(CN) — The Food and Drug Administration's refusal to provide documents on kratom’s dangers for a smuggling case led the prosecutor to say in a hearing Friday that she doesn’t want the agency on her team.
Meanwhile, a pro-kratom advocacy group claims the FDA was “forced to admit in federal court that it cannot prove that kratom is dangerous.”
The move comes in the case of Sebastian Guthery, a major kratom importer who pleaded guilty and agreed to a deal in July, in which prosecutors would seek a 366-day prison sentence for his willfully mislabeling the product to sneak it through customs. He was originally scheduled for sentencing in early October in federal court in San Diego.
A hearing is scheduled today to determine whether the FDA is part of the prosecutor’s “team.”
If the judge decides the FDA is part of the prosecution, the agency's refusal to help will mean that the prosecutor can’t allude to kratom’s adverse effects in its sentencing memo. If the judge rules the other way, the prosecution will have to rely on outside experts to attest to kratom’s danger.
Assistant U.S. Attorney Melanie K. Pierson declined to discuss the FDA’s move but suggested it won't affect the Guthery case much: “He’s pled guilty,” she said in a phone conversation. “The question is what we can argue for purposes of sentencing.”
But the question of kratom’s potential harm has hung over the case from the beginning. Pierson repeatedly referred in court filings to the overdose death of Guthery’s girlfriend, for instance, emphasizing that she died with kratom that Guthery had provided in her system.
The complications in the Guthery case come amid the American Kratom Association’s renewed push for a federal law that would fully legalize the product, a leaf from an Indonesian tree with psychoactive properties that more than a million Americans use for pain relief, as a stimulant or to help with opiate withdrawal symptoms.
Kratom is nominally illegal to import to the United States for human consumption, but it is legal to sell and consume in 45 states. The FDA tried to outlaw it in 2016 but was thwarted by kratom advocates originally backed by Guthery, and has left the herb in legal limbo.
The kratom group pounced on the obscure legal filing in the Guthery case last week, publishing a “special alert on the FDA disinformation campaign": “In a stunning disclosure in the United States District Court for the Southern District of California where a federal judge ordered the FDA to testify under oath to justify their claims that kratom is dangerous, the Department of Justice has reported to the judge that the FDA has refused to obey the order because ‘they ["FDA"] have not made a determination regarding whether kratom is dangerous.’”
A spokeswoman for the FDA declined to discuss its decision to withhold potential evidence in the Guthery case, writing in an email that the “FDA does not comment on possible, pending or ongoing litigation.”
Mac Haddow, the lobbyist for the American Kratom Association, the industry and consumer-backed nonprofit that is pushing versions of its own regulation in state legislatures and in Congress, did not respond to an email seeking comment for this story.
Evidence is growing that kratom is addictive and can be dangerous at high doses, with dozens of wrongful death lawsuits filed against distributors across the country. The Tampa Bay Times is rolling out a multi-part investigation into kratom, prompted in part by that state’s medical examiners’ findings that more than 500 Floridians have died in the past decade from overdoses with kratom in their bloodstream, with 46 of those deaths involving no other dangerous substances.
Courthouse News reported about widespread kratom-only overdose deaths — and the industry’s efforts to cover them up — in a series of stories published nearly two years ago, a year after a kratom overdose took the life of this reporter’s 21-year-old nephew.
The kratom group attacked the Times’ investigation in an email blast to supporters last week titled “The American Kratom Association Calls Out the FDA for Gaslighting the Tampa Bay Times Investigative Team,” decrying the story’s “sensationalized claims” and claiming the reporters “have been taken in by the FDA’s attacks on kratom.”
The Times says the FDA declined to make any officials available for an interview, mirroring the agency’s behavior two years ago during CNS’s investigation.
“I don’t personally understand where FDA is at at this point,” says Drew Turner, a longtime kratom advocate and user who acknowledges its potential dangers. “It’s like they’ve just gotten upset and taken their ball and gone home.”
The FDA’s refusal to help in the Guthery case has disappointed anti-kratom advocates. “There’s no reason they can’t produce documents showing why kratom is dangerous,” said Wendy Chamberlain, a Oneida, New York, retiree who founded a group called Kratom Danger Awareness after her son, Joseph Lumbrazo, died of a kratom overdose in 2020. “I mean, why not? Deaths are piling up. Are they up to something?”
Talis Abolins, an attorney with the Washington firm MCTLaw who has filed multiple suits against kratom vendors and won multimillion-dollar settlements, says the same in an email: “It suggests some back-door lobbying, or the FDA is trying to hide something and does not want to get dragged into the fight for that reason. This is disturbing — especially when the AKA is active in Congress as we speak.”
Chamberlain spent most of Wednesday at the Russell Senate Office Building in Washington, trying to counter the kratom advocacy group's congressional briefing and reception. She said when the briefing was over, Haddow looked at her and then shut the meeting down.
“At the end Mac got up and said there was no time for questions,” Chamberlain said. “I had one question. One question I wanted to ask: My question was, I would like to see the safety profile for safe kratom consumption. I’ve been asking for that and I haven’t got it.”
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