- Kratom is an opioid-like supplement derived from a plant native to Southeast Asia. It can be consumed in pills, powder, or tea.
- On Tuesday, the Food and Drug Administration sent warning letters to three kratom sellers accused of health fraud scams. It’s the first time the agency has cracked down directly on makers of the supplement.
- The crackdown comes on the heels of repeated warnings from the Centers for Disease Control about a salmonella outbreak linked to kratom that sickened more than 130 people.
The Food and Drug Administration is cracking down on several companies that make and distribute kratom, a supplement with psychoactive and pain-relieving qualities that’s been linked to a recent salmonella outbreak.
In a letter released on Tuesday, FDA commissioner Scott Gottlieb called on three companies in different states to stop selling unapproved kratom products with unproven health claims. In a statement, Gottlieb said the companies were engaged in “health fraud scams” that “pose serious health risks.”
Derived from a plant native to Southeast Asia, kratom is often sold as pills, powder, or tea in the US. Advocates say it helps curb the symptoms of opioid withdrawal, which has led people to flock to kratom in recent years as a means of stepping down from more powerful drugs like Vicodin.
But because kratom is classified as a supplement and has not been developed as a drug, it’s not subject to much federal regulation. That means tainted kratom pills and powders can easily make their way to store shelves — which appears to have occurred in a recent outbreak of salmonella that has so far sickened more than 130 people across multiple states.
Outlandish claims and little scientific research
The FDA’s recent crackdown appears to be the latest step in a growing divide between advocates and regulatory agencies regarding the use of kratom. The companies the agency has named are Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri.
The claims these three companies have made include marketing the supplement as “very effective against cancer” and suggesting that their products could help reduce the symptoms of opioid addiction.
But there are few existing scientific studies to back up those claims. Research on kratom has found, however, that the drug taps into some of the same brain receptors as opioids do. That spurred the FDA to classify it as an opioid in February.
Experts say that because of this, it makes sense that people with opioid use disorder are turning to kratom as a means of abating their symptoms and stepping down from more powerful drugs like Vicodin.
But taking any supplement that hasn’t been tested for safety by medical professionals can be dangerous.
The risks of taking kratom
Previous FDA testing found that several products distributed by Revibe — one of the three companies named in the FDA letter — were tainted with salmonella. Last month, as part of a request from the agency, Revibe destroyed several tainted products still at its facility, but the company has yet to confirm that it recalled products that had already shipped to stores.
Last month, the FDA issued its first-ever mandatory recall of kratom products after those produced by Las Vegas-based Triangle Pharmanaturals were found to be contaminated with salmonella.
As of April 5, a total of 132 people across 38 states had been sickened with the bacteria, which can cause diarrhea and abdominal pain lasting up to a week.
Besides dealing with the risk that kratom products could carry harmful bacteria, those who take the supplement have no reliable way to determine the proper dose. It’s also difficult to find a verify kratom supplement’s full ingredient list or account for potentially harmful interactions with other drugs or medications.
Kratom is currently banned in Australia, Malaysia, Myanmar, Thailand, and several US states (Alabama, Arkansas, Indiana, Tennessee, and Wisconsin). Across the US, several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of “drugs and chemicals of concern.” In 2016, the DEA proposed a ban on kratom but backtracked under pressure from some members of Congress and an outcry from kratom advocates.