Health Canada transitions food-like natural health products to the food regulatory framework
In fall 2011, Health Canada began charting a course for the transition of food-like Natural Health Products (NHPs) to the food regulatory framework. The products swept up in this transition were NHPs that Health Canada determined better fit the regulatory definition of a food, including those in traditional food format (for example, energy drinks, vitamin waters, supplements in candy or bar form), as well as certain products at the food-NHP interface (such as powders and chews). Many of these products were licensed as NHPs, while others had been issued exemption numbers that allowed them to be marketed while the Natural Health Products Directorate (NHPD) processed their submissions. For some industry members who had grown accustomed to the NHP regulatory framework, the change in course was not necessarily welcome news. Since 2004, the NHPD had established clear guidelines for claims associated with vitamin and mineral supplementation, caffeine and herbal extracts such as green tea. The food regulatory framework, on the other hand, was uncharted territory.
Taking industry concerns into consideration, Health Canada announced that it would use Temporary Marketing Authorizations (TMAs) as a method of transitioning food-like NHPs to the food regulatory framework. Using the TMA mechanism, Health Canada can issue temporary authorization for the sale of a food that is otherwise non-compliant with the requirements of the Food and Drug Regulations (FDR). During the course of the temporary authorization (two to five years), industry and Health Canada will work together to conduct research and generate information in support of amendments to the FDR. These amendments will likely include new benchmarks for vitamin and mineral fortification of foods and the use of additives such as caffeine.
To accommodate the transition of food-like NHPs, in April 2012 Health Canada’s Food Directorate also indicated that it had made a fundamental shift in its approach to health claims for foods. This newly developed approach will permit foods to make health claims without prior approval provided they are true, not false or misleading and do not relate to the Schedule A diseases outlined in the Food and Drugs Act.
In addition, the Jobs, Growth and Long-term Prosperity Act, introduced in April 2012, included provisions which will assist in the transition by reducing the red tape and procedural hurdles associated with market access for new food products and ingredients. These amendments to the FDR gave Health Canada new tools to expedite the regulatory change for foods including the ability to reference administrative lists as part of regulations (for instance, incorporation by reference) and a broader authority to issue Marketing Authorisations permitting the use of new food ingredients and health claims.
In the last year Health Canada has also published new guidance for industry on the TMA process, a revamped TMA submission form and specific guidance on the first category of products to be reclassified as foods, energy drinks. In 2013, consumers will begin to see the effects of this transition as labelling for energy drinks, and eventually all transitioned products, becomes food compliant. Changes include the addition of Nutrition Facts tables and compliance with food allergen labelling requirements.
In the next year, we can expect more changes as Health Canada is expected to release benchmarks for the fortification of food-like NHPs with vitamins, minerals and amino acids. In addition, the regulations for the Safe Food for Canadians Act will outline the new mandatory licensing and registration regime for those who manufacture, store, package, label, import or export food products both within Canada and internationally.
Unfortunately, the journey forward for food-like NHPs remains unpredictable as although permanent regulatory change may be on the horizon, there are still many unknowns. While we can’t expect it to be smooth sailing for all food-like NHPs making the transition, Health Canada has charted a course that for the most part has avoided widespread disruption in the marketplace and will hopefully provide a balanced approach to the development of a new food regulatory framework.
Laura Gomez practises with the Food, NHP and Cosmetics Law Group in the Ottawa offices of Gowling Lafleur Henderson LLP. Vacationing Ronald Doering will return next month.