The Food and Drug Administration is overseeing the recall and destruction of dietary supplements containing the herb kratom.
The agency said in a notice Wednesday that manufacturers should take their products off the market. The FDA’s announcement comes on the heels of a warning of a salmonella outbreak across 28 states linked to the herb, which is used in products to treat chronic pain.
“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,” FDA Commissioner Scott Gottlieb said. “At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use.”
The agency oversaw the voluntary destruction and recall of dietary supplements containing kratom sold under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Mo.
The FDA says kratom is a new dietary ingredient and any dietary supplement that includes kratom must demonstrate to the FDA that the product is reasonably safe.
“To date, the FDA is not aware of any evidence of safety establishing that kratom (or any compounds derived from kratom) will reasonably be expected to be safe as a dietary ingredient,” the FDA said.
Gottlieb added that he is aware of patients using kratom to treat opioid dependency, but there isn’t reliable evidence to support that. The agency pointed to 44 deaths related to the herb.
Kratom, which originates from a tree leaf in Southeast Asia, is legal, but the FDA is trying to categorize it as a Schedule 1 drug alongside marijuana and cocaine.
However, some scientists say a crackdown on kratom will lead to more opioid deaths.
A group of 44 scientists warned the Drug Enforcement Administration that banning the drug would worsen the opioid epidemic. The letter sent to DEA raised doubts about the deaths linked to kratom.
