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

A.1 Introduction

ASC will review both non-comparative and comparative non-therapeutic claims contained in nonprescription drug advertisements directed to consumers in accordance with the broad principles of drug advertising derived from subsection 9(1)1 of the Food and Drugs Act and Regulations, and relevant Therapeutic Products Programme (TPP) policies and guidelines and this Clearance Policy.

This ASC Clearance Policy complements the TPP Policy: Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products2. In accordance with the TPP Policy, this Clearance Policy encompasses only non-therapeutic comparisons made in drug advertisements between drugs and non-drugs. It does not address non-therapeutic comparisons made in advertisements for non-drug products between non-drugs and drugs (see also In accordance with the TPP Policy, this Clearance Policy encompasses only non-therapeutic comparisons made in drug advertisements between drugs and non-drugs. It does not address non-therapeutic comparisons made in advertisements for non-drug products between non-drugs and drugs (see also section A.2 Scope).

As this Clearance Policy is put into practice, future modifications or clarifications may be necessary.

A.2 Scope

As per section 3 of the TPP Policy: Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products:

"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:

  • the relative cost-effectiveness3 of drug products;
  • comparative claims, relating to therapeutic attributes including quality of life claims, or relating to ingredients in a drug product that contribute to its intended therapeutic use (e.g. vitamins, minerals, fibre) of drug products;
  • comparative claims, relating to therapeutic attributes including quality of life claims, or relating to ingredients in a drug product that contribute to its intended therapeutic use (e.g. vitamins, minerals, fibre)4, that are made in advertising for all drugs for human use;
  • the promotion of other product categories compared to non-prescription drugs (e.g. foods to drugs) using non-therapeutic comparative claims5;
  • emerging issues that relate to the classification of a product such as natural health products or functional foods, unless a determination has been made that a product is classified as a drug" (in which case, this ASC Clearance Policy applies).

B.1 - ASC Consumer Drug Clearance Policy - Definitions

TPP Definitions
As defined in section 4 of the TPP Policy: Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products:

Non-therapeutic attributes of a drug product relate to its physical, sensory6 or market characteristics7, to the impact on physical characteristics of the body organ8 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 refer to other product types such as cosmetics and foods.

Ingredient refers to the active ingredient(s) unless otherwise specified" (in the TPP Policy).

ASC Definition
Non-therapeutic comparative claim: a statement that compares an identified non-therapeutic attribute of a drug product/ingredient to that of one or more other drug product(s)/ingredient(s) or to that of one or more non-drug product(s)/ingredient(s)9.

B.2 - Comparison Between Drug Products - Non-Therapeutic Aspects

General Principles
ASC will review comparative non-therapeutic claims in accordance with subsection 9(1) of the Food and Drugs Act and section 5.I of the TPP Policy: Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products and other relevant TPP policies and guidelines:

Review Criteria
In accordance with subsection 9(1) of the Food and Drugs Act, the overall impression of the advertisement must not mislead the consumer as to the overall character, merit, composition, identity, function etc of the drug product(s).

Therefore,
(i) each advertisement will be evaluated on its individual merits;
(ii) a drug product may not be disparaged for its lack of a non-therapeutic benefit that it doesn’t currently have or claim to have.

To accomplish this, a drug product should be promoted primarily on the basis of its positive non-therapeutic benefits rather than on the absence of a non-therapeutic benefit the other product(s) never had or claimed to have.

Example: "Anti-Dandruff Shampoo A only conditions your hair – it doesn’t leave your hair tangle-free like Anti-Dandruff Shampoo B". This claim, even if factual, is unacceptable since it promotes Anti-Dandruff Shampoo B in a negative fashion by emphasizing a non-therapeutic characteristic that Anti-Dandruff Shampoo A never had or claimed to have.

However, a similar claim could become acceptable if presented in a positive fashion: "Anti-Dandruff Shampoo A conditions your hair but our Anti-Dandruff Shampoo B gets rid of tangles as well."

TPP Policy Section 5.1/ASC Application
Additionally, the policies and applications below will be followed to ensure that:

TPP Policy
(from TPP Policy section 5.I - Comparison Between Drug Products)
ASC Application
  1. the advertised product is primarily represented as a drug as defined in the Food and Drugs Act;
In accordance with the TPP Policy, the advertisement must represent the advertised product primarily as a drug. Therefore the advertisement must:
  1. clearly and understandably convey the therapeutic indication of each drug product in addition to any non-therapeutic benefit mentioned; and
  2. clearly and understandably convey the symptoms of the condition or disorder each drug is intended to treat; and
  3. not mislead the consumer about the primary therapeutic nature of each drug product.
  1. the compared products have an authorized indication for use in common with the advertised product;
  1. the authorized product information for each drug product in the advertisement (e.g. Product Monograph, Category IV Monograph, Labelling Standard, TPP-approved product label10) will be consulted to ensure the drugs have an authorized indication for use in common;
  1. the information provided may be of some benefit to some or most consumers, e.g., relevant to product selection;
  1. it will be for the advertiser to decide which information is of some benefit11 to some or most consumers.
  1. the claim is supported by adequate, up to date, unbiased and statistically valid data;
  1. Together with each non-therapeutic claim submitted for ASC approval, or as ASC may otherwise request, the advertiser will provide its written attestation that the advertiser possesses readily available, up-to-date, adequate, unbiased and statistically valid data to substantiate the non-therapeutic claim (see also section C of this Clearance Policy: Supporting Data for All Non-Therapeutic Claims).
  1. the claim does not obscure information on the authorized indication(s) or intended medicinal use(s) of the advertised drug product;
  1. each advertisement will be judged on its individual merits; benefit mentioned; and
  2. the non-therapeutic claims for each drug product will be evaluated in the overall context of the advertisement to ensure these claims do not obscure or mislead as to the intended medicinal uses contained in its respective authorized product information (e.g. Product Monograph, Category IV Monograph, Labelling Standard, TPP-approved product label10);
  1. any comparison of non-therapeutic characteristics should also include a reference to therapeutic characteristics; and
  1. each advertisement requires at least one clear therapeutic indication for each active ingredient in each drug product in the advertisement (equal focus on each therapeutic indication is not required);
  • In most cases, the advertisement should clearly identify the symptoms of the condition or disorder that the drug is intended to treat.
  • Example: a single-ingredient analgesic may have two approved indications (fever reduction and pain relief). The advertisement may focus on only one of these approved indications, and may also present a non-therapeutic benefit.
  • Example: a back pain remedy may contain two active ingredients, an analgesic and a muscle relaxant. In addition to presenting a non-therapeutic benefit, the advertisement may focus more on the muscle relaxant indication than on the analgesic indication but must not mislead the consumer to believe the drug is a single-ingredient product for a single therapeutic purpose.
  • Example: Multiple (3 or more) active ingredient products. A cough/cold preparation may contain 3 or more active ingredients to relieve 3 or more different symptoms. In addition to presenting a non-therapeutic benefit, the advertisement may focus more on relief of one particular symptom but must clearly communicate to the consumer that the product contains multiple ingredients for multiple symptom relief.
  • Note: If a drug contains two or more active ingredients that relieve the same symptom, then it is only necessary to identify the one symptom. However, the consumer should not be lead to believe the product contains only one active ingredient.
  1. messages with comparison of non-therapeutic characteristics should carry a statement to the effect that superiority in these areas does not mean better compliance and/or better therapeutic characteristics, unless such a claim can be substantiated by scientific data.
  1. In some instances, it may be appropriate and necessary to make a statement such as: "superior (non-therapeutic benefit) does not mean superior (therapeutic benefit) / compliance".
  2. An advertisement for a drug product will be rejected as being misleading if the advertisement creates the impression of disparaging the therapeutic benefits of another drug product by virtue of the fact that the other drug product has fewer, less or none of the non-therapeutic benefits found in the advertised product.
  • For example, an advertisement for fluoride toothpaste A will be rejected as being misleading if it creates the impression of disparaging the anti-caries benefits of fluoride toothpaste B by virtue of the fact that fluoride toothpaste B whitens less well than fluoride toothpaste A.
  • It is, however, acceptable for an advertisement to communicate superiority about a non-therapeutic aspect, (e.g. fluoride toothpaste A whitens better than fluoride toothpaste B) as long as the advertisement for fluoride toothpaste A does not convey the impression of disparaging the therapeutic activity (e.g. cavity fighting) of the compared drug product.
  • In other words, the advertisement must not convey the overall impression that the delivery of the superior non-therapeutic benefit also means delivery of a superior therapeutic effect.


B.3 - Comparison Between Drug Products and Products in Other Product Categories - Non-Therapeutic Aspects

TPP Policy Section 5.11/ASC Application
ASC will review comparative non-therapeutic claims in accordance with subsection 9(1) of the Food and Drugs Act and section 5.II of the TPP Policy: Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products and other relevant TPP Policies and Guidelines to ensure that:

TPP Policy
(from TPP Policy section 5.II - Comparison Between a Drug Product and Products in Other Product Categories)
ASC Application
  1. the advertised product is primarily represented as a drug as defined in the Food and Drugs Act, and the other product's identity/function/purpose is clearly identified (e.g. food, cosmetic...);

In accordance with TPP Policy, the advertisement must represent the advertised product primarily as a drug. Therefore the advertisement must:

  1. clearly and understandably convey the drug's therapeutic indication in addition to any non-therapeutic benefit mentioned; and
  2. clearly and understandably convey the symptoms of the condition or disorder the drug is intended to treat; and
  3. not mislead the consumer about the primary therapeutic nature of the drug product.
  4. clearly state the principal purpose of, or use for the non-drug product (e.g. gum; moisturizer);
  1. there is no implication of therapeutic activity attributed to the non-drug product(s);
  1. each advertisement will be evaluated on its individual merits in accordance with the Food and Drugs Act and Regulations and other relevant TPP Policies and Guidelines;
  1. the compared products are intended for use on or in the same body organ, e.g., hair, skin, mouth, teeth;
  1. the intended use on or in the same body organ will be evaluated based on the product label of the non-drug product and on the authorized product information (e.g. Product Monograph, Category IV Monograph, Labelling Standard, TPP-approved product label10) for the drug product;
  1. the information provided may be of some benefit to some or most consumers, e.g., relevant to product selection;
  1. it will be for the advertiser to decide which information is of some benefit11 to some or most consumers.
  1. the claim is supported by adequate, up to date, unbiased and statistically valid data;
  1. together with each non-therapeutic claim submitted for ASC approval, or as ASC may otherwise request, the advertiser will provide its written attestation that the advertiser possess readily available up-to-date, adequate, unbiased and statistically valid data to substantiate the non-therapeutic claim. (see also section C of this Clearance Policy: Supporting Data for All Non-Therapeutic Claims);
  1. the claim does not obscure information on the authorized indication or intended medicinal use of the advertised drug product; and
  1. the non-therapeutic claims for the advertised drug product will be evaluated in the overall context of the advertisement to ensure these claims do not obscure or mislead as to the intended therapeutic uses contained in the authorized product information for the drug product (e.g. Product Monograph, Category IV Monograph, Labelling Standard, TPP-approved product label10); and
  1. the overall impression of the advertisement does not mislead the consumer as to the overall character, merit, composition, identity, function etc of the drug or non-drug product.
  1. each advertisement will be evaluated on its individual merits;
  2. a drug product advertisement is misleading if it makes any direct reference to the lack of therapeutic benefit(s) in a non-drug product, since the non-drug product was never intended to possess or claim drug attributes. Example: It is not acceptable to claim that "Cosmetic Shampoo A only conditions your hair - it doesn't fight dandruff like Anti-dandruff Shampoo B" This claim is not acceptable because cosmetic shampoo A was never intended to possess therapeutic attributes. The claim, therefore, would be misleading. This claim is acceptable when reworded to present the positive attributes and intended use of each product: "Cosmetic Shampoo A conditions your hair. But Anti-dandruff shampoo B conditions and fights dandruff, too."
    It is, also acceptable to compare a drug to a non-drug product with respect to a non-therapeutic benefit. For example: Anti-perspirant A leaves you fresher smelling than deodorant B.
  3. a drug or a non-drug product may not be disparaged for its lack of a non-therapeutic benefit that it doesn't currently have or claim to have.
    To accomplish this, both drug and non-drug products should be promoted primarily on the basis of their own positive non-therapeutic benefits rather than on the absence of a non-therapeutic benefit the other product(s) never had or claimed to have.
    For example: "Non-drug Shampoo A only conditions your hair - it doesn't leave your hair tangle-free like Anti-Dandruff Shampoo B." This claim, even if factual, is unacceptable since it promotes Shampoo B in a negative fashion by emphasizing a non-therapeutic characteristic that Shampoo A never had or claimed to have.
    However, a similar claim could become acceptable if presented in a positive fashion: "Non-drug Shampoo A conditions your hair but our anti-dandruff shampoo gets rid of tangles as well."
  4. an advertisement is misleading if it directly or indirectly attributes any therapeutic properties to the non-drug product (see also item 2).


C - Supporting Data For All Non-Therapeutic Claims

When will ASC review the data that support a non-therapeutic claim?

  • ASC will not routinely review the substantiation for non-therapeutic claims. Historically, non-therapeutic claims have not required preclearance whether they were in the comparative or non-comparative classification of advertisements. Moreover, ASC is currently receiving very few trade or consumer complaints about non-therapeutic claims in drug advertising. Therefore, preclearance of the substantiation for the non-therapeutic claims does not appear to be necessary at the present time. However, a change in the volume and frequency of advertising complaints may stimulate a proposed change to this aspect of the Clearance Policy. This would be discussed with industry prior to implementation.
  • ASC will routinely ask the advertiser for written attestation that the advertiser possess readily available up-to-date, adequate, unbiased and statistically valid data to substantiate the non-therapeutic claim.
  • ASC will review the substantiation to support a non-therapeutic claim if requested to do so by the advertiser of that claim at the time the advertisement is cleared. ASC will provide an opinion as to whether the data is "up-to-date, adequate, unbiased and statistically valid". If ASC’s opinion of the substantiation is requested, the submission will be reviewed in its entirety and, as such, is subject to approval, rejection or a request for resubmission. Any complaints by consumers or competitors about such advertising will be handled according to ASC’s standard operating procedure outlined in section D of this Clearance Policy.
  • ASC may request and review the substantiation if needed by ASC to determine whether a claim is non-therapeutic or therapeutic in nature.
  • ASC may request the data or inquire about the supporting data to assist ASC in determining whether or not the claim meets the criteria of this policy.

What constitutes "up-to-date, adequate, unbiased and statistically valid" data?
It is not possible to pre-determine what constitutes "acceptable" data for all types of non-therapeutic claims. However, some principles of general application are listed here. The list is by no means exhaustive:

Up-to-date means data which have not been superseded by more recent and relevant data and information. Data must be valid at the time the claim is submitted for review (if review is requested by the advertiser), and every time the claim is advertised in any medium. As a general rule, the advertiser is expected to subject his available claim support to regular, periodic review by knowledgeable assessors either within or outside the advertiser’s company. Data should always be reviewed when conditions are such that the data may no longer be valid. New product entries and competitive formula changes could invalidate the data.

adequate means data derived from studies conducted according to accepted scientific and industry standards. Studies should be done with the Canadian marketed product(s) or the equivalent12 claimed to have and be designed to test the claim made. In some cases, "adequate" claim support may be based on the "available body of evidence" such as, but not limited to, information reasonably available as published or unpublished studies, or other data in peer-reviewed literature generally available in the public domain.

unbiased means the studies should be designed such that the results derived are impartial and fair, and do not favour a positive outcome for one product or another.

statistically valid means data has been evaluated based on generally accepted scientific statistical methodology.

periodic review: As a general rule, the advertiser should subject claims and claim support to regular periodic review. The only firm rule is that claims and claim support should be reviewed when it would be reasonable to question whether support continues to be adequate. New product entries and competitive formula changes could invalidate the claims or data as soon as they occur. On the other hand, a particular type of claim or a stable market condition might allow the data to be valid for years.

D - Complaints About Non-Therapeutic Claims

Advertising Standards Canada accepts the following types of complaints about non-therapeutic claims found in comparative or non-comparative advertisements:

  • Consumer or competitors may file a complaint under ASC’s Consumer Drug Section Complaint Procedure about a previously unapproved nonprescription drug advertisement which is seen, read or heard in a Canadian advertising medium. The complaint must be based on an alleged violation of the Food and Drugs Act, Regulations, the Consumer Drug Advertising Guidelines, the Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products or other TPP policies. Consumer or competitors’ complaints about a non-therapeutic claim that is allegedly misleading as to the therapeutic nature of a drug are accepted under this procedure.
  • Consumers may file a complaint under ASC’s Consumer Complaints Process about "advertising" for any nonprescription drug product (whether or not previously approved by ASC’s Consumer Drug Section). The complaint must be based on an alleged violation of the Canadian Code of Advertising Standards.
  • Competitors may file a complaint under ASC’s Trade Dispute Procedure about "advertising" for any nonprescription drug product (whether or not previously approved by ASC’s Consumer Drug Section). The complaint should be based on an alleged violation of the Canadian Code of Advertising Standards.

ASC will "assist in the compilation of the nature and quantity of complaints that may result further to the implementation of this (TPP) Policy", as noted on page seven (7) of the Director General’s November 9, 1998 letter that accompanied the TPP Policy, Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Nonprescription Drug Products.