PURPOSE: 23andMe is back on the market as the first direct-to-consumer genetic 
testing company that "includes reports that meet Food and Drug Administration 
(FDA) standards…." But, whereas its front-end product is selling individual 
genetic tests online, its back-end business model is amassing one of the largest 
privately owned genetic databases in the world. What is the effect, however, of 
the private control of bio/databases on genetic epidemiology and public health 
research?
METHODS: The recent federal government notices of proposed rulemaking for: (1) 
revisions to regulations governing human subjects research and (2) whether 
certain direct-to-consumer genetic tests should require premarket FDA review, 
were reviewed and related to the 23andMe product, business model, and consumer 
agreements.
RESULTS: FDA regulatory action so far has focused on the return of consumer test 
reports but it should also consider the broader misuse of data and information 
not otherwise protected by human subjects research regulations.
CONCLUSIONS: As the federal government revises its decades-old human subjects 
research structure, the Executive Office of the President (EOP) should consider 
a cohesive approach to regulating private genetic bio/databanks. This strategy 
should allow the FDA and other agencies to play a role in expanding current 
regulatory coverage.