A New Mexico resident has filed a putative nationwide class action against 23andMe, Inc., alleging that claims for its DNA Collection Kits— advertised as useful in providing accurate information about “genetic predisposition to a range of health factors such as coronary artery disease and arthritis”—are unsubstantiated, not based on scientific testing and unauthorized by the U.S Food and Drug Administration (FDA). Stanton v. 23andMe, Inc., No. 14-0294 (U.S. Dist. Ct., N.D. Cal., filed January 15, 2014). Information about similar litigation filed against the company in December 2013 appears in Issue 69 of this Bulletin.

The complaint relies on an FDA warning letter informing the company that it had violated the Federal Food, Drug, and Cosmetic Act by failing to seek the agency’s approval before marketing its DNA-analysis service. Details about the warning letter also appear in Issue 69. According to the plaintiff, FDA expressed doubts in its letter “about whether the PGS [personal genome service] tests, especially the tests associated with the Health Kit, performed as 23 warranted that they did. The FDA also said that it was concerned about the public danger surrounding false posi- tives and negatives for serious health conditions purportedly tested by the Health Kit.” Also included in the complaint are purportedly negative consumer product reviews. The plaintiff alleges violations of California’s False Advertising Law, Unfair Competition Law and Consumers Legal Remedies Act; negligent misrepresentation; unjust enrichment; breach of warranty of merchantability and fitness for a particular purpose; and deceit by concealment. He seeks injunctive relief; restitution; actual, statu- tory and punitive damages; attorney’s fees; costs; and interest.