Products at the Cosmetic-Drug Interface

What are Products at the Cosmetic-Drug Interface?

These are products that may share the characteristics of both "cosmetic" and "drug", as defined in the Food and Drugs Act, making them more difficult to classify. Such products may include, for example, acne therapy, anti-perspirants, anti-dandruff products, fluoride-containing anti-caries products, medicated skin products, diaper rash products, antiseptic skin cleansers, sunburn protectants, skin whiteners and tooth whiteners.

In Canada, a product at the cosmetic-drug interface (PCDI) 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, or
• the Natural Health Products Regulations.

In 2008, Health Canada finalized and published the Guidance on the Classification of Products at the Cosmetic-Drug Interface. The Guidance document clarifies how the Department interprets and applies the definitions of cosmetic and drug in the Food and Drugs Act so that products are regulated using the most appropriate regulatory regime.

What is a Product Assessment Against Criteria?

For identified categories of PCDIs, the guiding principles and criteria outlined in the Guidance document will be used to establish if products are classified under the appropriate regulatory regime. Each Product Assessment Against Criteria (PAAC) provides a documented, detailed rationale for a classification decision. There will be one PAAC for each PCDI category considered. Health Canada is reviewing product categories and releasing PAACs in groups, which then undergo an external consultation period.

The following PAACs have been finalized by Health Canada after having undergone consultation.

• Antiperspirants
• Diaper Rash Products
• Medicated Skin Care Products

The Medicated Skin Care and Diaper Rash PAACs were well received and required no changes. Comments on the Antiperspirant PAAC were mostly related to the details of the transition of classification from drug/natural health product(NHP) to cosmetic. These comments were considered in the draft Transition Plan (see below under "Current Consultations").

Consultations

Stakeholder consultations occur:

• For all PAACs (to consult on the content and classification decision); and
• For products with a revised classification (to consult on the potential implications and logistical considerations for affected stakeholders).

From the information gathered from these consultations, Health Canada will develop and communicate an action plan for products that are affected by any revisions to classification.

Current Consultations:

There are no current consultations.

Past Consultations:

• Consultation on Draft Transition Plan for Antiperspirants - The Final Transition Plan for antiperspirants is available upon request. Please contact the Health Canada Personal Care Products Working Group at: pcdi_pfcd@hc-sc.gc.ca.
• Draft Product Assessment Against Criteria: Antiperspirants
• Draft Product Assessment Against Criteria: Diaper Rash Products
• Draft Product Assessment Against Criteria: Medicated Skin Care Products
• Draft Guidance on the Classification of Products at the Cosmetic-Drug Interface

Additional Resources

• Requirements for the Sale of Cosmetics in Canada
• Applications and Submissions for Non-Prescription Drug products
• Applications and Submissions for Natural Health Products
• Drugs and Health Products
• Public Involvement (Health Canada)