It looks like the FDA smackdown on 23andMe was only the beginning. Another personal genetics firm, GeneLink Biosciences, has been charged with false advertising by the Federal Trade Commission (FTC), on the grounds that the company didn't have the requisite scientific grounds to market its services to consumers.
The lawsuit, which was disclosed after the FTC reached a proposed settlement with the company last week, marks the first time the commission has intervened so aggressively where genetic testing is concerned. According to FTC officials speaking to Scientific American, GeneLink's claims "got ahead of the science," and the company was thereby making unsubstantiated health claims that could put consumers at risk. "By taking action against GeneLink [...] we were trying to indicate to this industry we were aware of the claims being made," said Carolynn Hann, lead attorney on the case, "and we wanted the industry to understand where we stand on these issues."
"We were aware of the claims being made."
Officials with the FTC wouldn't disclose whether they're pursuing similar actions against other personal genetics firms, but it is clear that the claims being made by GeneLink were markedly different than those that got 23andMe into hot water with the FDA last year. The company promised to analyze a customer's DNA via saliva sample, and then offer a regimen of nutritional supplements customized to one's genome and able to help treat ailments including diabetes, insomnia, and heart disease. According to its settlement with the FTC, the company will no longer be able to claim that its supplements can help with medical problems without first conducting randomized, controlled trials. The FTC lawsuit also states that GeneLink didn't adequately safeguard the personal information — including social security and credit card numbers — of nearly 30,000 customers.
A regimen of nutritional supplements customized to one's genome
23andMe, in contrast, was last year blasted by the FDA for violating the agency's marketing approval process. Primarily, the FDA stated that 23andMe — even after operating for six years — hadn't submitted adequate research to bolster the company's claims about how their tests could yield accurate, meaningful health data for consumers. As of now, 23andMe still isn't selling its DNA testing kit for health-related purposes.
Though the cases differ, both point to a growing effort by federal regulators to manage the promises made by the burgeoning personalized genetics industry. "All along there's been the tension between the science and the business and marketing," Greg Lennon, co-founder of a genome research project called SNPedia, told The Verge with regards to 23andMe last year. "The business folks want to push the hype, and the FDA has a mission to control the hype. The science just gets caught in the middle."