This article first appeared in the July/August 2005 issue of Update. Reprinted with the permission of the Food and Drug Law Institute (c) 2005.
Health Canada, in collaboration with Advertising Standards Canada, has developed draft Consumer Advertising Guidelines for Marketed Health Products (Guidelines).1 The deadline for the submission of comments on the Guidelines was April 22, 2005. A revised draft of the Guidelines along with a tabulation of comments will be reviewed and finalized by Health Canada. The approved Guidelines are proposed for implementation in January 2006.
The Guidelines will apply to consumer- directed advertising of nonprescription drugs, including natural health products, for human use. Once approved, the Guidelines will replace and supersede Health Canada’s 1990 Consumer Drug Advertising Guidelines.2 The new Guidelines are intended to help advertisers develop advertising messages that meet all of the relevant provisions of the Food and Drugs Act3 and Regulations,4 the Natural Health Products Regulations,5 and other related Health Canada policies and regulations. The Guidelines will be applied by independent advertising preclearance agencies that have been endorsed by Health Canada. Submitting advertisements for preclearance review prior to their release is not mandatory, but is strongly encouraged by Health Canada.
Adhering to the Terms of Market Authorization
Under the Guidelines, therapeutic claims for natural health products must be consistent with the product’s terms of market authorization as listed in the product license; for other nonprescription drugs, these claims must be consistent with labeling standards, category IV monographs, or product monographs. The Guidelines provide that
- therapeutic claims in the advertisement may be paraphrased as long as they remain consistent with those authorized in the product’s terms of market authorization;
- the advertised product must not be directly or indirectly misrepresented as to the product classification under which the marketing authorization was obtained;
- the advertisement must communicate clearly the intended use of the product as per the market authorization;
- the directions for use and duration of action must be consistent with the market authorization;
- the duration of use must be consistent with the market authorization and must be specifi ed when a product is to be used for a defined period of time to obtain the desired effect;
- the degree of relief or benefit to be obtained from the use of the product must be consistent with the market authorization; and
- no medicinal benefit can be attributed, directly or indirectly, to a nonmedicinal ingredient.
Accurately Stating Absence of Ingredients and Side Effects
Advertisements cannot include statements relating to absent ingredients that could create an erroneous impression about the advertised product or a competitive product (e.g., a product may be described as "sugar-free" only if it contains none of the chemical classes of sugar, including sugar alcohols. If a synthetic sweetener (e.g., aspartame) is used, it must be identified on the label.) A statement about the absence of side effects, such as "Product X provides relief in a nondrowsy formula," may be made only if 1) scientific evidence exists to support the statement; 2) there is a widely held consumer perception that the side effect is associated with that class of product; 3) there is no undue emphasis of that statement; and 4) the statement provides practical information.
Drug advertising must be directed at adults. Health Canada considers it misleading to suggest that a child is capable of making a rational decision regarding the use of that type of advertised product. For example, a cough syrup advertisement depicting a child and father standing together, with the father holding the product bottle, is acceptable. An advertisement depicting a child self-administering the product would be unacceptable according to the Guidelines.
Seals and endorsements must not be used in a manner that creates an erroneous impression of the merits of the product. In advertising the merits of the product, it is unacceptable to suggest that use of an advertised product guarantees good health (e.g., it would be unacceptable for an antacid advertisement to show a person making the claim, "Since I discovered product X, I can eat whatever I want, whenever I want.")
Natural and Organic Claims
An advertisement must not mislead consumers into believing that the product is natural, or sourced from a natural product, if it has undergone more than minimal processing or refinement. A product can be described as "natural source" only if it contains a medicinal ingredient obtained via extraction. Ingredients found in nature that are obtained by chemical synthesis may not be referred to as "natural" or "natural source." A product’s therapeutic effect cannot be described as "natural action" or as acting "naturally" because all nonprescription drugs and natural health products modify the body’s physiological processes.
If an advertisement makes a claim that a product is organic, the product must be certified according to organic standards. Advertisers must provide evidence of certification (e.g., a copy of an Organic Certificate issued by a certification body).
The terms "new" and "improved" can be used for a period of one year from the date of marketing formulation. The nature of the improvement should be communicated clearly. The term "unique" may be used only if a product provides a unique or exclusive therapeutic benefi t or effect.
If Health Canada has issued and posted an "Advisory/Warning" on the Health Canada website6 about a specifi c nonprescription drug, including a natural health product or medicinal ingredient, this information should be communicated to consumers in advertising or at a minimum—consumers should be directed to a source for such information. Advertising should describe both positive effects and associated known serious adverse reactions. Claims of "safe" and "side effect-free" are unacceptable. Transcripts and footnotes must not be used to correct an otherwise misleading impression about a product, but may be used to provide clarifi cation.
Advertisements must not include offers of samples to the general public.
The Guidelines update the existing principles applicable to nonprescription drugs and clarify that the principles apply equally to natural health products. They represent a valuable tool for advertisers trying to develop advertising messages that meet applicable legal requirements. FDLI
1. See Health Canada’s website at www.hc-sc.gc. ca/hpfb-dgpsa/tpd-dpt/fi nal_consumer_advertising_ guidelines_consultation_draft_e.html (last visited May 17, 2005).
2. The 1990 guidelines can be obtained only in hard copy from Health Canada; they are not available online.
3. Available at http://laws.justice.gc.ca/en/f-27/61279. html (last visited May 2, 2005).
4. Available at http://laws.justice.gc.ca/en/f-27/c.r.c.- c.870/text.html (last visited May 2, 2005).
5. Available at http://laws.justice.gc.ca/en/f-27/sor-2003- 196/text.html (last visited May 22, 2005).
6. Available at http://www.hc-sc.gc.ca/english/protection/ warnings.html (last visited May 22, 2005).
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