Google-backed 23andme has been ordered to "immediately discontinue" selling its saliva-collection tests after failing to provide information to back its marketing claims.
The tests aims to show how personal genetic codes may affect future health.
The company said it would address concerns.
The start-up has been operating since 2006 and was co-founded by Anne Wojcicki, the wife of Google co-founder Sergey Brin.
For $99 (£61), users receive a kit allowing them to take sample of saliva. This is sent to the company and in return users receive a readout of their genetic code.
The website promises reports on 254 health conditions and traits as well as offering to help people trace their genealogy.
Under FDA rules, the company must provide proof about how accurate its detection methods are as well as supplying the error rates from its personal genome service (PGS).
In a public letter the FDA said that 23andme had not supplied this information, despite increasing its marketing campaign and the scope of its tests.
"FDA is concerned about the public health consequences of inaccurate results from the PGS... see more