They could sell them as supplements but then they wouldn't be legally able to claim efficacy or be billed as medicine. They can't make nearly as much money without FDA approval.
If they get an FDA approval, it would mean that there has been review that their outputs are actually appropriate. That's why the FDA is required by law to review items marketed for diagnosing disease.
Yes. The FDA regulates (among other things) "indications" for drugs. For example, you can't represent that a drug is effective at treating something without FDA approval. So, currently, only one company can make this pill, and even then they can only sell it for a specific list of diseases. After some time, other companies will be able to make the pill and sell it for the same list of diseases, except this one. The FDA has the power to regulate the claims made by various companies, so this was probably a compromise that was part of a larger deal.
The FDA has tiers of regulation. Things like "supplements" are loosely regulated, while "pharmaceuticals" are much more highly regulated.
With supplements, the FDA pretty much lets things go until they start causing problems. DMAA was legal for a long time until people started having heart attacks. Melatonin, which is a straight-up hormone, is over-the-counter in the US, and it's by prescription only in Europe.
Now, if you're marketing something as a treatment for a disease, you have to have concrete data to back it up.
So it's very possible to have something that the FDA will let you sell as a supplement (i.e. there's no evidence that it's dangerous), but not make any claims about its efficacy (i.e. you can't say it will treat XYZ).
I experimented with nootropics at one point of my life (found them worthless, FYI), and it was funny how all of the labels just stated what it was, purity, and a blurb about the company selling it. There was no language whatsoever telling you what the supplement was for. Just a giant "PIRACETAM" label on the front.
FDA approves certain substances for specific uses. One loophole that dietary supplement companies will use to stamp the FDA approval on themselves is to include one such substance, even if the specific use isn't what their product is being used for.
Another loophole that these dietary supplement companies use is the "FDA Inspected" stamp.
The FDA is prohibited from requiring safety and efficacy evidence before supplements go on the market. This is unlike substances categorized as drugs, which require both safety and efficacy evidence before going on the market. So the FDA won't know if a supplement is actually dangerous until after it is on the market, and then it will have to find that particular supplement among the thousands that exist, as the onus is on the FDA to find and prove it is dangerous.
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