Citing the Food and Drug Administration’s (FDA’s) November 22, 2013, warning letter, a California resident has filed a putative class action against 23andMe, Inc., alleging that its DNA-analysis service is falsely marketed to consumers because the company lacks “analytical or clinical data to support the device’s efficacy.” Casey v. 23andMe, Inc., No. 13-2847 (U.S. Dist. Ct., S.D. Cal., filed November 27, 2013). The plaintiff alleges on behalf of a putative nationwide class of consumers that the company claims its $99-test kit and analysis can provide information about more than 240 health conditions and traits thus enabling planning for the future if children are at risk for inherited conditions, documenting family health history and providing doctors with information that could be useful in prescribing medications.

According to the complaint, FDA has worked with the company since 2009 to address regulatory requirements and obtain marketing authoriza- tion, but that the agency still lacks assurance that the firm has analytically or clinically validated the product for its intended uses. The complaint  also notes that the company uses the “meaningless” test results by sharing with other sources “and the scientific community in general.”

Alleging violation of the “unfair,”“fraudulent” and “unlawful” prongs of California’s Unfair Competition Law, violations of the False Advertising Law and Consumers Legal Remedies Act, breach of warranty of merchant- ability and fitness for a particular purpose, unjust enrichment, deceit by concealment, and negligent misrepresentation, the plaintiff seeks equi- table relief; actual, statutory and punitive damages; attorney’s fees; costs; and interest.