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 Guidance on the Classification of Products at the Cosmetic-Drug Interface clarifies how Health Canada 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 above 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 reviews product categories and releases PAACs in groups, which then undergo an external consultation period.
Stakeholder consultations occur:
- for all PAACs (to consult on the content and classification decision)
- 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.
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