Proposed Regulatory Amendments

Proposals to amend advertising regulations in Canada

Proposals to relax advertising rules to allow certain drugs and natural health products to advertise their benefits for the treatment of serious diseases and disorders have been published in the Canada Gazette. The proposals would exempt drugs not listed on schedule F, which includes non-prescription drugs and natural health products, from the preventative and treatment prohibitions contained in subsections 3(1) and 3(2) of the Food and Drugs Act.

Subsections 3(1) and 3(2) prohibit the advertising or labelling of any food, drug, cosmetic or device as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in schedule A. This includes serious conditions such as cancer and heart disease. The Canadian regulatory body, Health Canada believes these recommendations would allow the Canadian public to make more informed choices about their health. Those who wish to comment on the regulations have 75 days to do so from the publication of the regulations.

Background

Schedule A and section 3 were added to the Food and Drug Act in 1934 to prevent fraud in advertising and labelling, to prevent the advertisement of treatments for disease with no known cure, to prohibit the advertisement and sale of treatments where self-treatment was not considered safe and to encourage people to seek medical attention. Health Canada believes that these objectives are well served by other provisions made in the Food and Drug Act and Regulations, such as section 9 of the Food and Drug Act. This section prohibits the fraudulent promotion of drugs. Section C.01.044 of the Food and Drug Regulations prohibits the

direct-to-consumer advertising of prescription drugs. Subsections 3(1) and 3(2) will still apply to prescription drugs.

References

1. Regulations Amending Certain Regulations Made Under the Food and Drugs Act, Canada Gazette Part 1,

19 November 2005, 3828-3836