Claims about Non-Therapeutic Aspects of Nonprescription Drugs in Consumer-Directed Advertising - Footnotes

1

Subsection 9(1) of the Food and Drugs Act prohibits advertising 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".

2

Note: The Consumer Drug Section of Ad Standards reviews and approves broadcast and mass print consumer-directed nonprescription drug advertisements. This is done in accordance with the Consumer Drug Advertising Guidelines, the Food and Drugs Act and Regulations, the authorized product information (TPP-approved product label, Product Monograph, Labelling Standard or Category IV Monograph) and other relevant TPP Policies, Guidelines or documents.

3

Cost-effectiveness claims include comparisons of the cost of drugs or programmes having a common health outcome (e.g. reduction of blood pressure, reduction of headache, life-years saved).

Claims not covered under this Policy:
Any comparison of the cost of drug therapy linked to a therapeutic attribute, or any cost comparison which provides a measure of value expressed in terms of improved health outcome, quality of life, better performance, reduced side-effects, etc. are considered therapeutic claims and not permitted within the scope of this TPP Policy.

Examples of claims not covered by this Policy:

• "Drug A costs less than Drug B to relieve symptom X";
• "Drug A costs less than Drug B to treat condition Y".
• "Drug A costs 50 cents less a day than Drug B to relieve your headache."

These claims are not acceptable since the comparative cost is linked to the therapeutic effect.

Examples of claims covered under this Policy:
Relative cost claims if there is no direct or indirect link to the therapeutic effect. Therefore, the last claim mentioned immediately above falls within the scope of this Policy if reworded as follows:

• "Drug A costs 50 cents less a day than Drug B". In this claim there is no reference to therapeutic effect. Please note, however, that the determination of whether a comparative cost claim falls within the scope of this Policy depends ultimately upon the context in which it is used and the overall impression conveyed by the advertisement (See also footnote 7).

4

As stated in the TPP Policy: "The content of fibre, vitamin or mineral in a drug usually related to the indications for use, e.g. therapeutic benefit, and directives are included in the Principles for Comparative Claims Related to the Therapeutic Aspect of Drugs".

5

As stated in the TPP Policy: "The provision of interpretation of advertising claims for foods and cosmetics is not within the TPP mandate. Additional initiatives would be required to address these types of comparisons."

6

Physical or sensory characteristics include colour, flavour, smell, etc.

7

e.g. market position, retail cost, cost per bottle, cost per tablet, cost per day or other duration (provided there is no link to therapeutic attribute - see also footnote 3). Caution: Advertisers should be aware that promoting the choice of a particular drug based solely on daily cost savings could be considered false and misleading if the information provided is not balanced. Also, consumers could be at risk if advertising encourages them to purchase, and therefore to intentionally or accidentally consume, large quantities of drugs based on cost savings.

8

e.g. cleansing/moisturizing effect; impact on texture, feel, softness, beauty, smoothness and any other cosmetic performance claims

9

Such non-therapeutic comparative claims include direct comparisons (e.g. product A tastes better than product B), parity claims (e.g. nothing whitens better than product X), self-comparisons (e.g. our best whitening toothpaste ever), and implied non-therapeutic comparisons (e.g. use of terms like better tasting, longer-lasting hair conditioner, best-selling headache remedy).

10

TPP-approved product label: Manufacturers are reminded that the Therapeutic Products Programme neither conducts a full review of nor approves labels submitted in Category IV Monograph and Labelling Standard submissions. Furthermore, it is the manufacturer’s responsibility to secure appropriate regulatory approval for label claims that exceed Category IV Monographs and Labelling Standards. Ad Standards will rely on manufacturers’ assurances that this additional regulatory approval has been obtained, and may, in certain circumstances, ask for written verification of such approval.

11

"Benefit" refers to a non-therapeutic advantage or characteristic of the product that would normally be considered by consumers in making product selection such as, but not limited to appearance, texture, colour, fragrance, taste, smell, cleansing or hydrating ability, ease of application or some other measurable physical characteristic or non-therapeutic attribute or market characteristic (such as cost or market position).

12

See current TPP Policies about Canadian Reference Products and bioequivalence requirements.