In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this article will discuss some of the specific requirements concerning the advertising of health products towards consumers. The overriding principle lies within the Canadian Food and Drugs Act, which prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Health product advertising is any consumer-directed advertising of health products, including nonprescription drugs, natural health products, medical devices and vaccines, in all Canadian media. Canadian “media” include, but are not limited to: television, radio, mass print, billboards, transit, in-store promotional materials, direct mail, websites, e-mail, mobile, and social media. Here are some of the common items to watch out for:
Therapeutic claims, directions of use, and duration of use must be consistent with the terms of Marketing Authorization.
A product’s terms of Marketing Authorization (TMA) sets out the claims authorized by Health Canada. These claims may be paraphrased, but must not directly or indirectly exceed the scope of the TMA. Any visuals, graphics, or schematics, should not be used to directly or indirectly suggest product benefits that exceed those found in the TMA.
- TMA for Nonprescription drugs: Labelling Standards/Category IV Monograph, approved product labels and product monographs
- TMA for Natural Health Products (NHPs): Product Licence
- TMA for Medical Devices: Medical Device Licence and approved Labels (Class II-IV)
For example, the authorized indication for product X is “Adequate calcium as part of a healthy diet may help prevent bone loss/osteoporosis.” An acceptable claim that you may use in advertising is, “Product X calcium supplement MAY assist in the prevention of osteoporosis”. An unacceptable claim would be, “Product X calcium supplement prevents osteoporosis”.
An advertisement must not suggest that a child is capable of making a rational decision regarding the use of the advertised health product.
Health product advertising must be overtly directed to adults only. An advertisement must not depict or encourage unsupervised use of drugs by children, or suggest that a child can self-diagnose or self-medicate. In addition, advertisements must not depict product storage in locations accessible to children. A child may approve of the taste of a medicine, but may not make recommendations concerning the use of the advertised product.
Terms that communicate a product is new, improved or reformulated may be used for a period of one year from the date it is first available for retail sale.
Examples of these terms include “new”, “improved”, “now available”, and “introducing”.The product attribute that is new or improved should be clearly specified, e.g. “improved taste”, “new format”.
When depicted or described, product performance must be consistent with the TMA and should not be exaggerated.
Hyperbolic terminology, e.g. “amazing”, “powerful”, “fantastic”, should not be used to exaggerate the therapeutic effect/benefit of a product or ingredient. Advertising should not suggest that a product is “potent” or has a “potent” formulation, or imply the product is powerful, strong or more effective based on the amount of medicinal ingredient(s).
All health products are authorized to be effective for the condition/symptoms they are designed to relieve/treat/prevent, and therefore, can claim to be “effective”, “strong enough”, “tough enough” or have the power to relieve/treat/prevent the condition/symptoms in question. However, it is unacceptable to suggest that the product in and of itself is “strong” or “powerful”.
An advertisement should not suggest that product use is “essential”. It is acceptable to communicate that one “needs or wants relief”. However, it is unacceptable to claim that a consumer “needs” a specific health product or ingredient.
For example, the authorized indication for product X is “For the treatment/management of acne.” An acceptable claim that you may use in advertising is “Clear your face. Fight acne with the power of Product X. It worked for me!” An unacceptable claim would be “Fight acne with powerful Product X!”
An advertisement should not directly or indirectly suggest that a product is effective for all individuals, or that it will be effective every single time it is used. Guarantees of overall product satisfaction or other non-therapeutic attributes (e.g. purity, quality or physical characteristics) are acceptable if true and supported.
For example, an acceptable claim that you may use in advertising is “Satisfaction guaranteed, or your money back”. An unacceptable claim would be “Guaranteed relief, or your money back”.
If you want to be sure your health products are advertised in compliance with Canadian legislations and requirements, Quality Smart Solutions has a team of specialists who can assist with developing messages that comply with the advertising provisions of Canadian federal legislations and are in accordance with Health Canada policies and guidance documents. Get prepared now and contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.
References Guidelines for Consumer Advertising of Health Products, 2018, Ad Standards, https://adstandards.ca/wp-content/uploads/2018/07/Consumer-Advertising-Guidelines-for-Marketed-Health-Products-EN.
How We Can Help
Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.
Contact us today to learn more about how we can support your compliance needs during and after licensing!