he Food and Drug Administration on Tuesday issued a public health advisory about the potential risks of an herbal supplement called kratom, warning that people who use it to treat pain in place of opioids or to wean themselves off opioids are exposing themselves to an unregulated product that has not been proven safe or effective.
The announcement from FDA Commissioner Scott Gottlieb is sure to rile devoted kratom users, who contend the supplement has provided them with a way to manage pain, anxiety, and a range of other conditions.
“Kratom has raised significant concerns given its increasing prevalence and potential safety risks,” Gottlieb said in a statement, adding that regulators know of 36 deaths tied to products containing kratom and that related calls to poison control centers spiked tenfold from 2010 to 2015.
Kratom is a plant from Southeast Asia that taps into some of the same brain pathways as opioids. It can be purchased easily online and in some stores, and even from a vending machine in Arizona.
Last year, the Drug Enforcement Administration announced it intended to temporarily list ingredients found in kratom as Schedule 1 drugs — defined as having no accepted medical use and a high risk for addiction — before abandoning the plan after an outcry from kratom advocates.
But Gottlieb’s statement shows the government is still worried about kratom, which people often use to treat conditions without seeing a doctor. Because the product is not regulated and is often bought online, it can sometimes be laced with other substances.
The FDA’s public health advisory was focused on kratom broadly, but Gottlieb seemed to focus on its use as an opioid-replacement therapy. While there are medications that can help people ease opioid addictions, there is no reliable evidence to support kratom’s effectiveness for that, nor has its safety profile been tested, Gottlieb said.
“Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects, or interactions with other drugs,” Gottlieb said.
Gottlieb said the plant should go through the FDA’s regulatory process to determine if it is safe and effective, but that no company has tried to develop kratom as an actual regulated product yet.
“While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse,” Gottlieb said. “They must be put through a proper evaluative process that involves the DEA and the FDA.”
He added: “If proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these health benefits.”