23AndMe made big news with their case with the FDA not too long ago and now we have another personal genetics company under fire and this time it is the FTC, looking at their advertising along with privacy and security with consumer data. With the primo price on data today, we find everyone doing something innovative however some of the innovation is not falling into compliance it appears with federal laws and regulations.
From what I am reading here, the company uses you DNA data to compile groups of nutritional products and supplements they feel are customized to compliment what is derived from your DNA swab. Now today when you go to the “products” page, and I am guessing this lawsuit from the FTC has an impact here, it is under construction. I have never been on the site before so I don’t know if there were products for sale before or not but the news page says the same thing. The about page says this:
“GeneLink Biosciences, Inc. is a genomics biotechnology company engaged in genetic profile development, product development, business development and support services for its subsidiaries and distribution partners. GeneLink's patented and patent pending technologies include proprietary genetic assessments and products linked to personalized health, beauty and wellness applications. Its DNA assessments provide information that enables the customization of nutritional products, skincare products and health maintenance regimens genetically matched to an individual customer's needs.”
If you read further though in the article the company did have a subsidiary, Foru International, which is no longer a subsidiary, but rather it’s own company now that sells skins products, nutritional supplements, etc. and looks like a multi level marketing company where you start your own distributorship of products. I guess the combination of the two companies together were perhaps not a good mix in the eyes of the FTC. It is interesting today though to see what is out there and how companies are structured and what kind of business each entity represents as with consumer products, people can and do get mislead all the time. Long and short of this one it seems is the representation that their products and any testing done do not represent any cure or treatment for diseases and the advertising and marketing could be misleading without providing double-blind trials, which is somewhat the same issue the FDA had with 23AndMe, where’s your scientific data to support your claims. BD
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 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.
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
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