FDA announces recall of dietary supplements after opioid declaration

The Food and Drug Administration (FDA) on Wednesday announced a recall of dietary supplements that contain kratom, a herb the agency has classified as an opioid.

FDA Commissioner Scott Gottlieb also urged manufacturers to stop selling products intended for human consumption if they contain kratom.

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“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” Gottlieb said in a statement. 

“At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use.” 

Last week, the FDA released findings showing kratom acts like an opioid and can be dangerous and addictive. 

Gottlieb said the FDA oversaw the destruction and recall of supplements containing kratom and being sold by Divinity Product Distribution, based in Missouri.

While the supplements had been intended to be used to help people with weight loss, there have been reports of people using them as an alternative to prescription opioids.

“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” he said. 

Gottlieb said there are no FDA approved therapeutic uses of kratom and the agency has evidence that it poses “significant safety issues.” 

He noted that there have been 44 reported deaths associated with kratom use.

The herb is also linked to an outbreak of salmonella in 20 states. 

Kratom grows in Thailand, Malaysia, Indonesia and Papua New Guinea.