Phased Approach Announced for Proposed Changes to Self-Care Product Regulation

Health Canada revealed on February 22 the proposed approach to be follow over the next few years to update the regulation of self-care products, namely cosmetics, natural health products and non-prescription drugs.¹

What You Need To Know

• Health Canada's approach to regulating self-care products will be updated in three phases.
• The first phase will begin in the fall of 2018 and will focus on proposed changes Natural Health Products Regulations, the second will begin in early 2019 and will focus on proposed amendments to the Food and Drug Regulations, and the third will take place in 2020 and will address further regulatory changes.
• Health Canada intends to align the regulatory regimes for the three product classes, which are currently separate and distinct.²
• The regulatory changes are intended to balance the levels of oversight and risk to consumers, as well as help consumers make more informed decisions when selecting and using self-care products.
• Health Canada plans to continue to engage stakeholders as regulatory proposals are developed and will accept public comments on the proposed changes for each phase of the update.

The Details

Phase I

In the fall of 2018, Health Canada plans to propose changes to the Natural Health Products Regulations to improve the labelling of natural health products. In particular, Health Canada is proposing that these changes would require manufacturers to include a facts table and risk information on natural health product labels, which would need to be clearly displayed and expressed in plain language. The purpose of these changes would be to better support consumers in choosing and safely using natural health products.

Phase II

In early 2019, Health Canada intends to propose amendments to the Food and Drug Regulations. These changes are intended to introduce a risk-based approach to the oversight of non-prescription drugs, such as implementing expedited regulatory pathways for lower-risk products. By introducing these changes, Health Canada is aiming to align the oversight of non-prescription drugs with other self-care products that have a similar level of risk.

Phase III

In 2020, Health Canada plans to propose further regulatory changes that will address evidence standards for similar health claims, extending risk-based regulatory oversight, and seeking additional powers for Health Canada. These additional powers may include, among other things, the ability to require a recall or label change for all self-care products.

This proposed three-phased approach to updating the regulations is generally consistent with Health Canada's initial proposal that was announced in 2016, although there is some additional divergence between the proposed regulation of different classes of self-care products. However, Health Canada has still not provided sufficient detail to assess the impact the proposed changes would have on regulated parties.

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¹ See https://www.canada.ca/en/health-canada/services/self-care-framework.html.

² See "Changes Ahead for Natural Health Products, Non-Prescription Drugs and Cosmetic Regulation in Canada."