Three months ago, federal health officials announced that the government planned to ban a potent opioid that Health Secretary Robert F. Kennedy Jr. said “put American lives at risk.”
The substance was a highly addictive compound derived from the kratom leaf, a plant from Southeast Asia that is in powders and tinctures sold as energy boosters and pain relievers in convenience stores and vape shops across the United States. The ban was crucial, the officials said, “to avoid an imminent hazard to public safety.”
This month, the government reversed course.
Mr. Kennedy announced Oct. 9 that his department had “followed the science” and decided to allow some levels of the compound.
The policy U-turn came after a number of kratom companies discovered the substance in products marketed as “natural” in recent months. The manager of a large kratom distribution company, faced with evidence of the compound in products at the center of several wrongful death lawsuits against him, mounted a concerted lobbying push.
The executive, David Gabbay, and his wife, Maya, had been giving steadily to Republican candidates and campaign committees this year, reaching about $2.9 million on Oct. 12. Mac Haddow, the leader of an advocacy group funded heavily by the company Mr. Gabbay manages, said he went to the White House to plead his case.
Then Mr. Kennedy and officials from the Drug Enforcement Administration announced that the opioid, called mitragynine pseudoindoxyl, or MGPI, would be allowed at certain levels, reasoning that “trace” amounts appear in otherwise natural products.
The new policy still bans the most concentrated and dangerous levels, but the allowable amounts are hardly traces: They are 25 to 500 times the levels currently found on the market, the senior author of a study cited by the Trump administration said in an interview.
Emily Hilliard, a spokeswoman for Mr. Kennedy and the Department of Health and Human Services, said the decision was based on science. “Neither litigation nor political contributions influenced H.H.S.’ recommendation,” she said.
The Federal Register notice on the latest proposal acknowledged that “neither H.H.S. nor D.E.A. has made a finding that these substances are safe to use” at the levels the new policy allows.
Although the MGPI has only been recognized since 2024, data from the Drug Enforcement Administration showed that it had been identified in at least 56 overdose cases, 48 of which were fatal, from February last year to this May.
“They’re not doing this because the science supports it,” said Dr. Andrew Kolodny, the medical director for the Opioid Policy Research Collaborative at Brandeis University, who reviewed the H.H.S. justification for eschewing the ban. “They’re doing this because the industry and the lobbyists are basically writing the policy.”
MGPI is a semi-synthetic opioid that has been found in lab tests to be far more powerful than morphine. Scientists are still exploring how it emerges in otherwise natural products. The Trump administration says it is targeting items that are manufactured and formulated to be highly potent.
They include items like the pills discovered near two University of Mississippi students found dead in September. Court records said that agents seized “Smax Pseudo DHM” pill packets that listed MGPI as an ingredient. The authorities are continuing to investigate the products and the deaths, which may have involved other substances as well.
The federal policy activity around kratom comes as many states are debating bans of the powdered products and the more potent derivatives. Surrogates for the kratom industry, including a scientist who worked on behalf of the prescription opioid maker Purdue Pharma, have downplayed the risks, contradicting the Food and Drug Administration and reports of thousands of deaths of people with kratom in their systems over recent years.
While medical regulatory decisions have traditionally been led by career federal scientists, the White House in the second Trump administration has been hands-on in a number of health-related areas, including tobacco policy and nursing home staffing when campaign contributions were at play.
In this case, the White House has said it was acting to target the fully synthetic and highly potent products, which began to dominate the kratom market in recent years.
“The administration is taking decisive action to get dangerous synthetic and concentrated products off the shelf to protect Americans,” a White House spokeswoman, Allison Schuster, said in a statement responding to detailed questions. “These actions were subject to rigorous scientific review and any assertion that they may be based in anything other than scientific evidence is completely false.”
Mr. and Ms. Gabbay did not respond to requests for comment.
Gwendolyn Payton, a lawyer for the company he manages, said the Gabbays donate to political candidates because they are advocates for kratom safety and for combating antisemitism. She said that MGPI appeared in natural products in “very, very minor amounts.”
Mac Haddow, the spokesman for the American Kratom Association, which is funded by companies related to Mr. Gabbay and others, said he was “very satisfied” with the new proposed order, which is expected to be finalized in the coming weeks. He dismissed the idea of Mr. Gabbay’s campaign contributions as a major factor, saying others in the industry donated and met with government officials.
“Everybody has to play on the same playing field,” he said, “and that’s all that’s happened here.”
The kratom industry has focused intensely on the second Trump administration from the start. A recent New York Times investigation described how one executive, Jerry W. Ross, whose company makes a popular natural kratom drink called Feel Free, encouraged allies in the administration to target synthetic kratom products that had taken market share. (Mr. Ross declined to comment at the time. The White House said it was not swayed by his advocacy.)
In the summer of 2025, Mr. Kennedy and others announced a plan to crack down on the kratom compound called 7-hydroxymitragynine, or 7-OH, which they described as an addictive opioid. The plan banned highly concentrated 7-OH items, but allowed it to remain in natural kratom at low levels.
For Mr. Gabbay, who is associated with a network of companies selling O.P.M.S., a brand also marketed as natural kratom, the formal move to ban 7-OH this summer was a short-lived victory. The D.E.A. said on July 1 that it planned to ban MGPI and two other compounds.
“The misuse of these semi-synthetic opioids poses a high risk for overdose and life-threatening events,” the agency said in a regulatory filing at the time.
Around two weeks later, the company Mr. Gabbay manages was confronted in court with findings that its products contained MGPI.
In mid-July, Talis Abolins, a Washington lawyer representing families of who had brought wrongful death lawsuits against Mr. Gabbay and others, learned that MGPI had appeared in lab tests of products used by loved ones who had died in Tennessee, Washington and Texas.
It was found in a powder product called Maeng Da found near Dustin Hernandez, a 29-year-old who died after a violent seizure while sipping the powder in tea when he was working a night shift at a Motel 6 near Dallas in 2021.
In a deposition, Mr. Abolins revealed to Marilyn Huestis, an expert witness for Mr. Gabbay’s company and others, that a University of California, San Francisco, lab had found that MGPI was in Mr. Hernandez’s powder.
Dr. Huestis, a retired National Institutes of Health toxicologist, said she had not been aware. She went on to testify that the lab results, if correct, suggested that it was an “adulterated” product, that MGPI tended to be a synthetic product added to natural kratom and that the toxic dose in humans was not known.
“It should not be in there,” Dr. Huestis testified. “I totally agree.”
Reached by email, Dr. Huestis said that trace amounts of MGPI can be found in botanical kratom, so an allowable threshold for natural products should be set.
Ms. Payton, the lawyer for Mr. Gabbay’s company, claimed in court records that Mr. Hernandez’s death was due to withdrawal from a benzodiazepine medication. She also said the lab results showing MGPI should be excluded from his case unless her team’s experts can test the same powder.
Mr. Abolins took a closer look at his wrongful death cases and found lab reports showing MGPI in other O.P.M.S. extracts from companies tied to Mr. Gabbay’s distribution business, including one that had prompted an F.D.A. warning after a death and many reports of harm.
That product, O.P.M.S. Black Liquid, was used by Josiah Berg, a guitar enthusiast from Vancouver, Wash., who died in 2023 at age 20 after using kratom for an energy boost after sleepless nights due to insomnia. Amandus Harrison, 46, a mother of six in Tennessee, used the same drink before a kratom overdose in 2024, court records say.
The breakthrough for the plaintiff lawyers became a problem for Mr. Gabbay and a lobbying group that represents his business interests in Washington, the American Kratom Association. Expert witnesses who earned $850 per hour working for Mr. Gabbay’s legal team sent letters urging policymakers to allow some MGPI in otherwise botanical kratom.
Letters were also sent by Dr. Rahul Gupta, the head of the White House drug policy office under President Joseph R. Biden Jr., and Jack Henningfield, who previously worked for Purdue Pharma.
Dr. Gupta, who suggested the level of MGPI that health officials adopted, said in an email that he sent the letter “in my own capacity” and was not paid to do so by “any litigant, the American Kratom Association or any other industry organization.” Dr. Henningfield did not respond to a request for comment.
The federal position on MGPI began to shift on Aug. 25, the day David and Maya Gabbay donated nearly $160,000 to the Republican National Committee, bringing their total for the year to $2.2 million.
That same day5, a Department of Justice news release announced the emergency temporary scheduling of MGPI and the two other compounds — placing them in the same federal category as heroin. But the Justice Department said it would not press charges if “incidental trace amounts” of MGPI were found.
The next day, the American Kratom Association sued the D.E.A., calling on it to allow some level of MGPI in what it described as otherwise natural kratom products, including O.P.M.S. products. In the days that followed, two other companies, New Hope Botanicals and Martian Sales, which license O.P.M.S. products, filed similar lawsuits in California and Wyoming, also acknowledging that MGPI was in their products.
In September, Mr. Haddow, of the American Kratom Association, went on a podcast and outlined the inroads he had made with the White House.
“So we filed the lawsuit, and the White House has gotten involved, and the D.E.A., they came to us and said, ‘Look, we think we can resolve this problem,’” he said. He also recalled outlining his concern that felony charges could be brought against people possessing or manufacturing kratom that includes trace amounts of MGPI.
“They’re working on that,” Mr. Haddow said, adding: “What they’ve assured us is that we’ll be happy with the outcome.”
The Drug Enforcement Administration and the Justice Department referred questions to the health department, which they said made the scientific recommendation on the new policy. That 10-page memo from Mr. Kennedy’s department to the D.E.A. cited a study on MGPI by Amar Chittiboyina, a natural products chemist at the University of Mississippi.
Dr. Chittiboyina said in an interview that his team measured MGPI in currently marketed kratom products and found it in tiny amounts of about two parts per million in tests of eight liquid products.
He said that the new threshold announced by H.H.S. was as much as 500 times as high for those products and “too permissive.” He noted that his recent study reported that MGPI had been identified, but did not list the amounts.
Dean Francis, president of the nonprofit End Kratom Addiction, said the revelation that powerful compounds were in natural kratom should force a reckoning akin to when cocaine was removed from Coca-Cola in 1929.
“It’s just hard to believe that in America we would knowingly permit what we know to be a highly potent opioid to exist in any product,” he said.
Earlier this month, lawyers for the families of the people who died after consuming kratom containing MGPI filed a motion in court claiming that the new thresholds harm their cases and allow kratom companies to say that their products are lawful, natural and “outside the scope of federal authority.”
They include David Berg, whose son Josiah died after consuming an extract that was found to contain MGPI. He recounted a wilderness trip to Washington’s Olympic Peninsula that the two of them took in the weeks before his son’s death.
Mr. Berg said that he knew other parents of young adults who died of kratom products marketed as “natural” and that he viewed all of them as dangerous. “There’s no safe level,” he said.
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