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Once a botanical is studied under an IND or approved as a new drug in an NDA, is its status as a dietary supplement jeopardized?

April 26, 2017Approved Botanical dietary drug IND NDA Status studied supplement

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Once a botanical is studied under an IND or approved as a new drug in an NDA, is its status as a dietary supplement jeopardized?

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No, dietary supplements lawfully marketed before the IND and subsequent NDA approval are not at risk. Please refer to the CFSAN website New Dietary Ingredients in Dietary Supplement for further information.