Recently, the Food and Drug Administration (FDA) ordered 23andMe to halt sales of their DNA testing kits. Now, the Federal Trade Commission (FTC) has brought a lawsuit against another company that sells direct-to-consumer DNA test kits. The FTC feels that GeneLink Biosciences (and its former subsidiary foru International) have made claims that were misleading and that were not based on science.
The case is the very first one that the FTC has filed against a personal genomics company. There is some speculation that it could be taken as a warning to other companies that are also selling direct-to-consumer DNA test kits.
There was a settlement between the FTC and GeneLink on January 7, 2014. In it, GeneLink agreed to stop making unsubstantiated health claims. It appears that the settlement prevents GeneLink from making any future claims that their products can impact the course of disease.
In order to be allowed to make that claim, GeneLink must first have the claims supported by two double-blind, randomized, control trials. If GeneLink fails to abide by this agreement, they could be fined.
The main problem involves GeneLink’s sale of custom-blended supplements. The company claimed that their supplements could help with with things like aging, heart disease, or arthritis. The FTC feels that those claims are not based on science.
In short, what happened was this: A consumer purchased a DNA kit from GeneLink. The consumer provided a DNA sample. GeneLink sent the DNA sample to another company that analyzed SNPs (single nucleotide polymorphisms). GeneLink was taking that information and using it as a basis for the sale of their nutritional health and aging supplements and skin health products.
>Basically, the consumer was getting a sales pitch for supplements based on his or her SNPs. Geneticist James Evans, editor in chief of the journal of the American College of Medical Genetics and Genomics said: “Any claims at all that one can look at those SNPs or other SNPs and make any meaningful recommendations for nutrition, cosmetics, or anything else along those lines are just entirely unfounded and without any scientific merit”.
There is also another issue. The FTC feels that GeneLink failed to adequately protect consumer data. GeneLink and foru International had collected information such as contact information, Social Security numbers, credit card numbers, and genetic data from around 30,000 individuals. The settlement requires the companies to set up comprehensive information security programs to protect that data and to receive external audits to check that the information is secure.
What does this mean for genealogists? It indicates that it would be better to see a doctor about your risk of developing potential diseases or conditions instead of relying on the information that comes from a direct-to-consumer DNA test. It also points out that not every company that sells health supplements has data that proves their products do what they are telling you they can.< Return To Blog