I mentioned the 23andMe Personal Genome Service last month, and I even considered the possibility of becoming a customer, although I noted that the service was effectively banned in two states.

Well, make that all 57 states:

[T]he FDA has ordered an immediate halt to sales of the kits. In a letter to Anne Wojcicki, 23andMe CEO and wife of Google co-founder Sergey Brin, the FDA claims the marketing of the 23andMe Saliva Collection Kit and Personal Genome Service is currently in violation of the Federal Food, Drug and Cosmetic Act.

According to the agency, the kit falls under the heading of a regulated medical device under section 201(h) of the FD&C Act.

How much slack is the FDA willing to cut them? Only this much:

While the agency called for the immediate halt to marketing of the product, it also gives the company 15 days to tell the FDA what steps it has taken to remedy the problems.

Which may explain why I saw a couple of ads for 23andMe on Fark last night.

1 comment

  1. Joseph Hertzlinger »

    28 November 2013 · 1:48 am

    Strange… I tried Googling “fascist twits” but it didn’t lead to the FDA…

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