Self-care products fall into three broad categories:

cosmetics

natural health products

non-prescription drugs

Currently, three different sets of rules apply to the regulation of self-care products, each with different requirements and oversight. Some of these rules – specifically, the regulations for non-prescription drugs – are over 50 years old. In comparison, newer regulations for natural health products were established in 2004.

Health Canada is looking to update its approach to regulating self-care products. Our updates are based on extensive consultations over recent years, and will continue in phases over the coming years:.

Phase I: 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.

Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labelling of natural health products. This includes: These changes are intended to better support consumers in selecting and safely using a product.

Phase II: 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.

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: These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk.

Phase III: 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

Introduce, for consultation, regulatory amendments to address:

We will continue to engage stakeholders as the regulatory proposals are developed.

For more information

Contact us

Email: hc.self.care.products-produits.autosoins.sc@canada.ca