Health Canada has released its Consultation Paper on the Regulation of Self-Care Products, the first step in a long anticipated regulatory overhaul of this category. The proposed framework, if adopted, will mean a sweeping overhaul of how cosmetics and personal care products are regulated, moving to a risk-based approach. Comments on the consultation will be accepted until October 24, 2016.

The current personal care product regulatory regime is a patchwork of separate regulations for cosmetics, natural health products and over the counter/non-prescription drugs. Each of these regulatory categories are subject to different requirements for licensing, premarket approval, claim review and labelling. This means that similar types of products are regulated in very different ways, depending on the product classification. For example, a toothpaste product could be regulated as a cosmetic, a natural health product or a non-prescription drug, depending on its ingredients and claims. Under the current regime, products making similar claims might be required to provide different levels of evidence to support those claims, notwithstanding that the difference in product classification may not be clear to consumers at the time of purchase.

The proposed approach would instead treat similar-risk products in a similar manner. Higher risk products would be subject to a full review by Health Canada, requiring evidentiary support of safety, quality and efficacy. These products would be subject to express review and approval of health claims, with some approvals based on monographs. Lower risk products not making health claims would not require licensing or claims approval, although all claims would still need substantiation. Health claims would be considered those that are related to the diagnosis, treatment, prevention, cure or mitigation of a disease or condition.

Further information on the consultation can be found here