In upcoming weeks, Health Canada is expected to release a draft
guidance document for consultation that will include proposed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 This draft guidance will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
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proposed policy, but it was withdrawn after stakeholders expressed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The draft guidance is expected to include a proposed definition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.
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