Recent amendments to the Food and Drug Regulations are designed to speed entry of new foods and use of new health claims
On April 26, the federal government announced it would be updating the Food and Drug Act to allow for quicker approval of new health claims and food additives. This announcement has been welcomed by industry, which has expressed concern over Health Canada’s ability to keep up with the latest developments under the current system.
In a nutshell, one of the biggest problems with the current system is that it requires amendments to the Act anytime Health Canada makes a new safety determination, for example, that a new food additive is safe or health claim is substantiated. This is because lists of approved food additives and health claims are explicitly included in the Act, item by item. Thus, anytime one of the lists is changed, the Act need to be amended.
As industry is all too aware, amending the Act is a very arduous process and can take many months and even years. As a result, Canadians are delayed access to the newest safe, innovative products, and the agency is unable to respond efficiently to the latest advances in science and technology, market trends or emerging food safety risks.
The proposed amendments (tabled in Bill C-38) provide for two targeted changes to the current regime: “Marketing Authorizations” (MA) and “Incorporation by Reference” (IbR). According to Health Canada, these tools will reduce delays, cut red tape and make the food regulatory system more efficient and flexible.
The proposed amendments to the Food and Drugs Act provide that the Health minister can issue a Marketing Authorization that exempts a product from specific prohibitions in the Act and Regulations. They also allow the minister to make general rules permitting the sale of foods and the use of substances in or on foods, and permitting the use of substantiated health claims.
The MA framework aims to provide the Health minister with an improved ability to act on certain food safety decisions. It will allegedly simplify and accelerate the approval of certain new or modified health claims for foods, and sets safe levels of acceptable substances for foods, such as food additives.
It is important to note that the new MAs only change the way decisions are implemented after scientific assessment by Health Canada. The proposed amendments do not change Health Canada’s scientific review process or the level or types of information industry will have to submit to support the use of new food additives or health claims.
Each MA will be issued having regard to a cost-benefit analysis, and the provisions allow the minister to apply specific conditions on the approval of a product or substance, allowing for greater flexibility to address specific risks.
Incorporation by Reference
Incorporation by Reference is a regulatory-making tool that essentially allows the government to make a document or list a part of the regulations without need for the lengthy amendment process.
Under the new proposed law, lists of approved health claims and food additives will be managed as publicly available documents that are incorporated by reference into the Regulations. This will make it much simpler and less time-consuming to add to, or change these lists, and will allow for changes to lists to be implemented as soon as the scientific assessment and related consultations have been completed.
Ideally, this will reduce red tape and provide Canadians with quicker access to the latest and greatest the food and beverage industry has to offer, while giving industry the ability to brand products with the latest and greatest health claims without delay.
The transition provisions of the proposed amendments provide that an interim MA that is issued and in effect immediately before the day on which the proposed amendments come into force continues to have effect until the earliest of (a) the day on which the minister publishes a notice cancelling the interim MA, (b) the day on which a MA that is issued has the same effect as the interim MA, or (c) two years after the day on which the interim MA is published in the Canada Gazette.
These proposed amendments come at a great time – just as the government announced that it would no longer allow food-like products to be marketed as Natural Health Products. That change will likely result in an increased number of applications for new food additives and health claims. Hopefully MAs and IbRs will be effectively used to move these new applications through the regulatory system and into the market quickly and efficiently.
Sara Zborovski is a partner at Gilbert’s LLP in Toronto, practicing food, beverage and drug law. She also hosts her own blog at www.thefoodlawyer.ca