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Cockmaster posted:There's also the fact that the FDA imposes no regulation whatsoever over herbal remedies. http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm079496.htm
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Oct 25, 2014 01:14
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Idran posted:Some herbs do fall under that category, but only because dietary supplement restrictions apply to supplements intended to add nutritional value to the diet. No, because the FD&C definition of drug includes quote:articles (other than food) intended to affect the structure or any function of the body of man or other animals ... A food or dietary supplement for which a claim, subject to sections 343 (r)(1)(B) and 343 (r)(3) of this title or sections 343 (r)(1)(B) and 343 (r)(5)(D) of this title, is made in accordance with the requirements of section 343 (r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343 (r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement. Any medical claims at all means it's regulated under one class or another.
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Oct 25, 2014 03:45
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Idran posted:Huh, I've been misinformed, then; I was under the impression that so long as you didn't make specific medicinal claims, the FDA had no jurisdiction over you. How does something like Airborne or a homeopathic remedy get away with not needing FDA approval, then? Dietary supplements don't need approval because the fact that they're limited to nutrients and plant-derived substances is supposed to make them safer (lol). Manufacturers still have to follow manufacturing standards and report severe side effects, and the FDA can take action if there's evidence that one is dangerous to more than just your wallet. Homeopathy has special exemptions just for their "medicine."
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Oct 25, 2014 04:10
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