Supplemented foods

Canadian food regulations are very prescriptive and prohibitive on the matter of fortification with vitamins, mineral and amino acids. Such matters are governed by the Food and Drug Regulations (FDR), which outright prohibits the addition of these nutrients to food, unless it otherwise makes specific provisions to do so. There are only about 27 categories of food that may or must be fortified, with the scope of nutrients limited to a particular food category. Many categories have not been amended since the 1970s or ′80s, with the last one being in 1996.

One possible relief from the prohibitive nature of the FDR is the issuance by Health Canada (HC) of a Temporary Marketing Authorization Letter (TMAL). This legitimizes the sale of fortified food that would otherwise be prohibited. Currently the only relief to fortification obstacles is a TMAL or a formal change to the FDR itself.

So why would HC not just fix the regs? Despite HC having been kicking at that can for almost 20 years, it still does not know what it wants to do. A TMAL as a regulatory instrument only provides temporary relief (maybe two to five years) from obstacles in the FDR. A condition of granting a TMAL is that the applicant will be recruiting information and data, so-called information gaps, for HC. This will be used in consideration of possibly developing future regulatory amendments. There is no guarantee that HC will formalize any changes. Many current TMALs are in this limbo status.

In February 2016 HC formalized “Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food.” This new Supplemented Food TMA is open to consider more, like herbal or bioactive ingredients. HC is considering issuing TMALs for foods with unapproved novel ingredients like panax ginseng, Siberian ginseng root extract, L-carnitine and green tea extract. The interesting approach here is the use of a TMAL to provide relief from novel food regulations that would otherwise require a premarket notification to HC establishing the safety of a food. The purpose of a TMA is to provide temporary relief to recruit information in support of regulatory amendments. This means making the food available for consumption, with a reasonable level of assurance that the food is safe. Failing this, the matter is pushed back into the premarket notification arena of a novel food notice.

The TMA guidance provided by HC defines a “supplemented food” 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. These ingredients may perform a physiological role beyond the provision of nutritive requirements.” It also sets out the scope of food which might be considered a supplemented food. Foods represented for children younger than four years of age and foods that contain alcohol are among a number that are excluded. Foods that contain unapproved food additives and novel ingredients other than those in Appendix 2 are also excluded. Caffeinated beverages will continue to be subject to their own category specific TMA criteria. The guidance sets out what vitamins and minerals are not acceptable under this TMA. These include folic acid, iron, iodine, nicotinic acid and vitamin K. It also sets two paths for permitted fortification of vitamins and minerals, those with a low and those with a higher potential for adverse health effects.

Many supplemented foods currently under TMALs are set to expire Aug. 31, 2016. HC is proposing to grant an extension until Feb. 22, 2017 to allow manufacturers to reformulate and relabel their products. Food compliant with the new rules will then be eligible for a further extension.

So how will HC regulate supplemented foods in the future? With some predicable speculation, HC may formally define supplemented food in the FDR and incorporate the criteria and labelling of such foods by reference. HC is also thinking of creating a clear way to identify and distinguish supplemented food. What is perhaps the most predicable is that Canada will not see any formalized amendments to supplemented food anytime soon.

Gary Gnirss is a partner and president of Legal Suites Inc., specializing in regulatory software and services. Contact him at president@legalsuites.com