Understanding FTC Guidelines for Advertising Claims Substantiation

Dec. 18, 2002, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced a new initiative called "Consumer Health Information for Better Nutrition," which was aimed in part at increasing enforcement action against false and misleading claims.

Public statements by Daniel Troy, chief counsel at FDA, and J. Howard Beales III, director of FTC's Bureau of Consumer Protection, have made clear that both agencies intend to use this initiative to take action against dietary supplement claims that are not substantiated. FDA and FTC plan to work closely together as they move forward.

It is not entirely clear how FDA will approach this issue, because the agency has not traditionally focused on the substantiation of dietary supplement label claims. At least initially, FDA will be looking toward FTC as the agency with greater experience on this issue. It is likely, therefore, that FTC's standard will become--at least for the short term--the de facto standard for claims substantiation. FDA has jurisdiction over dietary supplement product labeling, a category that includes labels as well as other materials associated with the product. In contrast, FTC has jurisdiction over dietary supplement product advertising.

For that reason, it is important that dietary supplement manufacturers, distributors and retailers alike understand FTC's approach to dietary supplement claim substantiation and know how to meet the relevant burdens.

FTC's Jurisdiction

FTC has primary responsibility for ensuring that all consumer product advertising is truthful and not misleading. The basic law guiding FTC states: "unfair methods of competition in commerce and unfair or deceptive acts or practices in or affecting commerce" are prohibited (Federal Trade Commission Act, Section 5).

Under this law, an advertiser is required to have a "reasonable basis" for all product claims before the claims are made. FTC's interpretation of this standard is somewhat flexible but generally requires that any claims made in advertising be backed by sound scientific evidence, also referred to as "competent and reliable scientific evidence."

In general, the "competent and reliable scientific evidence" standard consists of tests, studies or other scientific evidence that has been conducted and evaluated according to standards that experts in the field accept as accurate and reliable. Any study results relied on must be relevant to the claims being made.

Studies should test the same ingredients at substantially the same dosage level as that contained in the product, and the test population should be similar to that targeted in advertising claims. FTC does not consider anecdotal reports, articles in popular magazines, opinions or inadequately controlled open label studies to be adequate substantiation and, as a result, these kinds of materials cannot be used as substitutes for scientific support.

FTC's publication "Dietary Supplements: An Advertising Guide for Industry" (1998) suggests that express or implied dietary supplement claims must be supported by more than one study. It reads, "Although there is no requirement that a dietary supplement claim be supported by any specific number of studies, the replication of research results in an independent study adds to the weight of the evidence."

Many in the dietary supplement industry have taken this to mean that FTC is likely to require a two study minimum for dietary supplement claims just as it does for over-the-counter (OTC) drugs or other health products. However, FTC has not confirmed this interpretation.

In practical terms, adequate substantiation is a subjective quantity, depending on the overall impression of the ad, including language used and pictorial or other representations. The more disease-related the claim, the greater the level of substantiation required--and the greater the likelihood that the advertising will draw FTC's attention.

When a claim is explicit about the amount of support, FTC generally expects the advertiser to have evidence to substantiate the claim. For example, FTC has explained that statements such as "university studies prove" or "90 percent of cardiologists regularly take the product" that make express claims must actually have that level of support. Thus, the advertiser would be responsible for substantiating the claim to the level stated, e.g., if making the claim, the advertiser should have evidence on file showing that 90 percent of all cardiologists actually do take the product.

Retail Impact

Over the years, FTC has made it clear that "advertising" includes all product statements made in everything from print and broadcast advertisements to catalogs, store fliers, Internet sites, infomercials and direct marketing materials. This broad definition of advertising means that a retailer will be considered an advertiser subject to FTC's substantiation standard if the retailer includes a dietary supplement's label claims in its own store fliers (e.g., fliers with the retail store's name on them). Before including such claims, retailers should ensure that adequate substantiation exists for any and all material. Retailers may also want to carefully review advertising claims for products and ask for substantiation before carrying the product in a store, as well.

FDA and FTC's renewed focus on dietary supplement claim substantiation means that those in the industry should have a good understanding of what is expected. The bottom line is that all advertisers, including retailers, should ensure that any advertising material distributed in their name is adequately substantiated.

Emily Marden, Esq., is a partner in the Washington, D.C., office of Sidley, Austin, Brown & Wood. The firm serves as counsel to the National Nutritional Foods Association (NNFA) (www.nnfa.org).

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