5 ms·

All they need to do is slap a disclaimer all over the place and instead of mentioning specific diseases say something non-specific like "this test result indica

by spikels 13y ago

All they need to do is slap a disclaimer all over the place and instead of mentioning specific diseases say something non-specific like "this test result indicates your heart/lung/bone/etc is unhealthy/risky/bad/etc". The completely bullshit vitamin/herbs/supplements/alternatives industry has been making similar claims without a peep from the FDA. You gotta know the rules to the game even if they are arbitrary.

carbocation 13y ago
> "this test result indicates your heart/lung/bone/etc is unhealthy/risky/bad/etc" It's pretty unlikely they would escape the FDA's review simply by making their medical diagnoses slightly more vague.
- 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 ago
    If 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 ago
      Can'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.

by spikels 13y ago

carbocation 13y ago

> "this test result indicates your heart/lung/bone/etc is unhealthy/risky/bad/etc" It's pretty unlikely they would escape the FDA's review simply by making their medical diagnoses slightly more vague.

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 ago
  If 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 ago
    Can'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.