FDA issues warning letters to companies connected to kratom

By Clyde Hughes

June 26 (UPI) -- The Food and Drug Administration said Tuesday it issued warning letters to two marketers and distributors for making unproven claims and selling unapproved products containing the drug kratom.

The FDA said Cali Botanicals in Folsom, Calif., and Kratom NC in Wilmington, N.C., illegally sold and misbranded products containing kratom while saying without proof that it could cure things like opioid addiction and withdrawal symptoms.


Kratom contains the alkaloid mitragynine, which can produce stimulant effects in low doses and some opioid-like effects at higher doses, according to the Centers for Disease Control and Prevention. It has been marketed as a dietary or herbal supplement in the U.S. and some studies suggest it can be abused.

"We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls," acting FDA Commissioner Dr. Ned Sharpless said in a statement.

"Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence," he continued.


The CDC said it found kratom present in the systems of 152 people who died of overdoses from July 2016 to December 2017.

"As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions," Sharpless said.

The FDA complained that the companies also claimed that kratom could be used to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue.

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