Next steps on the self-care framework

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 will be done in phases:

  • 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

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

For more information

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

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