Warning letters, Part 1: Personalized nutrition

We’ve seen a lot of warning letters this year, so we’ve picked out a couple with big implications. First up is a company that isn’t even a dietary supplement firm, but the warning letter to genetic tester 23andMe​ could have implications for nutrigenomics.

Industry sources have noted that the warning letter does not mean that these types of tests are not allowed, just that FDA is looking for it to be done by the right channels.

“The agency’s approach to 23andMe goes to two points.  Can the test itself yield consistent, analyzable factors?  Can you get an adequate sample of out saliva?”​ said Jason Sapsin, an attorney in the firm Fox Rothschild.

“The second part is, either implicitly or explicitly, are the relationships that a company is looking at between those factors sufficiently well documented that they can be presented to consumers as fact? Can you derive results on which it is reasonable to ask consumers to rely?”​