A consultation paper proposing a risk-based approach to regulation of “self-care” products represents significant change in how cosmetics, natural health products and non-prescription drugs are regulated in Canada.
Health Canada is responsible for regulation of both prescription and non-prescription (or “self-care”) products sold in Canada. Self-care products cover three categories of goods:
- Cosmetics, which includes skin care products, as well as products for hair or teeth (e.g., toothpaste, deodorants, shampoos, moisturizing creams);
- Natural health products, which include vitamins, probiotics, herbal and homeopathic remedies, and traditional medicines (e.g., traditional Chinese medicines);
- Non-prescription drugs, or “over-the-counter drugs” such as products for pain relief, cold and flu symptoms, and allergies.
Currently, each of these categories is regulated in a unique manner pursuant to a separate federal Act governing each category. However, a new Health Canada consultation paper released in September 2016 suggests that the federal government may move to bring them all under one regulatory regime, and categorize products according to risk, instead of product type, to determine whether and what type of approvals may be necessary before a product can be placed on store shelves.
The consultation paper, which invites feedback from the public about the proposed changes, sets out a new regime in which products from all “self-care” categories would be classified as lower, moderate, or higher risk. The classification would then determine what level of scrutiny the product is subject to prior to being approved for sale in Canada. This will include determining what information must be provided to Health Canada for review, what approvals – if any – must be obtained, and what level of monitoring would be required to ensure ongoing compliance.
For example, products classified as lower risk level would require no approvals prior to marketing in Canada. This category would likely include items such as cosmetics, many vitamin and mineral products, toothpaste, mouthwash, homeopathic products, and diaper rash products.
Moderate risk products would require some review by Health Canada and would be licensed for sale based on evidence of their safety and effectiveness as published in the product monograph. Products falling in this category would likely include things like topical and oral pain relievers, cough and cold products, laxatives, and allergy relief products.
Higher risk products would be subject to a full review by Health Canada. Companies manufacturing these products would be required to submit evidence supporting the safety, quality and effectiveness of their product. Health Canada would have to approve any claims made by the manufacturer related to the ability of the product to diagnosis, treat, prevent, cure or mitigate a disease or condition. Products likely to fall into this category would be those that are switching from a prescription to non-prescription status, those containing new medicinal ingredients, or products related to cardiovascular health.
The stated impetus behind the proposed changes is the concern over oversight of ingredients which, although derived from natural substances, may nonetheless pose health risks. In addition, Health Canada has concerns over the potential for labeling that makes claims about a product’s efficacy in treating ailments, without those claims having been adequately tested or substantiated by scientific research.
The proposal has drawn both criticism and approval. Critics fear that the new regime would increase costs for manufacturers of natural products, and could force some products out of the market. Proponents of the changes, on the other hand, consider that tighter controls on safety and labeling of natural products are warranted. See this recent article in the Globe and Mail for an overview of some of the arguments on each side of the debate.
Written By: Linda Jensen