In March 2016, Health Canada released the Category Specific Guidance for Temporary Marketing Authorization: Supplemented Foods, dated February 2016 (Guide). The Guide is intended to provide a process through the use of a Temporary Marketing Authorization Letter (TMAL), allowing for the temporary sale of foods defined in the Guide as "supplemented foods." Consumption and usage data will be collected from TMAL holders to fill data gaps and allow for the development of amendments to the Food and Drug Regulations (FDR) facilitating market access for supplemented foods under the same regulatory system that applies to most other categories of foods.
A supplemented food is broadly defined as a pre-packaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. It is recognized that these ingredients may perform a physiological role beyond the provision of nutritive requirements. It is also anticipated that for most supplemented foods there may be language limiting the total daily consumption of supplemented foods, not consumed ad libitum.
The Guide is not intended to be a process to permit the addition of vitamins, minerals or amino acids for broad population-based public health needs, traditionally known as food fortification.
The Guide does not apply to supplemented foods that contain unapproved food additives, novel food ingredients (other than those set out in Appendix 2), alcohol, or caffeine outside of the permitted use as a food additive. The Guide does not apply to: foods recommended for children less than four years of age or pregnant/breastfeeding women, infant foods (Division 25 of the FDR), or foods for special dietary uses (Division 24 of the FDR, i.e. meal replacements, nutritional supplements).
The Guide limits the use of some vitamins and minerals, either by exclusion, setting out maximum limits on a "per serving basis," Path 1, or "per daily basis," Path 2, based on the age of the targeted population. No maximum limits are included for amino acids, which are addressed on a case-by-case basis.
The Guide sets out various tables: Table 1, vitamins and minerals that are not acceptable for addition for supplemented foods; Table 2, Path 1 limitations for products recommended for the general population, four years of age and older; and Table 3, Path 2 limitations for products intended for "adult use only." The "adult use only" limitation permits higher levels of vitamins and minerals to be added, but labelling is required to contain certain cautionary statements. The use of these statements is dependent on the perceived potential for adverse health effects. Table 5 sets out the labelling statements and corresponding nutrient threshold levels where cautionary statements are required.
Where cautionary statements are required, the holder of a TMAL is also required to maintain and submit an annual summary of all consumption incidents. A consumption incident is characterized by a suspected causal relationship between the consumption of a food and an adverse event.
Health Canada is exploring the possibility of requiring a front of pack identifier, visual or in text, to be included on the PDP of supplemented foods to help the consumer recognize that these foods are different from regular foods.
It is encouraging that the Food Directorate continues to look at ways to modernize the regulatory regime for a new category of products, allowing for industry to meet the increasing demands of consumers looking for an expanded food offering containing nutrients, including bioactive substances, with the intention of supplementing their health. A further encouraging note is the new approach implemented by the Food Directorate with respect to the inclusion of some novel food ingredients in supplemented foods. These novel food ingredients are not required to follow the traditional path, recognizing that supplemented foods are not likely to be consumed ad libitum and as such, the review will take this more limited consumption into account. With the change in oversight and interpretation of claims for foods, this new category of foods may represent a real opportunity for those wishing to bring supplemented foods to the marketplace. Let's hope the Food Directorate's effort to modernize continues.
This article originally appeared in Food in Canada.
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