The Food and Drug Administration is still pressing down hard on kratom—the plant treatment that adherents say has helped them manage their opioid addiction or chronic pain. This week, the agency announced it was sending warning letters to two online marketers and distributors, accusing them of illegally selling kratom products with false or unproven claims about their health benefits.
The letters, addressed to the California-based company Cali Botanicals and North Carolina-based Kratom NC, don’t mince words. They allege that both companies are skirting the law by selling their wares.
While kratom itself isn’t illegal for people to take (at least not on a federal level yet), the government doesn’t allow it to be marketed as a dietary supplement. And because the companies are making health claims about their products, they’re essentially selling kratom as an unapproved drug. These claims, detailed by the FDA in its warning letters to the two firms, include that kratom can help with opioid addiction or pain relief, but also go as far as to suggest that it can treat arthritis, insomnia, and even cancer.
The letters are the latest salvo in the government’s crusade against kratom. In addition to sending similar letters to other companies last year, the agency has warned the public about kratom products being contaminated with Salmonella. And earlier this April, the Centers for Disease Control and Prevention published a report linking 91 deaths to kratom use between 2016 and 2017.
“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” Ned Sharpless, the current acting FDA chief, said in a statement. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”
Oliver Grundmann, a clinical toxicologist at the University of Florida’s College of Pharmacy, agreed that the FDA should go after companies that make bold claims about kratom’s miraculous properties. But he and other experts are less certain about the FDA’s assertion that there’s no evidence that kratom can be helpful for some struggling with addiction.
“The FDA is correctly making the point that we don’t have the definitive evidence that kratom can help some people mitigate their withdrawal symptoms, such as Phase 2 or 3 clinical trials. But there is some research out there,” he told Gizmodo over the phone. “We’re really in something of a grey area right now.”
Aside from concerns about kratom products being contaminated, the crux of the FDA’s argument is that the plant functionally acts as an opioid in the brain. Because of this, the logic goes, kratom isn’t any safer for people to take than illegal opioids like heroin and should be just as heavily regulated and/or outright banned. But critics have argued back, asserting that while kratom does interact with opioid receptors, it’s probably not doing so anywhere near as strongly as classic opioids do. Others have similarly criticized reports tying kratom use to overdose deaths, pointing out that many people had other drugs in the system that were likely more to blame for their passing, such as stimulants and other opioids. And given that people would be using kratom to treat their pre-existing addiction in the first place, it’s not necessarily damning that kratom would be found in some who had died of a drug overdose.
That isn’t to say that kratom use can’t come with serious risks, Grundmann noted. One issue, common to many dietary supplements, is that the amount of kratom found in a product can vary widely. That’s enough of a problem when only the kratom leaf is used, but it’s especially risky when pure kratom extract is used instead, as that can expose someone to a much higher dose than they’d ever get from dried kratom alone. Mixing kratom, which can have a stimulant effect similar to caffeine in lower doses, with other drugs can also raise the chances of trouble.
In response to these concerns, some in the kratom community have tried to self-police themselves. The American Kratom Association, in particular, has established its own certification process for vendors, complete with a set of good manufacturing practices. None of the vendors in the program appear to have been issued a warning letter from the FDA for their kratom products. And in contrast to these companies, the vendors seem to refrain from advertising any explicit health claims to using their products. Some researchers are also trying to scrounge up the resources to conduct the sort of larger clinical trials needed to test kratom’s health benefits, according to Grundmann.
It’s tough to say whether these gestures will do much to dissuade the FDA from its hardline stance on kratom, though. According to the American Kratom Association, the FDA has so far refused to acknowledge their request for a meeting.
The Drug Enforcement Agency, for its part, has still not issued its final verdict on whether kratom should be classified as a Schedule 1 controlled substance, as illegal drugs like heroin and LSD are, despite a recommendation to do so from the Department of Health and Human Services, the agency that oversees the FDA.