Reflections on FDA Warning to 23andMe

“Reflections on FDA Warning to 23andMe.” by Jim Evans, The Cancer letter.

There’s been much recent gnashing of teeth (at least within the narrow and rather insular world of do-it-yourself genomics) about the gall of the FDA in choosing to issue a warning letter to 23andMe, effectively shutting down marketing of their direct-to-consumer personal genomic profiling. And adding to 23andMe’s woes, a class action suit has been filed against them.

The FDA’s call was an easy one. That agency is charged with regulating drugs, complex medical tests and medical devices to ensure that they are generally safe and that there is evidence to support the claims of efficacy made on their behalf. Had they not taken action they simply would not have been doing their job. 23andMe’s advertising about their product consistently claimed (both implicitly and explicitly) that the information they provided would improve your health.

The only problem was that there is no evidence to back up these claims, forcing them instead to rely on wishful thinking and anecdotes.

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