This article originally appeared in Food in Canada and is republished with the permission of the publisher.
In upcoming weeks, Health Canada is expected to release a draft guidance document for consultation that will include proposed criteria on the fortification of foods sold under a Temporary Marketing Authorization Letter (TMAL). This draft guidance will outline suggested maximum levels for the addition of vitamins, minerals and amino acids to a new category of "supplemented foods" - providing a window into what a future food fortification policy may look like. Health Canada will look to industry and stakeholders to provide comments on the draft guidance.
But why now? Health Canada has been working on a review of food fortification since 1998. In 2005, Health Canada released a proposed policy, but it was withdrawn after stakeholders expressed concerns about permitting discretionary fortification of foods. At the same time, the Natural Health Product Regulations came into force, creating an opening to sell a fortified food-like product as a natural health product (NHP). In all, it is estimated that between 2004 and 2012 more than 750 food-like NHPs obtained market access via this route.
In 2011, Health Canada took the position that products in food-like format, such as energy drinks, should not be regulated and sold as NHPs, and undertook to transition these products to the food regulatory framework. However, many products previously marketed as NHPs cannot legally be sold as foods because they do not meet the limitations on vitamin and mineral fortification or other requirements in the Food and Drug Regulations.
To facilitate the transition, Health Canada used TMALs which permit the sale of a safe, non-compliant food for a limited period of time while information is gathered to address gaps in data and updates to regulations are considered, drafted and approved. Since the transition began, 370 TMALs have been issued, 173 for caffeinated energy drinks and 197 for other food products like sports drinks, cereals and gum. Generally, the TMALs issued are valid for two to five years.
This answers the "why now" question - TMALs are a temporary measure and Health Canada can choose to move forward to develop an appropriate regulatory framework for these products, or otherwise risk perpetual uncertainty in the marketplace. But how will Health Canada effect these changes?
The draft guidance is expected to include a proposed definition of a "supplemented food" and will provide specific exclusions for foods intended for vulnerable populations such as children or pregnant women. Maximum levels of vitamins, minerals and amino acids to be added to foods sold under a TMAL will be proposed, likely with similar restrictions on the addition of ingredients such as herbal extracts as outlined in the Category Specific Guidance for Temporary Marketing Authorization for Caffeinated Energy Drinks. Health Canada has also indicated it will be exploring the use of product identifiers to assist consumers in distinguishing these products from conventional foods.
Future updates to regulations will be informed in part by these consultations as well as data and research gathered by industry on products sold under a TMAL. Health Canada is requiring TMAL holders to submit sales data and conduct research on marketing and consumer understanding. TMALs may also contain a requirement to report any consumption incidents linked to certain foods or ingredients, and guidance on this topic is expected in the near future.
As outlined by Health Canada when the transition began, ultimately, foods sold under TMALs may have to be reformulated or discontinued if they are not compliant with the changes that result from the current review.
While the transition of NHPs to the food regulatory framework was achieved without much fanfare, this draft guidance is likely to raise a few eyebrows. It is not yet clear how Health Canada will address the concerns expressed by stakeholders which halted prior attempts at regulatory change - including controversial issues such as the fortification of so called "junk foods" versus the right of Canadians to have choice. While change may be contentious, hopefully this kick at the can will lead to changes in food policy that will provide greater legal clarity to the food industry.
Laura Gomez and Katrina Coughlin work at the Ottawa offices of Gowling Lafleur Henderson, practicing primarily in the area of regulatory law. Contact Laura Gomez at Laura.Gomez@gowlingwlg.com. Ron Doering returns next month.