Health Canada Workshops Shed Light on a Regulatory Grey Area

Health Canada’s recent workshop series took some of the pressure off industry members with regards to the March 2010 deadline and the backlog of product license applications (PLAs) still awaiting completion, stating that this deadline is an internal target deadline rather than a compliance and enforcement date. According to Health Canada personnel, one of the primary purposes for holding these workshops was to obtain the feedback of the industry with regards to making a reasonable transition into the enforcement of the new regulations given the current backlog situation.

While the enforcement date and backlog discussion may have taken the spotlight over the course of the two day workshop, many other crucial issues were discussed. What will perhaps be the next major regulatory change and is currently a regulatory “grey area”, is the licensing process for products at the Food-NHP interface. Currently 10% of backlog PLAs fall into this category, and many of them might benefit by being classified as foods rather than Natural Health Products (NHPs).

“In the NHPD workshop, it was revealed that Health Canada is currently reviewing the classification of products at the food-NHP interface with the intention of transitioning most of these products to the food regulatory framework over a period of time,” Dr. Regan Tessis, a senior consultant at dicentra Inc. said. “This will require major changes to the food regulatory framework to support innovation and product development.”

“Generally, the industry is confused about how to classify products at the food-NHP interface,” Dr. Tessis, explained. “NHPs require extensive testing and premarket approval but products can bear unique, therapeutic claims, whereas the easier food route can be a possibility for some products but the allowable claims are limited.”

While changes may be on the horizon, this transition to the food regulatory framework is likely still years away. In the interim, the NHPD will still be assessing NHPs in food-like format and will license products that meet the safety, efficacy, and quality requirements of the Natural Health Products Regulations (NHPR).

Dr. Tessis has extensive experience advising on NHPs in food format and was chosen to participate in Health Canada’s Brainstorming workshop on NHPs in food format earlier this year. She will be partnering with Anne Wilkie to host a webinar entitled Classification of Products at the Food-Natural Health Product Interface – A Deeper Look on Wednesday December 9th at 2pm. Register for the course and learn:

  • To accurately classify your products as NHPs or Foods
  • To understand the costs and market entry obstacles/advantages of each category
  • To mitigate risk and ensure regulatory compliance
  • To capitalize on allowable, strong and unique health claims
  • To potentially save time and money by avoiding the extensive registration process for NHPs or Novel Foods

Anne Wilkie, former Vice President and Head of Regulatory Affairs for the Canadian Health Food Association (CHFA), will be partnering with Dr. Tessis to provide her insight into this complex regulatory interface. During her ten years at the CHFA, Anne was actively involved in the creation and implementation of the NHPR and consultations on the Organic Products Regulations. Prior to the CHFA, Anne worked for a combined 17 years at Health Canada and for the Canadian Food Inspection Agency.

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