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10 FDA Regulatory Note: The FDA determined that NAC is excluded from the statutory definition of a 'dietary supplement' under the FD&C Act because it was authorized as an active pharmaceutical ingredient (the antidote for acetaminophen overdose, sold as Mucomyst) before it was widely marketed as a supplement
Fedoreyeva LI, Kireev II, Khavinson VKh, Vanyushin BF
pH 7.4)
The FDA is not required to explain publicly how it weighed each member's conflict against their expertise
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