As we reported, Health Canada is proposing to change the way it regulates non-prescription drugs, natural health products and cosmetics, which will now be referred to collectively as “self-care products.” Under the new proposed regime, a product will be regulated by Health Canada based on the risk posed to consumers. Products will be classified as lower risk, moderate risk and higher risk and a product’s classification will dictate: (a) the amount and type of information Health Canada will review, (b) the degree of scrutiny necessary before the product can be made available on the market, and (c) the level of monitoring required for safety and compliance once the product is in the marketplace.
Health Canada recently announced it intends to advance the self-care products framework under existing legislation, including the Natural Health Products Regulations and the Food and Drug Regulations. Updates to these regulations will occur in the following three phases:
Phase 1 (Fall 2018): Health Canada will introduce amendments for consultation to the Natural Health Products Regulations regarding labelling requirements for natural health products. Amendments will include requirements for a facts table (similar to the drug facts table for non-prescription drugs), and the inclusion of risk information clearly displayed in plain language on the label.
Phase 2 (Early 2019): Health Canada will introduce amendments for consultation to the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for non-prescription drugs. The amendments will include an expedited approval pathway for lower-risk products.
Phase 3 (2020): Health Canada will introduce amendments for consultation to address: (a) evidence standards for similar health claims, (b) the extension of risk-based regulatory oversight, and (c) additional powers for Health Canada in enforcement and compliance, such as the ability to require a recall or label change for all self-care products. This phase will likely require amendments to the Natural Health Products Regulations, the Food and Drug Regulations and potentially, the Cosmetic Regulations.
Interested stakeholders can expect the opportunity to provide comments on the proposed amendments as proposals are released by Health Canada.