23andMe Genomics LLC – FDA Warning Letter

The FDA issued a Warning Letter to 23andMe for marketing its Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act (FD&C Act). The PGS is classified as a medical device due to its intended use in diagnosing, mitigating, treating, or preventing diseases, and affecting body structure/function, as advertised for 254 diseases and conditions, including carrier status, health risks, and drug response.

The FDA expressed concern over potential health consequences from inaccurate results, particularly for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity), which could lead to inappropriate medical interventions or self-management of treatments.

Despite 23andMe submitting 510(k)s in July and September 2012, they failed to provide requested information, leading to the withdrawal of these submissions. The FDA stated that 23andMe has not provided adequate information to support substantial equivalence to a legally marketed predicate device.

The FDA noted a history of extensive interactions with 23andMe since July 2009, including meetings, emails, and written communications, providing feedback on study protocols, validation requirements, and regulatory pathways. However, 23andMe has not analytically or clinically validated the PGS for its intended uses, which have expanded.

Consequently, the PGS is considered adulterated under section 501(f)(1)(