Statement from FDA Commissioner Scott Gottlieb, MD, on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims

Epidemics don‘t occur overnight. As we deal with the devastating crisis of opioid abuse and overdose plaguing our nation, the US Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.

Mitragyna speciosa, known more commonly as kratom, is a plant native to Thailand, Malaysia, Indonesia, and Papua New Guinea. While it is important to generate more evidence, there is evidence that certain substances found in kratom are opioids and data suggest that one or more may have a potential for abuse. And its use has been on the rise and is of concern to the FDA. We‘re not alone in our concern about the opioids found in kratom—it‘s already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia, and Thailand. The substance is also banned in a number of states and municipalities in the US.