‘Operation Failed Resolution’ was launched yesterday by the FTC to target deceptive advertising claims for ‘fad’ weight- loss products. The commission announced four law enforcement actions against Sensa Products, LLC, HCG Diet Direct, LLC, L’Occitane, Inc., and LeanSpa, LLC, which would recover about $34 million for consumers.
The initiative has been welcomed by leading industry figures. Marc Ullman, a partner in the firm Ullman, Shapiro & Ullman, LLP, told us that, for these particular companies, “this is very clear evidence of the risks of engaging in this type of baseless marketing designed to target vulnerable consumers.
“For industry in general, these cases should reinforce the need to ensure that you have substantiation for your claims and the importance of responsible marketing.”
The 7 Gut Check Claims
FTC has also compiled a list for media to spot false weight loss representations. FTC’s ‘Gut Check’ is a list of seven statements in ads that experts say simply can’t be true:
1. Causes weight loss of two pounds or more a week for a month or more without dieting or exercise;
2. Causes substantial weight loss no matter what or how much the consumer eats;
3. Causes permanent weight loss even after the consumer stops using product;
4. Blocks the absorption of fat or calories to enable consumers to lose substantial weight;
5. Safely enables consumers to lose more than three pounds per week for more than four weeks;
6. Causes substantial weight loss for all users; or
7. Causes substantial weight loss by wearing a product on the body or rubbing it into the skin.
Please click here for additional information on the ‘Gut Check’ list.
Ullman said that is gratifying to see the Commission call on the media to accept some sort of responsibility for allowing totally bogus advertising claims onto the airways or into print.
“The media is very quick to chastise companies (especially dietary supplement companies) for irresponsible marketing practices at the same time it is perfectly willing to provide a venue for those claims as long as it’s getting paid” he added.
Substantiating the claims
The Council for Responsible Nutrition (CRN) said it commended the FTC for its initiative. Steve Mister, CRN President and CEO, said: “All products marketed for weight-loss, whether they are sold as dietary supplements, food additives, cosmetics or homeopathic drugs, are required to have evidence that substantiates the claims they make. FTC’s announcement is also a good reminder to consumers that if something sounds too good to be true, it probably is.”
The association recommended consumers avoid quick fixes and magic bullets. “It’s no secret that the best way to lose weight is to focus on gradual weight loss over time through healthy eating, regular exercise and supplementing as appropriate,” said Mister.
“There are beneficial weight management dietary supplements on the market, and supplements also help fill nutrient gaps for those people not getting all the nutrients they need from food alone. Whether it’s a topical cream, a dietary supplement, or a diet plan, consumers should be wary of products that promise to make weight loss easy.”
Two RCTs?
Commissioner Maureen Ohlhausen said that she strongly supported the Commission’s enforcement efforts. However, which Ohlhausen voted in favor of the action against Sensa Products, LLC, HCG Diet Direct, LLC, L’Occitane, Inc., and LeanSpa, LLC, she voted against the consent agreements in the matter of GeneLink, Inc. and foru International Corporation.
“[The GeneLink and foru actions] impose an unduly high standard of at least two randomized controlled trials (or RCTs) to substantiate any disease-related claims, not just weight-loss claims,” she said. “Adopting a one-size-fits-all approach to substantiation by imposing such rigorous and possibly costly requirements for such a broad category of health- and disease-related claims may, in many instances, prevent useful information from reaching consumers in the marketplace and ultimately make consumers worse off.
“Recently, however, Commission orders, including the ones in the matter of GeneLink and foru International, seem to have adopted two RCTs as a standard requirement for health- and disease-related claims for a wide array of products. RCTs can be difficult to conduct and are often costly and time-consuming relative to other types of testing, particularly for diseases that develop over a long period of time or complex health conditions.
“Requiring RCTs may be appropriate in some circumstances, such as where use of a product carries some significant risk, or where the costs of conducting RCTs may be relatively low, such as for conditions whose development or amelioration can be observed over a short time period. Thus, I am willing to support the order requirement of two RCTs for short-term weight loss claims in the Sensa, HCG Diet Direct, L’Occitane, and LeanSpa matters because such studies can be conducted in a relatively short amount of time at a lower cost than for many other health claims.
“My concern with GeneLink and foru International and the series of similar orders is that they might be read to imply that two RCTs are required to substantiate any health- or disease-related claims, even for relatively-safe products. It seems likely that producers may forgo making such claims about these kinds of products, even if they may otherwise be adequately supported by evidence that does not comprise two RCTs.”
“Although raising the requirement for both the number and the rigor of studies required for substantiation for all health- or disease-related claims may increase confidence in those claims, the correspondingly increased burdens in time and money in conducting such studies may suppress information that would, on balance, benefit consumers.”
To read Commissioner Ohlhausen’s full comment, please click here.