“Given that numerous stakeholders, former opioid addicts, and scientific researchers vouch for kratom’s safety and support its use, and responsible manufacturers of kratom products ensure that their products are properly labeled for adult-only consumption, we respectfully request that the FDA reconsider its stance and take a closer look at the facts and recent science regarding this plant,” the members wrote in the letter. After the letter was received by the FDA, the DEA decided to hold off on its scheduling.
But controversy surrounding the botanical product continues. Earlier this year, the FDA ordered the recall and destruction of kratom-containing dietary supplements made by a company in Grain Valley, Mo., the agency said in a statement. The FDA also is investigating a possible association between kratom intake and an outbreak of salmonella in North Dakota and Utah, in which 17 of 24 patients reported taking products thought to contain kratom before becoming sick, the agency wrote. Meanwhile, in late March, the FDA reported that it was investigating a multistate outbreak of salmonella infections tied to products that were reported to contain kratom. For example, the agency said, it is "reporting four additional products tested by Oregon Health Authority identified as positive for salmonella in four additional product samples collected from the retailer Torched Illusions." As of March 15, the FDA said, the Centers for Disease Control and Prevention reported that 87 people had been infected with outbreak strains of salmonella reported from 35 states.*
Dr. Gottlieb had issued a statement a few weeks earlier, in February, saying that the agency was able to confirm that kratom contains opioids. “The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” Dr. Gottlieb wrote. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use, and take aggressive enforcement action against kratom-containing products.”
For physicians like Dr. Levounis, who treat kratom users in emergency departments, patients should heed those warnings. “People erroneously feel that herbal products are milder than other products,” he said. “Nature can manufacture incredibly strong stuff – for good and for bad.”
*This story was updated 3/23/2018.