Following external stakeholder consultations, Health Canada has released a new guidance document, the Classification of Products at the Cosmetic-Drug Interface. The document establishes criteria by which Health Canada will classify products at the cosmetic-drug interface (PCDIs). PCDIs are those products which share characteristics of both drugs and cosmetics as defined under the Food and Drugs Act and associated Regulations. Examples of these types of products include anti-dandruff shampoos, skin whiteners, antiperspirants, medicated skincare products, acnetherapy and sunburn protectants.
PCDIs which fall into the drug (including natural health product) category must obtain pre-market approval from Health Canada, which may involve submission of efficacy and safety data. However, PCDIs which are classified as cosmetics do not require Health Canada approval and have fewer marketing restrictions. The new guidance document communicates the approach by which Health Canada’s approach to the interpretation and application of the definitions of “cosmetic” and “drug” under the legislation so that industry can expect a consistent approach to the regulation of PCDIs.
Classification of Cosmetics and Drugs
Cosmetics and drugs are generally classified based on the product’s function, purpose and representation for use based on the definitions provided under the Food and Drugs Act. A drug is defined as any substance or mixture of substances manufactured, sold or represented for use in:
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals;
(b) restoring, correcting or modifying organic functions in human beings or animals; or
(c) disinfection in premises in which food is manufactured, prepared or kept.
A cosmetic, however, is defined as any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, including deodorants and perfumes. Based on these definitions, the distinction between drugs and cosmetics is based on representations made about the product and its composition.
Product Assessment Against Criteria
Using the criteria set out in the new guidance document, Health Canada proposes to establish a Product Assessment Against Criteria (PAAC) for identified categories of PCDIs. Each PAAC would provide a detailed classification rationale for each PCDI category. Currently, PAACs have been proposed for three PCDI categories: Antiperspirants, Diaper Rash Products and Medicated Skin Care Products. A 60-day public consultation period on these three PAACs expires on November 3, 2008. To access any of the PAAC consultation documents, visit Health Canada’s website.
Classification Criteria under the New Guidelines
The Classification of Products at the Cosmetic-Drug Interface sets out three criteria according to which Health Canada will classify PCDIs:
- Representations - Is the product represented in a manner suggesting it is used for treating, diagnosing, preventing, or curing disease; or restoring, correcting or modifying organic functions in human beings? Is the product likely to be understood by consumers to have the characteristics of a drug?
- Composition – Does the product’s composition suggest it is an agent for treating, diagnosing, preventing, or curing disease; or restoring, correcting or modifying organic functions in human beings?
- Level of action - Does the product exert solely a superficial effect?
Other factors may also be considered such as the past decisions and classification schemes of other regulatory authorities.