Over the past few years, a flurry of consent decrees have articulated the new level of substantiation that the Federal Trade Commission (FTC) requires marketers to produce, especially in support of products making wellness, weight-loss, or toning/slimming claims. By many accounts, the agency has set the bar high even for companies selling legitimate products to largely satisfied consumers, and cases have run the gamut from ingestible supplements and exercise equipment to footwear and cosmetics.
While these consent decrees bind only the companies that entered into the agreements, the FTC often uses consent decrees to send a message about certain marketing practices to the industry. Accordingly, marketers should not ignore the provisions of FTC consent decrees—especially when making similar claims or marketing products similar to those covered by a decree.
The apparent increase in substantiation requirements began in 2010. That year, two FTC consent decrees required marketers to substantiate certain claims with at least two human clinical studies that were randomized, double-blind, placebo-controlled, and conducted by different researchers. The consent decrees further required that the studies be conducted independently of one another, and that each research firm conducting the studies be qualified to conduct such studies.
The first decree, which pertains to the marketing of a weight-loss product, requires that the results of the clinical studies are sufficient to substantiate the advertising claims "when considered in light of the entire body of relevant and reliable scientific evidence." Under its terms, the marketer is required to substantiate any claims made for any dietary supplements or food product about its effects in weight loss.
The second decree, which pertains to the marketing of a probiotic product, requires the marketer to substantiate advertising claims for any beverage product containing probiotics, if the marketer claims the product will reduce the duration of acute diarrhea in children or reduce absences from school due to illness. It waives the double-blind and/or placebo-control requirements if it can be demonstrated that those controls cannot be effectively or ethically implemented.
In 2011, yet another FTC consent decree addressed the probiotic advertising claims of a different marketer. It requires the same level of substantiation as the 2010 probiotic agreement and applies to all advertising for yogurt, dairy drink, or other foods containing probiotics in which the marketer claims the product will relieve temporary irregularity or help with slow intestinal transit time. The FTC order does not apply to such claims for the challenged product, as long as the advertising discloses that three servings per day are required for the user to achieve the performance claimed.
In a 2011 settlement with Reebok pertaining to the marketing of "Toning Shoes," the FTC required at least one randomized, controlled clinical study that is blinded to the maximum extent practicable and at least six weeks in duration. The settlement also requires the use of an appropriate measurement tool (such as a dynamometer, if measuring strength) by persons qualified to conduct and measure compliance in such a study. This standard applies to any footwear or apparel the marketer claims improves or increases muscle tone, strength, or activation, resulting in a quantified percentage or amount of muscle toning.
A 2012 "Toning Shoe" settlement with another marketer applies the same standard as the Reebok settlement. However, it also requires that the study or studies have additional controls. These include, but are not limited to, controls for dietary intake, if testing for weight loss or a reduction in body fat. The settlement covers any claims that the product will improve or increase muscle tone, strength, or activation; overall circulation; or aerobic conditioning. It also applies to claims that use of the footwear will result in increased caloric burn, weight loss, loss of body fat, or improvement of, or reduction in, body composition. Under the consent decree, any weight-loss claims about the product must be supported by two clinical studies.
These four cases are just a sample of the many settlements that illustrate the FTC's new, more "muscular" stance on substantiation. Marketers should expect the substantiation push to continue in 2013, and consult with counsel to fully understand the risks associated with certain claims.
Originally published in the March 2013 edition of electronicRETAILER.
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