Earlier today, the FDA released a letter it sent last Friday to personal genomics startup 23andMe.
The warning letter served notice to the company — and the broader digital health startup community — that the power of the FDA is not something to be taken lightly.
Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. James L. Woods — Deputy Director, Patient Safety and Product Quality, Food and Drug Administration
It’s a strongly worded warning against the high-profile personal genomics startup. Founded in 2006, the company has raised over $160 million through some leading Venture Capitalists including New Enterprise Associates, Mohr Davidow, Google Ventures — and Google Co-Founder himself — Sergey Brin.