The purpose of this message is to provide you with an overview of the transition of products at the food-natural health products interface to the food regulatory framework.
Some products with added vitamins, minerals or amino acids, that appear to be foods, as well as foods making certain health claims, have previously been able to gain market access as natural health products (NHPs) under the Natural Health Products Regulations (NHPR). Examples of products that are currently marketed as NHPs include waters and juices with added vitamins and minerals, and yogurts and bars with specific health claims. These products represent a very small portion (2%) of the approximately 50,000 NHPs on the market.
Health Canada has determined, based on consumption patterns, history of use, representation to consumers, and in accordance with its guidance document on “Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats”, that most of these products fit the definition of a food. The Department, therefore, intends to classify and transition most of these products to the food regulatory framework. This is consistent with the policy intent of the NHPR, as outlined in the regulatory impact analysis statement, as well as the outcomes of the Natural Health Product Regulatory Review conducted in 2007, which reiterated that foods are excluded from the scope of the NHPR.
A phased transition is underway by Health Canada, beginning with the transition of caffeinated energy drinks. Additional categories of products now marketed as NHPs, which have been classified as foods, will begin to transition in April 2012. The transition process is expected to be complete by December 2012 in order to coincide with the repealing of the Natural Health Products (Unprocessed Product Licence Application) Regulations scheduled for February 4, 2013. The end goal is that products that look like foods and are consumed as foods are regulated as foods.
Food-Natural Health Product Transition
As of April 17, 2012, the Natural Health Products Directorate will no longer accept NHP applications for products that are represented, packaged and sold as foods.
Health Canada now has a process to transition products already on the market as NHPs to reduce market disruption, as long as the products are safe to be consumed as foods. Products that are captured under the transition are those where a Product Licence Application has been received by the Natural Health Products Directorate and have been issued either a Natural Product Number, an Exemption Number or are considered “application in progress”.
There are three main principles that underlie this transition:
A risk-based approach to protect the health and safety of Canadians
Procedural fairness and transparency; and
Minimal disruption to the stream of commerce.
These three principles will be respected and applied throughout this transition.
To facilitate the transition, products deemed to present no immediate safety concerns, but found to be in contravention with the Food and Drug Regulations, will be transitioned through the issuance of Temporary Marketing Authorization Letters (TMALs). TMALs will allow eligible products to be marketed subject to specific conditions, while industry collects and provides data that are required to finalize regulatory requirements for these products (Section B.01.054 of the Food and Drug Regulations).
Products identified as unsuitable to be sold and consumed as foods or products that do not meet the conditions for a TMAL will be provided with the opportunity to reformulate, change the representation of the product so that it can no longer be similar to an equivalent food product. These products will be identified early to permit the maximum possible window for reformulation.
It is anticipated that most products will need to be transitioned using TMALs as a tool, except for a small number of products that are currently compliant with the Food and Drug Regulations as it relates to their composition. While most health claims used on food labels are not subject to pre-market clearance by Health Canada’s Food Directorate, the Directorate is open to work with interested companies to ensure that claims used on their food labels are compliant with the Food and Drugs Act and Regulations.
In July 2012, Health Canada, in consultation with stakeholders, will develop and share performance standards for TMA submissions, explaining the commitment and timelines with respect to the processing of new submissions. TMA submissions are only needed for new products for which there is a regulatory impediment to the legal marketing of a safe food in Canada. New compliant foods are not subject to pre-market scrutiny and do not require TMAs.
Companies will be receiving correspondence from Health Canada in the coming days with the details of the transition plan and the various options for their products.
Health Canada will provide regular updates, and continues to work with affected stakeholders throughout this process. We encourage you to visit the newly developed Food-Natural Health Products webpages for more information on the transition of products at the food-natural health products interface. We also encourage you to contact the Food Directorate at SMIU-UGDI@hc-sc.gc.ca should you have any questions.
Natural Health Products Directorate