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in 2016, the food and drug administration (fda) denied an application from swedish match north america to classify their snus oral tobacco product as a “modified risk tobacco product” (mrtp). according to federal law, the purveyors of tobacco products that seek to amend and market their tobacco product differently from standard regulatory controls must seek approval from the fda. swedish match followed this process and submitted an mrtp application for eight general snus products to the agency’s tobacco products scientific advisory committee.
upon denial, the committee denied swedish match from amending their product’s packaging, advertising, and marketing materials. the company proposed to sell a product that removes legally required warning labels. to note, the mrtp suggested the removal of two types of warning labels: “one stating that the product can cause gum disease and tooth loss, and the other stating the product can cause mouth cancer,” according to an official agency commentary piece. under the requirements of section 911 of the federal food, drug, and cosmetic act of 1938, as amended, there needs to be demonstrable scientific evidence to justify the approval of an mrtp.
based on the evidence at the time provided to the agency, the justification to claim that snus, among other oral tobacco products, won’t cause gum disease, tooth loss, or even cases of oral cancer was lacking. while i agree with the agency in this regard, the fda should allow the claim that swedish snus is a safer alternative to traditional combustible tobacco and has provided population-level proof that these alternative nicotine products (anps) can give a full positive impact on public health than argued.
as the fda continues to extrapolate with the current amended mrtp application for swedish match, regulators should take stances more accepting of snus as a viable anp that offers notable harm reduction benefits. like e-cigarettes, snus, sadly, has always been the subject of scrutiny by foreign public health regulators and international bodies like the world health organization.
according to research published in the lancet academic journal by carol e. gartner et al., of the university of queensland, in australia, it was found that snus could provide overall benefits to a smoke-free population.
i wish to remind the fda, and international regulators, that smoking rates in sweden are the lowest in all of europe. only five percent of the swedish population smoke, while the prevalence of oral tobacco products, primarily snus, are among the highest in the population. while the widespread use is a question of overall public health, the fact that remains is that snus has proven to be a leading harm reduction strategy.
sadly, the majority of the european union has outlawed snus under the eu tobacco products directive. nonetheless, the proof is in the numbers. now in the united states, snus is becoming more and more popular among nicotine consumers, and companies wish to market the product as a less harmful alternative to traditional cigarettes. fda should allow companies greater latitude to promote products like snus as non-medical anps that can deliver a state of harm reduction and offer net benefit for a population’s health. as long as anps are compliant and companies know to communicate proof that these products are merely a solution to reduce the harm associated with tobacco consumption, there shouldn’t be such a restrictive process.
for the case of snus, the proof of reduced harm couldn’t be more evident. there is no founded proof that snus causes lung cancer given the fact that its used orally. snus doesnt increase risks for diabetes. several researchers have concluded that snus is at least 95 percent safer than traditional combustible tobacco. plus, given its classification as a “low risk” nicotine product and if you consider how snus is prepared (it’s pasteurized, not fermented like other dips and oral tobaccos), the exposure to bacteria and chemicals is limited. on content alone, a snus pouch only contains 8 to 10 milligrams of nicotine with only a fraction of the thousands of substances found in combustible cigarettes, suggesting a case of improved health outcomes if a consumer chooses to use snus.
michael mcgrady is the executive director of mcgrady policy research & public affairs. he is also a public policy columnist for the geneva, switzerland-based vaping post and an international journalist covering foreign affairs, economics, and public health issues. an independent researcher, most of mcgradys recent work focuses on tobacco harm reduction and the vaping industry. he submitted this piece on his own accord, and his opinions dont necessarily reflect the views of his publishers or partners.
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