Following a public comment period, the Federal Trade Commission has approved final consent orders settling charges that two marketers of genetically customized nutritional supplements deceptively advertised that their personalized nutritional supplements treat diabetes, heart disease, arthritis, insomnia, and other ailments. The orders also settle charges that the companies’ data security practices were lax. The Commission also approved responses to the two comments received during the public comment period.
First announced in January 2014, this case marks the first law enforcement action taken by the Commission against marketers of purported personalized genomics products. The final settlements prohibit GeneLink, Inc. and its former subsidiary, foruTM International Corp., from claiming that any drug, food, or cosmetic will treat, prevent, mitigate, or reduce the risk of any disease – 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. Under the orders, claims that a product effectively treats or prevents a disease in persons with a particular genetic variation must be backed up with randomized controlled trials conducted on subjects who have that genetic variation. The orders also prohibit GeneLink and foruTM International from misrepresenting scientific research regarding any drug, food, or cosmetic, or any genetic test or assessment and from providing their affiliates with the means to make the prohibited health claims.
Under the orders, the companies also are prohibited from misrepresenting their privacy and security practices. They are required to establish and maintain comprehensive data security programs and submit to security audits by independent auditors every other year for 20 years.
The Commission vote to approve the final orders in this case was 3-1-1, with Commissioner Ohlhausen dissenting and Commissioner McSweeny not participating. (FTC File No. 112 3095; the staff contact is Carolyn Hann, Bureau of Consumer Protection, 202-326-2745.)
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