By William Morkel, Director of Quality & Compliance
February 7, 2012

Sometime in early 2010 the Natural Health Products Directorate (NHPD) decided to halt reviews of all product licence applications for Natural Health Products (NHPs) in food-like formats. The driver behind this decision is Health Canada’s plan to exclude food-like NHPs altogether from the Natural Health Products Regulations and move them back under the purview of the Food Directorate. One can still submit a product licence application for a food like NHP, but the submission will unlikely ever see the NPN light-of-day.

The Achilles’ heel of food-like NHPs is just that – their food-like format. NHPs are a subcategory of drugs and are intended to be taken in defined doses or according to set regimens. NHPs in food format, however, including bars, gums, cakes, or juices, may be seen by the public as snacks and consumed accordingly in arbitrary amounts at arbitrary times, thereby exposing the end user to undue risk of overdosing. Herein lies the reason for Health Canada’s decision to reclassify these products.

The first publically notable move in this area came in October of 2011 when the Minister of Health, Leona Aglukkaq, held a press conference to announce that all caffeinated energy drinks would henceforth be considered foods and not NHPs. Currently, the NHPD is contacting all caffeinated energy drink applicants (whether thy hold an NPN or not) and advising them that they will have to withdraw their NHP applications and instead apply for Temporary Marketing Authorizations or TMA (as foods) in order to continue marketing their products.

Unfortunately, as of the writing of this article, the NHPD and Food Directorate have yet to provide any clear guidelines for the transitions. What, exactly, constitutes a “food-like” NHP? What information must be submitted with the TMA application? Will products that have NPNs/ENs be permitted to keep their claims? Will they have to reformulate? What are the TMA review timelines? All of these questions remain unanswered, yet the deadline for transitioning from NHPs to foods is fast approaching. Food-like NHPs must obtain TMAs by February 2013 when UPLAR is set to expire.

In light of the prevailing uncertainty, how should industry respond? First, it is the recommendation of this author that companies that have submissions in the NHPD queue or products that are licenced keep them in queue or licenced until such time as they apply for and receive their TMA. The Food Directorate may be more inclined to agree to the carryover of certain claims and formulations for products that are already on the market. Second, companies should file their TMA applications as soon as possible. The Food Directorate is concerned that, given the volume of food-like NHPs that need to be transitioned, they will end up with a backlog. Companies who file for a TMA now can get a jump on the rest of the industry and at a time when Health Canada is still defining their policies (and therefore more likely to be flexible).

Some in the industry, no doubt, will welcome these developments: Foods do not require product and site licencing, nor do they require the degree of testing that is mandatory for NHPs. Some however, may find the re-classification of their products too restrictive with respect to allowed claims and formulations. The Food Directorate has promised to release an official guidance document on the food-like NHP transition sometime this week. However, the full impact on industry will only become clear in the months to come.

References:

Health Canada Guidance Document, Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats, June 10, 2010, Version 2

Natural Health Products Directorate, Charting A Course: Redefining Canada’s Approach to Regulating Natural Health Products, www.healthcanada.gc.ca/hpfb-blueprint

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