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
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
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.
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