The unsuccessful NDI notification, submitted by American Botanicals Corporation (NDIN #1220), marks the sixth time an NDIN has been filed with the agency for kratom. All have been unsuccessful*.
Two of the previous six attempts were also filed by American Botanicals Corporation. In its new response, which can be found HERE, FDA stated that it has significant concerns about the evidence presented, noting that it was unable to establish the identity of the ingredient described as a ‘kratom extract’.
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