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The Federal Trade Commission (FTC) has primary jurisdiction over the advertising of foods, nonprescription drugs, cosmetics, devices, and services that are marketed in interstate commerce. It also has jurisdiction over the advertising of "dietary supplements," which the 1994 Dietary Supplement Health and Education Act (DSHEA) defines as any product (except tobacco) that contains at least one of the following: (1) a vitamin, (2) a mineral, (3) an herb or botanical, (4) an amino acid, (5) a dietary substance "for use to supplement the diet by increasing total dietary intake," or (6) any concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. DSHEA was passed in response to intense lobbying by the dietary supplement industry and its allies. The campaign's purpose was to weaken the FDA's ability to stop false claims and to drive worthless ingredients from the marketplace.
DSHEA permits manufacturers of supplements and herbs products to make "structure/function" claims as long as their products are not falsely promoted for cure, mitigation, treatment, or prevention of disease -- which could subject them to FDA regulation as "drugs." Manufacturers have responded by making hundreds of questionable claims that they previously were afraid to make.
Although DSHEA has weakened the FDA, the FTC has become more vigorous. In December 1998, the FTC issued "Dietary Supplements: An Advertising Guide for Industry," a detailed document to clarify the need for substantiation. The guide describes how the FTC uses make its analyses and provides a step-by-step roadmap for others who wish to do the same.
To determine whether an ad complies with FTC law, the first step is to identify all express and implied claims that the ad conveys to consumers. Once the claims are identified, the scientific evidence can be assessed to determine whether they are adequately supported. Advertisers must make sure that whatever they say expressly is accurate. Often, however, an ad conveys other claims beyond those expressly stated. Advertisers cannot suggest claims that they could not make directly. When identifying claims, advertisers should consider the ad as a whole, assessing the "net impression" conveyed by all elements of the ad, including the text, product name, and depictions.
For example, if an ad claims that "university studies prove" that a mineral supplement can improve athletic performance, the advertiser should have "university studies" that document the benefit as well as evidence that the studies are methodologically sound. And if advertisement for a vitamin supplement claims that 90% of cardiologists regularly take the product, the advertiser should have adequate support for both the percentage and the implied representation that taking the product is beneficial for the heart.
A statement about a product's effect on a normal "structure or function" of the body may also imply that the product is beneficial for treatment. If elements of the ad imply that the product provides a disease benefit, the advertiser must be able to substantiate the implied claim even if the ad contains no express reference to disease. Thus if an ad for "Arthricure" shows an arthritic woman using a walker before taking the products and dancing afterward, the manufacturers should be able to substantiate the implied claims that the product can cure or mitigate arthritis.
The FTC typically requires claims about the efficacy or safety of dietary supplements to be supported with "competent and reliable scientific evidence." Anecdotal evidence about the individual experience of consumers is not sufficient to substantiate claims. Even if those experiences are genuine, they may be attributable to a placebo effect or factors unrelated to the supplement. Individual experiences are not a substitute for scientific research. Ads that include testimonials should be backed by adequate substantiation that the testimonial experience represents what consumers will generally achieve when using the product. Vague disclaimers like "results may vary" are likely to be insufficient. Whenever an expert or consumer endorser is used, the advertiser should disclose any material connection between the endorser and the advertiser of the product that the consumers would not reasonably expect.
Claims based solely on traditional use should avoid implying that the product has been scientifically evaluated for efficacy. Claims that, if unfounded, could present a substantial risk of injury to consumer health or safety will be held to a higher level of scientific proof. For example, a claim that a mineral supplements has been a popular American folk remedy for shrinking tumors should not be made without scientific evidence that the product is effective.
An advertisement can also be deceptive because of what it fails to say. For example, if an herbal weight loss product contains an ingredient that, when regularly consumed can result in a significant increase in blood pressure, the advertiser should disclose this potentially serious risk.
When the disclosure of qualifying information is necessary, that information should be presented so that it is actually noticed and understood by consumers. A fine-print disclosure at the bottom of a print ad, a disclaimer buried in a body of text, a brief video superscript in a television ad, or a disclaimer that is easily missed on an Internet web site, are not likely to be adequate.
Text of FTC Guide to Dietary Supplement Advertising
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