[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.