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Unsubstantiated Weight-Loss Claims May Slim Marketers’ Wallets

6 Nov, 2012 By: Gary D. Hailey, Jeffrey D. Knowles, Venable LLP’s Advertising

Marketers of exercise equipment, diet programs and dietary supplements rely on weight-loss claims to sell their products. Recent Federal Trade Commission (FTC) consent orders have called for differing levels of substantiation to support weight-loss claims. For marketers that are not subject to a particular consent, interpreting the differing provisions of these orders and figuring out what they need to do to avoid a challenge is no easy task – and the consequences of getting it wrong could be severe.

The FTC set forth what it believes the appropriate standard for substantiation of weight-loss claims for dietary supplements is when it announced its three-tier template for substantiation requirements in consent orders a couple of years ago. According to that template, dietary supplement marketers are expected to substantiate future weight loss claims with, “two adequate and well-controlled human clinical studies … conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true.”

But marketers of other kinds of weight-loss products may not need two studies to substantiate their weight-loss claims. In September, the FTC signed off on a weight-loss order that only required a single “adequate and well-controlled human clinical study” to substantiate weight-loss claims for a reduced-calorie diet. And in August, the FTC agreed to a consent judgment that only required one study from a marketer of an exercise product.

One possible explanation for the FTC’s single-study requirement for the reduced-calorie diet and exercise product is that the FTC acknowledges that a reduced-calorie diet and/or regular aerobic exercise will produce significant weight loss for the typical consumer. The two-study requirement for dietary supplement weight-loss claims may signal that staffers at the FTC are skeptical that dietary supplements can produce significant weight-loss results, so they demand a higher level of substantiation.

That sounds like good news for marketers of exercise equipment and reduced-calorie diets. However, those marketers still have to figure out how long their one study needs to last to be valid. The August order against the exercise product seller states that the study had to be at least six weeks in duration. But the September order against the reduced-calorie diet marketer requires that the study’s duration be at least 16 weeks.

That begs a question for the many marketers of exercise equipment that backstop weight-loss claims for their equipment by combining a reduced-calorie diet with an aerobic exercise program. Do they need a six-week study or a 16-week study?

There is not a one-size-fits-all answer for this question. The safest bet is to consult with legal counsel well versed in the nuances of direct marketing, the FTC and the science behind claim substantiation.

Jeffrey D. Knowles and Gary D. Hailey are partners in Venable LLP’s Advertising, Marketing and New Media Group. Knowles is the chair of the group. They can be reached at (202) 344-4000, or via E-mail at and

About the Author: Gary D. Hailey

About the Author: Jeffrey D. Knowles

Jeffrey D. Knowles

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