Health Canada Adopts Supplement RegsHealth Canada Adopts Supplement Regs

OTTAWA--Canada officially adopted the Natural Health Products Regulations, published in the June 18 Canada Gazette, Part II. Previously classified as either foods or drugs, supplements now have regulations that create a new category for natural health products (NHPs). Products covered by the regulation include vitamins, minerals, traditional medicines, herbal remedies, homeopathics, probiotics, amino acids and essential fatty acids (EFAs).

"Consumers have asked for labeling of all ingredients, for any warnings to be clear and understandable, for assurances of quality and safety, and for a system of product licensing," said Anne McLellan, Canada's minister of health. "With the introduction of these regulations, Canadians will now be in a much better position to make more informed decisions about the natural health products they consume."

Under the regulations, there will be mandatory pre-market approval, as NHPs must receive a product license before they enter the sales chain. Health Canada will require information about ingredients, source, potency, recommended use and any associated product health claims to assess licensure. Product license numbers must appear on their labels; additional labeling requirements include directions for use, health claims, a complete ingredient list, and warnings or contraindications.

Allowable health claims will include structure-function, risk-reduction and therapeutic or treatment claims. Manufacturers must supply the government enough information to verify the claim, with the level of support dependent on the "intensity" of the claim. Also, Health Canada committed $5 million to create the Natural Health Products Research Program, which will address the need for more research on NHPs and human health.

Companies that already have NHPs in Canada have two years to bring their facilities, products and labels into compliance. New products will immediately be subject to the pre-market approval regulations. Full information on the regulatory framework is available on the Health Canada Web site (www.hc-sc.gc.ca).