The first regulations controlling vitamins and minerals in Canada came into force in 1941, under the Federal Food and Drug Regulations (FDR). By 1945 vitamins and minerals were consolidated in their own part of the regulations. While significant revisions have been made to the FDR since then, the governance over the addition of vitamins and minerals has remained restrictive. Unless the FDR specifically permits the addition of a vitamin or mineral to a food, a food in Canada may not be fortified. Effectively, what this means is that the FDR has to be amended in order to permit vitamins and minerals to be added to foods where such addition is not currently provided.
There have been a few remedies provided in the FDR. A very old one is a Temporary Marketing Authorization (TMA). A TMA can be used to work around the prohibitive nature of the FDR. It is an instrument employed by Health Canada to allow the sale of a food that would otherwise be prohibited, while gathering the necessary information in support of possibly making regulatory amendments. There is, however, no assurance that the regulations will be amended.
In 1997 the FDR was amended to include Interim Marketing Authorizations (IMAs). These are regulatory instruments permitting Health Canada to allow the sale of a food while they make the necessary FDR amendments. There have been a number of IMAs issued related to food fortification. The first IMA was that related to the addition of calcium and vitamin D in orange juice. Prior to this fortified orange juice could not be sold as a food and was sold as a drug product – a calcium supplement. To this day, the FDR has not been formally amended to permit calcium and vitamin D in orange juice beverages. Many IMAs related to vitamin and mineral fortification are technically no longer in effect, as the amendments in 2008 put a two-year limit on their life expectancy. However, these are still acknowledged by Health Canada. The difference between an IMA and a TMA is that in the case of an IMA, Health Canada has already accepted that the FDR will be amended. In the case of a TMA they are “still thinking about it.”
In 2012 the FDA was amended to give Health Canada the authority to issue Marketing Authorizations (MAs). MAs can be issued for matters related to the addition of vitamins and minerals. The 2012 amendments also repealed the statutory provision for Health Canada to issue IMAs. The FDR still includes those provisions, but these are to be eventually repealed by the more formal Governor in Council (GIC) regulations.
To make life even more interesting, Health Canada was given the responsibility to transition the many food-form Natural Health Products (NHP) into the food regulatory framework by the end of 2012. Many of these NHP food forms included issues related to vitamin and mineral fortification. To address this, the ministry has dusted off the old provision and has issued TMAs like never before – everything from fortified water and fruit juice beverages, to energy drinks and even more conventional foods.
One of Health Canada’s priorities now is to set up MAs to govern food fortification. That process will likely not be very different from what has been done with food additives. For instance, Health Canada could define a class of fortification via an MA and then by Incorporation by Reference (IbR) include tables of foods that would be permitted to contain added vitamins and minerals. Those tables can then include foods already listed in the FDR and current IMAs.
If the TMA processes for foods that involve fortification are successful, they could eventually find themselves in those IbR tables. The FDR will also need to be amended by the more formal GIC regulatory process. This could include setting up the parameters of the type of fortification the ministry may be willing to consider. Of course this is speculation, as we will not see the structure of the new regulations until Health Canada has made them available.
The changes that are coming will be some of the most significant since those in the early 1940s. Be assured that Health Canada will retain its tight control over food fortification in Canada.
Gary Gnirss is a partner and president of Legal Suites Inc., specializing in regulatory software and services. Contact him at [email protected]