Kratom is not regulated as a controlled substance, though the Drug Enforcement Administration lists it [3] as a “drug of concern.” The FDA has not approved kratom for any purpose, but supplements do not require the agency’s sign-off to be sold.

Kratom was the cause of 91 overdose deaths from July 2016 to December 2017, according to a report [4] from the Centers for Disease Control and Prevention. But some estimates put the toll far higher: An analysis by The Washington Post [5] found kratom listed as the leading or partial cause of death in at least 4,100 deaths from 2020 to 2022, and an investigation by the Tampa Bay Times [6] last year found that more than 580 people in Florida alone had died from kratom-related overdoses since 2013.