Welcome back to the Regulatory Arena. We promised you an “issues facing industry” focus this year, and I’m hoping this installment doesn’t disappoint.
One of the big issues I see in my practice relates to product classification: is my product a food or a natural health product (“NHP”)? It’s no secret that over the years many “food” manufacturers have taken advantage of the NHP pathway to bring products to market. Since their introduction in the late 1990s, the Natural Health Products Regulations have provided a way for industry to sell product containing vitamins, minerals, amino acids and other “natural” substances while making claims that were not permitted by the Food and Drug Regulations. Examples of food products that are marketed as NHPs include energy drinks, waters and juices with added vitamins and minerals, and yogurts and bars with specific health claims.
More recently, Health Canada has been transitioning food products marketed as NHPs to the food regulatory framework. As explained by Health Canada: “the end goal of this transition process is to ensure that products that look like foods and are consumed as foods are regulated as foods. In doing so, Canadians will be able to make more informed choices due to consistent nutrition information and labelling requirements”.
The most recent step in the transition described above is the recent release of Health Canada’s “Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food” Guidance (the “Guidance”).
The transition of products from the NHP to food regulatory regime has been facilitated by the use of Temporary Marketing Authorization Letters (“TMALs”). TMALs are issued for individual products that fit within defined subsets of foods that are safe to consume but also non-compliant with the Food and Drug Regulations. In brief, the TMAL allows the non-compliant food to be sold temporarily while information is gathered to amend (modernize) the regulatory framework.
As set out in the Guidance, Health Canada’s long-term plan is to facilitate market access for supplemented foods under this same regulatory system. The Guidance provides a definition of a “supplemented food”, outlines the objectives of the temporary market authorization process, the scope of the types of foods for which a TMAL may or may not be issued, the regulatory requirements for food additives, flavours and novel food ingredients in the context of supplemented foods, eligibility criteria for TMAL submissions, including maximum levels of vitamins and minerals, and guidance on labelling, advertising and health claims associated with supplemented foods.
Defining “Supplemented Food”
Section 2 of the Food and Drugs Act defines “food” as “any article manufactured, sold or represented for use as a food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever”. The Guidance broadly defines supplemented food as a subset of foods as defined in the Act:
A supplemented food is broadly defined 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.
The Guidance contains additional details about the meaning of certain elements of the defintiion of “supplemented food”.
The Scope of the Guidance
Keep in mind that the purpose a TMAL is to generate information to support a possible regulatory amendment. Health Canada has determined that a subset of supplemented foods, as set out in the Guidance, will provide a sufficient pool of products from which to gather data to inform future regulatory amendments.
In general, in order for a supplemented food to fall within the scope of the Guidance (and be eligible for a TMAL), it:
• Will be safe for use under the conditions of the TMA;
• Is pre-packaged;
• Contains a non-compliant vitamin, mineral or amino acid (more on this below) and/or an unapproved novel food listed in Appendix 2 to the Guidance (more on this below);
• Does not contain non-compliant food additives or unapproved novel ingredients other than as noted above;
• Does not contain alcohol;
• Is not represented as water; and
• Is not targeted to children less than four years old or pregnant or breastfeeding women.
Regarding non-compliant vitamins, minerals and amino acids: the Guidance specifies certain maximum levels which, if exceeded, take a supplemented food outside the scope of the Guidance. Additionally, the Guidance provides that certain vitamins and minerals cannot be added to a supplemented food at any level, including: folic acid, iodine, iron, nicotinic acid, and vitamin K. Finally, the Guidance sets out maximum levels for a number of vitamins and minerals.
Regarding novel food ingredients: as set out above, certain unapproved novel foods fall within the scope of the Guidance, as set out in Appendix 2 of the Guidance. The list includes: green tea extract, maca root extract and pomegranate rind extract. Any novel food not falling within the scope of the Guidance remains subject to the requirements of Division 28 of the FD Regulations (i.e. pre-market notification). The Guidance is clear that just because a novel food ingredient appears on the list at Appendix 2, does not mean it is authorized for use in a supplemented food.
If you need additional information about whether one of your products might fall within the scope of the Guidance, check out its Appendix 6 which provides a helpful TMA-eligibility flowchart.
Supplemented foods are subject to all of the regulatory requirements that apply to other foods. For example, the labelling and advertising of supplemented foods cannot be false, misleading or deceptive, and must meet the requirements of the relevant legislation and regulations. The Guidance comments on certain issues commonly identified by Health Canada in its review of label claims in TMA submissions.
As set out in the Guidance, TMALs previously issued to supplemented foods will expire on August 31, 2016. However, in order to give TMAL holders sufficient time to label and formulate their products in accordance with the Guidance, these TMALs will be extended until February 22, 2017. At that time, supplemented foods must comply with the requirements outlined in the Guidance to receive a further extension.