FDA Warns 23andme to Stop Providing Inexpensive Genetic Testing

On November 22, 2013 the FDA sent a letter to 23andme telling them to stop selling their “23andMe Saliva Collection Kit and Personal Genome Service (PGS)” The reason for the halt is that their $99 service, which provides purchasers with a genetic analysis of their saliva, hasn’t been approved by the FDA.


In the last year 23andme has directed their advertising toward testing for diseases and drug interaction. This is what the FDA seems to be warning them to stop doing.

23andme is not the only genetic testing company to get warning letters. The FDA has been coming down on many testing facilities. Inexpensive genetic testing has become available in the last few years and the U.S. government’s bloated bureaucracy has now decided it is time to take it away from you. Or at least that’s my opinion. Others with really cool titles may disagree.

Christine Gorman from blogs.scientificamerican.com, in an article titled “FDA Was Right to Block 23andMe” compared “home gene kits” for finding your ancestors ethnicity to a “21st century equivalent of looking up your horoscope.”

Some have stated that “ the FDA is concerned about the consequences of both false positive and false negative results.” But considering how long it takes to get better medications in the U.S., I don’t buy that argument.

Razib Khan from blogs.discovermagazine.com, in his article titled “The FDA and 23andMe” compared the FDA move to the “Recording Industry Association of America” attack on Napster. Napster took the hit, but as any teenager knows, if you want the free music, you can get the free music. The FDA may successfully break 23andMe, but once we have had a taste of inexpensive genetic testing, we will find a way to continue to have it.

My opinion, for what it’s worth, is that it is just another of many attacks by the federal bureaucracy on the small businesses of America.

Article by Dale Ralph Meitzler

One thought on “FDA Warns 23andme to Stop Providing Inexpensive Genetic Testing

  1. Some people with really cool titles are a lot more knowledgable on genetic testing than me and I’m glad they and the FDA are monitoring the services.

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