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Substantiating Health and Weight Loss Claims: Has the FTC Moved to a New Standard?

27 Feb, 2011 By: Linda A. Goldstein

The Federal Trade Commission’s (FTC) recently issued consent orders against Iovate, Nestle and Dannon have left marketers wondering whether the FTC has moved to a new and higher standard for substantiating health and weight-loss claims for foods and dietary supplements.

Historically, the FTC has adopted a “flexible” approach to substantiating advertising claims stating that the degree of substantiation required will depend on a number of factors, such as the type of product advertised, the type of claim, the benefits of a truthful claim, the consequences of a false claim and the amount of substantiation that experts in the field believe is reasonable. For health and safety claims, though, the FTC has historically required “competent and reliable scientific evidence,” defined broadly to mean “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.” Although in practice, the FTC has often required double-blind clinical studies to support specific health and weight-loss claims, the FTC has never specifically stated that double-blind clinicals are required – until now.

In the consent orders issued in the Iovate, Nestle and Dannon cases, the FTC adopted a three-tiered approach setting forth different standards that must be met by these advertisers in the future when making certain health and/or weight-loss claims.

Tier 1 includes claims that a product can cure, prevent, mitigate or reduce the risk of a disease. These claims must either be approved or expressly permitted by the Food and Drug Administration (FDA).

Tier 2 includes weight-loss claims or specific health-benefit claims. Examples of Tier 2 claims include claims that the product causes weight loss or rapid weight loss or that the product reduces the duration of acute diarrhea or that the product relieves temporary irregularity. These claims must be supported by two independent, double-blind clinical studies.

Tier 3 includes general claims about the health benefits, performance or efficacy of the product. These claims are subject to the traditional competent and reliable scientific evidence standard.

Although these order provisions have been heralded by many as representing “new” standards for the industry, the FTC is contending that the substantiation requirements set forth for the different tiers represent the type of substantiation necessary to support the particular claims being made, and the standards have been set forth with more specificity in these orders in order to provide more guidance and make enforcement easier.

So what should marketers be doing? The first step is to continue to ensure that any health-related claims do not cross the line into disease-prevention claims. The orders provide some helpful guidance as to the types of claims that the FTC is likely to view as falling into this category.

Most importantly, marketers need to look at the health and weight-loss claims being made for their products. Unfortunately, the orders do not provide clear guidance as to what distinguishes a Tier 2 claim from a Tier 3 claim. It is likely that most weight-loss claims and any specific health-benefit claims will be classified as Tier 2 and require two double-blind clinicals. Such clinical studies will have to be conducted on the product or on a substantially equivalent product by two independent researchers and conform to rigorous protocol and design standards. It is unlikely that the FTC will accept ingredient testing unless the advertising makes very clear that the efficacy claims being made are limited to the ingredients rather than the product. Furthermore, advertisers should be very wary of making any claims that the product has been proven or tested absent well-controlled clinical studies.

Finally marketers should be aware that even with clinical studies in hand, the FTC may still take issue with the claims if the studies are not consistent with the body of scientific evidence. The FTC is increasingly looking for consensus within the scientific community, particularly for novel claims or novel products.

Linda Goldstein is chair of the Advertising, Marketing and Media division of Manatt, Phelps & Phillips, LLP, based in the firm’s New York office. She can be reached at (212) 790-4544, or via E-mail at

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