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FDA Announces FSMA Food Traceability Proposed Rule
Post author By Quality Smart Solutions
On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record keeping requirements for certain foods.
Although existing FDA regulations already require that certain records are established and maintained, it only forms a baseline for traceability record keeping. These additional proposed requirements will not only allow for standardization of records throughout the industry but will also allow the FDA to more quickly identify a source of contaminated product, reduce the scope of recalls and conduct more timely root-cause investigations.
A list of foods that will be subject to the proposed requirements has also be drafted and can be found here, "Food Traceability List". The requirements of this proposed rule would only apply to foods that are on the FTL, which includes foods that have the listed foods as ingredients. However, the FDA encourages the voluntary adoption of these practices for all foods.
Critical Tracking Events (CTEs)
Growing, receiving, transforming, creating and shipping have been identified as CTEs where records with Key Data Elements will be required. These records will need to contain the traceability lot code of the foods relevant to these elements.
Traceability Program Records
Additionally, any persons who manufacture, process, pack or hold foods that are listed on the FTL will be required to maintain traceability program records.
A description of relevant reference records – This traceability program record must include a description of the reference record including where on the reference record the traceability information appears.
A list of foods on the FTL that are shipped – Anyone who ships food that is listed on the FTL is required to keep a list of which listed foods they ship. This includes the traceability product identifier and the traceability product description for each food.
A description of how traceability lot codes are assigned.
Other information needed to understand the data provided within the require records.
The proposed rule would also require that:
Records be maintained as either original paper records, electronic records, or true copies. They must also be legible and stored in a way that will prevent deterioration or loss.
Traceability records must be provided to the FDA no later than 24 hours after the request is made.
An electronic sortable spreadsheet containing all relevant traceability information must be provided to the FDA within 24 hours of a request when necessary to assist during an outbreak, recall or other threat to public health.
Full details can be found here https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-food-traceability?utm_medium=email&utm_source=govdelivery
Tags FDA, Food, FSMA, Records, Traceability
What is HACCP and Food Handler's Certification
What is HACCP Plan
Food safety is always evolving and becoming more complex, as companies require constant updating with safety regulations and industry trends. Before discussing about What is HACCP Plan , let's talk about the importance of Food Safety Training. According to Health Canada, an average of four million cases of food borne illness occurs every year, over 11,000 Canadians are hospitalized, and more than 200 people die. Food safety incidents are serious and should not be taken lightly. The solution to reducing and preventing such negative consequences is proper food safety training. HACCP Certification and Food Handler's certification are two methods to ensure food safety procedures are put into place.
Importance of HACCP Plan
Hazard Analysis Critical Control Points is a system that establishes safety guidelines in all stages of food production and processing. HACCP Certification analyzes and manages physical, chemical, and biological hazards in food production and handling, all the way up to distribution and consumption of the food products.
There are seven principles of this certification that ensure food products are consumed as safely as possible.
To be reputable and trustworthy, this certification is expected in any organization that is involved in the food production business. In countries like Canada and the USA, HACCP Certification is mandatory and annually audited. Overall, this prevents risks that can lead to severe financial, legal, and health consequences.
Importance of Food Handler's Certification
For many of us, food handling practices are considered common sense, as they are such a frequent occurrence in everyday life. However, "common sense" is not on par with the level of professionalism required to serve food products to the public.
The majority of food-borne illnesses are caused by food-handling mistakes, improper food preparation, mishandling equipment, and poor personal hygiene. A Food Handler's Certificate ensures front line workers must:
Understand how food become contaminated
Understand causes of food-born illness
Know how to store, prepare, cook, and serve food
Know how to clean equipment, supplies, and surroundings
Obtaining a Food Handler's certificate ensures the knowledge and skills are acquired to handle food safely at a higher standard. There are also numerous benefits that a Food Hander's certificate can serve:
Protect business reputation
Prevent customer complaints and media scrutiny
Reduce unnecessary operational costs such as pest control and food wastage
Avoid legal fines or business closures.
Food Safety Training is Essential
HACCP and the Food Handler's Certificate are important in today's food industry, as consumers demand higher quality, and government agencies are critical in food safety measures. Food safety is training is essential as it is mandatory in many countries. Legal and financial penalties can occur if companies and workers fail to obtain training. Quality Smart Solutions delivers high-end training and consultation to help your business grow and comply with industry safety standards. To find out more on our services, do not hesitate to contact us.
Tags FOOD HANDLERS CERTIFICATION, HACCP CERTIFICATION, HACCP PLAN, WHAT IS HACCP
Protecting Canadians from Unsafe Drugs Act
close up of a group of white tablets with an out of focus prescription bottle in the background
The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) introduces amendments to the Food and Drugs Act that will improve Health Canada's ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified.
These amendments are designed to better protect a patient's health and safety, and increase consumer confidence in therapeutic products on the market. The Act applies to therapeutic products, including: prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices. The amendments brought to the Food and Drugs Act by Vanessa's Law do not apply to natural health products, which continue to be regulated under the existing Natural Health Product Regulations (NHPR) of the Food and Drugs Act.
Key amendments to the Food and Drugs Act include:
New power for the Minister to require companies to modify or replace drug or medical device labels or packaging
In certain situations, the potential harm from the use of the therapeutic product may not be adequately reflected on the approved label. In addition, similar looking or sounding brand names or similar looking packaging may pose a risk to health and lead to prescribing and dispensing errors. When a determination is made that it is necessary to make revisions to prevent injury to health, the Minister of Health will now be able to direct an authorization holder to revise the label of a therapeutic product to include new harm information, or to change the brand name or packaging.
New power for the Minister to recall unsafe therapeutic products
The Minister of Health will now be able to order the removal of a therapeutic product from the marketplace when a product presents an imminent or serious risk to health.
New powers for the Minister to compel information, gather more information, require new tests or studies, monitor experience, and conduct product assessments
Over the course of a therapeutic product's lifecycle, new information may raise questions about the product's effect on health and safety. The Minister of Health will now have the authority to gather more information about the product. This can be done either by compelling persons to provide information for the purpose of assessing serious risks to health, or by requiring a therapeutic product authorization holder to compile information, conduct new tests or studies, or monitor experience. The Minister of Health may also direct a therapeutic product authorization holder to assess the benefits, harms and uncertainties of a product.
Tougher measures for those who do not comply
Fines and penalties for those who do not comply with the Act will be increased, to a maximum penalty of $5,000,000 or 2 years in prison, to better reflect the serious nature of the offence. Additionally, a person who knowingly makes a false or misleading statement to the Minister of Health, or who knowingly or recklessly causes a serious risk of injury in contravening the Act or its regulations, could face a higher fine or up to five years in jail, at the discretion of the court. An injunction power will also be added, such that, upon application of the Minister of Health, a court will be able to order a person to refrain from performing an act related to the commission of an offence under the Act.
Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions
Certain healthcare institutions will be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.
While most drugs are prescribed and used by patients outside of healthcare institutions, patients who experience serious reactions to drugs generally require hospitalization. Healthcare institutions, such as hospitals, are therefore in a unique position to identify and report serious adverse reactions. Certain healthcare institutions will now be required to report serious adverse drug reactions and medical device incidents to the Minister of Health.
New ability for the Minister to disclose confidential business information related to therapeutic product safety
The Minister of Health will now have the authority to disclose confidential business information about a therapeutic product if the Minister believes it is necessary to determine whether a therapeutic product presents a serious risk of injury to human health. As well, the Minister may now disclose confidential business information about a therapeutic product to a government, a person from whom the Minister seeks advice, or a person who carries out functions relating to the protection or promotion of human health or the safety of the public. This disclosure of info is authorized if the purpose of the disclosure is related to the protection or promotion of human health, or the safety of the public.
Obligation on therapeutic product authorization holders to make information about clinical trials publicly available
This new section places an obligation on therapeutic product authorization holders to ensure that prescribed information concerning any clinical trial is made public in a time and manner that will be set out in regulations. This could be accomplished by requiring mandatory registration of those trials on publicly accessible, well-established clinical trial registries.
If you want to be sure you are in compliance with the Canadian regulatory requirements, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.
Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), 2014, https://laws-lois.justice.gc.ca/eng/annualstatutes/2014_24/page-1.html
Overview of Vanessa's Law, 2014, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines/overview-vannessa-law-protecting-canadians-unsafe-drugs-act-vanessa-law-amendments-food-drugs-act.html
Protecting Canadians from Unsafe Drugs Act (Vanessa's Law): Questions/Answers, 2014, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines/questions-answers-regarding-law-protecting-canadians-unsafe-drugs-act-vanessa-law.html
Tags Drug
Reporting Adverse Reactions to Marketed Health Products
All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only after a product is in use by consumers. Reporting a suspected adverse reaction helps to identify potential safety issues and improve health product safety for all Canadians.
Every marketing authorization holder is required to report serious Adverse Reactions (AR) known to them involving their marketed health products, in accordance with the requirements of the Food and Drugs Act and the Regulations.
An Adverse Reaction is a noxious and unintended response to a drug taken at doses normally used, and is characterized by the fact that a causal relationship between the drug and the response is suspected. If the noxious and unintended response requires hospitalization, is life-threatening, or results in death, it is considered a Serious Adverse Reaction. Health professionals and consumers are also encouraged to report adverse reactions if they suspect an adverse event is related to a health product.
Every marketing authorization holder (MAH) should put into place written procedures for the receipt, evaluation, and reporting of ARs. Reporting of ARs electronically is the preferred and most reliable method for MAHs to comply with regulatory timelines.
Marketing authorization holders who do not yet meet the technical requirements to submit ARs electronically may continue to send AR reports to the Marketed Health Product Directorate (MHPD) by fax or postal mail. The regulatory reporting time clock is considered to start on the day when the MAH first receives all the information that satisfies the minimum criteria for an AR report. This date should be considered day '0'. The minimum criteria for an AR report includes the following components:
An identifiable reporter (source)
An identifiable patient
A suspected health product
An adverse reaction
Reporting Domestic Adverse Reaction
AR reports concerning reactions occurring in Canada, to a product that is marketed in Canada, are considered "domestic" AR reports.
In order to report in accordance with the Regulations, each MAH should report to MHPD within 15 calendar days of receiving the relevant information the following domestic reports:
serious ARs
unusual failure in efficacy reports for new drugs
Reporting Foreign Adverse Reaction Reports
Foreign AR reports are those concerning reactions occurring outside Canada to a product that is marketed in Canada.
In order to report in accordance with the Regulations, each MAH should report to MHPD within 15 calendar days of receiving the relevant information the following foreign reports:
serious unexpected Adverse Reactions (An AR is considered 'unexpected' when its nature, severity or frequency is either not identified, or is not consistent with the terms or description used in the product labelling. In cases where the MAH is uncertain whether an AR is expected or unexpected, the AR should be treated as unexpected).
In addition, all foreign serious unexpected AR reports involving the MAH's foreign products, with the same combination of active ingredients that is also marketed in Canada, must be reported to MHPD in accordance with the Regulations.
If you want to ensure you are in compliance with Canadian regulatory requirements with respect to reporting adverse reactions (ARs) to marketed health products, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry, Health Canada, 2018 https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry/guidance-document.html
Post-Drug Identification Number (DIN) Changes
All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN). After gaining authorization to market a drug, a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. For those drugs regulated under Part C, Division 1 of the Regulations ("Old Drugs") the sponsor must comply filing requirements for post-DIN changes when undertaking any changes.
Health Canada recognizes that any change to a drug may impact the safety, efficacy or quality of that drug and/or the safe and effective use of that drug. To manage these risks, Health Canada requires the sponsor of a drug that has received a DIN and is not a New Drug to report changes to the drug via a DIN Application or Notification and any data (if applicable) to support the change.
Post-DIN changes filed through a Drug Identification Number (DIN) Application
The changes included in this reporting category shall be filed, along with any recommended supporting data, to Health Canada as a DIN Application. Any change that requires a DIN application to be filed may not be implemented prior to the review of the supporting data by Health Canada and confirmation that this data is acceptable in support of the change. If acceptable, a new DIN may be issued, or the existing DIN may be retained for the changed drug, and a No Objection Letter will be issued.
Examples of changes included in this reporting category:
Change in name of the manufacturer for a human, veterinary or a disinfectant drug.
Addition or change to the authorized route of administration.
Addition, deletion or change, including quantity, to the medicinal ingredients of the product.
Post-DIN changes filed through OSIP or SKMD Notification
The changes included in this reporting category should be filed, along with any recommended supporting documentation, to Health Canada as a notification, within 30 days of the change being implemented as defined in the Regulations. These notifications do not necessitate assessment by Health Canada.
Health Canada may, upon receipt of the notification:
– update its records;
– uphold the change;
– request that the change be undone, or;
– request that a DIN application be filed to support the change.
Although the sponsor is allowed to submit these notifications within 30 days of making the change, it is strongly recommended that notification be provided to Health Canada prior to the sale of the drug to enable a risk assessment of the change, and thus, better ensure the safety, efficacy and quality of the drug.
Any change in the name of the Canadian importer of the product listed on the original HC/SC 3011.
The name of the contact for the Drug Identification Number ownership, regulatory contact and/or billing contact changes.
Post-DIN changes filed through Post-Authorization Division 1 Change, PDC/VPDC
The changes included in this reporting category should be filed, along with any recommended supporting documentation, to Health Canada as a notification, within 30 days of the change being implemented as defined in the Regulations. These changes will be assessed by Health Canada and a standard PDC/VPDC has a service standard of 30 days. If the change is deemed acceptable, a No Objection Letter will be sent to the sponsor. If the change is deemed to fall outside the scope of a notification, Health Canada may request the re-filing of a full submission through the issuance of a Not Satisfactory Notice (NSN). Please note that if a NSN has been issued, the sponsor should refile a new PDC/VPDC or other submission to effectuate the authorization of any new revisions or changes.
Removing a therapeutic claim, indication, or condition of use (including removal of patient categories, claims about duration, onset of action, sterility etc.).
Additions or revisions to the adequate directions for use (that is, warnings, precautions, adverse event information etc.).
Not required to file
For changes where it is indicated in the guidance that no filing is necessary, the sponsor should maintain a record of the change in accordance with GMP and ensure that this information is made available to Health Canada if it is requested at any time.
The pharmacopeial standard used at time of original market authorization has been revised (e.g. authorized as United States Pharmacopeia (USP) grade, but USP revises standard).
Change to the Universal Product Code, item or lot number.
If you want to be sure your post-authorization changes are in compliance with Canadian regulatory requirements, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
Guidance Document: Post-Drug Identification Number (DIN) Changes, 2019/04/18, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-drug-identification-number-changes.html
Regulatory requirements for Drug Identification Numbers (DINs)
When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and must be printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations, and the drug has a favourable risk/benefit profile. Manufacturers of prescription and non-prescription drugs must obtain a DIN before they are marketed in Canada. The DIN assigned to a drug is unique and serves as a tool to help in the post-market activities of products on the market, such as product identification and verification by health care professionals, recall of products, inspections, and quality monitoring. While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.
DIN issuance by Health Canada to the manufacturer
Once a drug has been authorized for sale in Canada, Health Canada issues a DIN under Part C, Division 1 of the Food and Drug Regulations, which permits the manufacturer to market the drug in Canada. For drugs that meet the definition of a new drug under Part C, Division 8 of the Food and Drug Regulations, the drug is required to have a Notice of Compliance (NOC) in addition to a DIN, in order to be authorized for sale in Canada. The DIN is issued in the form of a Drug Notification Form (DNF). The DNF contains, in addition to the DIN, information that is specific to the drug as it has been authorized by Health Canada. DNFs are sent by email directly to the manufacturer by Health Canada. For manufacturers seeking authorization under Part C, Division 1 of the Food and Drug Regulations for drugs for human or veterinary use, no NOC is granted. Instead, the DIN, in the form of a DNF, represents the market authorization.
Issuance of a revised Drug Notification Form by Health Canada to the manufacturer
Any change that the manufacturer wants to make to one or more of the drug characteristics (i.e. Product name, manufacturer name, active ingredients, strength of active ingredients, dosage forms, route of administration) must be authorized by Health Canada before the DNF can be revised. A submission or application seeking authorization for the proposed changes must be filed. Changes to an authorized label to include or modify retail-specific branding elements (e.g., graphics, colour, and font, etc.) also may require a review and authorization by Health Canada before they can be introduced on the market. After the change is approved by Health Canada, a revised DNF with the same DIN or a new DIN may be issued to the manufacturer.
Filing of market notifications by the manufacturer to Health Canada
As per section C.01.014.3 of the Food and Drug Regulations, the manufacturer has the obligation to notify Health Canada when it first sells a drug that has been issued a DIN. A manufacturer must submit a completed DNF to Health Canada within 30 days of first selling the drug. The DNF must be filled out, signed, and dated. All pages of the DNF must be returned to Health Canada. If a manufacturer has been issued a revised DNF, it must notify Health Canada when it begins to market the drug with the authorized change within 30 day of selling the drug with new changes.
A market notification consists of:
A completed and signed DNF
Labelling material, when applicable
Filing of 12 months without sale notifications by the manufacturer to Health Canada
After a drug has been marketed, a manufacturer is obligated under the Food and Drug Regulations to report when 12 months have elapsed without a sale of its drug to Health Canada when the following conditions are met:
the drug has received an NOC and/or a DIN
the drug has been marketed; and
the drug has not been sold on the Canadian market for a period of 12 consecutive months
Manufacturers of all drugs are encouraged to report 12 months without sale within 30 days as this will allow Health Canada as well as patients, health care practitioners, and other health care stakeholders to have a clear and up to date picture of which drugs are available on the Canadian market. However, manufacturers of prescription drugs for human use must submit a notification to Health Canada within 30 calendar days after a period of 12 consecutive months without sale.
After a complete notification is received and processed, Health Canada updates the status of the drug in the Drug Product Database to "Dormant". A drug that is deemed Dormant is still authorized for sale in Canada.
Filing of discontinuation of sale notifications by the manufacturer to Health Canada
The manufacturer must submit the notification of discontinuation of sale within 30 days after the sale of the drug was discontinued as per section C.01.014.7 of the Food and Drug Regulations. The date of discontinuation is when the manufacturer last sells its drug, not when it is last sold at retail. Health Canada cancels the DIN further to the receipt of the notification.
The notification of discontinuation of sale from the manufacturer should be in writing on company letterhead and should provide the lot number and the expiry date of the last lot distributed in Canada, the discontinuation date, and signed by an authorized official.
If you want to be sure your products are in compliance with Canadian regulatory requirements associated with a DIN, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs), June 19, 2019, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-requirements-drug-identification-numbers/document.html
Plain Language Labelling Regulations
The label and package are the first points of interaction between a health product and a consumer. Prior to the implementation of the Plain Language Labelling (PLL) initiative, the general practice in Canada was to present key information within blocks of text on the product label. This sometimes made it difficult for the consumer to easily identify information necessary for appropriate selection and proper use of the product. In some cases, the information appeared in small type, with poor contrast between the label text and the background. All of these factors can prevent the consumer from finding the information needed to make informed purchasing decisions in a timely manner.
As part of Health Canada's PLL initiative, the outer label of non-prescription drugs is required by regulations to display a Canadian Drug Facts Table (CDFT) to place information required by the regulations in a standardized, easy-to-read format and in a consistent location on the label in order to enhance the safe and effective use of non-prescription drugs. The concept is similar to that of the Nutrition Facts Table for foods in Canada and the Drug Facts box required by the Food and Drug Administration for over-the-counter (OTC) drugs in the United States.
What are the Plain Language Labelling (PLL) Regulations?
The PLL Regulations impose new obligations on health products sponsors to:
Provide information in plain language;
Assess the name of their health products to avoid confusion;
Submit mock-ups of labels and packages for review;
Indicate how to report harm(s) on their product's label;
Provide information in an easy-to-read and standardized format, and;
Provide a Canadian Drug Facts Table (CDFT).
What products are within the scope of the PLL Regulations?
The PLL Regulations apply to prescription and non-prescription pharmaceutical drugs, biologic drugs, radiopharmaceuticals and disinfectants. However, there are specific requirements that only apply to subsets of these products. For example, the Canadian Drug Facts Table requirement only applies to non-prescription drugs. These PLL Regulations do not apply to medical devices, veterinary drugs, drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces, or natural health products.
When do the PLL Regulations come into force for non-prescription drugs?
For non-prescription products, the PLL Regulations came into force on June 13, 2017. New PLL requirements will be applied to submissions received on or after the coming into-force date.
By June 30, 2021, all non-prescription drug products must be in full compliance with the PLL Regulatory requirements at the retail level.
What is the purpose of submitting label mock-ups?
The Plain Language Labelling Regulations obliges sponsors to provide Health Canada with full color 2-dimensional mock-ups of labels and packages that represents the information consumers and health professionals will see at the time of filing an application for a drug identification number. These mock-ups will be reviewed by Health Canada to ensure labels comply with existing regulatory requirements on labelling. The review will focus on (but is not limited to) comprehension, legibility, accuracy and valid application of the CDFT, and design elements such as font size, type, colour, and placement.
What flexibilities are available for the Canadian Drug Facts Table (CDFT)?
All products under the scope of the PLL Regulations must provide a CDFT. However, some products and package sizes may not present sufficient space to accommodate the CDFT in the standard format on the label. In some cases, an innovative label may be the most effective way to accommodate the space requirements of the CDFT. In other cases, a modified format with graduated flexibilities may be considered according to the criteria outlined in Table 3 of the Guidance Document: Labelling Requirements for Non-prescription Drugs.
If you want to be sure your product labels and packages are in compliance with Canadian Plain Language Labelling requirements, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
Guidance document: Labelling Requirements for Non-prescription Drugs, 2018-09-28, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling-requirements-non-prescription-drugs.html
Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs, 2018-09-28, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-questions-answers-plain-language-labelling-regulations-non-prescription-drugs-contact-lens-disinfectants.html
Consumer Advertising of Health Products
In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this article will discuss some of the specific requirements concerning the advertising of health products towards consumers. The overriding principle lies within the Canadian Food and Drugs Act, which prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Health product advertising is any consumer-directed advertising of health products, including nonprescription drugs, natural health products, medical devices and vaccines, in all Canadian media. Canadian "media" include, but are not limited to: television, radio, mass print, billboards, transit, in-store promotional materials, direct mail, websites, e-mail, mobile, and social media. Here are some of the common items to watch out for:
Therapeutic claims, directions of use, and duration of use must be consistent with the terms of Marketing Authorization.
A product's terms of Marketing Authorization (TMA) sets out the claims authorized by Health Canada. These claims may be paraphrased, but must not directly or indirectly exceed the scope of the TMA. Any visuals, graphics, or schematics, should not be used to directly or indirectly suggest product benefits that exceed those found in the TMA.
TMA for Nonprescription drugs: Labelling Standards/Category IV Monograph, approved product labels and product monographs
TMA for Natural Health Products (NHPs): Product Licence
TMA for Medical Devices: Medical Device Licence and approved Labels (Class II-IV)
For example, the authorized indication for product X is "Adequate calcium as part of a healthy diet may help prevent bone loss/osteoporosis." An acceptable claim that you may use in advertising is, "Product X calcium supplement MAY assist in the prevention of osteoporosis". An unacceptable claim would be, "Product X calcium supplement prevents osteoporosis".
An advertisement must not suggest that a child is capable of making a rational decision regarding the use of the advertised health product.
Health product advertising must be overtly directed to adults only. An advertisement must not depict or encourage unsupervised use of drugs by children, or suggest that a child can self-diagnose or self-medicate. In addition, advertisements must not depict product storage in locations accessible to children. A child may approve of the taste of a medicine, but may not make recommendations concerning the use of the advertised product.
Terms that communicate a product is new, improved or reformulated may be used for a period of one year from the date it is first available for retail sale.
Examples of these terms include "new", "improved", "now available", and "introducing".The product attribute that is new or improved should be clearly specified, e.g. "improved taste", "new format".
When depicted or described, product performance must be consistent with the TMA and should not be exaggerated.
Hyperbolic terminology, e.g. "amazing", "powerful", "fantastic", should not be used to exaggerate the therapeutic effect/benefit of a product or ingredient. Advertising should not suggest that a product is "potent" or has a "potent" formulation, or imply the product is powerful, strong or more effective based on the amount of medicinal ingredient(s).
All health products are authorized to be effective for the condition/symptoms they are designed to relieve/treat/prevent, and therefore, can claim to be "effective", "strong enough", "tough enough" or have the power to relieve/treat/prevent the condition/symptoms in question. However, it is unacceptable to suggest that the product in and of itself is "strong" or "powerful".
An advertisement should not suggest that product use is "essential". It is acceptable to communicate that one "needs or wants relief". However, it is unacceptable to claim that a consumer "needs" a specific health product or ingredient.
For example, the authorized indication for product X is "For the treatment/management of acne." An acceptable claim that you may use in advertising is "Clear your face. Fight acne with the power of Product X. It worked for me!" An unacceptable claim would be "Fight acne with powerful Product X!"
Therapeutic guarantees are not permitted in advertising.
An advertisement should not directly or indirectly suggest that a product is effective for all individuals, or that it will be effective every single time it is used. Guarantees of overall product satisfaction or other non-therapeutic attributes (e.g. purity, quality or physical characteristics) are acceptable if true and supported.
For example, an acceptable claim that you may use in advertising is "Satisfaction guaranteed, or your money back". An unacceptable claim would be "Guaranteed relief, or your money back".
If you want to be sure your health products are advertised in compliance with Canadian legislations and requirements, Quality Smart Solutions has a team of specialists who can assist with developing messages that comply with the advertising provisions of Canadian federal legislations and are in accordance with Health Canada policies and guidance documents. Get prepared now and contact us today to discuss how we can be your solution!
References Guidelines for Consumer Advertising of Health Products, 2018, Ad Standards, https://adstandards.ca/wp-content/uploads/2018/07/Consumer-Advertising-Guidelines-for-Marketed-Health-Products-EN.
Illegal Marketing of Drugs and Medical Devices in Canada
Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and enforces the regulatory requirements related to health product advertising. While smart marketing strategies are important for driving sales, it is also crucial to ensure those strategies comply with Canadian legislative and regulatory requirements.
The Canadian Food and Drugs Act prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. BEWARE of these common illegal marketing practices!
Promoting an Unauthorized Product:
Marketing of prescription drugs, non-prescription drugs, natural health products, as well as Class II, III and IV medical devices is prohibited unless the product is authorized for sale by Health Canada. All medical devices (with the exception of Class I devices) must obtain marketing authorization from Health Canada in the form of a Medical Device Licence before it can be marketed in Canada. All natural health products must obtain marketing authorization from Health Canada in the form of a Product Licence, and be assigned a NPN number. Similarly, all drugs (prescription and non-prescription drugs) must obtain approval from Health Canada and be assigned a DIN number.
Promoting Unauthorized (Off-Label) use:
Prescription drugs, over-the-counter drugs, natural health products, as well as Class II, III and IV medical devices are authorized by Health Canada for specific indications. These products may not be marketed for uses beyond the scope of the Health Canada authorized indications or notified recommended uses. For example, if a particular opioid product is authorized by Health Canada to "treat moderate to severe pain", you would be prohibited to claim that the product can be used to treat "mild pain", or give misleading impression that the product is intended to be used in this manner.
Omitting or Downplaying Risks:
Marketing of drugs and medical devices to health care providers, including any promotional materials, must present product information in a balanced manner. Risk information including side effects, contraindications, warnings and precautions must be clearly presented and given the same prominence as the therapeutic benefits of the product. In addition, since all health products, including those derived from nature, carry some degree of risk, it is unacceptable to suggest that a product is "safe", is "side effect free", or has "no known side effects".
Overstating Effectiveness:
Some companies may be tempted to promote their products by exaggerating their effectiveness. However, this is strictly prohibited. Promotional claims must not be directly or indirectly inconsistent with the scope of the Marketing Authorization, including the approved product licence, the product monograph, or the product label. For example, a drug may not be marketed as "providing relief within 2 days" when the approved product monograph indicates that the drug provides relief after 10 days.
Misleading Endorsements:
Endorsements, seals of recognized organizations, testimonials and quotations are only acceptable if they represent the honest and current opinions of the individuals or organizations. Furthermore, they must be consistent with the Health Canada-authorized indications for the product. Claims of endorsement by government authorities, such as Health Canada itself, are not permitted. While Health Canada authorizes products for sale for specific indications, you cannot advertise the product as "approved" or "endorsed" by Health Canada. Thus, only claims of Health Canada authorization are permitted, meaning you may claim the product is "authorized for sale by Health Canada".
Misleading Comparative Claims:
A common advertising strategy is to promote products through comparisons with other products on the market. These comparisons may claim that their product is equivalent, non-inferior or superior to an established product in terms of effectiveness or safety based on scientific evidence or data. You cannot make any untrue or exaggerated comparative claims. The comparative claims must also be within the terms of the authorized indications of the compared products. In addition, all comparative claims must follow additional requirements outlined in the Therapeutic Comparative Advertising Directive.
Direct-to-Consumer Marketing of Prescription Drugs:
Direct-to-consumer marketing of prescription drugs is restricted. Any drug product listed in the Prescription Drug List is subject to Section C.01.044 of the Food and Drug Regulations. This prohibits consumer-directed prescription drug advertising beyond the drug's name, price and quantity. This means, for example, that when a prescription drug is advertised by name to consumers, no reference can be made to its therapeutic use and/or benefits.
Illegal marketing of health products may potentially harm patients and adversely influence prescribing practices by health care providers. Therefore, Health Canada is always proactively monitoring drug and device marketing to enforce the existing rules around illegal advertising, and take action where necessary, including recommending criminal charges where appropriate. More information on Health Canada's compliance and enforcement approach is available in the Inspectorate's Compliance and Enforcement Policy (POL-0001).
If you want to be sure your health products are marketed in compliance with Canadian legislations and requirements, Quality Smart Solutions has a team of specialists who can assist with preparing and obtaining marketing authorization for your product or reviewing your promotional materials. Get prepared now and contact us today to discuss how we can be your solution!
Canadian Food and Drugs Act, 2019-06-21, https://laws-lois.justice.gc.ca/eng/acts/f-27/
Inspectorate's Compliance and Enforcement Policy (POL-0001), 2018-12-21, https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html
Stop illegal marketing of drugs and devices, Health Canada, 2019-08-29, https://www.canada.ca/en/health-canada/services/drugs-health-products/marketing-drugs-devices/illegal-marketing/stop.html
SFCR: What to expect when you're inspected?
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into effect on January 15, 2019. The new regulations will require food businesses that import or prepare food for export/interprovincial shipping to have licences, as well as preventive controls that outline steps to address potential risks to food safety.
The Canadian Food Inspection Agency (CFIA) currently conducts inspections of production facilities, importers/exporters and retail outlets. Under the new SFCR, the manner in which the CFIA conducts these inspections may be enhanced and there are many reasons why CFIA will inspect your facility, including:
Verification of compliance against regulations
Responding to industry request (i.e. import/export permits)
Following up on previous inspections
Investigation facility or product contamination
So, what will occur when CFIA inspects your facility under the new regulations?
Before Inspection:
Your company receives a notice from CFIA for inspection
An inspector will meet with your company to determine scope. Your Preventative Control Plan (PCP) will need to be provided at this time.
Inspector conducts initial walk through and confirms scope
During Inspection:
Inspector determines if the regulatory requirements have been met and completes an initial inspection report
Inspector determines if the elements of the preventative control are complete and effective
After Inspection:
The inspector will meet to discuss inspection results and the final report is given to your company
Your company takes corrective actions on any noted non-compliances identified during inspection
The inspector schedules a follow up inspection
If you want to be sure your food safety practises are in line with the new SFCR and will pass the CFIA's inspection, Quality Smart Solutions has a team of specialists who can assist with preparing and implementing a PCP or reviewing your documents and conducting an audit of your facility. Get prepared now and contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.
Canadian Food Inspection Agency. Inspection modernization. 2018-01-03. http://www.inspection.gc.ca/about-the-cfia/accountability/inspection-modernization/eng/1337025084336/1337025428609
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