International Monographs Do Not Qualify As Claims Substantiation – FDA
This article was originally published in The Tan Sheet
International and third-party monographs are not sufficient substantiation for dietary supplement claims, according to FDA.
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“To the extent these claims pertain to the ingestion of peanuts, they are not consistent with the claim in the  Letter of Enforcement Discretion FDA issued in response to a petition for a qualified health claim for ground peanuts and reduced risk of developing peanut allergy,” state CFSAN officials.