May 16, 2014

FTC Settles Litigation That Targeted Deceptive Marketing of Genetic Tests and Treatments

In its first law enforcement action in the personalized genomics sector, the Federal Trade Commission (FTC) has entered a final consent order against several personal genomics companies for engaging in business practices that deceived consumers. In general, personalized genomics companies follow several business models. A company may offer genetic testing services in which a consumer pays to have her DNA analyzed for mutations that, in the company's claim, are alleged to correlate with various medical conditions or susceptibilities. In another model, genomics companies provide genetic testing and also offer products which are alleged to treat or alleviate the medical conditions identified by the DNA testing. GeneLink, Inc. and its former subsidiary, foru International Corporation, followed the second model and offered what were claimed to be “genetically guided personalization of nutrient and skin care formulations” as part of a general anti-aging portfolio of services and products. The FTC filed a complaint against GeneLink and foru for statements and practices that violate the Federal Trade Commission Act, which prohibits false advertising and “unfair or deceptive trade practices.” The FTC complaint recited promotional materials from GeneLink
[B]y analyzing and understanding your unique genetic strengths and weaknesses, you can eliminate the guesswork and “genetically guide” the optimal nutritional supplement or skincare formulation to match your LifeMap Healthy Aging Assessment®.  
The FTC cited the scope of the claims made by GeneLink: 
According to ads and other promotional materials, the supplements could treat serious conditions like diabetes, heart disease, arthritis, and insomnia. Claims for the skin serum cited a “double blind, randomized and controlled study” and promised the product would “compensate for particular deficiencies in areas of skin aging, wrinkling, collagen breakdown, irritation, and the skin’s ability to defend against environmental stress.” 
The violation of the FTC Act was recited in the complaint:
12. Through the means described in Paragraph 11, respondents have represented, expressly or by implication, that genetic disadvantages identified through respondents’ DNA Assessments are scientifically proven to be mitigated or compensated for with nutritional supplementation. 
13. In truth and in fact, genetic disadvantages identified through respondents’ DNA Assessments are not scientifically proven to be mitigated or compensated for with nutritional supplementation. Therefore, the representation set forth in Paragraph 12 was, and is, false or misleading. 
Following a period of public comment, a final consent order was entered to settle the charges brought against the companies. The companies are now prohibited from offering products for purposes not supported by credible scientific data and the level of scientific support required for health-related claims is specified: 
“[C]ompetent and reliable scientific evidence” shall consist of at least two adequate and well-controlled human clinical studies. 
This FTC action no doubt puts the personalized genomics sector on notice that dubious claims for genetic “treatments” will be subject to FTC monitoring and enforcement actions. This action also exemplifies how the FTC, as the federal consumer protection agency, employs its broad mandate to capture many potentially deceptive business practices in a high-technology areas: the companies were also charged with inadequate data security practices with respect to the collection of consumer information, and the consent order further requires the companies to institute appropriate data security measures for any future data collection. More generally for the genomics sector, the FTC action follows the Food and Drug Administration's (FDA) 2013 warning to 23andme, one of the leading providers of personalized DNA testing, that its services constituted the marketing of an unapproved medical device in violation of the Federal Food, Drug and Cosmetic Act; the company then took corrective actions in removing certain health-related reporting from its products.

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