Three U.S. Senators Call for FDA Regulation of Leaf Kratom
/By Pat Anson
Three U.S. Senators are calling on the FDA and DEA to regulate the “entire kratom plant” under the Controlled Substances Act, a step that far exceeds current plans by the DEA to classify concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) as illegal Schedule One controlled substances.
Sen. Chuck Grassley (R-Iowa), chair of the powerful Senate Judiciary Committee, initially said in a post last week on Twitter/X that “All Kratom is deadly” and that it “is killing our kids BEWARE of special interest snake oil.”
The 93-year old Grassley was joined this week by two other U.S. senators, Sen. Mike Lee (R-Utah) and Sen. Susan Collins (R-Maine) in a joint letter to the DEA administrator and acting FDA commissioner calling for the immediate scheduling of 7-OH and to “consider scheduling the entire kratom plant.”
“We urge the Food and Drug Administration to conduct the necessary scientific and medical evaluations of these substances and provide a permanent scheduling recommendation to the Drug Enforcement Administration for the full kratom plant, its derivatives, and all levels of the semi-synthetic analogues like mitragynine pseudoindoxyl, MGM-15, and MGM-16 that are being marketed as natural products.”
The DEA, in fact, has already scheduled mitragynine pseudoindoxyl, MGM-15 and MGM-16 – synthetic forms of kratom alkaloids – as Schedule One controlled substances.
The agency announced plans to schedule 7-OH in July, but has delayed implementing the order at the request of the Department of Health and Human Services (HHS), to allow more time for public comment on the appropriate threshold level of 7-OH that would still be legally allowed.
Nearly 36,000 public comments were made in the Federal Register, most of them opposed to the DEA’s plan to set a limit of 1 mg per 7-OH tablet, gummy or shot, saying there is no evidence to support it.
Confusion Over Letter
“I think there is a tremendous amount of confusion about the letter,” said Mac Haddow, a spokesman and lobbyist for the American Kratom Association (AKA), an advocacy group for leaf kratom vendors. “I know for a fact that Senator Lee does not agree with the request that all natural kratom be scheduled.”
In talking with Judiciary Committee staff about the letter, Haddow said there were “misunderstandings” about the differences between 7-OH and leaf kratom, and confusion about how the substances might be regulated under the Controlled Substances Act (CSA).
Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a stimulant and pain reliever. 7-OH occurs naturally in kratom in trace amounts, but manufacturers have recently found ways to concentrate the alkaloid in 7-OH products, turning a mild pain reliever into a more potent one that has opioid-like effects.
The AKA maintains that 7-OH and other concentrated alkaloids are synthetic opioids created in a lab that have no relation to leaf kratom. The AKA supports the scheduling of 7-OH, but wants leaf kratom left alone.
“I know where Mike Lee is on this, and my understanding is he didn't agree with the premise of that letter at all, and maybe because he's out of town, didn't read it carefully,” Haddow told PNN. “But that’s neither here nor there, the letter's written. I hope they rescind it and they give a more detailed analysis of what they really want.”
Haddow said the Judiciary Committee staff, which likely wrote the letter, thinks leaf kratom should be classified under the CSA as a Schedule Two or Three substance that could be used for medical purposes. But that requires the approval of the FDA, which has long maintained that kratom is not approved for any medical condition.
“You can schedule FDA-approved drugs in any of those schedules,” explained Haddow. “But you can't take one that doesn't have a drug approval and schedule it anywhere but Schedule One. And they didn't even know that, so that was surprising to me. You'd think the Judiciary staff would understand the Controlled Substance Act better than that, but maybe I misunderstood them. But I don't think I did.”
If what Haddow says is accurate, it’s a surprising level of ignorance, as the Senate Judiciary Committee oversees the U.S. Justice Department, DEA, FBI and Department of Homeland Security. The DEA is the primary agency responsible for enforcing the CSA.
It’s not the first time Haddow has encountered confusion at the federal level about kratom and its derivatives. In August, he told PNN there was “enormous confusion among some members of Congress and even staff at the DEA” about the differences between leaf kratom, 7-OH, and other kratom alkaloids.
He fears that confusion could lead to all kratom related products being scheduled or banned – including leaf kratom – which is exactly what the Grassley, Lee and Collins letter is proposing.
The American Medical Association (AMA) also supports the regulation of leaf kratom and kratom derivatives. In June, the AMA’s House of Delegates passed a resolution calling for a complete ban on 7-OH and recommended that kratom be scheduled under the CSA after the FDA evaluates its safety and efficacy through clinical trials — a process that could take several years.
Until that happens, the AMA says kratom should not be “marketed or prescribed as treatment for any condition.”
