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Out of the key regulations, what is pre-market notification?


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The manufacturer or distributor of a new dietary ingredient or of a dietary supplement that contains a new dietary ingredient must submit a notification to FDA at least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains the new dietary ingredient. (21 U.S.C. 305b(a) and 21 CFR 190)

Jan 29, 2016

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