The Food and Drug Administration launched the latest attack on Tuesday in a drawn-out war between regulators and patients over the safety of a popular herbal supplement called kratom, branding the plant a dangerous drug.
“Compounds in kratom make it so it isn’t just a plant — it’s an opioid,” FDA Commissioner Scott Gottlieb declared in a statement.
Some users have argued that kratom is a safe way to treat pain and wean oneself off opioids, but the agency concluded otherwise — based on case reports and a computer analysis of the molecular structure of kratom ingredients.
“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids,” Gottlieb said. “There is no evidence to indicate that kratom is safe or effective for any medical use.”
The debate had exploded in the summer of 2016, when the Drug Enforcement Administration announced, on an emergency basis, that it would unilaterally classify ingredients in the herbal supplement as a Schedule I drug. If it had gone through, that action would have made kratom as illegal as heroin or LSD. But there was an outcry from the American Kratom Association and the community of patients who say they rely on the greenish powder — the response included a petition with over 140,000 signatures, and criticism from lawmakers. The DEA changed course: In October 2016, the agency announced that it would delay its decision until there had been time for a public comment period and for a scientific evaluation by the FDA.
Kratom advocates celebrated the fact that the substance would still be legal, at least for now. But since then, the FDA has issued a series of findings that made it seem as though that may not be true for long.
In November, Gottlieb issued a warning about kratom’s “potential safety risks.”
On Tuesday, the commissioner gave more details about his concerns. Agency scientists used a 3-D computer model to look at the structure of 25 ingredients in kratom, and reported that these molecules seem similar to those found in controlled opioids. Then, using the same digital simulation, the researchers tried to figure out the path these chemicals might take in the body. Their findings predicted that 22 of the 25 compounds analyzed would bind strongly to specific opioid receptors, which led the commissioner to write that “kratom compounds are predicted to affect the body just like opioids.”
The statement was also based on a review of the kratom-related literature. It did not specifically address previous research showing that when tested on cells in lab dishes, some of these compounds only partially activated certain opioid receptors. Those experiments had led the scientists involved to wonder whether these chemicals might reduce pain like some opioids without some of the harmful side effects.
Gottlieb warned of side effects that could be caused by kratom, such as changes in neurological and cardiovascular function. He also cited 44 reported deaths “associated with the use of kratom.” In the past, advocates for the herbal supplement have argued that many of these cases involved other drugs besides kratom.
“Claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” Gottlieb said. “After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.”
While the DEA has already received the report it had requested from the FDA, this newly released evidence may influence the decision as to whether the substance should remain legal, the agency said Tuesday. A spokesperson could not say when that would be determined. “For any substance that goes through this process, it can be months, or it can be years,” said spokeswoman Katherine Pfaff. She added that a number of states have banned kratom, but for the time being, “federally, it is still a legal substance.”
The American Kratom Association did not immediately respond to requests for comment, but on a Facebook page devoted to the substance, frequent users reacted to the FDA’s findings with anger and fear. They questioned the results, predicted that it would lead to a federal kratom ban, and called for kratom supporters to contact the FDA to express their dismay. One man who said he was from Hingham, Mass., described a litany of health problems for which kratom gave him some relief. “If kratom were banned, I’d probably go on disability and live at home for the rest of my life,” he wrote.