Products at the Cosmetic-Drug Interface

There are several product groups on the border-line between cosmetics and drug products in Canada. Understanding which category your product belongs to is the first step in successful marketing your health product or cosmetic to Canadians.
Here’s a few categories of products that sit on the cosmetic-drug borderline in Canada.
• Acne products
• Anti-perspirants and deodorants
• Oral care products such as toothpaste, tooth whiteners
• Skin care products
Product on the cosmetic-drug border line share characteristics of both cosmetics and drugs as defined in Health Canada’s Food and Drugs Act, and therefore their classification can be challenging. By spending a bit of time carefully considering your product classification in Canada (which may be different than other countries outside of Canada) you can proceed with the correct applications with confidence and avoid delays associated with submitting the wrong type of submission to Health Canada for your product.
In Canada, a product at the cosmetic-drug interface can be regulated by one of three sets of regulations under the  Food and Drugs Act, depending on their ingredients and on the claims they make:
• the Cosmetic Regulations
• the Food and Drug Regulations
• the Natural Health Products Regulations
In order to assist sponsors in understanding their product classification, the guidance document entitled Guidance on the Classification of Products at the Cosmetic-Drug Interface may be consulted for clarification. Although this guidance document is several years old, the concept and principles within remain current today. The guidance will be useful for those manufacturers and distributors of new-age products such as adult acne-care, make-up products with UV filters, sheet masks and more.
Two major points of consideration for your regulatory strategy will be 1) the composition of your product, and 2) the representation of your product. Health Canada considers “representations” to include pictures and statements planned for advertisements, product labels or package inserts.

While the composition of a product alone can’t be used on its own to determine a product classification, the presence of an ingredient may make the product unsuitable for a cosmetic product in Canada. Although both representation and composition of a product are important, ultimately the intended purpose of the product takes precedence in the classification decision.
Consult the guidance document at the link below, or contact us for assistance with your product classification and registration in Canada.
Guidance Document Link: