The U.S. Department of Health and Human Services (HHS) has revised its earlier plan to ban mitragynine pseudoindoxyl (MGPI), a semi-synthetic opioid compound found in some kratom products, allowing its presence at certain levels in the market. The decision, announced in October, followed months of scrutiny over MGPI’s role in numerous overdose deaths and growing concerns about the safety of concentrated kratom derivatives.
MGPI, identified only since 2024, has been linked to at least 56 overdose cases between February 2023 and May 2024, with 48 fatalities, according to Drug Enforcement Administration (DEA) data. Laboratory tests have shown MGPI to be significantly more potent than morphine, raising alarms among public health experts. Nevertheless, HHS officials justified the new limits by citing scientific evidence that trace amounts occur naturally in some kratom products, which are marketed as botanical or “natural.”
The announcement allows quantities of MGPI ranging from 25 to 500 times higher than levels previously detected in kratom products on the market. Some scientists have criticized this threshold as excessively permissive. Amar Chittiboyina, a chemist whose study was cited by HHS, noted that the agency’s allowable levels far exceed those found in most tested products, describing the policy as too lenient. Similarly, public health advocates argue that the presence of such a potent opioid in consumer products deserves stricter regulation.
The policy shift emerged amid extensive lobbying efforts by kratom industry representatives, including David Gabbay and his wife Maya, who have been significant political donors. By mid-October, their contributions to Republican candidates and committees totaled nearly $2.9 million. Advocacy groups funded by the Gabbays, such as the American Kratom Association, have argued for allowing limited MGPI levels in natural kratom, emphasizing the compound’s minimal concentrations in botanical products.
HHS spokeswoman Emily Hilliard denied that political contributions or litigation influenced the department’s decision, asserting that the recommendation was strictly science-based. The White House also maintained that efforts were aimed at removing highly potent synthetic and concentrated kratom products, not natural variants, with spokeswoman Allison Schuster describing the process as “rigorous scientific review.”
Critics, including medical experts like Dr. Andrew Kolodny of Brandeis University, have accused the administration of succumbing to industry pressure. Kolodny contended that the policy appears driven more by lobbying than by scientific evidence. Legal actions against kratom companies have intensified following findings that MGPI was present in products linked to wrongful death lawsuits. Families of individuals who died after using kratom products containing MGPI have challenged the new limits in court, arguing that the thresholds compromise their cases and enable companies to market unsafe, opioid-containing items as natural and lawful.
The existence of MGPI in products branded as natural kratom has raised further concerns about adulteration and consumer safety. Expert testimony in ongoing litigation describes MGPI as an additive rather than a naturally occurring ingredient in many commercial kratom formulations. Some company representatives have disputed the toxicological findings and the connection to deaths, attributing fatalities to other causes while calling for verification of lab results.
The regulatory developments around MGPI and kratom come amid a patchwork of state-level debates on banning or restricting powdered kratom and synthetic derivatives. While federal authorities emphasize targeting highly potent synthetic compounds, the broader question of kratom’s safety and classification remains contested among scientists, policymakers, industry stakeholders, and affected families.