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Veterinary Biologics Guideline 3.5E

Guidelines For Advertising Of Veterinary Biologics

INTRODUCTION

The purpose of this guideline is to provide information on requirements for advertising of veterinary biologics in Canada. The advertising of veterinary biologics is regulated under the Health of Animals Act and Regulations^{1, 2}. Recently, the regulations concerning advertising of veterinary biologics have been amended to remove the requirement for pre-approval of all advertisements prior to distribution.

The Section 135 (1) of the Health of Animals Regulations (January 1997) states that "No person shall, in any advertisement for the sale of a veterinary biologic, make any claim with respect to the purity, safety, potency and efficacy of the veterinary biologic that is not supported by the product outline for such veterinary biologic." There has been no amendment to this section. Therefore, advertising of veterinary biologics will continue to be regulated under the Health of Animals Act and Regulations.

The Sections 135 (2) of the regulations which state that "No person shall advertise a veterinary biologic for sale unless he first submits the advertisement to the Minister for examination and the Minister signifies that he has no objection to the advertisement" (June 1993) has been amended to state that "No person shall in any advertisement for the sale of a veterinary biologic, make any representation that is false, misleading or deceptive or that is likely to create an erroneous impression regarding the character, value, quality, composition, merit or safety of the advertised veterinary biologic" (January 1997).

The section 135 (3) which states "Where the Minister has examined an advertisement submitted to him pursuant to subsection (2) and is satisfied that the advertisement does not make any representation that is false, misleading or deceptive or that is likely to create an erroneous impression regarding the character, value, quality, composition, merit or safety of the advertised veterinary biologic, the Minister shall, within 45 days of the submission, signify the person submitting the advertisement that he has no objection to that advertisement." (June 1993) has been repealed (January 1997).

Prior to these amendments (January 1997), the advertisers were required to submit all advertisements to Veterinary Biologics Section (VBS) for approval before the publication. The advertisers are now not required to submit the advertisements to VBS for pre-approval. This will also allow the option of establishing an independent review agency designated by Canadian Animal Health Institute (representing the industry) and Canadian Veterinary Medical Association (representing the users) to self-regulate veterinary biologics promotional material.

The VBS will continue to investigate any complaint, and take necessary actions against false or misleading advertisements until another agency has been designated by CAHI and CVMA. At the request of those advertisers who wish to obtain pre-approval on voluntary basis, VBS will continue to review and approve the advertisements. The fee for review of the advertising material is $100.⁰⁰ per page³.

SCOPE AND DEFINITION OF ADVERTISEMENT

For the purposes of this guidelines "advertising" includes all information intended for publication or presentation on television or radio, promotional brochures, handouts or other materials designed to bring a veterinary biologic to the attention of the user. Labelled pens, matches and similar articles lacking claims and company materials prepared for the specific purpose of briefing a salesperson are not considered to be advertising and these items are not subject to regulation.

Manuscripts for presentation at scientific meetings and publication in peer reviewed scientific journals are not considered as advertisements. Such reports should contain a complete description of the experiment including a detailed description of the objectives, materials & methods, results, and discussions. Data should provide sufficient details to enable the intended audience to objectively evaluate the merit of the conclusion. If research data is condensed into a summary format which highlights the conclusion but omits the materials & methods and results, it would generally be classified as advertisement. Similarly, if text or data are extracted from research reports to prepare "headlines" or "simplified graphics", then the material would be considered advertising materials.

GENERAL GUIDELINES

The advertisers are recommended to observe the following general guidelines when preparing the advertising materials:

1. Veterinary biologics which are not licensed by VBS for general sales in Canada should not be advertised or promoted in Canada.

2. All advertisements should be consistent with label claims.

3. All claims must be supported by Outline of Production and research reports filed with VBS.

4. Veterinary biologics should be advertised and promoted on their own merits, in a positive manner and not by comparison to other licensed product.

5. The use of superlative statements, negative statements, absolute statements and dangling comparatives are generally considered to be misleading and therefore should not be used.

6. Comparisons whether statements or illustrations, should not mislead, directly or indirectly or by implication and must be supported by reliable data.

7. Testimonial statements are subject to critical review and should be supported by proper documentation.

8. Specific examples of wording which may be controversial are "new", "unique" "first" "only" and "no stress." The words "new" and "unique" should only be used if the biologic is in fact a prototype and similar products are not available in Canada or a product is first for the company and the advertisement contains that qualification. The words "first" and "only" should only be used if it is possible to verify these claims. The term "no stress" should not be used as the safety of all biologics must be demonstrated prior to licensing.

9. The statement that a particular route of administration is quicker, faster or easier is considered to be subjective and controversial. For example, an advertisement stating that the intramuscular route is "easier" and time-saver" compared to the subcutaneous route, may be misleading when one considers that proper intramuscular technique require that the syringe plunger be withdrawn to confirm that the needle is not located in a blood vessel prior to injection of the biologic.

10. A statement that a parental administration is easier or speedier than intra-nasal administration may or may not be true depending on the method of restraining the recipient. It is recommended that in fairness to all advertisers, that route of administration and ease of administration not be equated in future advertising

The above examples are not all inclusive but should serve to illustrate the type of statements likely to be acceptable or unacceptable.

All complaints against published advertisements should be submitted in writing, along with the details of the complaints and supportive materials to:

National Manager
Veterinary Biologics Section
Canadian Food Inspection Agency
2 Constellation Crescent
Ottawa, Ontario K1A 0Y9 Canada

REFERENCES

1. Health of Animals Act, Section 64 (1) (s)
2. Health of Animals Regulations, Part XI, Sections 120 - 135
3. Canadian Food Inspection Agency Fees Notice - Part 11, Services Related To Veterinary Biologics (Items 40 - 50).