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Gov't Consultation on Regulation of 'Self-Care Products'

Health Canada recently launched a public consultation with respect to the regulation of the so-called "self-care products", including cosmetics, shampoos, deodorant, toothpaste, sunscreen, vitamins and non-prescription drugs. The deadline to submit comments is October 24, 2016. More information on how to participate may be found on the Health Canada web site.

In addition to the pharmaceutical industry, Health Canada also regulates three other classes of products, namely cosmetics, natural health products and non-prescription drugs. For any business engaged in the sale of these so-called "self-care" products in Canada, the regulations can be confusing and complex.

Current System for Cosmetics

For instance, cosmetics are not subject to review or approval by Health Canada before their introduction to the market. However, information on each new cosmetic product must be provided to Health Canada within 10 days after its introduction by filing a "cosmetic notification form", which includes the identity of the manufacturer, the purpose of the product and a list of all the ingredients together with their concentration limits. The use of some ingredients is prohibited while others are subject to restrictions.

While cosmetic claims with respect to the efficacy of a cosmetic product are permitted, health claims are not. However, the difference between a cosmetic claim and a health claim can be difficult to discern. And even cosmetic claims must be substantiated by evidence available before the claims appear on any label or promotional material. If a cosmetic product has a health benefit (ie. like sunscreen), it may be instead be classified as a non-prescription drug which does require prior review and approval by Health Canada which will also assign it a "drug identification number" or DIN which must be displayed on the label.

Finally, there is a confusing maze of rules about what information must be included on the label for these self-care products and where each type of information may be placed, including where the list of ingredients must be placed and how described. These rules can vary depending on whether the product is classified as a cosmetic, a natural health product or a non-prescription drug. Products sold in pressurized containers must also include additional warnings about the associated risks of explosion and these may also vary depending on the classification of the product.

Health Canada Proposal

For cosmetics and other "low risk" self-care products in particular, Health Canada proposes to add a new requirement for the label, namely a disclaimer indicating that Health Canada has not reviewed the product for effectiveness. While this may increase transparency from the perspective of Health Canada, it may also be considered misleading and it will certainly create challenges for manufacturers.

First, the disclaimer may unnecessarily alarm some consumers by falsely suggesting that the manufacture and sale of such products is not regulated in Canada. This will have an obviously negative impact on the marketing of such products for manufacturers.

Second, the disclaimer will occupy valuable space on the product label which can already be quite crowded with other mandatory notices and the existing requirements to display some or all the text in both French and English, depending on where the product may be sold in Canada.

Finally, the disclaimer will make it increasingly difficult to use the same label in multiple countries and thereby drive up costs for both manufacturers and consumers. This will be particularly true if the disclaimer must refer to "Health Canada". In this regard, the proposal also bucks the international trend towards harmonizing regulations for the labelling of products across jurisdictions to avoid such unnecessary costs and barriers to the participation of small business in international trade.

While there is much that could be done to reduce the complexity and confusing manner in which these self-care products are presently regulated in Canada for the benefit of both consumers and manufacturers, I doubt that the proposed disclaimer will have benefits that outweigh the costs.