By Riëtte van Laack –
On January 7, the FTC announced an initiative “Operation Failed Resolution” stating that it wants to protect consumers against deceptive weight loss claims. Among other things, the FTC announced actions against four companies for advertising fad weight-loss products, issued an updated guidance for media and developed a website called “Fat Foe” that mimics commonly used allegedly deceptive weight loss claims.
FTC’s enforcement actions against products allegedly marketed with bogus weight loss claims
As part of its initiative, the FTC announced enforcement actions against four different companies marketing foods, cosmetics or dietary supplements.
The FTC filed a complaint against Sensa for marketing its product as a food that you could sprinkle on your food and “watch the pounds come off.” According to the FTC, the company did not have the science to back up this and other claims however. Alleged deficiencies in the clinical studies include lack of blinding and use of a placebo, failure to account for subjects that do not complete the study, and failure to monitor the subjects’ diet and exercise. In addition, Sensa allegedly failed to disclose that its consumer endorsers had received compensation in exchange for their endorsement. According to the complaint, sales of Sensa in the United States from 2008 through 2012, totaled nearly $364 million. To settle the case, Sensa will pay 26.5 million dollars into a fund to be used for consumer refunds. The FTC will post information on how consumers can file a claim for a refund, at a later date.
The Sensa settlement agreement makes an exception for studies on conventional foods recognizing that a conventional food “need not be placebo controlled or double blind if placebo control or blinding cannot be effectively implemented given the nature of the intervention.” Defendants have the burden to prove that a placebo control or blinding is not feasible. To our knowledge, this is a first.
The case against L’Occitane involves slimming claims for skin creams. According to the complaint, L’Occitane marketed its products with claims that they “trim 1.3 inches in just 4 weeks” of thighs. Although the company claimed that it had clinical evidence to support these claims, the FTC disagreed. According to the FTC, the evidence relied on consisted primarily of results from a single unblinded, uncontrolled clinical trial and L’Occitane exaggerated the results of the trial; the average reported reduction in thigh circumference was less than one quarter of an inch.
The third case concerns HCG Diet Direct. Allegedly, the company marketed its homeopathic product HCG direct, purported to contain human chorionic gonadotropin, with claims that consumers could lose as must as a pound a day merely by putting drops under the tongue before meals. HCG Diet Direct was one of the seven companies that received the November 2011 joint FTC-FDA warning letters. A judgment of three million, two hundred twelve thousand, three hundred ten dollars for consumer redress is suspended due the defendants’ claimed inability to pay.
The FTC’s fourth case concerns a partial settlement with LeanSpa, LLC, an operation that allegedly deceptively promoted acai berry and “colon cleanse” weight-loss supplements through fake news websites. Under this proposed settlement, the LeanSpa settling defendants will surrender assets valued at an estimated $7.3 million.
Updated guidance for media outlets on spotting bogus weight-loss claims in advertising
As part of its initiative, the FTC also issued an updated guidance for media to recognize bogus weight loss claims, “Gut Check.” This guidance instructs media outlets on how to screen advertisements for facially deceptive weight loss claims, so that they will refuse to publish or to air deceptive ads. While the FTC has the authority to sue media outlets for running deceptive ads, based on statements made at the FTC’s press conference announcing this guidance, the FTC does not intend to pursue action against media. Instead, it appears to be looking for media’s voluntary cooperation. The updated guidance includes tips on testimonials and an online tutorial.
As part of “Gut Check,” the FTC is sending letters to 75 broadcasters and media outlets to update them on how to spot bogus claims in weight loss ads.
Additional consumer education materials
The FTC has also created a website advertising a fake weight loss product called “FatFoe.” FatFoe is not a real weight loss product. The ad is intended to warn consumers about diet rip-offs and provides further guidance on how to spot false weight loss.
Commissioners question the “standard” requirement for two randomized clinical trials
On the same day that the FTC announced its cases regarding the weight loss products, it also announced a case against GeneLink, a business advertising customized dietary supplements to treat diseases (see here).
All of the (proposed) settlements, including the Genelink settlement, define “competent and reliable evidence,” for the relevant products as well-controlled human clinical studies (randomized controlled trials or RCTs). However, there appears to be disagreement within the Commission about whether this high standard is justified under all circumstances. Notably, Commissioners Ohlhausen and Wright issued separate statements (here and here), in which they, among other things, raise questions regarding the requirement for two RCTs to satisfy the standard of “competent and reliable scientific evidence” for other than weight loss claims. Commissioner Wright writes that “[t]he optimal amount and type of evidence to substantiate a future claim will vary from case to case,” and urges the Commission to consider whether this requirement “strikes the right balance between deterring deceptive advertising and preserving for consumers the benefits of truthful claims. Commissioner Ohlhausen similarly expresses concern that “[a]dopting a one-size-fits-all approach to substantiation by imposing such rigorous and possibly costly requirements for . . . 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.” She advocates use of the factors from Pfizer, Inc., 81 F.T.C. 23 (1972), rather than requiring two RCTs without consideration of the specific claim and science at issue.