Right now in Canada, self-care products can be classified into 3 categories: cosmetics, natural health products (NHPs) and non-prescription drugs. In order to sell a product, it must be under one of these classifications and thus be regulated according to its category. Although this appears to be very straightforward, the regulations are inconsistent and confusing. A product containing sunscreen active ingredients can be classified as a non-prescription drug, cosmetic or natural health product based on its ingredients and its label claims. Consequently, each sunscreen product will have different label requirements, efficacy testing and more as part of its regulations.

For this reason, Health Canada is working to improve the way self care products (cosmetics, NHPs and non-prescription drugs) are regulated, in order to treat low risk self-care products the same way and reduce the differences of how each product is regulated. Health Canada hopes that this initiative, called the Self-Care Framework, will provide easier to understand labels for products that will help Canadians select the right products for them. It is also hoped this will reduce barriers within the industry that will ease the regulation requirements of self-care products.

After their public consultations, Health Canada concluded that they will apply their updates to the self-care framework in 3 phases over the course of 3 years:

Phase 1 (Fall 2018) – Health Canada will announce changes to labelling of NHPs. This includes improved labelling such as improving the facts table and adding risk information in clear display and in plain language.

Phase 2 (Early 2019) – Introduction of a risk-based approach when regulating non-prescription drugs. This will allow expediting pathways for lower-risk drug products such as sunscreen and acne product.

Phase 3 (2020) – Introduce regulatory amendments to work on health claim evidence standards, extend the risk-based regulatory oversight introduced in Phase 2. Additionally, amendments to allow Health Canada to obtain more powers such as the ability to request recall or label change of any self-care products.

In the meantime, Health Canada will continue to communicate with stakeholders throughout the development of the regulatory proposals.

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for Natural Health ProductsOTC DrugsCosmetics, and other personal care products.