Todd Harrison11.01.04
FTC Regulation Of Marketing Claims In The U.S.
When marketing dietary supplement or functional food products in the U.S. there are some general principles that should be followed.
By Todd Harrison
Sections 12 and 15 of the Federal Trade Commission Act (FTC Act) prohibit the dissemination of false or deceptive advertisements. This means that advertising claims must be truthful, non-misleading and properly substantiated at the time they are made. Advertising claims may be express or implied: Express claims are those claims that are directly stated in the advertisement (e.g., “CoQ10 lowers homocysteine levels”). Implied claims are those claims that are not expressly stated but may be inferred by examining the advertisement in its entirety, including express claims, vignettes, pictures, etc.
Most health-related claims carry both express and implied meanings. For example, implicit in the express claim “reduces insulin insensitivity” is the claim that the product may be useful as a treatment for diabetes. Thus, while the FTC is not technically concerned about the form of the claim, it will strictly construe a health-related claim and require proper substantiation not only for the express meaning of the claim, but also the implied meaning. Indeed, in certain respects, implied health claims appearing in advertising may be more closely scrutinized than claims found in product labels and labeling.
A false or misleading claim generally will be actionable if it is “material” and is likely to deceive more than an insubstantial number of consumers. A claim is considered material if it is likely to influence consumers’ purchasing decisions or other significant consumer action or inaction. Express false claims, as well as intended false implications, are presumed by the courts and regulators to be material. As a general rule, all express and implied health, safety, quality and performance claims are considered material. Additionally, in determining whether the claim is deceptive, all representations and material omissions will be considered within the context of the whole advertisement in which the claim appears. Thus, a truthful claim may be deceptive if it misleads consumers about the potential benefits of the product or service.
When the disclosure of pertinent information is required, the information must appear in a manner that is likely to be noticed and understood by the consumer. For example, suppose a supplement marketer was to send out a three-page direct mail piece titled “helps alleviate joint pain in one week.” The first two pages of materials are devoted to a description of this wonderful new discovery, while at the bottom of the third page the following disclaimer appears in fine print: “Individual results will vary. Most individuals will not see any relief in less than 8 weeks.” Because the disclaimer is buried in the fine print, the disclaimer likely would be considered inadequate to overcome the advertisement’s primary message, i.e., that individuals using this product can expect to feel relief from joint pain in less than on week. To avoid potential issues over the disclaimer, the disclaimer should appear in close proximity to the claim in a clear and conspicuous manner.
As for substantial (or “not insubstantial”), there is no set percentage of a claim’s audience that constitutes a “substantial” number for purposes of deciding whether the claim is deceptive. Generally, deception of 20-25% of the audience is considered “substantial,” with less being so considered where there is a potential for physical injuries or large financial losses. (See Coca-Cola Co. v. Tropicana Prods., Inc., 690 F.2d 312,317 (2d Cir. 1982); McNeilab, Inc. v. American Home Products Corp., 501 F. Supp. at 525.)
Substantiation…Generally
All material advertising claims must contain adequate substantiation at the time the claim is made. Substantiation means that the company has a reasonable basis for concluding that the claims being made in an advertisement are true. As a general rule, to substantiate a health-related claim, the advertiser should have “competent and reliable scientific evidence” to support the claim. The FTC defines “competent and reliable scientific evidence” as tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. (FTC Statement Pertaining to Dietary Supplements Concerning the Effect of The Product on The Structure or Function of The Body, 1998)
This standard is meant to be sufficiently flexible to allow for the use of claims that are based on new and emerging research. However, this standard does not provide an opportunity for an advertiser to imply that new research, or one particular study, is definitive on a particular issue. Rather, the standard is sufficiently flexible to allow advertisers to make adequately qualified claims based on emerging research, or a single study if the claim is properly qualified.
The level of support necessary to substantiate a claim depends largely on the claim being made. Claims that expressly state the level of support (e.g., “10 studies show”) or suggest a certain level of support (e.g., “doctors agree”) must be supported by that level of evidence. More often than not, however, advertising claims will not suggest that a certain level of support exists for a claim. In this situation, the level of scientific support necessary to substantiate a claim depends on the amount of research experts in the field would consider adequate to establish the claim’s truthfulness. Indeed, although the FTC states that the quality of a study matters more than the quantity of studies, it will be the unusual occasion that one or two relatively small clinical studies will be adequate to substantiate a broad health-related claim. For example, a claim for “blood sugar control” would likely require more than a couple of short-term studies to substantiate an unqualified claim because the FTC would likely consider it to be an implied “diabetes control” claim requiring well-controlled, long-term studies.
The type of evidence used to substantiate a claim may vary. Generally, the FTC prefers well-controlled human studies. However, animal studies and in vitro studies may be used to support a claim if experts in the field would consider them suitable substitutes for human studies. Epidemiological studies may be substituted for well-controlled human studies, especially when the study is supported by other scientific evidence such as an explanation of how the nutrient works in the body. As stated previously, the studies used to support a claim must support the actual claim being made.
Competent and Reliable Scientific Evidence
“Competent and reliable scientific evidence” means that the research must be conducted in such a manner as to yield meaningful results. In other words, claims must be based on solid scientific research, rather than on personal opinions—even those of an expert in the field. In assessing the competency and reliability of research, the FTC will generally look at the design, implementation and results of the research. As a general rule, the FTC will consider the following in assessing the competency and reliability of research:
• Well-controlled studies with blinded subjects and researchers are likely to be given greater weight than non-blinded studies;
• Longer-term studies are better than short-term studies;
• The study’s result should be statistically significant;
• The nature and quality of the written report is important;
• Studies appearing in reputable peer-reviewed scientific journals are looked upon with favor; and
• Studies that are not published in peer-reviewed journals may be used to substantiate claims if they would be considered properly designed and controlled studies by experts in the field.
Scientific evidence should not be viewed in a vacuum. It is the FTC’s position that any claim must be evaluated in light of the totality of the scientific evidence available. In other words, it is unlikely that one positive study will be sufficient to support a claim if there are 10 studies that suggest the opposite conclusion. Indeed, in this situation, qualified language appearing in the claim such as “a recent study suggests” would be unlikely to remove the misleading nature of the claim unless the opposing studies are also disclosed in an equally prominent manner. However, if the most recent study is of such a caliber that it would virtually dispel the conclusions of the opposing studies, disclosure of the opposing research might not be necessary.
Use of Testimonials are Product Endorsements
A testimonial or endorsement for a product must represent the actual opinion of the endorser and must be true at the time that the advertisement is running. For example, if an expert endorser states that he/she has done significant research on herbal products that reduce cholesterol levels, then that person must be an expert in the relevant area and have, indeed, done significant research in the area.
Testimonials and endorsements for dietary supplements and functional foods that pertain to the health benefits of a product must be substantiated, or properly qualified. While there is some latitude for companies to use testimonials and endorsements to promote their products, there is no “personal belief” exception. Moreover, a testimonial must represent the experience that a typical consumer can expect from the product. Claims such as “I lost 50 pounds in 30 days” may not be made unless this experience would be typical of users of the product, or an equally prominent disclaimer appears along with the claim. Indeed, merely putting a claim in the form of an endorsement or testimonial will not avoid a challenge on the basis of deception, particularly if the subject of the claim is a serious disease or health-related condition.NW