Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb isn’t mincing words about kratom, the increasingly popular herbal substance that’s been hawked as an alternative to painkillers and anti-depressants by companies promoting its ostensible curative properties (and supposedly innate safety as a “natural,” plant-based product). Those are medically unproven claims that could prove deadly considering kratom’s promotion as an opioid addiction fighting tool in the midst of a painkiller overdose epidemic, the FDA says—and it’s been linked to at least 36 deaths the agency knows of.
So what is kratom? As Gottlieb explains in an FDA statement, it’s “a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea.” But despite the hype about kratom’s ability to treat anxiety, pain, and depression, there aren’t any clinically validated studies to support those claims. “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence,” said Gottlieb.
Gottlieb also pointed to the the 10-fold increase in calls to American poison control centers related to kratom-containing substances between 2010 and 2015. One crucial issue that may have prompted the harsh FDA safety warning about kratom has to do with the ongoing opioid epidemic, which is claiming tens of thousands of lives every year in America. Kratom has been promoted as both a healing cure for opioid addiction as well as a drug to be added on to existing opioids to enhance the euphoric high (it’s also used purely recreationally by some people).
Under kratom’s current legal status, it can’t be marketed for therapeutic reasons, and there are no FDA-approved uses for the herbal product. That’s not to say there aren’t any medicinal benefits to kratom—it just hasn’t gotten the scientific scrutiny required for regulatory clearance. The FDA has applied the same kind of scrutiny to claims that marijuana-derived products can help prevent, treat, or cure cancer (claims which aren’t supported by any existing scientific evidence).