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Therapeutic Products Programme
Address Locator # 0702A
November 9, 1998
This is further to my letter dated June 5, 1997, in which I invited stakeholder input on an initial policy for comparative claims made on behalf of drug products with respect to the presentation and substantiation of comparisons relating to the non-therapeutic aspects of non-prescription drugs.
The attached policy: Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products is intended to define the conditions under which such comparisons will not be considered false, misleading or deceptive to the intended audience.
In response to the comments received on the initial policy proposal, the Therapeutic Products Programme (TPP) has finalized the broad principles related to substantiation and presentation of comparative non-therapeutic claims. The TPP is not responsible for reviewing non-therapeutic comparative claims, however, this policy is intended to guide the development by the independent review agencies endorsed by the TPP of more detailed standards for presentation of non-therapeutic comparative claims related to non-prescription drugs. This approach will also permit development of separate interpretative guidelines for health professional and consumer-directed advertising that will take into account the differences in these target audiences.
These broad principles are based on the fundamental principles of scientific evidence and the basic tenets of interpretational guidance related to another federal statute that governs all marketing practices, the Competition Act. The principles developed by stakeholders at the June 1996, Comparative Advertising Consultation Workshop, and comments on the initial policy proposal, were also considered in the development of this policy.
The TPP received seven responses from stakeholders. Three of the respondents had no comments or agreed with the proposal. Specific comments from other stakeholders were incorporated in the policy, however a number of suggestions have been considered and addressed as follows:
The full impact of this policy on market behaviour and subsequent risks cannot be fully anticipated at this time. Because there is a lack of empirical evidence to support or refute the concern that comparisons of non-therapeutic aspects of non-prescription drugs with other product categories may put consumers at risk due to inappropriate product selection, we will monitor the impact of this policy. This will also permit the incorporation of changes to this policy in order to ensure its continuing relevance especially in the area of categorization of various products, such as herbal medicines and functional foods. The TPP encourages sponsors and associations to do research on consumer comprehension of the claims during the first few years of use of this policy. Independent review agencies will assist in the compilation of the nature and quantity of complaints that may result further to the implementation of this policy. These results, along with other information gathered may prompt amendments to the various sections of this policy. If significant health hazards are observed, major revisions or even withdrawal of this policy may be considered.
The attached policy is effective immediately, however we expect the provisions, as they relate to non-prescription drug advertising, to be put into effect by the independent pre-clearance agencies endorsed by the TPP upon finalization of the separate guidelines on data requirements.
With regard to drug product labelling, the attached policy will be applied by the TPP to pre-market label review upon the date of publication.
We will be pleased to consider any comments that relate to interpretational issues or clarity. These comments should be forwarded to Ann Sztuke-Fournier, A/Head, Advertising and Promotions Unit, Bureau of Drug Surveillance, Finance Building, Tunney's Pasture, Address Locator 0201C1, Ottawa, Ontario, K1A 1B9.
Implementation of this policy and associated interpretative guidelines is expected to ensure that non-therapeutic comparative claims will not be misleading to the intended audience and will provide for consistency of advertising review.
Original signed by
Dann M. Michols Director General
From the Health Products and Food Branch
Issued October 1998
Administrative Update: August 2005
To define the conditions under which comparison can be made of non-therapeutic aspects of non-prescription drug products with those of other non-prescription drug products, or with other product categories in labelling and advertising, such that these claims will not be false, misleading or deceptive as to the therapeutic character, value, quantity, composition, merit or safety of the drug product to the intended audience.
Section 9(1) of the Food and Drugs Act prohibits advertising and labelling for any drug that is "false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety". This legislative provision is intended to help minimize the risk associated with selection and use of drug products.
The following broad principles of drug advertising are drawn from this statutory provision:
Although there is no published policy regarding inclusion in advertising of non-comparative statements that refer to non-therapeutic aspects of a drug product (eg., taste, cosmetic benefit), there has been no objection to this practice, since it is considered to pose little risk to consumer safety. Similarly, there has been no objection to a comparison of these aspects between drug products provided the comparisons are made between products in the same drug category, eg., fluoride toothpastes and they are adequately supported.
However, the Health Canada Guideline: Consumer Drug Advertising indicates that comparison of non-therapeutic aspects of "cosmetic-like" drugs, such as taste, appearance, cleansing ability, with those of other product categories (eg., cosmetics, foods), is not acceptable. This restriction has been based on a perception that such cross-category claims and counterclaims may lead to inappropriate product selection and expose consumers to unnecessary risk; for example, by encouraging selection of a drug product when a cosmetic product is indicated and vice versa.
There is no empirical evidence that would support or refute this concern.
A preliminary round of stakeholder consultation on comparative advertising in June 1996, indicated that standards for comparative claims should ensure that the claim:
It is Health Canada's responsibility to provide interpretation of regulatory provisions and to set minimum standards that would help ensure that false, misleading or deceptive advertising for therapeutic products does not occur. Health Canada wishes to ensure that any concern with misleading non-therapeutic claims does not adversely impact the therapeutic understanding of a drug product. Based on the above and an analysis of the risks involved, the development of this policy responds to the will to expand on previous restrictions on comparative advertising. The observation of the broad principles of drug advertising, as expressed in the provisions of this policy, would ensure that appropriate measures exist to minimize any potential risk associated with permitting such comparisons in consumer-directed advertising or labelling of non-prescription drugs. It is unlikely that a consumer would select a drug product instead of a cosmetic or food solely on the basis of non-therapeutic comparative claims where the intended use of the advertised drug product is stated both on the product label and in advertising. Furthermore, the risk associated with use of an antidandruff product (drug) instead of a regular shampoo (cosmetic), or an antiperspirant (drug) instead of a deodorant (cosmetic) etc. is negligible.
Since Health Canada is not responsible for reviewing non-therapeutic claims, this policy is intended to guide the development by the independent review agencies of more detailed standards for presentation of non-therapeutic comparative claims related to non-prescription drugs.
This policy applies to the comparison of the non-therapeutic aspects of a non-prescription drug product with that of other non-prescription drug products, or with that of other product categories for human use in consumer-directed labelling and advertising.
This policy does not apply to:
Note that a separate directive exists with respect to the principles for comparative claims related to therapeutic aspects of drugs.
For the purposes of this policy the following terms are defined:
Non-therapeutic attributes of a drug product relate to its physical, sensory Footnote 3 or market characteristicsFootnote 4, to the impact on physical characteristics of the body organ Footnote 5 upon or in which it is used, to cosmetic-type characteristics and to other aspects such as presentation, but excluding any characteristics that relate to the classification of the product as a drug.
Other product categories refers to other product types such as cosmetics and foods.
Ingredient refers to the active ingredient(s) unless otherwise specified.
Advertising sponsors are responsible for ensuring that applicable comparative claims meet the requirements of this policy. It is also the advertising sponsor's responsibility to ensure the continuing validity of comparative claims made in drug advertising by reassessing the supporting evidence, and amending the claim as necessary, in the light of new evidence or information.
The independent pre-clearance agencies endorsed by Health Canada are responsible for the evaluation of non-therapeutic comparative claims in accordance with the principles outlined in this policy. Health Canada does not accept complaints concerning the overall impression of non-therapeutic comparative claims. Complainants may refer this type of complaint:
With respect to the review of product labelling, this policy is effective upon the date of publication.
With respect to product advertising, this policy is effective upon the date of publication and will be put into operation upon finalization of implementation guidelines by the independent pre-clearance agencies endorsed by Health Canada.
The content of fibre, vitamin or mineral in a drug usually relates to the indications for use, eg, therapeutic benefit, and directives are included in the Principles for Comparative Claims Related to the Therapeutic Aspect of Drugs.
The provision of interpretation of advertising claims for foods and cosmetics is not within the Marketed Health Products Directorate (MHPD) mandate. Additional initiatives would be required to address these types of comparisons.
Physical or sensory characteristics include colour, flavour, smell etc.
e.g., market position, retail cost
e.g., cleansing/moisturizing effect; impact on texture, feel, softness, beauty, smoothness and any other cosmetic performance claims