Canada considers new regulatory scheme for self-care products

Health Canada is seeking comments on a proposed new risk-based regulatory system for “self-care products”, which includes cosmetics, over-the-counter non-prescription drugs, and natural health products. The agency says these three consumer product classes are currently regulated by separate sets of rules that are often unclear to consumers. The new proposed system would require government regulation based on perceived risk, broken into three tiers: the lowest risk category would include cosmetics, vitamins, mouthwash and similar consumer products, and would require little government oversight; moderate risk products, such as pain relievers, laxatives and cough medicines, would face a more limited government review, which would also encompass product claims; and the most stringent – high-risk self-care products – would cover those medicinal in nature and would require a full Health Canada review, including examining claims. Manufacturers of low-risk products would be required to notify Health Canada when their products reach the marketplace. This is similar to the current regulatory system for cosmetics. These products would continue to need to meet government requirements concerning chemical ingredients, labelling and quality. Although Health Canada would not review each product before coming to market, companies would remain responsible for quality and manufacturing standards. Low-risk products would not be permitted to make claims about diagnosis, treatment, prevention or mitigation of a disease or condition. Any claims made outside these areas may be required to be accompanied by a disclaimer, indicating that Health Canada has not reviewed the product for effectiveness. All claims would need to be “truthful and accurate”, and companies would be required to have supporting information. Health Canada says it is “still in the early stage of exploring this new approach”. It will accept comments on the proposal until 24 October. A copy of the new proposal is available at: Proposal

Chemical Watch, 29 September 2016 ; ;