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Health, Beauty And Wellness Regulatory News: FDA, Kratom Group Trade Criticisms, LifeLink 'Key Words' Warned

This article was originally published in The Rose Sheet

Executive Summary

FDA's latest concern about kratom is "disturbingly high levels of heavy metals," but American Kratom Association adds to its reasons for "strong objections to methodology and lack of scientific rigor" in agency's finding that kratom is unsafe because some constituent ingredients are opioids. LifeLink supplement marketer caught FDA's attention not only for drug claims but also for key words on websites to identify diseases as search terms to find its products.

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Kratom Industry Offers Own Standards As Another Firm Warned About FDA Rules

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.

Salmonella In Kratom, Like Use Of The Herb, Exceeds FDA Expectations

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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