4 ms·

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

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-parents-take-aim-at-gnc-and-a-supplement-maker.html 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/productsingredients/ucm346576.htm 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.

refurb 8y ago
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.
- scott_s 8y ago
  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.

refurb 8y ago

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.

scott_s 8y ago
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.