DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Exemption of drugs not listed on Schedule F of the Food and Drug Regulations, including natural health products, from the preventative and treatment prohibitions in subsections 3(1) and 3(2) of the Food and Drugs Act)- Notice of Withdrawal
The Therapeutic Products Directorate (TPD) and the Natural Health Products Directorate (NHPD) of Health Canada are withdrawing the regulatory proposal, Project 1474, which would have amended the Food and Drug Regulations and the Natural Health Products Regulations. The intent of this regulatory proposal was to permit nonprescription drugs and natural health products (NHPs) to carry, in labelling and advertising to the general public, preventative and treatment claims for Schedule A diseases if the products had undergone pre-market review and had received market authorization for those claims. This regulatory proposal was prepublished in Canada Gazette, Part I, (CG I) on November 19, 2005.
In its place, Health Canada is prepublishing Project 1539 in CG I, a regulatory proposal that achieves the original intent of Project 1474 by revising the list of Schedule A diseases and by lifting the prohibition on nonprescription drugs and NHPs for carrying preventative claims for diseases in the revised Schedule A.
Schedule A to the Act is a list of diseases, disorders or abnormal physical states (referred to as diseases). Subsections 3(1) and 3(2) (referred to as section 3) of the Act prohibit preventative, treatment, and cure claims in labelling and advertising to the general public of any food, drug, cosmetic, or medical device.
Reason for change from Project 1474 to Project 1539
In September 2005, Health Canada convened a Scientific Advisory Panel (SAP) to examine Schedule A diseases. In March 2006, the SAP recommended revisions to Schedule A. When Health Canada considered the recommendations, it became evident that revisions to Schedule A should take place before or at the same time that any prohibitions for Schedule A diseases were lifted.
Furthermore, this position is supported by comments received during the CG I consultation period for Project 1474.
Inquiries may be directed to:
Project 1474
Policy Division
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street, Holland Cross Building
Tower B, 2nd Floor
A.L. 3102C5
Ottawa ON K1A 0K9
Email: regaff-affreg@hc-sc.gc.ca (Please refer to Project 1474)
Tony Clement
Minister of Health
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