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From the FDA letter to 23andMe describing why they have regulatory oversight: "because it is intended for use in the diagnosis of disease or other conditions o
by spikels 13y ago
From the FDA letter to 23andMe describing why they have regulatory oversight:
"because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."[1]
No mention of disease (or structure or function) then there would be no problem.
The FDA makes many arbitrary distinctions because of the long and twisted legal and political history of "health" industry regulation[2].
[1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...
[2] http://www.fda.gov/NewsEvents/Testimony/ucm112576.htm http://www.fda.gov/NewsEvents/Testimony/ucm112576.htm
- carbocation 13y agoIf 23andMe marketed their service purely for, say, genealogical purposes, there wouldn't be an obvious problem. Instead, they not only report on disease-related SNPs, but try to interpret those into a coherent diagnostic message. In my opinion, this is stepping into the FDA's realm of regulation.
- spikels 13y agoCan't disagree with you there. Seems like their original plan of testing for genetic risk factors for a large number of diseases will require lengthy approvals for each and perhaps require conditions such as counseling that are not compatable with a kit. My original comment was more a snark about the free pass the FDA gives to the supplement industry. This is a much less settled area so it is unclear if some fudge like I suggest could work either with the FDA or in the market. Perhaps they will even seek legislative of legal relief like the supplements industry.