December 2 2016
Towards new refulations for self-care products
Health Canada launched earlier this year a consultation among Canadians regarding new regulations proposed for self-care products.
Self-care products are categorized as health care products (1) used to improve appearance, maintain health or even treat minor ailments. Under the current legislation, Health Canada defines three umbrella self-care product categories:
- Cosmetics: This category includes products used for cleansing, improving or altering the complexion, skin, hair or teeth;
- Natural Health Products (”NHPS”): This category includes probiotics, vitamin and mineral supplements, herbal preparations, homeopathic remedies and traditional medicines;
- Non-prescription drugs (also referred to as “over-the-counter drugs” or “OTC drugs”): This category includes products for pain relief, cold and flu symptoms and allergy relief.
All self-care products fall under the Food and Drugs Act. However, each category described above is regulated by different regulations. According to Health Canada, this system lacks consistency, notably in how the products should be brought to market or what evidence is required from manufacturers to support claims on product labels. Under current legislation, Health Canada only reviews claims for non-prescription drugs and natural health products. Health Canada’s objective is to create a more consistent regulatory framework for self-care products.
PROPOSED REGULATORY FRAMEWORK
More precisely, Health Canada proposes a new classification for self-care products based on each product’s risk level. Risk level would be determined by the safety of the product and “level of concern of failed efficacy” (i.e. the possible impact on consumers if the product fails to do what it claims). Each new product category would be regulated by specific rules, including with regard to bringing the product to market and what kind of claims would be allowed.
- Lower Risk Self-Care Products: This category includes, without limitation, cosmetics and homeopathic products. Under the new regulations, an authorization would be required before making the product available on the market, but Health Canada would not review claims regarding the product. However, no health claims (i.e. about the diagnosis, treatment, prevention, mitigation of a disease or condition) could be made. Other types of claims (such as more general claims regarding what the product does, for example “Moisturizes and nourishes the skin”) would still be allowed as long as they are truthful, accurate and properly supported. Moreover, so that the difference between these claims and a health claim is clear to consumers, Health Canada is considering the inclusion of a disclaimer on products not reviewed by Health Canada.
- Moderate Risk Self-Care Products: Topical and oral pain relievers and allergy relief products, among others, would fall under this category. Under the new regulations, a “moderate” review would be carried out by Health Canada and a license would be required before the product could be brought to market. Licensing of products would be based on evidence of the product’s effectiveness and safety. Furthermore, “health claims” would still be permitted, but would have to be approved beforehand by Health Canada and be based on sufficient scientific data.
- Higher Risk Self-Care Products: Products which are considered to present a higher risk would include products that contain new medicinal ingredients or products related to cardiovascular health. A full review would be done by Health Canada and a license would be required before the product could be brought to market. Licensing would be based on evidence of product effectiveness, safety and quality. Health claims would be allowed, but would have to be approved beforehand by Health Canada and would have to be based on sufficient scientific data.
The consultation was open and available on line until October 24, 2016. Health Canada must now prepare a report on the comments received. Considering the importance of the proposed changes, Health Canada has probably received numerous comments. Any change to the regulatory framework for self-care products will therefore take time. We will follow the case closely.
(1) Other health care product categories include prescription drugs, vaccines and certain medical devices.