This article originally appeared in Food in Canada and is republished with the permission of the publisher.
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don't be fooled by the innocuous title and limited consultation (it isn't published on Health Canada's website); this draft guidance introduces the possibility of dramatic change to Canada's food laws, including a new category of "supplemented foods," with tremendous implications and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 four 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 foods.
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 extension.
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 law.
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 five 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 2013.
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.
Laura Gomez and Katrina Coughlin work at the Ottawa office, practicing primarily in the area of regulatory law. Contact them at Laura.Gomez@gowlingwlg.com and Katrina.Coughlin@gowlingwlg.com