Jun 13 – Canada: Classification of Products at the Cosmetic-Drug Interface

An update from Health Canada on Drugs and Health Products:

Health Canada has identified the need to clarify and communicate an established approach to the classification and regulation of products which may share characteristics of both “cosmetic” and “drug”, as defined in the Food and Drugs Act. The articulation of the established criteria has been published in the form of a draft guidance document, which is currently presented for 30-day comment.

Health Canada’s draft Guidance on the Classification of Products at the Cosmetic-Drug Interface will serve as an administrative policy that will clarify how the Department interprets and applies the definitions of cosmetic and drug in the Food and Drugs Act and Regulations so that products are regulated using the most appropriate regulatory regime…

Starting in Fall 2007, product assessments will be conducted by applying the criteria to a number of products at the cosmetic-drug interface such as acne treatments and toothpastes. This will determine if these products are being reviewed under the appropriate regulatory regime and if not, will determine which regime applies. Additional stakeholder consultations will then be held on the product assessments and the potential implications for affected stakeholders. Health Canada will also develop and communicate an action plan for products that are affected by any revisions to classification.

For more information on how your company can engage Health Canada on the matter, visit
Consultation on the Draft Guidance on the Classification of Products at the Cosmetic-Drug Interface.