– Wednesday, January 21, 2009

Health Canada is currently in the process of drafting a guidance document to help industry differentiate between Foods and Natural Health Products (NHPs). This is a challenging task as the definitions of foods and NHPs often overlap and lines between them can be blurry. Once a decision template is completed it will be easier for industry to determine whether to register products as Foods or NHPs. With the large backlog that the NHPD has accumulated, having more products streamed over to the Food Directorate would benefit both the NHPD and industry.

Some challenges in setting clear parameters between foods and NHPs are listed below:

• Health Claims – The Natural Health Product Regulations make it difficult to attach health claims to products unless they are registered as NHPs. In order to classify more products as foods, the Food Directorate will need to allow a greater number of generalized, structure-function health claims for foods so that more applications will be able to be shifted from the NHPD.

• Natural Health Products in food-like format – In order for this type of product to be registered as an NHP it must include a dosing regime that allows it to be consumed in measured, controlled amounts. The Food Directorate’s main concern here is the potential safety hazard of consumers taking these products ad libitum.

• Certain ingredients inherently deem a product to be an NHP – There is a question of how to treat products hoping to be classified as foods but that contain ingredients that are considered to be medicinal by the NHPD, even in low amounts.

• Past precedent – If a product was previously classified as an NHP or food, will this mandate that similar products be classified accordingly?

• “Functional foods” – There are many foods that have added medicinal ingredients in the hopes of attaining health claims. Will there be guidelines on the amounts of certain ingredients that can be added and allowable claims so that these products can be classified as foods or will these be treated as NHPs?

In the weeks and months ahead as these decisions are sorted through and finalized, dicentra will be providing input to Health Canada and will keep all of our clients informed on the progress of this initiative. If you have any questions about the food/NHP status of your current products, or if you have new products to be evaluated, we can be reached at 1-866-647-3279 or at dicentra.com

regan@dicentra.ca
tel. 416-361-3400 ext. 223