The FDA can only regulate certain things. If something isn’t shown to be harmful, and doesn’t claim to treat a medical condition then it is a “nutritional supplement” and falls under food regulations not drug regulations.
However, since they fall under food regulations, they are generally required to attach “Supplement Facts” – a standardized text box similar to “Nutritional Facts” found on foods. Information presented in these boxes is required to be true and each lot must be tested for label claims.
You would think that they would be regulated, but in 1994 Congress passed a law that limits how FDA can regulate them.
As long as your product isn’t actively harmful and you don’t claim that it treats a specific disease, you’re fine. You don’t even have to register your product.
Yes, it’s really really stupid.
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