Health Canada is looking to update its approach to regulating self-care products. Currently, three different sets of rules apply to the regulation of self-care products, each with different requirements and oversight. Health Canada is proposing to put in place one system that treats self-care products with low risks the same way and does not create new burdens for industry. The proposed approach would also give Health Canada the authority to recall any product that may pose a danger to Canadians.
Self-care products fall into three broad categories:
- cosmetics
- natural health products
- non-prescription drugs
Updates will be in phased-in:
- Phase I – Fall 2018: Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labelling of natural health products.
This includes:- a facts table
- requirements for risk information, which will be clearly displayed and expressed in plain language
These changes are intended to better support consumers in selecting and safely using a product.
- Phase II – Early 2019: Introduce, for consultation, targeted amendments to the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for non-prescription drugs.
These include:- expedited pathways for lower-risk products
These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk.
- Phase III – 2020: Introduce, for consultation, regulatory amendments to address:
- evidence standards for similar health claims
- extending risk-based regulatory oversight
- seeking additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products
Contact us
Health Canada – Health Products and Food Branch
Natural and Non-Prescription Health Products Directorate
250 Lanark Avenue, A.L. 2003C
Ottawa, Ontario
K1A 0K9
Email: selfcareproducts-produitsautosoins@hc-sc.gc.ca
More information
Visit the Self-Care web page at: http://www.Canada.ca/selfcare-products
- Self-care products
- Regulations of non-prescription drugs
- Regulations of cosmetics products
- Regulations of natural health products
- Self-care products consultations – 2017
Report of online consultation on modernizing the regulation of self-care products in Canada.