By Rupika Malhotra, MSc
Food, Scientific and Regulatory Affairs Associate
Recently, the Food Directorate and the Natural Health Products Directorate have made announcements with regards to new categorization of certain products such as caffeinated energy drinks and food-like NHP’s to foods. The reason for the shift is said to be the fact that several products currently regulated as Natural Health Products (NHPs) are packaged, perceived and consumed by the end users as foods. Consequently, these products should then be regulated by and adhere to the legislations associated with foods.
The most common question many companies and businesses are left asking is, where do their products stand in light of these recent policy changes. The guidance documents have indicated that all considered products will be placed into one of the three following categories:
Health Canada has provided guidance in that NHPs sold as juice, drinks, water, energy drinks, protein products, bars, teas, wafers, gums, gels and/or soups are to submit a Temporary Marketing Authorization (TMA) application. The assessment and approval of a TMA will grant the applicant with a Temporary Marketing Authorization Letter (TMAL), giving access to the market for a specific time frame (2 to 5 years) in which research, collected data and reports will be submitted to Health Canada. It should be noted that TMAs and consequently TMALs will only be issued for products which contain ingredients prohibited under the Food and Drug Regulations and which require additional research such as added vitamins, minerals and novel ingredients not considered to have a history of safe use in Canada. For products that have approved ingredients, adjustments to labels seem to be the only regulatory requirement needed to be fulfilled.
Health Canada is moving ahead with the transition process with what they believe are three guiding principles, outlined as follows: – risk-based approach to protecting health and safety – minimal disruption to the stream of commerce and – procedural fairness and transparency. Keeping this in mind, the impact of this transition and the requirement to meet criteria set out by Health Canada in order to be compliant is yet to be seen. Past regulation and policy changes have shed light to what seems to be a fairly vocal and active Natural Health Products industry. While some argue that the transition will reduce costs of production and testing in the long run, others point out that complying with the rigid and constricting Canadian food regulations is no cake walk to begin with. Does this then mean that the already limiting regulations will further constrain innovation in the sector of natural health products and foods or, will this in contrast allow for more movement? Perhaps this is to be determined once the TMALs are granted and what if any changes are brought about in long awaited update of the Food and Drug Regulations. With this transition process companies, businesses and consumers alike wonder where they stand as food-like NHPs are transitioned to foods.
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com