FDA Steps Up Action Against Kratom Distributors

The substance is now in the crosshairs of the opioid debate.

The Food and Drug Administration has issued warning letters against three marketers of the drug kratom, a natural remedy hailed as a miracle cure by some, but branded as dangerous by the federal government.

In Chicago, kratom is sold openly in stores, online shops, and three “CBD Kratom” retail outlets in Bucktown, Andersonville, and North Halsted.

While supporters hail kratom for everything from pain relief, to relaxation, to liberation from opioid addiction, the FDA warns that the substance is actually a dangerous opioid relative. In Tuesday’s action, the agency issued warning letters to three marketers and distributors, in Colorado, California, and Missouri, for illegally selling unapproved products with “unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.”

“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there is no scientific proof,” FDA commissioner Scott Gottlieb said in a statement. “Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic, and puts patients at risk of serious side effects.”

Known officially as mitragyna speciosa, kratom is harvested from a plant which grows naturally in Thailand, Malaysia, Indonesia, and New Guinea. The FDA says it is being marketed through “health fraud scams” which can pose serious risks.

During a visit to CBD Kratom in December, manager Matthew Warren told NBC 5 he had personal knowledge that the drug was safe and extremely effective.

“I haven’t had anyone ever have any kind of dangerous reaction to kratom,” he said. “I have first-hand experience of giving kratom to friends of my own going through opioid withdrawal, and I physically saw the difference within about five minutes.”

After Tuesday’s announcement, Warren declined comment, referring NBC 5 to his company’s corporate headquarters. There, a spokesman who identified herself as Dafna, said by email, that the stores do not stock any product from the distributors who received warning letters from the FDA.

“We take our business very seriously, and appreciate your outreach,” she said. “I hope that we will in no way be tired to these recalls in the story, since we do not sell any recalled products and would never do so.”

Earlier this year, the FDA warned the public not to consume any brand of kratom because of potential danger from salmonella. Two years ago the agency attempted to ban the drug, but reversed course after over 50 members of Congress complained that it should be researched as a valid opioid substitute.

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