Food and Drugs Act Amendments (Bill C-51) Update: Health Minister Proposes Creation of a Separate Category for Natural Health Products

As previously reported (see E-TIPS®, Canadian Government Proposes Major Changes to Food and Drugs Act, Vol 6, No 22, May 7, 2008), Bill C-51 was tabled in the House of Commons on April 8, 2008. Currently, the Food and Drugs Act (Act) applies to the regulation of four categories of products: food, drugs, cosmetics and therapeutic devices. Under this regime, natural health products fall within the category of drugs. Bill C-51 proposes that the Act would apply to "…foods, therapeutic products and cosmetics", and the category "therapeutic products" would include, (a) drugs, (b) devices, (c) cells, tissues or organs and (d) a combination thereof. The Bill provoked strong opposition from the natural health products industry, which expressed concerns that the continued treatment of natural health products as a drug under "therapeutic products", would result in over-regulation of natural health products. For example, the natural health products industry feared that the standards of evidence to obtain authorizations for pharmaceutical drugs would be applied to natural health products. Proposed broad compliance and enforcement powers were also objected to as lacking a reasonableness requirement. On June 10, 2008, MP Gary Goodyear indicated that the Government supported revisions to Bill C-51, including the creation of a separate category for natural health products within "therapeutic products", explicitly stating that the scientific evidence required for natural health products can include traditional knowledge and history of use, and requiring the compliance and enforcement powers to be exercised with reasonableness. On June 12, the Minister of Health, Tony Clement, tabled a letter to the Chair of the Commons Standing Committee on Health containing these proposed revisions to Bill C-51. Bill C-51 continues to be debated at second reading and, if passed, will be referred to the Standing Committee on Health. On June 20, the House of Commons was adjourned until September 15, 2008. For further information, visit: http://www.nationalpost.com/news/story.html?id=586144; and http://tinyurl.com/4uw5a3 For the status of Bill C-51, see: http://tinyurl.com/5sadwg Summary by: Lauren Lodenquai