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Kratom Group Sharpens Criticism Of 'Opioid' Finding In FDA's Report To DEA

This article was originally published in The Rose Sheet

Executive Summary

American Kratom Association realizes FDA could have significant influence on DEA decision on whether to schedule kratom constituent ingredients as controlled substances. The association and experts on kratom say FDA's, which concluded that mitragynine and 7-hydroxymitragynine are opioids and use of kratom is dangerous, contains numerous inaccuracies and incorrect conclusions.

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Warning to contract manufacturer Avalon Packaging points out all but one of the problems that have dogged the kratom industry, including saying the herb's safety for its intended use should be proved to FDA before it is used in supplements and noting GMP problems, an area a kratom industry trade group discusses specifically in the standards program also published Nov. 20. While FDA also notes another problem kratom industry has wrestled with over past year, salmonella contamination, it doesn't allege Avalon's products are opioids.

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Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.

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Proponents say the herbal ingredient extracted from a plant in the coffee family and available in powders, capsules or pills and beverages has been used in the US since long before the October 1994 grandfather date for ingredients to be eligible for use in supplements without being notified to FDA as new. But FDA wants NDI notifications, and the four submitted so far have been incomplete or did not show safety for intended use in a supplement.

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