FDA Reiterates Its Concerns on Risks Associated with Kratom

The FDA announced the voluntary destruction and recall of large volumes of kratom-containing dietary supplements manufactured and distributed nationwide by Divinity Products Distribution. Divinity also agreed to stop selling all products containing kratom.

The FDA is also strongly encouraging all other companies that sale products containing kratom intended for human consumption to stop manufacturing and distributing kratom containing products in a full fledged effort to protect the public from the risks associated with kratom.

Kratom, a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea, shares most structural similarities with controlled opioid analgesics, such as morphine derivatives, and been associated with over 44 reported deaths.

According to FDA Commissioner Scott Gottlieb, MD, scientific data provides conclusive evidence that compounds contained in kratom are opioids and have similar addictive effects, risks of abuse and potential for overdose and death. Additionally, Gottlieb reiterated that there is no evidence to indicate kratom is safe or effective for any medical use.