The announcement comes hot on the heels of other FTC action this week. The commission announced yesterday the launch of its ‘Operation Failed Resolution’ initiative to crack down on deceptive advertising claims for weight- loss products.
The against GeneLink and foru alleges that the companies violated the FTC Act by making false or unsupported health claims about their genetically customized products. Company-approved marketing materials included claims that the customized nutritional supplements could compensate for an individual’s genetic disadvantages, and that the customized skin repair serum’s effectiveness was scientifically proven. The companies also claimed through testimonials that the customized nutritional supplements could treat serious conditions such as diabetes, heart disease, and insomnia.
According to the FTC, the companies also deceptively and unfairly claimed that they had taken reasonable and appropriate security measures to safeguard and maintain personal information collected from nearly 30,000 consumers, including genetic information, Social Security numbers, bank account information, and credit card numbers.
“This case is about the consequences of making false claims,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “It doesn’t matter whether the claims deal with the benefits of direct-to-consumer genetic testing or the privacy of personal information. It’s against the law to deceive people about your product and to make promises you don’t keep.”
Two RCTs
The proposed settlements prohibit the marketers from claiming that any drug, food, or cosmetic will treat, prevent, mitigate, or reduce the risk of any disease including diabetes, heart disease, arthritis, or insomnia – by modulating the effect of genes, or based on a consumer’s customized genetic assessment – unless the claim is true and supported by at least two adequate and well-controlled studies.
The orders also require that claims that a product effectively treats or prevents a disease in persons with a particular genetic variation must be backed up with randomized clinical trials conducted on subjects who have that genetic variation.
In addition, the companies may not make any other claims about the health benefits, performance, or efficacy of any drug, food, or cosmetic by modulating the effect of genes, or the consumer’s customized genetic assessment – unless the claim is true and based on competent and reliable scientific evidence. The proposed orders also prohibit the marketers from misrepresenting scientific research regarding such drug, food, or cosmetic, or any genetic test or assessment. The orders also provide a safe harbor for advertising claims that have been approved by the FDA.
Two RCTs?
Commissioner Maureen Ohlhausen said in a statement that she voted against the consent agreements in the matter of GeneLink, Inc. and foru.
“[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.