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According to FDA, imported kratom is subject to FDA regulation and DWPE because it appears to be a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury or it appears to be a new drug within the meaning of Section 201(p) [of the Federal Food, Drug, and Cosmetic Act] without an effective new drug application. FDA based its initial import halt of kratom on the lack of evidence establishing its safety, as well as concerns regarding its toxicity in multiple organ systems

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