Just days into 2014, the Federal Trade Commission (“FTC”) made headlines by announcing enforcement actions against four weight-loss companies. As a result of this so-called “Operation Failed Resolution,” the companies—HCG Diet Direct, Sensa Products, L’Occitane, and LeanSpa—must pay a collective total of $34 million to refund consumers who may have been misled by their ads. Among the products with unsupported weight-loss claims are the Sensa Weight-Loss System and L’Occitane’s Almond Beautiful Shape and Almond Shaping Delight skin creams. Sensa’s ads boldly proclaimed: “Lose weight without dieting”; simply sprinkle Sensa on your food, and you will feel fuller quicker. And L’Occitane promised that you could lose inches in just four weeks, simply by applying its skin creams. Unfortunately for the companies and their consumers, FTC found that the claims were false.
Despite the recent cries that dietary supplements are “unregulated,” supplement companies know that they face enforcement from FTC, as well as the Food and Drug Administration (“FDA”), the Better Business Bureau, state district attorney’s offices, and private litigators. Large and visible targets for these entities are a supplement company’s advertisements—just ask Sensa Products.
To cover themselves and successfully fend off enforcement actions, supplement firms must be able to provide “substantiation” for each of their products’ advertised effects. That is, each claim must be supported by “competent and reliable scientific evidence.” Under FTC precedent, “competent and reliable scientific evidence” is defined as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has 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.” While this standard doesn’t tell a company exactly what it needs to adequately support a claim, it does say something: No single document will meet the threshold of “competent and reliable scientific evidence.” One animal study, one in vitro study, or even one double-blind placebo-controlled peer-reviewed study likely will not satisfy FTC. Companies should assemble a substantiation package for each of its claimed effects, consisting of all the relevant support it can gather.
Fortunately, supplement companies in the weight-loss arena can avoid a future headache by taking a hint from FTC. In conjunction with its “Operation Failed Resolution,” FTC released a guidance for broadcasters and publishers on how to assess weight-loss claims when evaluating advertisements for publication. The guidance, Gut Check: A Reference Guide for Media on Spotting False Weight Loss Claims, highlights seven claims that FTC’s experts say simply cannot be true. A supplement company would thus do well to avoid saying that any product:
- causes weight loss of two pounds or more a week for a month or more without dieting or exercise;
- causes substantial weight loss no matter what or how much the consumer eats;
- causes permanent weight loss even after the consumer stops using product;
- blocks the absorption of fat or calories to enable consumers to lose substantial weight;
- safely enables consumers to lose more than three pounds per week for more than four weeks;
- causes substantial weight loss for all users; or
- causes substantial weight loss by wearing a product on the body or rubbing it into the skin.
Collins, McDonald & Gann is staffed with FDA lawyers experienced in handling enforcement actions and lawsuits by FTC, FDA, the Better Business Bureau, district attorney’s offices, and private litigators. We help supplement companies compile substantiation packages in response to FTC inquiries, but more importantly, we work with our clients from the outset to try to prevent any regulatory action from slowing their business and growth. Call us anytime at 516-294-0300 if you are facing FTC or FDA action, or if you’d like to know how to better avoid such problems. We’re always here to help.