23andMe Lawsuit Filed After FDA Slams Home DNA Test

Last week, the Food and Drug Administration ordered 23andMe to halt all sales of its DNA testing kit after the company failed to provide scientific evidence to support the product's advertised claims. The results provided by the $99 tests, which the company claimed would reveal information about a user’s ancestry and potential health risks, have recently been described as “meaningless” in a class action lawsuit that’s attracting a lot of attention.

The lawsuit accuses 23andMe of falsely and misleadingly advertising their product.

The lawsuit, filed in California on November 27, accuses 23andMe of “falsely and misleadingly advertis[ing] their Saliva Collection Kit / Personal Genome Service (PGS) as providing ‘health reports on 240+ conditions and traits’, ‘drug response’, [and] ‘carrier status.’” This comes after the company, originally backed by Google, ended its radio, TV and online advertising in response to the FDA’s warning letter (which you can view here). The letter cites 23andMe for violating the Federal Food, Drug and Cosmetic Act by marketing its product without clearance. According to The Guardian, the FDA and 23andMe had been working together since either 2008 or July 2009 (the two disagree as to when they first made contact) to ensure the product complied with federal regulations.

The class action lawsuit was filed on behalf of all consumers who purchased the kit and who are now learning that they may have been duped by 23andMe’s reportedly baseless claims. At the time of the warning, the FDA noted they “still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.”

That means that five years after it first told the FDA it would provide statistics to support its claims, 23andMe has still not followed up on its promise. The company has also been criticized for collecting customers’ genetic information into a database it then markets to scientific researchers. Some accuse the company of building the database at the customers’ expense.

Are consumers simply being conned into buying a “test” that has no real bearing on their future health? Possibly – and now the fight looks like it’s moving to the courtroom.

The class action is seeking more than $5 million in compensation on behalf of a class of 400,000 consumers. 23andMe’s own website – quoted in the filing – notes that “living well starts with knowing your DNA.” For 23andMe, perhaps good business should have started with knowing how effective their product actually was.

If you’ve bought one of 23andMe’s DNA kits, now is the time to get in touch with lawyers who can review your situation to help determine whether you are entitled to compensation.