In June 2014, Health Canada made a guidance document available
for consultation entitled Category Specific Guidance for
Temporary Marketing Authorization: Beverages, Beverage Mixes and
Concentrates, Powders, Bars and Confectionaries. But don't
be fooled by the innocuous title and limited consultation (it
isn't published on Health Canada's website); this draft
guidance introduces the possibility of dramatic change to
Canada's food laws, including a new category of
"supplemented foods," with tremendous implications and
opportunities for the food industry.
What is a "supplemented food"? The proposed definition
is a food that has been modified or has added substances, such as
vitamins, minerals, amino acids, herbals or bioactives, with the
intent of providing a health benefit. This definition is broad, but
it's limited by exclusions for certain foods fortified to
address a known public health issue (e.g. vitamin D in milk), foods
making health claims relating to diseases, disorders or abnormal
physical states in Schedule A of the Food and Drugs Act,
foods targeted to children under 4 years or pregnant/breastfeeding
women, foods regulated under Divisions 24 & 25 of the Food
and Drug Regulations (e.g. meal replacements, infant foods,
human milk substitutes), traditional medicines and novel foods.
The proposed framework outlines how supplemented foods could be
formulated, sold and marketed, including maximum levels for
vitamins, minerals and amino acids (based on a total of both added
and naturally occurring amounts), criteria for the addition of
caffeine and a prohibition on sampling to children. It also
describes labelling requirements being considered, such as standard
formatting for cautionary statements and directions of use, and a
mandatory product identifier on principle display panels to help
consumers distinguish supplemented foods from conventional
Once the guidance is finalized (expected in 2015), products must
meet the eligibility criteria when applying for a Temporary
Marketing Authorization Letter (TMAL). Health Canada has informed
industry that all existing and new TMALs (issued prior to the final
guidance) will expire on Aug. 31, 2016, and as of that date,
products must comply with the final guidance in order to receive an
A key feature of the TMAL framework is that it provides industry
an opportunity to introduce new supplemented foods into the
marketplace, generating in-market data needed to help inform
potential regulatory changes so such products can be sold as
compliant foods. While Health Canada has decided to regulate
fortified products in food-like format as foods instead of NHPs (as
discussed in our March column), from a legal perspective, these
products could meet the definition of an NHP or a food and it will
take a change to regulations to transform this policy change into
Generating, collecting and analysing data to inform regulatory
change is a monumental task. The fortification limits outlined in
the draft guidance result from a model based upon 2004 Canadian
Community Health Survey (CCHS) data and arguably conservative
assumptions (e.g. consumption of 5 supplemented foods/day). This
data may not be reflective of current consumption patterns for a
variety of reasons. Health Canada is seeking industry participation
and input (e.g. consumption data and market research) to assess
along with 2015 CCHS data. Health Canada may also consider the New
Zealand marketplace, as a similar (though less conservative)
regulatory framework for supplemented foods was enacted there in
Stakeholders will likely expect Health Canada, and ultimately
industry, to justify the public health benefit of a change of this
magnitude to Canada's food laws. Concerns over displacement of
foods, supplementation of high-energy low-nutrition foods, and
over-consumption by children and teens have already been raised.
While research may help address data gaps, ensuring consumers
understand and follow label instructions will be a key aspect in
creating a new regulatory framework that permits development of
innovative new food products that provide health benefits and
increase consumer choice in the marketplace.
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