Changes Could Be Coming in Canada’s Regulation of Self-Care Products: Your Chance to Weigh In!

Health Canada is undertaking a public consultation on its regulation of self-care products (non-prescription drugs, natural health products and cosmetics). This is part of a larger consultation on the Framework for Consumer Health Products, started in 2014.

The proposed new Framework would implement a revised risk-based approach to regulation that categorizes products by risk profile rather than product type and would dramatically change the requirements to market these products in Canada.

What Are The Current Requirements?

At present, cosmetics, natural health products and non-prescription drugs are all subject to distinct regulatory oversight:

  • Non-prescription drugs – must obtain pre-market licensure and are reviewed and monitored by Health Canada in essentially the same manner as prescription drugs.
  • Natural health products – must obtain pre-market licensure, but depending on the nature and novelty of the health claims being made the level of scientific proof of safety and efficacy is generally at a lower standard than for non-prescription drugs.
  • Cosmetics – do not require a pre-market review or licence. Manufacturers and importers must notify Health Canada within 10 days of the first sale in Canada.

What Does The Framework Propose?

The Framework proposes a three-part system, with licensing and substantiation of claims being tied to risk level as follows:

 

Lower Risk

Moderate Risk

Higher Risk

Examples

Cosmetics, toothpaste, homeopathic products

Oral pain relievers, cough/cold products, allergy relief products

Products with new medicinal ingredients, products relating to cardiovascular health

Review & Licensure

No pre-market review or authorization required

Some pre-market review of safety and effectiveness based on standard reference monographs

Full pre-market review of evidence to support safety, quality and effectiveness

Claims

Health Canada would not review claims

No claims to be made re: diagnosis, treatment, prevention, mitigation of a disease or condition

Other claims to be accompanied by a disclaimer that Health Canada has not reviewed the product for effectiveness

Health Canada would approve claims related to diagnosis, treatment, prevention, cure or mitigation of a disease or condition (or those in the monograph) based on science

Health Canada would approve claims related to diagnosis, treatment, prevention, cure or mitigation of a disease or condition (which must be based on science)

Under the Framework, Health Canada would only review “health claims,” being those relating to the diagnosis, treatment, mitigation, prevention or cure of a disease, disorder or abnormal symptoms in humans.  General functional claims would not be licensable.

What is Next?

The current consultation is open until October 24, 2016.  Feedback can most easily be provided by completing the online consultation that Health Canada has developed.