Consultation on the Draft Guidance on the Classification of Products at the Cosmetic-Drug Interface - June 11, 2007

The online consultation is now closed. The final guidance is available now. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

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 The articulation of the established criteria has been published in the form of a draft guidance document, which is currently presented for 30-day comment.

Health Canada's draft Guidance on the Classification of Products at the Cosmetic-Drug Interface will serve as an administrative policy that will clarify how the Department interprets and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.

How to Engage

Health Canada is interested in your feedback on the guidance document. Comments and questions may be sent to the e-mail address below. Following the 30-day comment period, Health Canada will proceed with finalizing the guidance document, taking into consideration the comments received. The finalized guidance document will be available electronically on the Health Canada website.

Questions to Keep in Mind

In reading the document, Health Canada asks that you keep the following questions in mind, which may assist you in providing feedback.

1. Are the terms used in the document clear and understandable? If not, please specify which terms and why.
2. Do you agree that, overall, this guidance document clearly explains how classification decisions will be made? If no, please explain.
3. Are there other areas that the guidance document should address?
4. Are there other comments or questions Health Canada should consider for this guidance?

Next Steps

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.

Additional Information

We encourage you to bookmark the Health Canada Consultations site and check back regularly. If you have questions, contact us at PCDI_PFCD@hc-sc.gc.ca.