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>Yes, it does, but the scope of its regulatory authority set by Congress over supplements is different than the scope it has over food, drugs, and medical devic
by cromwellian 13y ago
>Yes, it does, but the scope of its regulatory authority set by Congress over supplements is different than the scope it has over food, drugs, and medical devices.
It does a piss poor job of it. Stop wasting time on 23andme, and pour resources in that. The FDA admitted that a whopping 70% of all supplements violate their rules.
>Dianetics/Scientology is neither a food, drug, supplement, medical device, nor anything else vaguely related to the FDA's scope of regulatory authority.
Point is, these things make unwarranted health claims and cause consumers of them to take actions which directly harm themselves. If someone published health recommendations that tell people to drink bleach to "cleanse" themselves, the FDA can do nothing, but if someone tells them they have the BRCA gene and here's a link to resource that shows it increases risk of breast cancer, well then, shut em down.
> I still don't see that as an argument that the FDA shouldn't act thoroughly within the domain they are charged with regulating now.
Right, the law says smoking pot is illegal, so there are millions of people who have had their lives ruined by the criminal justice system because of that rule, and millions more who have to pay billions for prison funds. But yes, that is not an argument that cops and judges shouldn't prosecute pot smokers to the fullest extent of the law and not prioritize, because, well, it's the law! Ditto for illegal immigrants. Just ship em all back because it's the law. Obama has been asked to de-prioritize going after pot smokers and illegals, do you think that is a bad idea and instead, he should prosecute them to the fullest extent of the law up until the last minute when the law is changed?
The law can be wrong. In this case, the FDA has been given the power to regulate something that straddles an entirely new industry and they are preemptively intervening before any harm has been shown. My argument is, regardless of the law, one can shift around one's priorities. The FDA claims 70% of supplement makers are violating rules. Companies like Ranbaxy are shipping adulterated generics. These are actually harming people and the FDA has at least some authority.
There's an entirely new industry cropping up around the "Quantified Self". Individuals are gaining more and more power to monitor their biological systems, and personal genomics are just another in a long line of this evolution. The traditional power structures in the medical community do not like this decentralization towards consumers being able to get medical information about themselves without consulting doctors first, without doctors ordering tests, without doctors first interpreting the results.
I am stone cold libertarian on this. When it comes to my body, I demand the right to do anything to it, even if it may be bad for me, and to have any information on it, and to contract with those who can provide such information. My own concern is real fraud, that is, if someone says here's a blood pressure monitor, that doesn't actually measure BP, or here's someone selling a DNA test, which actually gives me a totally false randomized DNA profile. My concern is not over someone giving my a dump of my DNA and then generating a series of correlated links to potential diseases. I will ultimately take that information and do the research myself. Anymore than I am not concerned with a health site that takes my medical records or personal survey, and gives me a bunch of self-diagnoses diseases that match.
In short, where you and the FDA see "health claims", I see a search engine.
- dragonwriter 13y ago> Stop wasting time on 23andme, and pour resources in that. AFAICT, the time wasting that has gone on with regard to 23andMe has been the FDA bending over backwards to try to help them get into compliance. I agree that the FDA, in retrospect, shouldn't have done that and should have spent that time more productively.