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Comment by refurb | Hacker News Reader

What do you mean prohibited from regulation?

The reason why we know these supplements have unapproved pharmaceuticals in them is because regulations say: 1) you can't, 2) the FDA has the power to test them, 3) the FDA has the power to force a recall.

The FDA is prohibited from banning supplements that have been in use prior to 1996 (or so). They are also allowed to restrict what can be said about the supplements (they can't make unsupported medical claims).

I don't know about you, but unless a supplement is actually dangerous, I think it's good the FDA can't come in and tell adults what they can and can't put in their own bodies.

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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.

That’s not accurate. You can’t just create a new chemical and call it a supplement. There has to be pre-existing data indicating that a supplement has been used in the past (prior to the legislation).

If data suggests a supplement isn’t safe, the FDA can ban it.

Plus, you’re not allowed to make specific safety or efficacy claims when selling a supplement. You can be vague about “It’s been used for insomnia”. But that’s about it.

Yes, you can. You have to submit safety information, but you're not barred from entering the market. From an article about a supplement that was essentially an unregulated drug because it was an unknown drug:

> Under a 1994 federal law, supplement makers must submit some kind of safety data to the F.D.A. if they plan to introduce new ingredients to the market. And manufacturing-practice rules require them to make sure their products contain only the ingredients listed on the labels, with no hidden substances. But, unlike drug makers, supplement makers are not required to prove that their products are safe and effective on humans. Nor do they have to get federal approval before selling their products. That means it is up to the F.D.A. to identify any risky supplements from among the estimated 85,000 on the market, and to prove that they are adulterated or present health hazards.

https://www.nytimes.com/2013/03/17/business/a-soldiers-paren...

Again, the onus is on the FDA to find supplements that are previously unknown, regulated drugs. If we flipped the requirements, supplement makers would be barred from selling their supplements without clearing them with the FDA first. The active drug in that story has since been banned by the FDA: https://www.fda.gov/food/dietarysupplements/productsingredie...

You're not allowed to make specific medical claims. But you are also not required to show any efficacy for what you do claim, and the supplement industry regularly gets as close as they can to "specific medial claim." And sometimes they cross it! And, again, the onus is on the FDA to find such cases.

We are in agreement then. My statement “you can’t just create a new supplement” was in reference to the claim they don’t need safety information. They do, either new data (for a new molecule) or existing data (for a supplement with known activity).

In terms of the onus being on the FDA, that’s how it should be. A default “it’s banned unless we say so” would limit access to supplements that have been used for decades. They’d need to be pulled off the market. Supplement makers are unlikely to have access to the millions of dollars it would take to a supplement through clinical trials to prove safety and efficacy.

And as for the claims, the FDA issues warning letter by the ton when supplement makers step over the bounds.

We're in agreement on the facts, but not apparently on what we want to do about them. I have no problem that this would take most supplements off the market, as I think the current system makes companies exploiting consumers very likely.

sure you can.

its being done, daily.

and the FDA doesn't work the way you think it does; they are the rubberstamp for massive testing on the populace. Look up the scandal with fake sugars during the 1980's.

Even an inert supplement is dangerous if its marketing and labeling leads uninformed people to believe it's a substitute for an actual working pharmaceutical.

The FDA already prohibits efficacy claims on supplements.

You can claim it’s used, but t can claim it treats any disease.

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