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. 

(Update: The DEA now intends to implement the ban on November 13.)

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.”

Senate Report Finds Opioid Makers Paid Millions to Non-Profits

By Pat Anson, PNN Editor

The U.S. Senate Finance Committee has released a new report accusing patient advocacy groups and professional pain societies of being front organizations for opioid manufacturers.

The 39-page report by Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) identifies $65 million in payments made by drug companies to 10 non-profit organizations since 1997. The report alleges that the groups “echoed and amplified the business interests of their pharmaceutical donors” by promoting the use of opioid medication.

Teva Pharmaceuticals, Pfizer and Purdue Pharma were the biggest donors to tax-exempt groups. The largest beneficiaries were the American Chronic Pain Association, International Association for the Study of Pain, American Academy of Pain Medicine, American Pain Society and the U.S. Pain Foundation.  

“Tax-exempt advocacy organizations like the ones we looked at are created with good intentions. They can be forces for good, advocating and highlighting issues that might not otherwise receive the warranted attention,” Sen. Grassley said in a statement. “But we’ve found that the possibility of donor influence could and has undermined the efforts to develop and advocate good policy.”

“Our bipartisan investigation shows how pharmaceutical companies use tax-exempt groups to help seed the market for their products by shaping the views of patients, doctors and policymakers,” Sen. Wyden said. “The potential dangers presented by opioids makes this Trojan horse-style of marketing particularly troubling, but make no mistake that such practices are widespread across the pharmaceutical industry, and consumers are often left in the dark.” 

Ironically, several organizations cited in the Senate report have either ceased operations or scaled back their advocacy efforts after significant cuts in funding from the pharmaceutical industry. The American Pain Society, for example, filed for bankruptcy in 2019 due to declining donations and the cost of defending itself in opioid litigation cases.

“Advocacy groups and professional organizations are reasonable forums to help provide science-based information to people in pain about how to minimize harm from opioids or any other treatment. Without industry support, many of the organizations would not exist,” said Lynn Webster, MD, a past president of the American Academy of Pain Medicine.

“We saw this with the bankruptcy of the American Pain Society, a preeminent scientific organization trying to advance the science to help people in pain. The government doesn't provide this support so, thankfully, industry has stepped in to partially fill the void.” 

‘Nothing New Here’

Webster and other critics said there was little new information in the report from the Senate Finance Committee, which has been looking into donations from the pharmaceutical industry since 2012. 

“It's puzzling why the senators would choose to finally put out a report on material they gathered eight years ago. Pretty much everything in this report has been reported repeatedly over those eight years. There really is nothing new here, and it's sad that the senators haven't put their efforts into more productive endeavors, such as promoting greater access to safe and effective pain care for the 50 million Americans with chronic pain,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management, which also shutdown in 2019. 

“Instead, they seem to be intent on rehashing stale information that pretty much everyone has accepted and from which they have moved on. They need to move on, as well, and use their positions with the Finance Committee to help improve pain care coverage, especially in Medicare and Medicaid, which is part of their committee's oversight area.” 

To improve the transparency of industry donations, Grassley and Wyden are recommending that the Centers for Medicare and Medicaid Services (CMS) expand its Open Payments database to require drug and medical device manufacturers to report payments made to tax-exempt organizations. They also called on the Secretary of Health and Human Services (HHS) to develop guidelines requiring members of federally funded task forces and research groups to disclose their funding ties.  

“Industry has long been supporting advocacy groups and professional organizations. This is not unique to pain organizations or advocacy groups. Almost every area of healthcare has industry support,” said Webster, who was one of the first doctors investigated by the Senate Finance Committee.

Webster says the report overlooks the fact that the opioid crisis is largely being fueled by illicit fentanyl and other street drugs, not pain medication. And that efforts to limit opioid prescribing have been harmful to many patients.

“The real crisis is with illicit drugs. Focusing exclusively on prescription opioids as the source of the problem is like sending all the fire trucks to one burning house when the whole city is burning down.”

— Dr. Lynn Webster

“Senators Grassley and Wyden seem not to acknowledge there are people in pain who, for a variety of reasons, don't have any treatment option other than opioids. In fact, the senators simply don't acknowledge the millions of Americans in pain. This is negligence or worse,” Webster said.

“Prescription opioids can be abused and have led to problems, but the real crisis is with illicit drugs. Focusing exclusively on prescription opioids as the source of the problem is like sending all the fire trucks to one burning house when the whole city is burning down.”

Campaign Donations

There is a certain amount of hypocrisy in congressional complaints about industry funding. A database maintained by OpenSecrets shows that Grassley and Wyden have long benefited from campaign contributions from donors affiliated with the healthcare industry. From 2015 to 2020, Wyden accepted about $2.75 million from health professionals, pharmaceutical companies, hospitals, nursing homes, and insurers. Grassley accepted about $1.1 million from the same groups over that period. 

Law firms involved in opioid litigation, which stand to make billions of dollars in contingency fees from opioid lawsuits filed by states, cities and counties, have also been prolific donors to Congress.  

For example, the law firm of Simmons Hanly Conroy donated nearly $500,000 to Sen. Claire McCaskill (D-MO) during her campaign for re-election in 2018. McCaskill lost the election, but not before releasing her own report critical of pharmaceutical donations to non-profit groups. The American Academy of Pain Medicine and the American Pain Society, two of the organizations cited by McCaskill, were both being sued by Simmons Hanly Conroy.