It sounded like a miracle of science and convenience: swab your cheek and drop the saliva sample in the mailbox and GeneLink Biosciences, a personal genetics company, would analyze your DNA and send back nutritional supplements customized to your personal genome. The regimen, the company promised, was good for diabetes, heart disease, arthritis, insomnia and other ailments. The Federal Trade Commission (FTC), however, thought it sounded like false advertising and brought a lawsuit against the company, charging its claims were misleading and not founded in sound science.
The case is the latest in the continuing controversy over personal DNA testing services. Two months ago the U.S. Food and Drug Administration warned 23andMe to stop marketing some of its personal genetics health services because the company failed to prove those tests worked and the agency worried about the public health consequences of inaccurate results.* The GeneLink case, the FTC’s first against a personal genomics company, could serve as a shot across the bow to other similar businesses. Under the terms of a proposed settlement announced on January 7, Orlando, Fla.–based GeneLink agreed to stop making unsubstantiated health claims. The settlement, which would only take place after a 30-day public comment period and a final decision from the FTC, would keep GeneLink and its former subsidiary, foru International, from making any future claims that their products can impact the course of disease unless such claims are supported by two double-blind, randomized control trials—the gold standard of medicine. A violation of that agreement could lead to fines.
“What we’re alleging is that [GeneLink’s] claims got ahead of the science,” says Carolyn Hann, a lead attorney on the case for the FTC’s Bureau of Consumer Protection. “By taking action against GeneLink and foru we were trying to indicate to this industry we were aware of the claims being made and we wanted the industry to understand where we stand on these issues,” she says. The FTC could not comment on whether other cases against genetic companies are in the offing. Although the commission opened investigations into two other genetic firms in the past, both cases were closed before action was taken, in part because the outfits were no longer going to market their products in the U.S.
GeneLink and its former subsidiary, now an independent company, had claimed that they were sending cheek swab samples to a third-party laboratory for analysis of genetic variations called single nucleotide polymorphisms (or SNPs). The companies claimed they could examine specific SNPs that affect nutritional health and aging and then offer personalized nutritional supplements and skin health products. “Any claims at all that one can look at those SNPs or other SNPs and make any meaningful recommendations for nutrition, cosmetics or anything along those lines are just entirely unfounded and entirely without any scientific merit,” says geneticist James Evans, editor in chief of the journal of the American College of Medical Genetics and Genomics.
The heart of the controversy was GeneLink’s claims that its custom-blended supplements could help compensate for aging or mitigate health issues such as heart disease and arthritis.
Under this lawsuit the FTC also charged that GeneLink failed to adequately protect consumer’s personal data, including contact information, Social Security and credit card numbers, and genetic data. According to FTC documents, GeneLink and foru had obtained genetic information from nearly 30,000 consumers since 2008. The proposed agreements would force the firms to set up comprehensive information security programs to protect such consumer data in the future and to assign at least one employee at each company to oversee that program. The corporations would also be required to receive initial regular external audits to check that the information is secure. The FTC cannot file criminal charges, only civil suits.
Consumers and regulators alike are struggling to keep pace with the burgeoning direct-to-consumer health industry, and this latest case may raise new questions about personal genomics. “I think if the standard consumer, because of this type of activity, looks with somewhat of a cynical eye at such claims that’s good,” Evans says. “People have to be able to trust products and claims, and when outlandish claims are exposed, in the long run that’s a good thing.”
*Editor's Note (1/13/14): This sentence was edited after posting to provide a clearer description of the FDA's warning to 23andMe.