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FDA Waves Stop Sign At Kratom Product Launch After Failed NDI Notification

This article was originally published in The Rose Sheet

Executive Summary

FDA published an untitled letter the same day it was submitted stating that Industrial Chemicals' website includes statements on kratom's safety as a dietary ingredient and its pending launch of product sales even though the agency in December said an NDI notification the firm submitted in September did not establish safety for the use of mitragynine, an extract from dried kratom leaves, in a supplement branded Mitrasafe.

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