New claim authorized by Health Canada

Health Canada has indicated that it will permit the claim “Product X is authorized for sale by Health Canada” in advertising of an authorized health product bearing a Drug Identification Number (DIN), Homeopathic Medicine Number (DIN-HM) or Natural Product Number (NPN).

Previously, Health Canada took the position that such a claim was not permitted on the basis of Section C.01.007 of the Food and Drug Regulations, and Section 92 of the Natural Health Products Regulations.  These sections prohibit making any reference to the Food and Drugs Act or the foregoing regulations on the label of, or in any advertisement for, a drug unless such reference is a legislatively prescribed requirement.  Health Canada’s previous position on the application of these sections is articulated in Section 2.10 of Health Canada’s Consumer Advertising Guidelines for Marketed Health Products, which states that “claims that state or imply product endorsement or authorization by Health Canada or any other government agency are prohibited”. Part of the rationale behind  Health Canada’s previous position was that the use of a DIN, DIN-HM or NPN is a sufficient indicator that a product had been authorized by Health Canada.

Health Canada’s new stance appears to be in response to requests from manufacturers to be able to clearly communicate to Canadian consumers the distinction between their authorized drug products and unauthorized third party products. It is anticipated that Health Canada will update its Consumer Advertising Guidelines for Marketed Health Products and any other materials that reference its previous position on this point during the next round of revisions.