.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The FDA’s proposal stops short of broader restrictions sought by many tobacco-control advocates. Regulators at this point are not seeking to halt online sales of e-cigarettes, curb television advertising, or ban the use of flavorings such as watermelon, grape soda and piña colada — all tactics that critics say are aimed at attracting young smokers and that have been banned for traditional cigarettes. The FDA proposed rule must undergo several steps before becoming final. The CDC report Thursday noted that the regulation does not address the use of e-cigarettes in public places. The report also said federal law allows states and localities to adopt or enforce more stringent requirements. E-cigarettes vary from brand to brand, but they generally resemble the size and shape of traditional cigarettes. Instead of burning tobacco, the battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” Supporters say that makes e-cigarettes an attractive alternative to their cancer-causing tobacco counterparts.

Putting the science behind FDA’s tobacco regulation

The law giving the Food and Drug Administration (FDA) authority to regulate tobacco products requires that it base decisions on science, including proposals to reduce the harm caused to those who smoke and to discourage youngsters from using tobacco. Leading this ambitious effort is David Ashley, the science director of the FDA’s Center’s for Tobacco Products, who sees his job as “an incredible opportunity to have an impact on public health.” “With over 400,000 Americans dying every year from smoking, tobacco use is the greatest preventable cause of disease and death in the United States,” said Ashley. “We have a critical mission because we help provide the science that supports the guidance and regulations, and assists in the review new product applications.” “If we do our job well, we will largely end the tragedy that results from tobacco use and people will no longer have to suffer a painful, agonizing death years before they should,” said Ashley. President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act in June 2009, granting the FDA authority to regulate the manufacture, marketing and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Ashley was appointed to his science position a year later after spending 27 years at the Centers for Disease Control and Prevention (CDC), where he directed scientists who examined the public health effects of heavy metals, organic compounds, and how tobacco product ingredients and additives impact the diseases that result from their use. Ashley said he has spent the past two years hiring a staff of about 70 people, “getting our feet on the ground,” establishing the research agenda, and building relationships with outside organizations like the National Institutes of Health that will conduct the scientific inquiries. He said some of the top priorities for research include looking at ways to reduce addiction to tobacco products; reducing the toxicity and carcinogenicity of tobacco products and smoke; understanding the adverse health consequences of tobacco use; and better understanding communications and marketing regarding tobacco products. Ashley said the science agenda as well as the work of the entire tobacco regulatory center has been steadily making progress. However, he said one of the frustrations is that decisions are not made as fast as he would like. “There are good reasons for that,” said Ashley. “We need to get input from many different stakeholders in order that the decisions we make will be the most appropriate and most effective.” Nevertheless, Ashley said that it is “a challenge to know that for every day a decision is delayed and we cannot act, about 1200 people die from using tobacco products.” Kim Elliott, the associate director at the FDA’s Center for Tobacco Products, said Ashley is “a world renowned chemist who has tremendous expertise on tobacco product design and what goes into the products.” “His knowledge has been essential in building the FDA’s regulatory science foundation for tobacco,” said Elliott. “His leadership and vision are essential for the FDA to achieve its crucial new mission. He has brought together some of the best scientists in the country on tobacco.” Ashley, who commutes every week from an Atlanta suburb to his FDA office in Maryland, said he was motivated to pursue a career in science and public health as a teenager when his mother was diagnosed with colon cancer, and then died a few years later. “I had the desire to do something that would make a big difference in people’s lives and their health, even if I couldn’t help her,” said Ashley. “Working at CDC and FDA has given me that opportunity. That’s what continues to get me to work every morning and keeps me going every day.”

Compounding pharmacy legislation doesn’t go far enough

I was stunned to read the uncritical editorial [“Concocting a cure,” May 7] lauding the draft Senate bill on pharmacy compounding. The Post’s statement that compounding pharmacies engaged in drug manufacturing, newly dubbed “compounding manufacturers,” would “meet the same standards as large drugmakers” is absolutely false. Contrary to current law for manufacturers, under the Senate bill, compounding manufacturers would not be required to seek pre-market approval from the Food and Drug Administration (FDA) or meet some important federal labeling requirements. They could mass-produce new drugs without testing for safety and efficacy and would undergo inspections only after a drug is on the market. The FDA would have the burden of proving that the compounding manufacturers’ advertising was false or misleading, even for unsupported safety and efficacy claims. The Senate proposal is a clear step backward, one that would profoundly weaken standards for ensuring the safety and effectiveness of a large class of manufactured drugs. The Senate should scrap the compounding manufacturing idea and focus on drawing a clearer line between traditional compounding and manufacturing, making it easier for the FDA to prevent abuses by traditional compounders through stronger registration and inspection requirements and a national “do not compound” list for dangerous or unapproved drugs. ****Sidney M. Wolfe** , Washington** The writer is director of the Health Research Group at Public Citizen.

A promising decline in teen smoking

AMID THE nationwide furor over the Senate draft health-care bill, a public- health victory has gone mostly unnoticed. According to a new report from the Centers for Disease Control and Prevention, the estimated number of middle and high school students who are tobacco users dropped from 4.7 million in 2015 to 3.9 million in 2016. This was largely driven by a reduction in the number of teenagers using e-cigarettes, which are less harmful than regular cigarettes but still contain nicotine. The downturn is a success for advocates and officials who have worked to curb teen tobacco use — but it should not be heralded as the end of the road. Teenage smoking has long been one of the most serious public-health issues. Smoking is the leading cause of preventable death in the United States, and 9 in 10 American smokers had their first taste of tobacco before the age of 18. Although policies to curb teen smoking showed signs of success for a time, youth tobacco rates remained stagnant between 2011 and 2015. During this period, the use of e-cigarettes among high school students increased by a staggering 900 percent. With these statistics in mind, the recent decline in teen tobacco and e-cigarette use is an encouraging signal that interventions may be working. It is difficult to determine causation, but experts have attributed the drop to a range of federal, state and local policies designed to dissuade young adults from using tobacco, such as increasing tobacco taxes and expanding antismoking ordinances to include e-cigarettes and other new products. States have run targeted media campaigns that work alongside federal efforts, such as the Food and Drug Administration’s “Real Cost” campaign and the CDC’s “Tips from Former Smokers.” The CDC report suggests that at least some of these strategies have been effective. But the report also highlights challenges that lie ahead. Millions of teenagers across the country are still using tobacco in some form, and the introduction of new tobacco products could drive up rates. There are also significant disparities among states and communities: Rural, low-income, and lesbian, gay, bisexual and transgender youth are particularly at risk due to targeted marketing and policy variation between different jurisdictions. This makes federal regulation by the FDA all the more important. The FDA, however, has delayed the enforcement of new regulations on e-cigarettes and cigars. Delays are commonplace in new administrations, but it is important that the agency take up these stricter standards after the three- month postponement. It would be a pity if these long-awaited signs of progress were undercut because the FDA declined to do its job. **Read more here:** The Post’s View: Raise the smoking age to 21 The Post’s View: Maryland’s cigarette tax is saving lives Sally Satel: How e-cigarettes could save lives The Post’s View: How to regulate e-cigarettes

Vaping came to Congress on Thursday

With one defiant puff in a congressional hearing, Rep. Duncan Hunter (R-Calif.) blew up an otherwise quiet debate Thursday. "So," he said as he exhaled a cloud of mist in a House Transportation Committee hearing. "This is called a vaporizer." "There is nothing noxious about this whatsoever," Hunter went on. The congresswoman next to him wasn't so sure; she waved the cloud away. The committee was voting on Del. Eleanor Holmes Norton's (D-D.C.) proposal to ban vaping on airplanes. Hunter, the "Yes, I vape" congressman, was most definitely opposed to it.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico In rather theatrical fashion, he urged his colleagues to say no too. Vaping has helped him quit smoking, he said, and he argued Norton's amendment would also make it tough for people with asthma inhalers or people inhaling "medicine of the future" through vaporizers to take their hits on a plane. "For freedom's sake," he said. The amendment ended up passing. It was one of dozens of amendments the committee voted on as part of a larger aviation bill making its way through Congress, and while interesting, it probably wouldn't have made national news without Hunter's brand of civil disobedience. Vaping advocates are ostensibly grateful. They have been waging what looks like a losing battle in Washington to fight back what they say is an onslaught of onerous legislation and federal regulation that's strangling an industry lawmakers don't understand. Greg Conley, with the upstart nonprofit advocacy group American Vaping Association, said groups like his are fighting a battle on a lot of fronts. President Obama just signed a bill requiring that all packaging containing nicotine is child-resistant. The Federal Drug Administration is finishing up regulations that would essentially put vaping products under the same strict regulations as other tobacco products — a move that Conley argues would put the burgeoning industry on death watch. There are efforts at the state level to treat vaping products as traditional tobacco products, from packaging to labeling to advertising to taxing them. There are also active debates about where you can mist up (to coin a phrase) and when. Vaping advocates are pushing a bill that would let the FDA regulate vaping products but requests it doesn't simply lump the industry in with cigarettes and other tobacco products. The House bill, led by Rep. Tom Cole (R-Okla.), currently has 45 co-sponsors, not an insignificant number. (Hunter is one of them.) As lawmakers across the nation decide how to handle this growing industry, most vapers are following their own code of conduct, Conley said: "Most vapers understand they wouldn't walk into a Walmart and do it."    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Hunter, a regular vaper himself, probably knew that when he decided to mist up in Congress with the C-SPAN cameras watching. But thanks to his little vaping stunt, you know all this stuff too, now.

Giving away company secrets

I commend Dennis Blair and Jon Huntsman Jr. for their insightful analysis on protecting U.S. intellectual property rights [“Safeguard U.S. ingenuity,” op- ed, May 22]. If the United States is to realize a renaissance in manufacturing, it must address the theft of intellectual property. By giving impunity to perpetrators who steal our trade secrets, we are giving away our competitive advantage. Measures should be in place to punish such thieves, and government must balance the public’s right to know with adequate protection of intellectual property. For example, the Environmental Protection Agency’s policy discourages chemical makers from claiming chemical names as confidential. The EPA must retain its statutory responsibility to protect confidential business information by not revealing a chemical identity when a legitimate claim is made. Otherwise, the agency would serve up an opportunity for competitors to mine U.S. intellectual property. The majority of Freedom of Information Act requests to the EPA come from companies, not from curious members of the public. We know foreign companies are sitting in on U.S. agency grant hearings at which U.S. companies provide explicit detail about their product development to justify grant money. Industrial espionage is a serious and omnipresent threat to U.S. manufacturing. Why facilitate it? ****Lawrence D. Sloan** , Washington** The writer is president and chief executive of the Society of Chemical Manufacturers and Affiliates.

FDA to tobacco companies: Stop calling your cigarettes ‘natural’ or ‘additive-free’

Federal regulators on Thursday ordered three tobacco companies to cease claims that their cigarettes are "additive-free" or "natural," saying they could mislead smokers into believing that the products are healthier than other cigarettes. The warnings marked the first time that the Food and Drug Administration has exercised its authority under a far-reaching 2009 tobacco-control law to take action against such claims on cigarette labels. “The FDA’s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like 'additive-free' and 'natural' pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,” Mitch Zeller, director of the agency's Center for Tobacco Products, said in a statement. “This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use.” _[Should you have to be 21 to buy cigarettes? Most Americans say yes.]_    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The FDA sent warning letters to Santa Fe Natural Tobacco Co., which sells American Spirit cigarettes; ITG Brands, which sells Winston cigarettes; and Sherman's 1400 Broadway N.Y.C., which sells Nat Sherman cigarettes. Officials at Santa Fe and at Sherman's said they had received the FDA's letter but had no comment. In a statement, ITG Brands said it believes its product "comply with all applicable state and federal regulations, including those of the U.S. FDA. While we disagree with the FDA's position on this issue, we intend to engage with the FDA and respond to their letter in the coming days." Tobacco-control advocates were quick to praise the FDA's action. "There is no question that terms such as additive-free and natural imply a safer cigarette, as confirmed by consumer research and the industry’s own documents. and, therefore, are health claims covered by the FDA Tobacco Act," said Matthew Myers, president of the Campaign for Tobacco-Free Kids. Earlier this week, his organization and dozens of others wrote to the FDA about a new advertising campaign for Natural American Spirit cigarettes, urging the agency to rein in such "natural tobacco" claims. But, Myers said, "It is clear that the FDA both initiated its investigation and made the decision to take action before receipt of this letter."    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico The agency gave the three companies involved 15 days to respond to the warnings.

Cigars expected to be targeted by FDA regulation

Nearly four years after it began regulating cigarettes, the Food and Drug Administration is poised to extend its reach to a broader range of tobacco products. At the top of that list: cigars, which have experienced a boom in recent years even as cigarette sales have declined, in part because of growing popularity among young people. Anti-tobacco advocates and industry representatives widely expect the agency to require changes in the marketing and manufacturing of cigars. But the central question remains: What kind of cigars will the FDA target, and how? On one end of the spectrum are the hand-rolled Cohibas and Arturo Fuentes that stock the humidors of high-end cigar shops and are favored by aficionados who don’t blink at paying top dollar. On the other are the convenience-store brands that appeal primarily to young smokers, such as 59-cent blueberry Swisher Sweets, peach-flavored White Owl Cigarillos, Phillies Blunts Sour Apple and menthol Cheyenne “little cigars” that are barely distinguishable from cigarettes. Public health experts and some anti-tobacco lawmakers are pressing the FDA to regulate all cigars, but they mostly worry about the inexpensive, flavored varieties that have proliferated in recent years. Such cigars “are marketed aggressively and have resulted in high school kids and young adults being twice as likely as their older counterparts to be cigar smokers,” the Campaign for Tobacco-Free Kids said in a recent report. Meanwhile, makers of “premium cigars” have been lobbying intensely in an effort to avoid being lumped in with the candy- and fruit-flavored, corner- store varieties. A bill on Capitol Hill, co-sponsored by dozens of lawmakers, would keep carefully defined “traditional large and premium” cigars out of the FDA’s reach, although its prospects remain uncertain. “You don’t see a teenager with a $15 premium cigar sticking out of his mouth, standing on the corner,” said Bill Spann, president of the International Premium Cigar & Retailers Association. “Nobody’s ducking outside for a 15-minute cigar break. Nobody’s smoking two boxes of cigars a day. You don’t inhale them. And they are not marketed to, desired by or affordable to underage youth.” The industry’s main trade association, the Cigar Association of America, which represents all kinds of cigar manufacturers, is pushing a simple message: One-size-fits-all regulation won’t work. “All our products are different, so you should look at all of them differently,” said Craig Williamson, president of the cigar group. The 2009 law that gave the FDA power to regulate cigarettes and several other types of tobacco also authorized it to broaden its jurisdiction to include other products, such as cigars, pipe tobacco and e-cigarettes. Late last year, the FDA said it would issue a proposal by April. In the interim, cigarmakers have begun to brace for their first brush with government regulation and the changes that might bring. “It’s something we’ve been planning for,” said David Sylvia, a spokesman for Altria Group, the parent company of John Middleton, which manufactures the popular Black & Mild cigar brand and a variety of pipe tobaccos. The FDA has yet to outline its plans, leaving plenty of speculation about whether the agency will regulate different cigars differently — without creating loopholes. “If they can’t figure out a way to keep this thing from being gamed, then they basically shouldn’t make any exemptions,” said Richard A. Daynard, a Northeastern University law professor and president of its Public Health Advocacy Institute. The 2009 tobacco control law banned candy and fruit flavorings in cigarettes, which had been shown to disproportionately appeal to young people. Some companies reacted by making small changes in the products, such as adding tobacco to the wrapper to help them meet the legal definition of cigars. Another 2009 federal law put in place sharp tax increases on cigarettes and small cigars but spared larger cigars. In response, companies added weight to their products to qualify for the lower taxes. Even as cigarette smoking decreased between 2000 and 2011, consumption of loose tobacco and cigars grew 123 percent, according to the Centers for Disease Control and Prevention. The CDC found that tax disparities prompted many smokers to switch from cigarettes to other products such as cigars. In at least six states, including Maryland, youth cigar smoking now equals or surpasses cigarette smoking, according to numbers compiled by the Campaign for Tobacco-Free Kids — a figure the group says underscores the urgency of FDA regulation. Spann hopes that the FDA at least decides to exclude the small companies and storefronts that make and sell premium cigars — or that if the agency doesn’t, Congress will. “There are 85,000 Americans working in or around the premium cigar market in America,” he said. “The government should be helping them, not trying to regulate them out of business.” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said there is no evidence that the FDA intends to impose a host of onerous, unnecessary regulations on mom-and-pop manufacturers of large cigars. “They have bigger fights to fight,” he said.

Why the United Nations should press for higher taxes on tobacco

_Michael R. Bloomberg was mayor of New York from 2002 to 2013. Margaret Chan is director-general of the World Health Organization._ _F_ or the first time, the global sustainable-development goals being negotiated at the United Nations treat tobacco use — and the chronic diseases it causes — as a development issue. It’s long overdue. Around the world, about 6 million people die every year from a tobacco-related disease. That’s one person every six seconds, or 10 every minute. By 2030, 8 million people are expected to die each year from tobacco use — and 80 percent of those deaths will occur in developing countries. In the United States alone, smoking-related illnesses result in $170 billion in annual medical spending. The cause of these problems — tobacco sales — can also contribute to their solution. The tobacco industry, which generates more than $35 billion in profits annually, should bear the costs it inflicts upon society. And there is a straightforward way to ensure that it does: taxation. Why, after all, should governments effectively subsidize tobacco companies by picking up the tab for the health-care costs they generate? Increasing taxes on cigarettes and other tobacco products has mostly been a strategy for reducing usage — and it has proved incredibly successful. The evidence is clear that raising tobacco taxes cuts use, encourages smokers to quit and discourages young people from starting. In fact, the most price-sensitive demographic for tobacco use is young people, who tend to have less disposable income than their elders. Low-income populations are also sensitive to price increases, making taxes especially effective in poorer countries where tobacco use is rising fast. Those same countries also have the greatest need for better health-care services. In addition to reducing the burdens on health-care systems, tobacco taxes can help countries absorb the huge costs imposed by tobacco usage. Fortunately, governments have begun waking up to the idea that tobacco taxes provide an opportunity to achieve both of those critical goals: reducing use and raising revenue. In South Africa, France and New Zealand, tobacco taxes have helped cut use and provided funding for health care. In 2012, the Philippines passed its landmark Sin Tax reform law. This legislation, which increased tax rates on low-priced cigarettes by more than 300 percent, generates revenue for the country’s universal health-care insurance program. By 2014, these funds had helped the government subsidize the health-insurance premiums of approximately half the population. The tobacco industry, of course, rejects the idea that it should pay for the long-term health costs its products generate, and it is working hard, directly and through front groups, to persuade governments to go easy on the taxes. If any other consumer product were known to kill one in two of its users, there would be calls on governments to ban it. Yet in much of the world, tobacco is only lightly regulated and taxed. This is despite the fact that tobacco taxes have already been formally endorsed by governments representing 90 percent of the world’s people, through a legally binding global treaty — the World Health Organization Framework Convention on Tobacco Control  — as an important and effective means to reduce tobacco consumption. The treaty even provides guidelines for governments to put in place or strengthen tobacco taxes. If the primary role of government is to protect lives — and we believe it is — then tobacco taxes are an essential tool. The United Nations should encourage countries to raise tobacco taxes to support the world’s development goals and reduce tobacco use. **Read more on this issue:** The Post’s View: Raise the smoking age to 21 George F. Will: When bootleggers and Baptists converge The Post’s View: Maryland’s cigarette tax is saving lives Richard Cohen: Cigarette smoking is a fast track to an early death The Post’s View: Health premiums for smokers should be tweaked

Raising all federal tobacco taxes can stop tax avoidance

ENACT A LAW, and companies will find loopholes to exploit. That was the fear which drove lawmakers in2009 to raise cigarette taxes together with taxes for roll-your-own tobacco and small cigars, both easy substitutes for cigarettes. To prevent manufacturers from shifting toward lesser-taxed alternatives, Congress equalized taxes between all three products — hiking the existing roll-your-own tobacco tax by over 24 times and small cigars by over 27 times. These products have plunged in sales since 2009. But tobacco manufacturers, unfazed in their quest to fatten their purses, found a new loophole. Unlike these three highly taxed tobacco products, post-2009 taxes on pipe tobacco and large cigars are relatively low. All it took to shift consumers to those products was relabeling roll-your-own tobacco as pipe tobacco, and slightly adding weight to qualify small cigars as large cigars. As evidence from a recent Senate finance committee hearing shows, the popularity of pipe tobacco and large cigars have exploded. That market shift has cost the federal government up to $3.7 billion in forgone revenue. Even worse, it’s hampered the effect of high tobacco prices on preventing teen smoking. The first instinct might be to blame the Alcohol and Tobacco Tax and Trade Bureau, which has yet to sharpen definitions of many of these products. While action by the bureau could help close the loopholes, it faces a daunting task. For example, where should it draw the line between roll-your-own and pipe tobacco? In many cases, “it is difficult to establish objective physical standards for differentiating between the two products,” the bureau’s chief said in his testimony. Sometimes the difference is virtually nothing at all. So forget rewriting definitions. The foolproof solution is for Congress to pass a law equalizing all tobacco taxes. That would raise taxes for pipe tobacco and large cigars to the same level as cigarette taxes, preventing any market shift. A bill introduced by Sen. Richard Durbin (D-Ill.) in 2013, still stuck in committee, would accomplish this task. Better yet, Congress should hike all tobacco taxes — not just the lower ones — up to higher and equal levels. State taxes vary widely, from $4.35 per cigarette pack in New York to $0.17 per pack in Missouri, making smuggling a big problem for law enforcement. The current cigarette and small cigar federal tax is a meager $1.01 per pack of 20; a higher federal tax would diminish the effect of inconsistency between states and allow for a more uniform response. These are two common-sense solutions to close tobacco tax loopholes. But the problem of tobacco manufacturers exploiting definitions has another dimension. The Food and Drug Administration, the other arm of the U.S. public health response, has proposed a long-awaited rule to expand its regulatory authority over “all” tobacco products. But premium cigars may be exempted from these regulations, potentially allowing manufacturers to “sweep other cigar products under its umbrella,” as the FDA has admitted before. This proposed exemption, as demonstrated by the tax avoidance case, is a disaster waiting to happen. **Read more about this topic:** The Post’s View: New Jersey’s raising the smoking age is an experiment worth trying The Post’s View: Australia shows the impact of stronger cigarette warnings Richard Cohen: Cigarette smoking is a fast track to an early death The Post’s View: Higher taxes on cigarettes make good sense The Post’s View: E-cigarettes offer public health benefits The Post’s View: CVS’s smart shift away from tobacco

An unrealistic smoking ban

The regulations proposed by the Department of Housing and Urban Development described in the Nov. 13 Federal Eye column, “Plan to snuff smoking in public housing” [The Fed Page], are flawed. There is almost no evidence that proposals to prevent public housing tenants from smoking in their apartments are practical or enforceable. The few studies that have been done on multi-unit housing where smoking has been banned show that the majority of tenants who smoke ignore the prohibitions. The cost of enforcing an all-out smoking ban likely would be quite high, and higher still if it were expanded to include less-dangerous nicotine products such as chewing tobacco and e-cigarettes. In the context of a sustained effort to encourage smokers to quit or, at least, switch to safer forms of nicotine, a ban might be possible. As a free-standing effort, however, it seems almost certain to fail. ****Eli Lehrer** , Herndon**

Effects of cigarette packaging rules are not plainly apparent

The U.S. Chamber of Commerce strongly supports measures to protect public health and recognizes the importance of reducing smoking rates. We also support the right of every legal business to use its brands free from state- sponsored trademark destruction, such as the imposition of “plain-packaging” laws that confuse consumers and stymie legitimate choices between brands. This is especially the case when there is no clear evidence that such destruction is an effective deterrent to smoking, notwithstanding The Post’s conclusion based on Australia’s plain-packaging rules [“Take the cool out of Kools,” editorial, July 21]. Commenting on data showing that fewer Australians are smoking daily, Geoff Neideck of the Australian Institute of Health and Welfare said last month, “[I]t would be a stretch to say this data shows that [plain packaging] was a key factor” in cutting the smoking rate. This is hardly the caliber of definitive argument that warrants strong support of plain packaging. ****David Hirschmann** , Washington** The writer is president and chief executive of the U.S. Chamber of Commerce’s Global Intellectual Property Center.

‘Unless prohibited by law’ will guide regulatory reform

Former Office of Information and Regulatory Affairs administrator Howard Shelanski omitted some important facts in his Feb. 17 Washington Forum essay, “The rules about making new rules.” Any criticism of a regulatory budget must address Britain’s and Canada’s successes in addressing regulatory accumulation without jeopardizing health and safety. What’s preventing the United States? Mr. Shelanski knows all too well that presidents can cut regulatory costs. He oversaw dozens of rules that reduced billions of dollars in costs and millions of paperwork hours. The Trump administrator can’t replicate and build on that success? Critics of one-in, two-out seem to forget that the phrase “unless prohibited by law” litters the executive order on regulatory reform. The Environmental Protection Agency will not rescind the standard for carbon monoxide to implement new standards for particulate matter. It can amend rules to reduce costs and still ensure they fulfill their statutory purpose. The Obama administration did this. The Trump administration can follow. ****Sam Batkins** , Washington** _The writer is director of regulatory policy at the American Action Forum._

E-cigarette regulations may increase teen smoking (and help Big Tobacco)

As teen smoking rates have declined, teen use of e-cigarettes and other vaping devices have increased. This is a real concern, and it has prompted many states to ban e-cigarette sales to minors. Such regulation sounds like a good idea, but new research suggests it may backfire.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico A forthcoming paper in the _Journal of Health Economics_ finds that bans on teen access to e-cigarettes may _increase_ teen smoking rates. Here’s how the Yale School of Public Health describes the research:    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Teen smoking is a serious public health concern, so these results should be alarming. As a father, I don’t want my kids to use e-cigarettes — and I certainly don’t want them to even consider doing so until they are mature enough to make informed choices — but I don’t want them to smoke even more. Nicotine addiction is bad, but nicotine addiction combined with the serious health consequences of smoking are worse. If forced to choose — and I would prefer not to — smoking is clearly the greater evil. There is increasing reason to believe that, whatever the risks of e-cigarette use, they are a tiny fraction of those presented by conventional cigarettes. There is also good evidence that using e-cigarettes as an alternative source of nicotine can help smokers quit (at least those smokers who want to quit), and they may be as — if not more — effective than alternative smoking cessation methods (at least for some smokers). Again, while e-cigarettes are not risk-free — and there is still much to be learned about their potential long-term health effects — there is an emerging consensus that they are far less dangerous than smoking. Insofar as there is a trade-off between smoking rates and vaping rates, the preference for vaping should be a no-brainer.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico That e-cigarettes are a potential substitute for traditional cigarettes is well understood by the tobacco industry — and it has that industry worried. While the big tobacco companies have developed their own e-cigarette brands, they are also supporting the increased regulation of e-cigarettes and other vaping devices. Such regulation is likely to suppress competition to the tobacco companies’ benefit, both by restricting the relative availability of e-cigarettes and reducing competition within e-cigarette markets to the advantage of larger firms. I explore this point with Bruce Yandle, Roger Meiners and Andrew Morriss in this _Regulation_ article and this more extensive paper forthcoming in the _Yale Journal on Regulation. _The bottom line: Not only could poorly conceived e-cigarette regulation undermine public health, it could help tobacco companies as well.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico What does this all mean? Well-intentioned public health measures do not always protect public health. Premature or poorly constructed regulation of e-cigarettes may compromise smoking-reduction efforts and (as our research suggests) advance the interests of tobacco companies. I support measures to discourage teen e-cigarette use, and we should all want such measures to be effective. Regulation of new technologies is sometimes justified, but it can also do more harm than good. DISCLOSURE: In 2014, I co-authored a white paper on the political economy of e-cigarette regulation for which my co-authors and I received compensation from NJOY, an e-cigarette manufacturer. NJOY exercised no control over the conclusions of that white paper, and I have not maintained any relationship, economic or otherwise, with NJOY since completing that work. All of my conclusions about e-cigarette regulation are my own.

1 in 4 youths exposed to secondhand smoke from e-cigarettes, study shows

The finding translates to about 6.5 million youths exposed. Some of the students had smoked e-cigarettes themselves during that time, but 4.4 million were not users. More than 1 million were exposed to secondhand smoke only from e-cigarettes, the study concluded. The U.S. surgeon general reported last December that exposure to secondhand aerosol from electronic cigarettes is harmful because of the possible toxic substances, such as nicotine and heavy metals, they contain. Nicotine exposure can be particularly dangerous because it can affect adolescent brain development. “We know that secondhand e-cigarette aerosol is not harmless, and it’s critical to protect our nation’s youth from this preventable health risk,” said Brian King, deputy director for research translation in CDC’s Office on Smoking and Health and a co-author of the new study. It was published in JAMA Pediatrics.  Flavor is one of the most common reasons young people give for using e-cigarettes, according to the surgeon general's report. But some chemicals used for e-cigarette flavoring can be harmful to health, King said. “One example is diacetyl, which is known to produce the buttery flavor in popcorn, and studies have linked inhalation of diacetyl to a severe respiratory illness,” King said. The ailment is commonly known as popcorn lung syndrome. The CDC study drew on data from the 2015 National Youth Tobacco Survey. It found that secondhand exposure to e-cigarette aerosol was greater for girls (nearly 27 percent) than boys (22 percent). Fifteen percent of black students reported being exposed, compared to 27 percent of white students. Youth who used e-cigarettes or conventional tobacco products are most likely to be exposed to secondhand smoke because of the company they often keep. “People who use multiple tobacco products are also in social environments with others who use e-cigarettes or other tobacco products,” King said. To protect children from exposure to secondhand smoke from smoked tobacco products and aerosol from e-cigarettes, states and communities can consider modernizing smoke-free air policies to include e-cigarettes, he said. “These policies can address the use of such products in indoor environments, and there has been considerable momentum across the country in the past few years,” he said. Eight states and 500 communities currently cover e-cigarette aerosol in their smoke-free policies, he said. To decrease all forms of tobacco product use among young people, King recommends “access restrictions that prohibit youth who are less than a specified age from purchasing e-cigarettes, as well as educational campaigns that warn about the risks of e-cigarette use and secondhand aerosol exposure among youth.” The latest report confirms certain trends, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, and raises serious issues about how many youths are using e-cigarettes and being exposed to potentially harmful aerosol.

MLB takes a swing at smokeless tobacco

THE DECADES-LONG effort to eradicate tobacco use in the United States has been among the most important public-health achievements of recent times, saving countless lives and improving countless more. But even as national attitudes about smoking have changed, tobacco use has remained deeply ingrained in significant elements of the culture. One big-league example: professional sports, particularly baseball, in which the disgusting and deadly smokeless tobacco habit continues to claim many addicts. Major League Baseball owners have tried to get players to cut out smokeless tobacco products, such as chew, dip and snuff, for years, with limited success. Last month they struck a new contract with the players union that aims to phase out smokeless tobacco use, barring new players from dipping. That is progress. If this were merely an issue of a few pro athletes deciding to expose themselves to deadly carcinogens, it would not be a public-health issue. But sports stars set an example. They are (mostly) known for being in peak physical shape; if they can dip and play pro ball, why not everyone else? The Centers for Disease Control and Prevention found last year that, though smoking rates are low for high school athletes, use of smokeless tobacco products is high in this group. Even with the new contract, it may take a while for the culture to change. Smokeless tobacco has been banned in the minor leagues and by the NCAA for years, yet telltale wads still show up in players’ mouths. Moreover, current MLB players will still be allowed to use, meaning it would take well over a decade for everyone in the major leagues to be covered. The contract will run for five years, so the policy cannot be strengthened for a while. Then there is the question of how well teams and league officials will enforce the ban. MLB organizations should keep the pressure on, reminding players that tobacco use of all kinds has consequences. San Diego Padres great Tony Gwynn tragically died of salivary gland cancer complications at the age of 54. Pitching legend Curt Schilling waged a fight against oral cancer not long after retiring from baseball. Cities can take an even harder approach — 12 of them have banned smokeless tobacco from professional sports stadiums within their limits. More should follow suit. The fight against tobacco cannot stop with smoking. In all its uses, this addictive weed still constitutes a public-health disaster. The sooner major league sports make smokeless tobacco a memory of an earlier, less informed era, the better. **Read more on this topic:** The Post’s View: It’s time to get chewing tobacco out of baseball Michael Gerson: Giving cancer a first-person voice The Post’s View: The U.S. Chamber of Commerce should quit lobbying for tobacco abroad Vinay Prasad: Why a cancer ‘moonshot’ is unlikely to find us a cure Michael R. Bloomberg and Margaret Chan: Why the United Nations should press for higher taxes on tobacco

Whatever its motive, CVS does the right thing by ending cigarette sales

CVS STOPPED selling cigarettes last week. The move may be little more than a business calculation for the pharmacy chain. But it is one worth cheering: It makes the sale of cigarettes less ubiquitous, and it shows that, after decades of effort, smoking is getting the stigma it deserves. CVS wants to be known for more than running convenience stores: With demand for and spending on health care both rising, the company is aggressively expanding its prescription drug business and its “minute clinic” chain, offering basic health services such as flu shots and blood pressure readings. It plans to have 1,500 rudimentary clinics open in 2017. Ending cigarette sales will help rebrand the company and forge relationships with other players in the health-care industry. Give CVS credit. The company is forgoing some $2 billion in annual revenue to make its anti-tobacco play. Regardless of the motivation, the company will have washed its hands of a deadly, addictive social ill. Teenagers may have a harder time buying tobacco products. CVS’s effort to increase the availability of basic health services is also welcome, particularly now that the Affordable Care Act is encouraging more people to use preventive health care rather than waiting for flare-ups and then visiting emergency rooms. Any company that takes a risk to stand on the right side of public health deserves congratulations. It will save lives. More broadly, CVS’s move says a lot about American society’s relationship with tobacco. The company’s conclusion that selling cigarettes fundamentally conflicts with the mission of advancing people’s health caps a revolution in American thinking. Gone are the days when tobacco companies could successfully fog up the facts, sowing enough doubt about the deadliness of their products that they could minimize fear among potential or current addicts. After more than a half-century of effort by scientists, doctors and advocates to change attitudes, cigarette ads from years ago featuring doctors, dentists, singers and sports stars have become obviously perverse. They would be laughable if they didn’t represent a concerted campaign to hook people on a cocktail of inhaled poisons. Smoking has proven a difficult addiction to eradicate, with roughly a fifth of American adults still lighting up. It remains the leading cause of preventable death in the country, and tobacco companies continue to hook new customers overseas. The Food and Drug Administration is still in the early stages of its effort to fully regulate the tobacco industry. Tobacco consumption won’t end soon. But most Americans understand why that’s a worthwhile goal. **Read more on this topic:** The Post’s View: CVS’s smart shift away from tobacco The Post’s View: The war on smoking is working — and should continue The Post’s View: Health premiums for smokers should be tweaked Richard Cohen: Cigarette smoking is a fast track to an early death

Meet the cancer doctor who wants the FDA to soften tobacco warnings

The oncologist who works for a tobacco company -- a rare combination, to be sure -- was in a rush to get back to his hotel room in Washington. Dr. Lars-Erik Rutqvist needed to cram for a landmark hearing on tobacco before the U.S. Food and Drug Administration, where he was sure he'd be quizzed intently. Rutqvist is an executive with Swedish Match, the Stockholm-based maker of a smokeless tobacco known as snus. And his company has asked federal regulators to find that its product is less dangerous than cigarettes. It’s a tall task. And a controversial one. Swedish Match wants to soften the warning labels printed on its snus cans, stripping away dire mentions of mouth cancer, gum disease and tooth loss that the U.S. requires on all smokeless tobacco. The company says it has science to support its case. It points to what it calls the "Swedish Experience," where high rates of tobacco use hasn't translated into high rates of cancer. And with Rutqvist’s help, the company filed a 120,000-page report ahead of the first-of-its-kind FDA hearing set for Thursday and Friday.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico It can all sound a bit mad, given that tobacco is considered public health enemy No. 1. Rutqvist, a cancer doctor, understood that. “It has divided even the tobacco control community,” he said during a brief break from his preparations. “But it’s pragmatic,” Rutqvist added. “And I like that.” Swedish Match’s unusual campaign strikes at the heart of a bitter debate over how we think about tobacco. Most public health officials view tobacco in any form as dangerous. It’s why even electronic cigarettes are so contentious. But some public health officials – including prominent scientists -- question whether the “all tobacco is bad” approach is actually smart medicine. They argue that smoking tobacco poses the greatest risk by far, and anything that reduces the number of smokers is a positive. In their eyes, that means giving snus a boost by altering the warning label. They advocate for what’s known as “harm reduction.” But many tobacco researchers are dismissive of this practice. “Their ideas have not caught on because they are not very good ideas,” said Dr. Stanton Glantz, a professor of tobacco control at the University of California, San Francisco, who wrote a letter strongly opposing Swedish Match’s FDA application. The two camps of public health researchers agree on little, noted Dr. Kenneth Warner, a public health professor at the University of Michigan. “Right now, it’s not a civilized debate," said Warner, an advocate of harm reduction. "There’s a lot of animosity.” * Rutqvist, 60, didn’t start out believing in harm reduction. For more than two decades, he studied different cancers at the major research Karolinska Hospital in Stockholm. He published reams of studies. And for years, he held the traditional view that all tobacco was bad. Then, in the late 1980s, he worked on the largest study of oral cancer in Scandinavia. The study found disease risk increased with smoking and drinking, but not with using snus.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico “I was surprised,” Rutqvist recalled. The study had hit upon what today is widely accepted as “the Swedish Experience.” It describes the paradox that Sweden posts one of the highest tobacco-use rates in Europe, yet it has the lowest rates for smoking-related deaths, including lung cancer. The difference is that relatively few Swedes smoke. Instead, they consume snus. Nearly 20 percent of Swedish men and 3 percent of Swedish women use it. In 2001, as evidence accumulated, the Swedish government even removed the oral cancer warning from snus sold in that country and replaced it with a message about damaging health. About the same time, Rutqvist grew disenchanted with the medical community’s prevailing attitude toward tobacco. “The message is, all tobacco is bad for you: Quit or die,” he said. “But the tobacco harm reduction message is something different.” In 2006, he took a job with Swedish Match, rising to his current position as senior vice president for scientific affairs. He braced for a backlash from his former oncology colleagues. It never came. “Everyone in Sweden knows that snus doesn’t have anything to do with cancer,” Rutqvist said. * Swedish Match’s corporate slogan is, “A world without cigarettes.” Nearly half of the company’s $15 billion in annual sales come from snus. But the firm also sells cigars and, in the United States, chewing tobacco under brands such as Redman. Its General Swedish snus brand has only about 4 percent of the U.S. smokeless tobacco market, which is dominated by traditional chewing tobaccos such as Copenhagen. But Swedish snus is different than American chewing tobacco -- or even American-made snus. The finely-ground, moist tobacco comes in tiny packets that are traditionally inserted in the upper lip. Users don’t spit. And Swedish snus contains fewer cancer-causing agents than most chewing tobaccos, perhaps because of the way it’s manufactured. Supporters of harm reduction argue that snus is safer than other smokeless tobaccos -- and poses significantly fewer health risks than smoking. “Can you make the claim that a product is safer when it’s not perfectly safe? Yes, I think you can,” said Lynn Kozlowski, a University of Buffalo professor who studies tobacco use policy. “But there are some who think their job is satisfied only when they say nothing is safe.” The path that Swedish Match is pursuing was created under the 2009 Tobacco Control Act, the landmark law that gave the FDA authority over tobacco. The act banned the use of “light” and “low-tar” to describe cigarettes because those words could give consumers the false impression that these cigarettes were somehow safer than regular ones. The act also set standards for tobacco warning labels. The 2009 act also allowed tobacco firms to petition the FDA if they wanted to prove that one tobacco product was safer than another. Swedish Match filed its voluminous application last June. Later this week, the company will plead its case before the FDA’s Tobacco Products Scientific Advisory Committee, which will make a recommendation to the FDA. A final decision is expected this summer. In its application, the company contends snus can produce a public health benefit by reducing the risk of tobacco-related diseases. Swedish Match’s case is based on what’s happened in Sweden and the results from six studies, including two double-blind, randomized trials that compared snus to a placebo for people trying to quit smoking. The company said there’s no evidence that snus users graduated into cigarette smokers. And lab studies of Swedish snus show the product “is associated with considerably lower, if any, carcinogenic potential when compared with cigarettes,” according to the company’s FDA filing. The FDA, in a preliminary assessment of the application, sounded skeptical of some of Swedish Match's contentions, questioning whether the Swedish Experience could be replicated in the United States. Glantz, the University of California professor, also worried that a change in snus’ warning label could be interpreted as an FDA product endorsement. “When you put these things into the market, the market changes,” Glantz said. “It’s hard to convey risk to the public.” * Last week, Rutqvist and a team of Swedish Match officials made a visit to Georgetown Tobacco in Washington. The store has been around since 1964, long enough to see attitudes toward its main product line harden considerably. Rutqvist strolled past the rows of cigars and cigarettes until he reached a small refrigerator that contained round cans of General Swedish snus. Rutqvist pulled one out. Printed on the front was a standard FDA-mandated warning: “This product can cause mouth cancer.” Other cans read “This product is not a safe alternative to cigarettes.” If Rutqvist and Swedish Match get their wish, the FDA would do away with these warnings, replacing them with “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” A current warning about smokeless tobacco being addictive would be retained. David Berkebile watched as Rutqvist and the others huddled around the Swedish snus display. Berkebile, owner of Georgetown Tobacco, smoked a cigar and listened as Rutqvist gave a quick explanation of why he was in town. “Good luck,” Berkebile said with a laugh. But Rutqvist said he was optimistic. Yes, there was social and political resistance to his firm’s FDA request they needed to overcome. But, he said, the evidence is so compelling. He is an oncologist, after all. He trusts in the science.

Heart Association: E-cigs could help some quitters but are a ‘Trojan horse of nicotine’

The American Heart Association, an old foe of the tobacco industry, has taken an official position in the debate over electronic cigarettes. It’s not a fan. In a policy statement issued Sunday, the organization called for stricter regulation of the battery operated devices which contain nicotine, but not tobacco, and produce vapor instead of smoke.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico “Recent studies raise concerns that e-cigarettes may be a gateway to traditional tobacco products for the nation’s youth, and could renormalize smoking in our society,” said Nancy Brown, CEO of the American Heart Association.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Some say e-cigarettes are a safer alternative to the real thing, or could even help smokers quit altogether. The AHA didn’t categorically reject the idea, noting some “surprising” findings. “For example, currently available data suggests that e-cigarettes appear to be less harmful than traditional cigarettes. And in some cases the product could help people quit smoking,” the organization said in a press release. However, it cautioned that “those observations are based on a limited pool of medical research without long-term results.”    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico E-cigarettes have only been in the American market since 2003 and there are few long-term studies of whether smokers have successfully used them as a tool to quit smoking. Some studies show smokers continue to use both types of cigarettes. “If someone refuses to quit, we’re not opposed to them switching from conventional to e-cigarettes,” said Aruni Bhatnagar, a professor of medicine at the University of Louisville in Kentucky who led the 10 researchers and physicians who wrote the policy statement. “Don’t use them indefinitely. Set a quit date for quitting conventional, e-cigarettes and everything else. We don’t think that will be the long-term or useful way to look at it because e-cigarettes may continue and fuel nicotine addiction.” E-cigarettes don’t have tar and carbon monoxide, among the harmful ingredients in cigarettes that cause cancer and other health problems, but the AHA expressed concern that exhaled e-cigarette vapor may still expose people to toxic chemicals, including nicotine which has been shown to increase blood pressure. “We must increase the pace of research and understand the full range of health consequences before we allow this Trojan horse of nicotine back into society,” Brown said. The organization called for e-cigarettes to be treated like other tobacco products with a ban on the sale and marking of e-cigarettes to youth and regulation of how they are made and sold. In April, the Food and Drug Administration proposed rules that would ban the sale of e-cigarettes to kids under 18. But according to the AHA, the proposal doesn’t do enough to protect children.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico Broadcast ads for regular cigarettes have been banned since the 70s but e-cigarette ads are everywhere. The AHA is concerned that kids are targeted through social media ads and that they might find e-cigarette flavors like bubble gum or chocolate appealing. They also want the agency to act faster to require child-proof packaging given the spike in calls to poison control centers related to liquid nicotine used in e-cigarette. **Related:** When the FDA said it would regulate e-cigarettes, the reaction was swift.    *[WSU]: Wayne State University   *[Tue]: Tuesday   *[Wed]: Wednesday   *[UNM]: University of New Mexico

What’s in all that e-cig vapor?

Wander into a vape shop in the mall or online, and you can find a smorgasbord of flavors: cotton candy, vanilla custard, even Unicorn Milk or Katy Perry’s Cherry. Flashy flavors have helped e-cigarettes, designed to vaporize a nicotine solution, grow into an industry with an estimated $3.5 billion in annual U.S. sales. Less than a decade after the battery-powered devices were introduced in the United States, an estimated 10 percent of American adults and 13 percent of high school students “vape,” according to recent surveys. While many users perceive e-cigs as safer than traditional cigarettes, some of the flavorings that make them so enticing may have their own toxic consequences. A growing number of studies find that some of the liquids used in e-cigarettes contain flavorings whose inhalation has been associated with lung problems, ranging from irritation to a rare but serious lung disease. For example, diacetyl, a butter-flavored chemical, has been linked to dozens of cases of bronchiolitis obliterans, a life-threatening obstructive lung disease. E-cigarettes are unregulated, but that may change. The Food and Drug Administration is considering a rule to extend its cigarette-regulating authority to e-cig devices. More than 7,700 e-cig flavors are being sold under more than 450 brands, with no labeling or testing requirements. Jessica Barrington-Trimis, an epidemiologist at the University of Southern California who studies tobacco’s health effects, said that flavorings are particularly worrisome because they “have a history of being known respiratory toxins.” Barrington-Trimis, who spoke at an FDA panel looking into e-cigs in March, said that because the devices produce an ultrafine aerosol that goes deep into the lungs, their flavorings “are a natural target” for further investigation. “We need to research this more to understand what chemicals are in these things and what these chemicals may be doing to the lungs of the user,” she said. One of the first people to highlight e-cig flavoring concerns was a physician who uses e-cigarettes himself. Konstantinos Farsalinos, a researcher at the Onassis Cardiac Surgery Center in Athens, tested 159 sweet e-cig liquids, such as toffee, chocolate and caramel flavorings, and found that 74 percent of the samples contained diacetyl — the chemical associated with bronchiolitis obliterans — or a chemically similar substitute, acetyl propionyl. Among the ones that tested positive, nearly half would expose users to levels that exceed recommended workplace limits for breathing the two chemicals, his 2014 study found. Diacetyl is found naturally in butter, beer and other foods, and it is added to baked goods, candy and snack foods to impart a buttery or creamy taste. Although it is considered safe to eat, breathing it may not be. In 2002, the National Institute for Occupational Safety and Health, reported that eight workers in a Missouri microwave popcorn plant had developed bronchiolitis obliterans after breathing diacetyl on the job. Half of them needed lung transplants, and five have died of respiratory causes, Kathleen Kreiss, a NIOSH expert in occupational respiratory disease, said in an e-mail. Dozens of cases of bronchiolitis obliterans — known in some circles as “popcorn lung” — have since been found at other food and flavorings plants. Farsalinos, who has accepted some funding from the vaping industry, said he believes that e-cigarettes are safer than tobacco cigarettes. Acetyl propionyl and diacetyl are also naturally present in cigarette smoke, Farsalinos said, at levels higher than those he found in e-cigs. Still, Farsalinos said, “these specific chemicals should be completely removed” from e-cigs. “Why? Because it’s a 100 percent avoidable risk.” Some manufacturers avoid diacetyl. For example, Nicoventures, a division of British American Tobacco, does not use diacetyl in its nine e-cigarette flavorings, Sandra Costigan, a company toxicologist said in an e-mail. The American Vaping Association, an advocacy group for the industry, believes that diacetyl and acetyl propionyl should not be added to e-cigarette flavorings, association president Gregory Conley said. In 2012 the Flavor and Extract Manufacturers Association, which represents the U.S. flavorings industry, issued a list of 27 “high-priority” flavoring chemicals that, while safe in food, may pose a risk of respiratory injury and for which it recommends reducing inhalation exposure. The list includes chemicals found in e-cig liquids, such as diacetyl and benzaldehyde, which is used in almond and cherry flavors. “When we saw flavors were being used in e-cigarettes, we wanted to put the word out right away that it’s a possibility that flavors being inhaled through an e-cigarette could also be harmful,” John Hallagan, the association’s senior adviser and general counsel, said in an interview. “Flavors are not made to be inhaled,” he said. “In the absence of safety information, what we’re saying is we really need to pay attention to this from a safety perspective.” A 2013 study found that several cinnamon-flavored e-cig liquids contained a chemical, cinnamaldehyde, that researchers said was highly toxic to human cells in lab tests. A co-author of that study, Prue Talbot, a professor of cell biology at the University of California at Riverside, said the results corroborated online reports by e-cig users of problems related to cinnamon flavors, including swollen throats and mouth sores. Another study examined 30 e-cigarette liquids and found that many flavors — including a cotton candy, a bubble gum and a French vanilla — contained aldehydes, a class of chemicals that can cause respiratory irritation, airway constriction and other effects. The 2015 paper described two flavors, a dark chocolate and a wild cherry, that would expose vapers to more than twice the recommended workplace safety limit for the aldehydes vanillin and benzaldehyde. Different brands and even different batches of e-cig liquids can contain different amounts of flavoring chemicals. “There’s no going by the flavor names as to say what’s in it,” said James Pankow, a chemistry and engineering professor at Oregon’s Portland State University, one of the co-authors of the study. The FDA’s proposed rule on e-cigarettes would restrict sales to young people and prohibit unsubstantiated health claims. If e-cigs are brought under the FDA’s regulatory authority, the agency would have to go through additional rulemaking to set standards on flavorings, FDA spokesman Michael Felberbaum said in an e-mail. The FDA prohibits adding flavorings, other than menthol, in traditional tobacco cigarettes. Some e-cig companies are doing their own research on flavorings. Nicoventures, the British company, recently proposed a screening process to avoid liquid flavorings that are classified as respiratory allergens, carcinogenic, mutagenic or toxic to reproduction, among other criteria. The company has rejected diacetyl and acetaldehyde as flavorings and avoided developing a flavor that uses cocoa shell extract because of concerns that it might be a respiratory sensitizer, Costigan said in an e-mail. “We wanted to demonstrate that they [flavorings] could be used responsibly even when there are limitations in data,” she said. The company says that flavorings benefit public health by helping smokers transition away from combustible tobacco. However, the science isn’t settled yet on whether e-cigs help people quit tobacco cigarettes — or get them hooked. A recent study, for instance, found that ninth-graders who used e-cigs were about 2  1/ 2  times as likely as their peers to start smoking traditional cigarettes. Conley, of the American Vaping Association, says e-cigarettes flavored with watermelon helped him stop smoking five years ago, and he will fight to keep flavorings on the market. “There’s a reason why the gum, patch and lozenge have such pitiful success rates,” he said, referring to some common approaches to smoking cessation. “We have to avoid medicinalizing these products [e-cigarettes] and making them bland and boring,” he said. Even if e-cigarette users are exposed to diacetyl, he asserted, the risk of harm is only a fraction of that from smoking tobacco, which causes 480,000 deaths per year in the United States, according to federal data. Talbot, who conducted the cinnamon flavoring study, said the problem is that people are now “inhaling a product into their lungs, and we don't currently know what the consequences or long-term health effects of that will be.” While it is true, she said, that e-cIgs contain fewer chemicals than the brew of 7,000-plus that are in traditional cigarette smoke, “it would only take one bad one.” Hiles is a freelance journalist and an assistant professor at the University of Missouri School of Journalism in Columbia, Mo.

Kids believe e-cigs less dangerous than cigarettes

A majority of U.S. middle and high schoolers say that e-cigarettes are less harmful than traditional cigarettes and that such products as smokeless tobacco and cigars fall somewhere in between, according to national surveys. They’re not necessarily wrong, but that comes with caveats, experts say. “E-cigarette safety continues to be debated by public health experts,” said Stephen M. Amrock of Oregon Health and Science University in Portland, lead author of a study that analyzed attitudes about e-cigarettes. “U.S. youth may not be wrong that e-cigarettes are less harmful than cigarettes, but such a view captures only half the story,” Amrock said by email. “Less harmful does not equate with no harm.” Researchers used data from the 2012 and 2014 National Health and Nutrition Examination Surveys of children in grades 6 to 12. The surveys included questions about various tobacco products, asking participants’ perceptions of their harm and addictiveness. In 2014, almost three-quarters said e-cigarettes are less harmful than cigarettes, while only 26 percent said the same for cigars and 20 percent said the same for smokeless tobacco. Regarding addictiveness, almost half said e-cigarettes are less addictive than cigarettes, compared with 14 percent for smokeless tobacco and 31.5 percent for cigars. Users rated each product less harmful and addictive than did nonusers. Boys, Hispanic students and those living with a user of one of the products also were more likely to rate them less harmful or addictive. Between 2012 and 2014, more surveyed students thought they were able to assess the relative harm of e-cigarettes and increasingly believed them to be less harmful than cigarettes, according to the results, which appear in the journal Pediatrics. “Even over the past few years, our research captures a shift in children’s thinking about e-cigarettes,” Amrock said. “This comes at a time that e-cigarettes are now the most commonly used tobacco product among U.S. youth,” he added. “Children who believe e-cigarettes are safer are more likely to use e-cigarettes,” he noted. The Food and Drug Administration recently began to regulate e-cigarettes as tobacco, but those regulations have only partly taken hold, Amrock said.

E-cigarettes helped me quit smoking

Regarding the April 10 editorial “A risk worth taking”: I smoked off and on for more than 60 years. Nothing — not patches, not gum — helped beat my desire to smoke until the electronic cigarette came along. I have not smoked conventional cigarettes for two years. The e-cigarette I use comes with self-contained cartridges, so there is little danger of nicotine poisoning. In fact, I use nicotine-free cartridges, which give me the relaxation that I got from conventional cigarettes. No more morning hacking, shortness of breath and wheezing. I hope that the scientists who study the safety of e-cigarettes take into account the different types and methods used. ****Lucy Modrak** , Gainesville**

FDA backs low-nicotine cigarette research as it weighs new regulatory power

PITTSBURGH — Beverly Anusionwu, a smoker for three decades who favors Maverick menthols, was enticed to the small lab inside the University of Pittsburgh’s psychology department by an ad promising free cigarettes and a few bucks for her time. She spent a couple of hours on a recent morning answering questions about her medical history and undergoing a battery of cognitive tests. When she finished, researchers handed her five gray packs of cigarettes unlike any she had ever seen, along with instructions to report back daily on how much she was smoking and whether her cravings and moods changed. “Spectrum menthol,” Anusionwu said, reading the label aloud. “All right, then. I guess nicotine is nicotine.” Not quite. The Spectrum cigarettes she’ll be smoking for the next six weeks could contain as much as 95 percent less nicotine than her usual brand. Anusionwu, 54, is among the first of nearly 850 participants around the country who over the next year will help researchers and federal regulators try to answer an important question: How much does nicotine need to be reduced in cigarettes to make them less addictive? The answer to that question, long explored by academics, has taken on renewed urgency now that the Food and Drug Administration has the authority to regulate the amount of nicotine in cigarettes — although it can’t ban the substance outright. Congress gave the agency that unprecedented power in a landmark 2009 tobacco control law, and the FDA has faced growing pressure to use it — along with other efforts such as anti-smoking ad campaigns and graphic warning labels on cigarette packages — to reduce the estimated 443,000 deaths caused by smoking each year in the United States. Few experts argue that lowering levels of nicotine is the only solution to cutting the deadly toll of tobacco. And some say doing so too quickly risks unintended consequences, such as creating a black market for high-nicotine cigarettes or pushing smokers to compensate by smoking more or seeking equally harmful alternatives. But to advocates of the idea, the power to set limits on nicotine could hold the key to ending the checkered history of the cigarette. “Imagine a world where a cigarette wasn’t addictive,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, which provided millions of dollars to fund the Pittsburgh study and others like it. In that sort of world, the theory goes, longtime smokers might find it easier to drop the habit. Perhaps more important, the estimated 3,000 teenagers who try their first cigarette each day might not travel down the path of addiction and eventual disease. Harmful chemicals such as tar might remain, but without the ingredient most responsible for keeping people hooked — nicotine — the urge to smoke might wane. “The question is, how low would [FDA] have to go to produce a beneficial public health impact?” said Eric Donny, a University of Pittsburgh psychology professor overseeing the one-year project. The study unfolding in Pittsburgh and at nine other sites around the country is the largest of its type to date and eventually could give the agency the data it needs to set new, lower nicotine levels in cigarettes. “It’s been a key question in research for a while,” said Joni Rutter, acting director of the division of basic neuroscience and behavioral research at the National Institutes of Health, which has distributed the FDA’s tobacco research money through grants. “These studies are geared toward helping the FDA come up with these guidelines. They want evidence-based research to help them do that. We’re trying to help them achieve that goal.” Nearly two decades ago, in a seminal 1994 article in the New England Journal of Medicine, academics Neal Benowitz and Jack Henningfield proposed giving federal regulators the authority to reduce the nicotine content of cigarettes gradually until it reached a level that wouldn’t cause addiction. Their proposal came during a period of intense debate over the role of nicotine in keeping smokers smoking. An FDA advisory panel that year rejected the tobacco industry’s long-held position that the nicotine wasn’t addictive, and the following year an internal memo from tobacco manufacturer Philip Morris surfaced calling cigarettes “nicotine delivery systems” and asserting that nicotine was “the primary reason” people keep smoking. Despite the FDA’s efforts to regulate nicotine as a drug at the time, the agency would have to wait another 15 years for Congress to give it the ability to dictate how much nicotine companies could put in cigarettes. During the decades of political fights over whether — and how — the government should be allowed to regulate tobacco, researchers continued building a body of research on low-nicotine cigarettes. “What’s been found so far is that when people are given low-nicotine cigarettes, they do seem to reduce the number of cigarettes that they smoke,” said Dorothy Hatsukami, a psychiatry professor and director of the University of Minnesota’s Tobacco Research Programs, who is working with Donny on the study in Pittsburgh. “There are some promising results.” But plenty of unanswered questions remain. “I really don’t think we know what’s going to happen as we reduce nicotine levels,” said Gregory N. Connolly, a Harvard professor of public health and anti-smoking advocate who served on an FDA tobacco advisory panel before resigning in 2010. “Are people going to increase their smoking behavior [to compensate]? Are they going to reject the product? Tobacco addiction is very complex.” Connolly supports cutting nicotine levels, but notes that tobacco companies use other chemicals to create tastes and smells that enhance dependence on cigarettes. Focusing solely on nicotine could leave the door open for the industry to craft other creative ways to keep smokers hooked. Richmond lawyer Bryan M. Haynes, whose firm Troutman Sanders represents multiple tobacco firms, said the FDA should think long and hard before making major changes. “One consideration would be whether people smoke more cigarettes” if nicotine levels fall, Haynes said. Another consideration: “If you alter the fundamental properties of a product, people will start looking toward contraband. It could create black market.” Haynes also said any changes partly come down to fairness. While companies shouldn’t be allowed to increase nicotine levels to maximize addiction — one Massachusetts study years ago found that the amount of nicotine in most cigarettes actually rose an average of almost 10 percent from 1998 to 2004 — they shouldn’t be required to remove the nicotine that occurs naturally in tobacco. “It’s one thing to ensure that companies aren’t manipulating levels of nicotine to help keep people addicted,” he said. “But it’s another whole thing to tell the industry to alter a product and destroy its inherent properties when the public health benefit could be negligible.” William Phelps, a spokesman for Altria, the parent company of Philip Morris, said the company hopes the FDA will base any new nicotine regulations only on sound scientific data. “We’re aware the agency is funding research related to lower-nicotine cigarettes and will wait to see the outcome of that research,” he said. It likely will take the government years to figure out the low-nicotine riddle, but if anything, research on the topic is growing broader and more intense. The NIH’s National Institute on Drug Abuse has purchased millions of the Spectrum-brand cigarettes, which are made from genetically altered tobacco leaves and contain varying degrees of nicotine. Stored in a warehouse in North Carolina, the cigarettes are distributed free of charge to researchers around the country. The manufacturer that produces them, the 22nd Century Group, has sold the government 12 million low-nicotine cigarettes and plans to supply another 5.5 million soon, said founder and chief executive Joseph Pandolfino, whose company also has applied to the FDA to have one of its low-nicotine cigarettes licensed as a smoking-cessation device. Anusionwu and most other participants in the study getting underway in Pittsburgh and nine other cities, including at Johns Hopkins University, will smoke cigarettes containing a wide range of nicotine. After six weeks, researchers will ask them not to smoke for a day to see if they suffer withdrawal symptoms. They also will follow up to see whether the users’ smoking habits have changed, how they’re sleeping, and if the change in nicotine has altered their ability to concentrate. Next year, Hatsukami plans to oversee a larger and longer federally funded study to examine whether reducing nicotine levels quickly or gradually over time is more effective. Thomas J. Glynn, director of science and trends for the American Cancer Society, said that whatever the outcome, there’s little doubt that the FDA will move cautiously. But he said research like the kind taking place in Pittsburgh will help the agency build a case for exercising its newfound powers down the road. “This study will not be enough for FDA to say, ‘We’re ordering the reduction [in nicotine],’ ” he said. “But it’s going to take them a long way toward being able to do that if it shows people do smoke fewer cigarettes.” When and if that happens, former FDA commissioner David Kessler said in a 2010 interview, it could make a fundamental difference to the nation’s health. “If you do this, you can save 200,000 to 300,000 lives a year,” Kessler said. “Everything else pales in comparison.”

FDA to ease restrictions for smoking-cessation products

Are you concerned that you have been chewing Nicorette longer than recommended on the box? Have you ever had a lapse and smoked a cigarette while wearing a nicotine patch? The Food and Drug Administration has a reassuring message for you: Don’t worry about it and keep trying to quit. The agency announced Monday that it is relaxing some of the restrictions on labels for nicotine gum, patches and lozenges available over the counter. It is lifting a requirement that the products carry a strict limit on how long they can be used. And it is eliminating instructions that people stop using tobacco before starting one of the products. “If you are using an [over-the-counter nicotine replacement therapy] while trying to quit smoking but slip up and have a cigarette, you should not stop using [it],” the FDA said in its new consumer guidance. “You should keep using the [product] and keep trying to quit.” Smoking-cessation products contain the addictive substance nicotine but do not carry many of the other harmful chemicals found in cigarettes, chewing tobacco and snuff. The products, once available only by prescription, are now available over the counter. Several anti-smoking groups lobbied for the changes and lauded the FDA’s decision as a step that will help more people kick the habit. “These labeling changes recognize that cigarette smoking is extremely addictive, and most smokers make multiple attempts to quit before they succeed,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, one of the groups involved, said in a statement. Typically, the FDA approves such changes at the request of product manufacturers. But these actions came at the urging of health professionals and activists, who said that research no longer supports such strict rules and that they present a barrier for people trying to quit. Many smokers have a difficult time quitting in the eight, 10 or 12 weeks often listed as the limit for the safe use of over-the-counter smoking-cessation products, proponents said. And some stop using the products if they break down and have a smoke, fearing that it is not safe to double up. Years ago, “there were some concerns [about] getting too much nicotine and getting sick from that,” said Grail Sipes, senior regulatory counsel for the Office of Regulatory Policy at the FDA’s Center for Drug Evaluation and Research. Recent studies, however, show that this is not as risky as once feared. In one study the FDA cited Monday, more than 1,000 participants reported only minor, passing symptoms after using nicotine gum for a year or longer. Another study found that the long-term use of nicotine gum did not increase or decrease the likelihood of developing cancer. Other studies suggest a low likelihood of abuse or dependence. “What we’re saying is if people want to use [the products] a bit longer, that’s fine,” Sipes said. “In the same vein, if you want to use more than one [product] at once — a patch and also do gum — if you feel that that’s helping you, there’s not going to be a problem with that.”

Secondhand marijuana smoke is harmful, just like tobacco smoke

The Jan. 31 front-page article “D.C. rules on smoking pot may go down in ﬂames” described a “cloud of marijuana smoke” that rose from the audience at a Grateful Dead concert. That means the nonsmokers at the event were forced to inhale secondhand smoke. I doubt it would have been tolerated if audience members had lit tobacco cigarettes in the arena. Amid the controversies surrounding marijuana legalization, it’s important to understand that smoked marijuana is not just a drug. There’s a legitimate cardiovascular-health concern about exposure to the smoke itself, because secondhand marijuana smoke is similar to secondhand tobacco smoke, which impairs proper functioning of the arteries. Secondhand marijuana smoke impairs arterial function, and its effect is more extreme and lasts longer than that of secondhand tobacco smoke, potentially increasing the chances of heart attack and stroke. Exposing the public to secondhand marijuana smoke may put people at greater risk than if tobacco smoking were allowed in that space. However legal pot use is regulated, it should be understood that the adverse health effects of secondhand marijuana smoke exposure are not just hypothetical. Public smoke-free policies should include marijuana smoke. ****Matthew L. Springer** , San Francisco** The writer is a professor at the Center for Tobacco Control Research and Education at the University of California at San Francisco.

FDA: Menthol cigarettes probably pose greater health risk than standard ones

The Food and Drug Administration said for the first time Tuesday that menthol-flavored cigarettes probably pose a greater risk to public health than standard cigarettes, largely reaffirming the findings of an agency advisory committee two years ago and potentially laying the groundwork for tighter regulations in the future. In a 153-page “preliminary scientific evaluation,” the FDA found that although there is “little evidence” to suggest that menthol cigarettes are more toxic than non-menthol cigarettes, the mint flavor of menthol masks the harshness of tobacco, making it easier to get addicted and harder to quit. Despite those findings, the FDA stopped short Tuesday of proposing specific restrictions or a ban on menthol, instead saying it would solicit public input for the next two months before deciding how to proceed. That probably means that any potential regulations remain months, if not years, from becoming reality. The issue of menthol in cigarettes has long been controversial, in part because menthol cigarettes overwhelmingly are favored by African Americans and teenagers. Sales of them account for about a quarter of the U.S. cigarette market. But about 80 percent of black smokers prefer menthol, as do nearly half of all young smokers. When Congress gave the FDA power to regulate tobacco in 2009, lawmakers banned candy-, fruit- and spice-flavored cigarettes, saying manufacturers had used such products to lure young smokers into addiction. But the law exempted menthol, instead instructing the FDA to study the issue to determine whether restricting or banning menthol would benefit public health. In 2010, an FDA advisory panel made up of doctors, scientists and public- health experts convened to weigh that question. The next year, the group issued a 250-page report saying that menthol made it easier to get hooked and more difficult to quit smoking. The group concluded that “removal of menthol cigarettes from the marketplace would benefit the public health in the United States.” Meanwhile, the tobacco industry steadfastly defended its use of menthol, saying it is no more harmful than any other type of tobacco. Cigarette maker Philip Morris USA submitted its own report to the FDA, asserting that its scientific review had shown that restricting the use of menthol in cigarettes was “neither necessary or justified.” Another report, backed by R.J. Reynolds Tobacco and Lorillard Tobacco, maker of Newport, the country’s most prevalent brand of menthol cigarettes, warned of grave unintended consequences if the government banned menthol. “The evidence unequivocally shows that the result would be a dramatically larger illegal cigarette market than currently exists,” it said. “As a result, there also would be severe negative impacts on public health, including exposure of smokers to more harmful contraband cigarettes, increased access of youth to tobacco, increased criminal activity particularly in urban communities, reduced government revenues and loss of jobs.” Until Tuesday, the FDA had taken no public action on the topic for more than two years. Given the long wait, some tobacco-control advocates said the decision to seek more input was too timid even as they called the FDA’s findings a step in the right direction. “There is a real public-health cost to this delay,” said Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California at San Francisco. “But better late than never. “If FDA proceeds logically based on these conclusions, they’re going to have to ban menthol,” he added. Former FDA commissioner David Kessler, who has long favored tough government regulation of tobacco, praised the agency’s action. “This is about creating an administrative record, based on science, that is going to be sustainable when it’s subject to scrutiny,” he said. “I think the agency is doing a credible, methodical job.” Mitch Zeller, the head of the FDA’s Center for Tobacco Products, told reporters that there is “no holdup” in trying to settle the menthol issue. He said the agency merely wants to have a solid scientific basis for whatever regulations it might eventually pursue. “As a regulatory agency, we can only go as far as the regulatory science will take us,” he said. “The bottom line is, we need more information,” he added. In a statement Tuesday, Lorillard chief executive Murray Kessler said he was “encouraged” by the FDA’s vow to rely on sound science, which he said would show that his company’s primary product shouldn’t face any more scrutiny than other cigarettes. “It is Lorillard’s long-held belief,” he said, “that the best available science demonstrates that menthol cigarettes have the same health effects as non-menthol cigarettes and should be treated no differently.”