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AHPA Backs NDI Filing For Kratom, Experts Question FDA Enforcement

This article was originally published in The Rose Sheet

Executive Summary

FDA regulation of kratom as an NDI is necessary to avoid untenable state regulations, says AHPA chief Michael McGuffin, adding the trade group's support to kratom experts' push to keep the herbal ingredient available. Experts also say salmonella issues currently linked to kratom could be an indirect result of FDA's import alert as noncompliant suppliers filled continued demand.

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American Kratom Association accuses FDA of using “inaccurate, extrapolated and distorted” information on adverse events and deaths allegedly associated with the use of kratom to justify scheduling it as a controlled substance. After FDA Commissioner Gottlieb says the criticism is unfounded and kratom has no future as a dietary ingredient in the US, the group asks for joint meeting with NIDA to discuss "public health policy that allows for consumers to safely use natural kratom."

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Commissioner Scott Gottlieb says prior to investigating a "large outbreak of salmonellosis," FDA determined there are no proven medical uses for kratom and that it is inherently addictive and can cause harm. "The subsequent findings of this investigation only strengthen that public health recommendation. … Now, in addition to those risks, we can conclude that there may be a high proportion of kratom and kratom-containing products contaminated with salmonella," he says.

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