FDA Warns Kratom Makers Over Illegal Sales, Deceptive Marketing

Megan Brooks

May 22, 2018

The US Food and Drug Administration (FDA) has sent warning letters to three companies for illegally selling unapproved kratom products, which they claim can treat opioid addiction and withdrawal and a whole host of other problems.

The letters were sent to Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe Inc of Kansas City, Missouri.

"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's no reliable scientific proof to support their use," FDA Commissioner Scott Gottlieb, MD, said in a press statement.  

"As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. 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," added Gottlieb.

The companies also claim their kratom products ease pain, lower blood pressure and blood sugar, treat cancer, and reduce stroke-related brain damage, among other things.

Risky Business

The warning letters are part of FDA's ongoing efforts to crackdown on kratom and alert the public to the risks of using kratom products.

Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. The botanical's popularity has been increasing in the United States, with users claiming it helps treat pain, anxiety, depression, and, more recently, opioid withdrawal.

There are no FDA-approved uses for kratom, and the agency has advised against using kratom or its psychoactive compounds mitragynine and 7-hydroxymitragynine in any form and from any manufacturer. 

Kratom is already linked to more than 40 deaths. An analysis of the substance by FDA scientists found that its compounds act like prescription-strength opioids, as reported by Medscape Medical News.

The FDA says the three companies receiving warning letters take orders for kratom products online and/or use social media to make unproven claims about the ability of their products to cure, treat, or prevent a disease, which is against the law. 

"Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies," the agency said.  The warning letters called out more than 65 kratom products.

The FDA has requested responses from each of the companies within 15 working days.

Healthcare professionals and consumers are encouraged to report any adverse events related to these products to the FDA's MedWatch Adverse Event Reporting program.   

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