This article originally appeared in Food in Canada and is republished with the permission of the publisher.
Health Canada is proposing a new pre-market submission process for supplemented foods. Once finalized, this guidance will support the addition of new food categories and new ingredients to the supplemented food regime in Canada.
The supplemented food regulations that came into force last summer allow for the sale of certain categories of supplemented foods (e.g. bars, water-based beverages, chewing gum) supplemented with certain permitted ingredients (e.g. vitamins, minerals, amino acids, caffeine). It was supported by years of research under the temporary marketing authorization (TMA) regime. The ability to supplement foods is not a free for all - the categories, ingredients, and levels are limited, as set out in the Lists (the List of Permitted Supplemented Food Categories and the List of Permitted Supplemental Ingredients). Supplemented foods also have specific labelling requirements, including cautionary statements in some cases.
The draft guidance under consultation describes the process to request a change to the existing Lists. A submission must be filed, including a description of the requested change and scientific evidence that supports the safety of the change. If the requested change meets the requirements, the List will be updated.
With respect to safety of supplemental ingredients, the proposed process intends to address a range of ingredients, from plant extracts commonly used under the TMA regime, to new ingredients. A significant breadth of data is identified to support the addition of a new substance or modification to an existing entry. The Food Directorate will consider scientific evaluations and approvals from other programs, such as the European Union Food Safety Authority, but will conduct its own assessment. As such, it will be the responsibility of the applicant to submit sufficient information for a complete assessment, including a full review of the potential risks and toxicological data.
The list of toxicological data that can be submitted closely resembles that evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in their toxicology monographs, and includes acute, short- and long-term toxicity; genotoxicity; reproductive and developmental toxicity; and pharmacokinetics studies. The Food Directorate expects these studies to be performed according to robust testing standards and are supportive of non-animal methods, provided they give results of comparable quality.
The draft guidance provides human clinical trials may be submitted, but with the limiting condition that trials primarily focused on the therapeutic effects of the ingredient will not be considered "sufficient for use in a safety evaluation." Given the extent of the toxicological evidence contemplated, it would be valuable to stakeholders if the guidance included minimum evidence requirements, tailored to various levels of request complexity.
Also, the draft guidance doesn't include performance standards or timelines for the review of new submissions. The fact that the Lists are incorporated by reference, and can be changed without a formal regulatory process is beneficial, but reasonable and predictable performance standards for new submissions will be key to ensuring the framework is agile enough to encourage innovation and provide Canadians with safe access to new supplemented foods. Given how easy it is for Canadians to order online and legally import a variety of foods under personal exemptions, the Canadian regulatory regime needs to adapt to keep pace.