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Why is the supplement industry in the US completely unregulated by the FDA?

Shouldn’t it fall under foods?

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Answer

Others gave links to more specific information, but I’ll give a brief ELI5 version. They are regulated by the FDA and do fall under the foods umbrella. It’s because they fall under the foods umbrella that they aren’t more strictly regulated. If they were classified as medications then they would be subject to stricter guidelines.

They do have to meet certain requirements though. For example, there are limits to what claims they can make. They can’t make any claims of the product treating a disease or it will be reclassified as a drug and forced to meet the stricter requirements. They can make structure or function claims like, “fiber maintains bowel regularity,” but have to be a bit more careful in the wording of health claims like, “Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.” Health claims also have to be reviewed and evaluated by the FDA prior to their use on labeling. So there are some guardrails, but they aren’t as stringent as drug regulation.

Answer

That’s why it always baffles me when people say they don’t take any medication because big pharma lie, they’re corrupt and FDA has approved dangerous drugs before. And while all of that may be true. It’s even worse with the supplement industry. these same people then take a cabinet full of supplements every day. I’m a member of the supplement subreddit and I see this all the time.

In order for something to be labeled a supplement it just can’t have any substantial proof it’s dangerous. That’s how supps get banned. But in order for something to get approved by the FDA it must be shown that said medication is safe. So by definition, supplements have the potential to be much more dangerous than an approved medication

Answer

If you mean vitamins and things like that then off the top of my head I’d imagine it’s because they’re not necessary. Food is necessary, flintstone gummies not so much. If you meant something more then ignore this entirely but like I said this was just off of the top of my head anyway.

Answer

Ok so they are regulated as foods, my mistake. I have read that supplement testers commonly find that the supplement advertised contains very little or none of what the product says it is. How do companies get around this without getting massive fines? How does the FDA not deal with this? It surely kills many Americans annually I would assume?

Answer

It requires the FDA and other organizations to recognize supplements as valid and useful substances past pharmaceuticals.

Having a low cost supplement that helps whatever ailment you have isn’t good for business. No, this is not me saying some supplements are a magic cure for anything in any way shape or form.

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