The warning letter the U.S. Food and Drug Administration (FDA) sent to 23and-Me (Mountain View, Calif.) has reignited a fierce debate pitting the merits of FDA regulation of personal genomics tests against individuals’ rights to explore the data stored in their own DNA. In the Nov. 22 warning letter, the FDA demands that 23andMe “immediately discontinue marketing” its saliva collection kit and Personal Genome Service (PGS), which it launched back in 2007. The FDA contends that the PGS is a medical device that is being marketed without clearance or approval. This reaffirms the FDA’s 2010 position that personal genomic tests are medical devices and not laboratory-developed tests. The FDA calls the PGS a class III medical device, which carries the greatest associated risk and requires premarket approval. The letter argues that PGS “is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” Specifically, the FDA calls out as “particularly concerning” the company’s online marketing of “PGS for providing ‘health reports on 254 diseases and conditions,’ including categories such as ‘carrier status,’ ‘health risks,’ and ‘drug response,’ […]