Kratom Industry GMPs Target Swaying FDA By Exceeding Agency Standards
This article was originally published in The Rose Sheet
“We want to show that the kratom industry is maturing, that people want to do the right thing,” says AKA Chairman Dave Herman. The standards go “well beyond” FDA's minimum GMP requirements for dietary supplements, AKA says.
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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.
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.
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."