FDA’s recent warning letter to 23andMe, the largest and best-known company offering direct-to-consumer genetic testing, highlights the challenges FDA and the personal genetic testing industry face in regulating a rapidly evolving product while striking an acceptable balance in the risk-benefit analysis of the product. The warning letter demanded that 23andMe cease marketing its Personal Genomic Sequencing (PGS) product directly to consumers, as doing so is, according to FDA, in violation of the Federal Food, Drug and Cosmetic Act. FDA argued that PGS qualified as a medical device that yielded health reports regarding hundreds of diseases and drug interaction responses. FDA warned that false positives and negatives could cause consumers to suffer health consequences by undergoing unnecessary surgical procedures, failing to pursue screenings or abandoning certain drug therapies.

FDA’s move against 23andMe came after more than three years of joint communications that ended in May 2013. In 2012, 23andMe submitted two 510(k)s. In May 2013, FDA notified 23andMe that its 510(k) applications were withdrawn. Concurrently, 23andMe ended communication with FDA while increasing its marketing campaign. Six months later, FDA issued its warning letter to 23andMe. On December 5, 2013, 23andMe announced it will stop providing data on health risks and offer refunds for PGSs ordered after the date of the FDA warning letter. However, consumers who ordered PGSs before the warning letter would still receive health risk data. If FDA is unsatisfied with 23andMe’s response to its warning letter, FDA may pursue seizure, injunction and civil monetary penalties against 23andMe.

Overall, the incident highlights the evolution of personalized medicine and the lack of regulatory clarity in creating products that safely allow consumers to learn and comprehend the implications of their personal genetic information. In a letter to the Wall Street Journal, FDA indicated that it recognizes the value in the direct-to-consumer approach for genetic tests and believes the tests will allow consumers to take a more active role in their health. At the same time, however, active concerns exist in the scientific community about the sensitivity and specificity of the currently available direct-to-consumer genetic tests and how the results of those genetic tests are communicated to the consumer. While FDA admits that current regulatory schemes cannot keep up with the evolution of new technologies, FDA’s warning letter to 23andMe and disclosure of FDA’s extensive interactions with the company indicates that FDA will not tolerate a lack of communication and borderline defiance in the medical device approval and clearance process.