In fall 2011, Health Canada began charting a course for the
transition of food-like Natural Health Products (NHPs) to the food
regulatory framework. The products swept up in this transition were
NHPs that Health Canada determined better fit the regulatory
definition of a food, including those in traditional food format
(for example, energy drinks, vitamin waters, supplements in candy
or bar form), as well as certain products at the food-NHP interface
(such as powders and chews). Many of these products were licensed
as NHPs, while others had been issued exemption numbers that
allowed them to be marketed while the Natural Health Products
Directorate (NHPD) processed their submissions. For some industry
members who had grown accustomed to the NHP regulatory framework,
the change in course was not necessarily welcome news. Since 2004,
the NHPD had established clear guidelines for claims associated
with vitamin and mineral supplementation, caffeine and herbal
extracts such as green tea. The food regulatory framework, on the
other hand, was uncharted territory.
Taking industry concerns into consideration, Health Canada
announced that it would use Temporary Marketing Authorizations
(TMAs) as a method of transitioning food-like NHPs to the food
regulatory framework. Using the TMA mechanism, Health Canada can
issue temporary authorization for the sale of a food that is
otherwise non-compliant with the requirements of the Food
and Drug Regulations (FDR). During the course of the temporary
authorization (two to five years), industry and Health Canada will
work together to conduct research and generate information in
support of amendments to the FDR. These amendments will likely
include new benchmarks for vitamin and mineral fortification of
foods and the use of additives such as caffeine.
To accommodate the transition of food-like NHPs, in April 2012
Health Canada’s Food Directorate also indicated that it had
made a fundamental shift in its approach to health claims for
foods. This newly developed approach will permit foods to make
health claims without prior approval provided they are true, not
false or misleading and do not relate to the Schedule A diseases
outlined in the Food and Drugs Act.
In addition, the Jobs, Growth and Long-term Prosperity
Act, introduced in April 2012, included provisions which will
assist in the transition by reducing the red tape and procedural
hurdles associated with market access for new food products and
ingredients. These amendments to the FDR gave Health Canada new
tools to expedite the regulatory change for foods including the
ability to reference administrative lists as part of regulations
(for instance, incorporation by reference) and a broader authority
to issue Marketing Authorisations permitting the use of new food
ingredients and health claims.
In the last year Health Canada has also published new guidance
for industry on the TMA process, a revamped TMA submission form and
specific guidance on the first category of products to be
reclassified as foods, energy drinks. In 2013, consumers will begin
to see the effects of this transition as labelling for energy
drinks, and eventually all transitioned products, becomes food
compliant. Changes include the addition of Nutrition Facts tables
and compliance with food allergen labelling requirements.
In the next year, we can expect more changes as Health Canada is
expected to release benchmarks for the fortification of food-like
NHPs with vitamins, minerals and amino acids. In addition, the
regulations for the Safe Food for Canadians Act will
outline the new mandatory licensing and registration regime for
those who manufacture, store, package, label, import or export food
products both within Canada and internationally.
Unfortunately, the journey forward for food-like NHPs remains
unpredictable as although permanent regulatory change may be on the
horizon, there are still many unknowns. While we can’t expect
it to be smooth sailing for all food-like NHPs making the
transition, Health Canada has charted a course that for the most
part has avoided widespread disruption in the marketplace and will
hopefully provide a balanced approach to the development of a new
food regulatory framework.
This article originally appeared in the March issue of Food
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