FDA issues warnings to companies selling kratom to treat opioid addiction

Published: Jun. 26, 2019 at 4:30 PM EDT
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The U.S. Food and Drug Administration issued warning letters to two businesses, including a Wilmington, North Carolina store, for illegally selling unapproved, misbranded kratom-containing drug products claiming they can treat or cure opioid addiction and withdrawal symptoms.

According to the FDA, Kratom NC, located at 925 South Kerr Avenue in Wilmington, and Cali Botanicals, of Folsom, Calif., claim that their products can treat pain and cancer, as well as mental health conditions such as depression and anxiety.

“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," said acting FDA commissioner Ned Sharpless

. "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.”

The FDA said that the companies used websites and social media to “illegally market kratom products, making unproven claims about the ability of the kratom drug products they distribute to cure, treat or prevent disease.”

Advocates say kratom helps ease the pain and reduce the symptoms of opioid withdrawal, but the FDA has not approved it for any medical use. In 2018, the agency

declaring that kratom had opioid-like properties and could lead to abuse, addiction, and serious health consequences, including death.

A report from the Centers for Disease Control and Prevention

linked kratom to 91 overdose deaths in 27 states from July 2016-Dec. 2017, though in a majority of those cases, kratom was taken along with other drugs, including heroin and fentanyl.

“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.

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