The U.S. FDA on February 21 said it recalled and destroyed a large volume of kratom-containing dietary supplements made by a company in Missouri.
Kratom is a natural plant grown in parts of Asia that advocates say can help ease pain and reduce symptoms of opioid withdrawal, but which critics say can lead to addiction and death.
The FDA has long been skeptical of the benefits of kratom, having placed import alerts on the substance in 2012 and 2014. There are currently no FDA-approved therapeutic uses of kratom. The regulator has earlier said it was aware of 36 deaths associated with the plant, however declined to say over what period the deaths occurred.
The regulator said it is recalling all kratom-containing dietary supplements distributed under the brand names Botany Bay, Enhance Your Life, and Divinity. The brands are manufactured by Divinity Products Distribution of Grain Valley, Mo.
“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,” FDA Commissioner Scott Gottlieb said.
The regulator also said it was investigating a multistate outbreak of Salmonella infections linked to products reported to contain kratom. The CDC reported that 28 people in 20 states are infected and 11 people have been hospitalized. The ill people reportedly consumed kratom in pills, capsules, powder, or tea.