Report of Stakeholder Comments: Guidance on the Classification of Products at the Cosmetic-Drug Interface

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Table of Contents

• Background and Context
• Highlights of Changes made to Guidance
• Summary of Stakeholder Comments and Responses
  • Part I: Comments and Responses on the Content of the Guidance
  • Part II: Stakeholder Comments Outside the Consultation on the Guidance
• What's Next?

Background and Context

In June 2007, Health Canada held a 30-day online consultation on the draft Guidance on the Classification of Products at the Cosmetic-Drug Interface. This report provides a summary of the results obtained. Results of the consultation were integrated into the final Guidance on the Classification of Products at the Cosmetic-Drug Interface.

The Department created the Guidance to clarify and communicate its established approach to the classification of products at the cosmetic-drug interface. These are products that may share the characteristics of both cosmetics and drugs, as defined in the Food and Drugs Act, and are therefore more difficult to classify. Such products may include acne therapies, 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.

The Guidance is the product of collaboration between Health Canada's Cosmetics Division, Therapeutic Products Directorate, and the Natural Health Products Directorate, all of which regulate products at the cosmetic-drug interface. It is an early deliverable under the initiatives of the Blueprint for Renewal II, a long-term policy framework that will modernize health products and food regulation in Canada to help meet the evolving needs of Canadians. More information about the Blueprint is available at http://www.hc-sc.gc.ca/ahc-asc/ branch-dirgen/hpfb-dgpsa/blueprint-plan/index-eng.php.

The Guidance is a policy that clarifies how the Department interprets and applies the definitions of the Food and Drugs Act so that products are regulated under the most appropriate regime. It is intended to increase consistency in regulatory decision-making by the Department and to make regulatory decisions more predictable to the industry. It draws on, and is consistent with, federal statutes, policies and frameworks, including those governing science and risk-based decision-making and international approaches to classification decisions.

The consultation process sought stakeholders' input on the Guidance, soliciting feedback on the clarity and content of the document. Targeted e-mails were sent to industry and consumer advocacy groups to encourage participation. Of the fourteen official responses received, industry associations provided the most input while consumer advocacy groups chose to not participate. Input received served to revise the draft Guidance document.

Highlights of Changes made to Guidance

As a result of consultation input, the following changes appear in the revised Guidance:

• Reinforcement of intent and application of the document
• Clarification of terms such as "personal care product" and "product at the cosmetic-drug interface"
• A clear explanation of the risk-benefit balance associated with cosmetics and drugs
• "Perception of the product in the marketplace" removed as an independent criteria and integrated as a subset of "Representation"
• Greater distinction between the standard criteria for classification versus the role of supplementary considerations

Summary of Stakeholder Comments and Responses

A summary of the comments received in response to the online consultation, and Health Canada's response to these comments, follows below.

Part I contains feedback related specifically to the content of the Guidance, organized thematically by issue, while Part II outlines general stakeholder concerns that fall outside the scope of this classification document.

Part I: Comments and Responses on the Content of the Guidance

Issue #1: Transparency and Application of the Guidelines

Summary of comments:

• It is important to create an open and transparent process in which to apply the guidance document. This process should be designed to reduce uncertainty and increase transparency in classification decisions. Specifically, there is concern that the criteria in the Guidance move beyond those that could logically be derived from the definitions in the Act and thus may lead to more discretion on the part of regulatory officials.
• The process would be much stronger and more credible to industry if industry representatives were involved in the development of this process and in setting priorities for its application from the outset.
• The explanation of the Guiding Principles and Criteria is confusing. In section 1.3, Scope and Application, the statement

  The classification decisions reached by the use of this guidance may be based on the application of the general overarching principles for a type or class of product. The criteria will be applied to product-specific decisions when classification is not immediately apparent.

  should be changed to:

  The classification decisions reached by the use of this guidance may be based on the application of the general guiding principles below. The criteria specified in this guidance will be applied when classification is not immediately apparent.

Health Canada response:

We developed the Guidance to ensure an open and transparent process for the classification of products. In the development of the guidance document, we sought multi-stakeholder feedback, which we considered and integrated into the final guidance document.

The objective of the document is to provide stakeholders with a transparent explanation of how Health Canada interprets the definitions in the Food and Drugs Act to determine the most appropriate framework for the regulation of products at the cosmetic-drug interface. The Guidance clarifies criteria to increase consistency in decisions by regulators and to make decisions more predictable to stakeholders. It aims to decrease the amount of discretion of regulatory officials by providing clearer instructions. The Guidance draws on, and is consistent with, the current Guidelines for Cosmetic Advertising and Labelling Claims and is in line with Health Canada's obligations to make regulatory decisions based on the definitions in the Food and Drugs Act.

We made a number of changes to the Guidance based on the comments received on transparency and application. In the Introduction, we expanded the objective to include increasing consistency in classification decisions by regulators and making decisions more predictable for stakeholders. We amended the "Scope and Application", "Guiding Principles" and "Criteria" sections to ensure that the intended messages were clear and consistent. Specifically, we took into account the suggested change in the section "Scope and Application", when we reworded it to read:

Health Canada determines product classification using the guiding principles below. In the case where product classification is not immediately apparent, the criteria specified in this guidance will be applied.

Issue #2: Representation, Perception and Placement of Product

Summary of comments:

• "Representation" and "Perception" criteria leave too much room for discretionary decisions by reviewers, and reviewers are not adequately able to assess the perception of products in the marketplace. "Perception" should be removed, or at least related to the judgement of "a reasonable person" rather than "the general public." "Representation" should be amended to make its use more predictable.
• According to the Guidance, an important consideration for classification is a product's proposed claim, which can be determined by such factors as "a word, a sentence, a picture, a symbol, a paragraph, or an implication on product labels, package inserts, and advertisements." These factors are too broad in scope to consistently assess how a product is represented and would allow too high a degree of personal interpretation. An alternative approach would be to limit the factors considered by the regulator to the written labels and the package inserts.
• The reference in the document to claims considered cosmetic "puffery" make Health Canada regulators seem insensitive towards the global marketing reality of personal care products.
• Additionally, "placement and location" should be removed as factors of classification because they are often beyond the control of the manufacturer, and their determination provides too much discretion to the reviewer.

Health Canada response:

Health Canada's consideration of "Representation" for sale is consistent with the Food and Drugs Act and with the practice of other international regulators. In the Food and Drugs Act, "advertisement" is defined to include "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device."

As an example of what other international regulators use, the following is an excerpt from the UK's Medicines and Healthcare products Regulatory Agency "Guide to What is a Medicinal Product" explaining what is considered representation:

• the context in which the claims are made, and the overall presentation;
• how a product appears to the public, or to those to whom it is promoted;
• the labelling and packaging/package inserts including any graphics;
• the promotional literature, including testimonials and any literature issued by the person placing the product on the market or on their behalf;
• advertisements, including those appearing in advertorials, on television, other media and the Internet;
• the product form (capsule, tablet, etc.), and the way it is to be used;
• any particular target of the marketing information/advertising material, for example, population groups with, or particularly vulnerable to, specific diseases or adverse conditions.

The Guidance outlines factors Canadian regulators use to evaluate "Representation" for sale. The factors are similar to the ones presented above.

While consumer perception would not be considered the sole basis for a classification decision, it can be important in cases where it may influence how the average consumer uses a product. Since the average consumer or general public is the user of these products, the Guidance must refer to the general public rather than a subcategory of consumers.

We removed "placement and location" as a factor on its own and included it under section 3.1, "Representation", in response to concerns about its criteria. This is more appropriate since "placement and location" is a sub-component of "Representation".

"Puffery" is defined as "hyperbole about a product that does not contain factual claims of merit." (McGraw-Hill. 2003. Mass Media Law. 13th ed.). The term is widely used in this sense by industry and other stakeholders. The Guidance uses it to explain that claims about a product will not lead to its classification as a drug unless these claims stray into the therapeutic arena. Health Canada takes into consideration any claims of therapeutic benefit even if a company argues that they are cosmetic "puffery."

Issue #3: Risk of the Product

Summary of comments:

• The statement in section 3.1, that there should be no risk from lack of efficacy of a cosmetic should be changed to "no objective human safety risk to the wider population from the failure of a cosmetic product to deliver cosmetic benefits" because no consumer product is without risk.
• Products that do not pose a potential risk should be classified as a cosmetic.
• The inclusion of "Potential risk related to product use" under section 3.5, "Other Considerations", may be redundant and add another level of discretion for the reviewer.

Health Canada response:

The statement that there should be no risk from lack of efficacy of a cosmetic relates specifically to the risk of a cosmetic due to lack of efficacy. It does not signify that there should be no risk related to the use of a cosmetic. Risk or lack of risk due to lack of efficacy is an important factor in the classification of products. If a drug product is not efficacious, it can potentially incur a risk; for example, an ineffective anti-caries toothpaste creates the risk of developing cavities. On the other hand, if a cosmetic does not demonstrate efficacy, it should not incur an added risk.

However, it is not possible to classify a product according to risk alone. This principle is expressed in section 2.0, "Guiding Principles", point #3:

Risk alone does not qualify a substance as either a cosmetic or a drug. The regulatory frameworks under the Food and Drugs Act provide a tier of controls to mitigate the risks of the many and varied products captured by the definitions.

We revised the Guidance to better communicate the "no risk from lack of efficacy" concept: see Section 3.4a, "Inherent risk-benefit balance related to product efficacy".

We removed the reference to "potential risk", as suggested.

Issue # 4: Precedents

Summary of comments:

Cases and/or precedents and previous decisions should always be open to reconsideration based on new policies or new knowledge.

Health Canada response:

We revised the Guidance to reflect the suggestion. Section 3.4b now reads:

Cases of precedence or past decisions. While these are to be kept in mind, they should be open to reconsideration in the event of new policies and knowledge.

Issue # 5: Terms and definitions

Summary of comments:

• The term "products at the cosmetic-drug interface" (PCDI) will lead to a fourth category of product (cosmetic, drug, and natural health products are the other three) and to yet another form of interface.
• The sentence "The classification approach taken in this document applies to a broad range of products at the cosmetic-drug interface" (section 1.3 Scope and Application) should be changed to refer to external use products.
• The definition of "personal care product" (section 1.2) should be reworded to state: "While there is no legal definition for personal care product, for the purposes of this guidance document personal care products are defined as cosmetics that contain an active ingredient that provides a therapeutic benefit to the consumer. Personal care products are currently regulated by Health Canada as either non-prescription medicines or natural health products."
• The term "level of action" should be changed to "mode of action" since personal care products should have only superficial functions without any real or very modest systemic effects on the human organism.

Health Canada response:

The term "products at the cosmetic-drug interface" will not lead to a fourth category of products or an increase in interfaces. The term describes products that do not clearly meet a particular legal definition under the Food and Drugs Act, but that do fall within the definition of either "cosmetic" or "drug." Health Canada does not intend to create a new product category.

The term "external use" cannot be added before "products" because this would exclude products used in the mouth or on mucous membranes.

For the purposes of this document, personal care products are defined as a substance or mixture of substances that are generally recognized by the public for use in daily grooming. The suggested redefinition narrows the category and contradicts the definition of cosmetic in the Food and Drugs Act. Cosmetics cannot contain active ingredients that provide therapeutic effect, and personal care products encompass more than just non-prescription drugs and NHPs. Personal care products may fall into one of three regulations in Canada: Cosmetic Regulations, Food and Drug Regulations or Natural Health Products Regulations.

We did not change the heading "Level of Action" or its criteria to "Mode of Action" because we determined that the existing wording adequately reflects the intent of the section. "Mode of action" is defined by the U.S. Food and Drug Administration (FDA) as "the means by which a product achieves its intended therapeutic effect or action", tying the meaning of the phrase to therapeutic action in a way that would be inappropriate as we use it. The level of a product's action assists in the identification of cosmetics, which are intended to deliver only a topical, local and transient effect (with the exception of tattoos).

Part II: Stakeholder Comments Outside the Consultation on the Guidance

Summary of comments:

Industry would like a new approach to the classification of personal care products rather than a clearer definition of the interface. There were concerns that the Guidance might not provide sufficient infrastructure for reclassification - it might bring about the need for other amendments in the current regulatory framework. There was also concern that three sets of regulations for personal care products in Canada is out of sync with the regulatory regimes of its major trading partners. There were several suggestions for broadening the approach:

• An administrative renewal process that would change the definition of "cosmetic"
• Administrative changes surrounding the review of certain classes of personal care products by Health Canada
• A regulatory renewal approach
• Discussion of needed regulatory amendments involving all relevant stakeholders
• A legislative change to the definition of "cosmetic" at the level of the Act
• Consideration of the product classifications of other regulatory authorities

Specifically, industry stakeholders recommended that Health Canada build on the current Cosmetic Ingredient Hotlist, a list of substances restricted and prohibited in cosmetics, by incorporating restrictions from existing NHP and Category IV Drug monographs and aligning the Hotlist content with other robust and well-grounded inventories in major market places. They suggested that effective ingredient control coupled with recognition of producer responsibility for product safety and followed by post-market surveillance could reduce the need for pre-market control without compromising the safety of Canadian consumers.

They also recommended that Health Canada develop an amendment to the Cosmetic Regulations to allow for a closed list of health claims supported by scientific evidence. Personal care products would then be reviewed post-market by the Cosmetics Program at the Healthy Environments and Consumer Safety Branch.

Health Canada response:

This Guidance is a short-term solution to clarify classification criteria and to revisit the classification of certain personal care products. In the next phase, the Department will assess product categories to determine whether these products are classified appropriately. We will involve stakeholders in this process and consult them on appropriate measures for transition, should a product be reclassified.

The outcome of consultations on the Product Assessments Against Criteria (PAACs) will determine whether or not there is a need for classification changes to certain product categories. Consultations on the PAACs will begin as soon as the revised Guidance and this report on consultation are posted on the Health Canada web site. Health Canada invites stakeholders to remain involved in the development of the Guidance and the resulting Product Assessments Against Criteria (PAACs), to ensure that the management of products at the cosmeticdrug interface is as effective and efficient as possible.

The definitions of "cosmetic" and "drug" in the Food and Drugs Act must be respected and cannot be changed administratively. Health Canada is pursuing options to update the regulations. In the interim, we will continue to make improvements within the existing framework.

A legislative change to the definition of cosmetic would not address the need to review borderline products. For example, in the European Union (EU), all personal care products are included under the definition of cosmetic. However, should a personal care product carry a therapeutic claim, it no longer qualifies as a cosmetic and is regulated as a drug. For example, in the EU, a product that "soothes diaper rash" is a cosmetic, but if it "treats diaper rash," then it is a drug.

International classification schemes are considered in determining product classification but are not the sole basis for a decision, as legal definitions of "cosmetic" and "drug" differ among jurisdictions.

Health Canada will consider creating a document to facilitate the classification of personal care products (cosmetic, drug, NHP), based on ingredients, as a resource for industry. This would include information outlined in the Cosmetic Ingredient Hotlist and the Therapeutic Products Directorate and Natural Health Products Directorate monographs. However, the creation of a closed list of acceptable health claims for cosmetics is not an option. If a cosmetic makes a therapeutic claim, it then becomes subject to the drug provisions found in the Food and Drug Regulations, or the Natural Health Products Regulations.

What's Next?

The revised Guidance on the Classification of Products at the Cosmetic-Drug Interface has guided the development of several Product Assessments Against Criteria (PAACs). The PAACs will serve as tools to implement the criteria outlined in the Guidance. They will document detailed rationale of a classification decision for each personal care product considered. To date, three PAACs, including Antiperspirants, Medicated Skin Care Products, and Diaper Rash Products, have been drafted and consulted on. Final versions are expected for release in Spring 2009.