On September 7, the Government of Canada published a Consultation Paper proposing regulatory changes to a class of products identified as "self-care products," namely cosmetics, natural health products and non-prescription drugs. If implemented, the proposal would combine the separate regulatory frameworks for these three product classes. 1 The proposal presents a surprising approach and shift in policy to Health Canada’s current approach of regulating these products under separate and distinct legislation (i.e., the existing Cosmetic Regulations, Natural Health Product Regulations and Food and Drug Regulations).
What You Need To Know
The proposed framework for self-care products would include the following:
Risk-based approach to self-care products. The identified risk level (lower, moderate, higher) of a given product would determine: a) the amount of information Health Canada would need to review the product; b) the degree of scrutiny before market entry; and c) the level of monitoring for safety and compliance. (This is similar to the approach that Health Canada takes for medical devices.) For lower-risk self-care products, no Health Canada review or approval would be required prior to market entry; for higher-risk self-care products, Health Canada would review the safety of each product and issue approvals prior to market entry.
Health Canada approval of health claims only. For lower-risk self-care products, claims would not be reviewed; however, no claims could be made about the diagnosis, treatment, prevention, or mitigation of a disease or condition. For higher-risk products, Health Canada would review scientific evidence to support the claims (such as health claims) being made.
Compliance monitoring and addressing inconsistences in post-market powers. Under the proposal, post-market compliance monitoring activities would vary based on the risk category of the self-care products. As the potential risk of the product increases, more oversight would be applied, including fines, mandatory labelling changes, mandatory product recalls, etc.
The Consultation Paper does not address transition and proposed dates for implementation, nor does the Consultation Paper set out sufficient detail to fully assess the impact that the proposed changes would have on regulated parties. However, as with any significant regulatory changes, if the proposal were implemented, regulated parties would likely be impacted in a number of ways that could include increased costs associated with labelling and advertising amendments, additional regulatory filings and possible product reformulations.
Health Canada is accepting public comments on the proposed changes until October 24, 2016. This Consultation Paper represents a first step toward implementation of the proposed changes and it is expected that many stakeholders will submit comments on the proposal.
Please contact one of the authors if you would like to submit a comment or would like more information.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
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