New peer-reviewed paper draws the same line federal regulators have: regulate natural kratom leaf, treat concentrated synthetic 7-OH as a drug
Washington, DC, October 29, 2026
Federal regulators have already separated natural kratom leaf from concentrated synthetic 7-OH and other novel concentrated synthetic alkaloid products including MGM-15, MGM-16, and Mitragynine Pseudoindoxyl (MGPI). WATCH: What federal officials and leading researchers say: expertsonnaturalkratomleaf.co
In July 2025, the FDA recommended scheduling concentrated synthetic 7-OH without restricting natural kratom leaf. DEA’s temporary scheduling of three synthetic 7-OH derivatives took effect August 26, 2026, and a separate DEA proposal covering concentrated synthetic 7-OH is slated to go into effect on November 13, 2026.
Federal regulators have explicitly stated that this scheduling does not apply to natural kratom leaf. HHS Secretary Robert F. Kennedy Jr. stated in an October 9, 2026 press release that “We are drawing a clear line between natural kratom and dangerous, enhanced opioid products.” He further re-iterated that “We listened to the public, followed the science, and developed a clear recommended threshold for temporary scheduling that targets concentrated 7-OH and MGPI without sweeping natural botanical kratom into Schedule I. The Trump Administration will continue taking decisive action against dangerous products that fuel addiction while making sure our policies are grounded in rigorous science.”
Now seven of the field’s leading researchers have drawn the same line in a peer-reviewed paper, concluding that the available evidence does not support banning or scheduling natural kratom leaf, the Global Kratom Coalition (GKC) said today.
The new paper published in Frontiers in Pharmacology lays out the differences between natural kratom leaf, traditional preparations, concentrated extracts, isolates, and novel drug substances. Researchers from the United States, Canada, and Malaysia published the paper on October 22.
The last category includes chemically altered and synthetic alkaloids such as concentrated synthetic 7-OH and isolated concentrated mitragynine pseudoindoxyl (MGPI). The authors say these novel products are not kratom and should be treated as novel, unapproved drugs.
The authors find that 7-OH is not a meaningful part of natural kratom leaf. It appears only at trace levels, 0.003% to 0.04% by weight, as an oxidative byproduct in some post-harvest material.
Semi-synthetic 7-OH products entered the market in late 2023 at levels far beyond anything found in nature. The authors also cite preclinical research showing that isolated concentrated 7-OH caused respiratory depression comparable to morphine, while natural kratom leaf did not.
On the question of bans that capture natural kratom leaf, the authors write that preclinical, survey, clinical, and historical-use evidence is insufficient to justify banning or scheduling natural kratom leaf products. They note that no new data warranting such action has emerged in the decade since the first federal scheduling attempt.
Public-health data points in the same direction. CDC data show kratom-related poison-center reports plateaued from 2020 through 2024, then more than doubled in 2025 as concentrated synthetic 7-OH products spread. CDC links that surge to high-potency semisynthetic products, including 7-OH, the same products federal regulators have moved against. Poison-center reports and case studies often fail to identify the specific product involved, which blurs natural kratom together with adulterated and synthetic products. The deaths of two University of Mississippi students in September show how this happens: early coverage blamed “kratom,” but a search warrant affidavit shows the students bought “Smax” tablets, and preliminary testing found the products were scheduled MGM-15 and MGPI products, and also included concentrated synthetic 7OH.
For natural kratom leaf products, the authors recommend regulation rather than prohibition. Their recommendations include federal manufacturing and testing standards, labels that disclose mitragynine, and 7-OH content, serving instructions, and sales limited to adults 21 and older. They also call for science-based warnings on the risks associated with these products.
The authors recommend limits on the amount of mitragynine per serving and per day for natural kratom leaf products.
The authors are clear that without explicit, enforced regulations, risk will remain. They argue that poor manufacturing, false marketing, and a lack of serving guidance can escalate risk—and that regulation can address those problems where bans do not. Blanket bans that capture natural kratom leaf also risk pushing consumers toward an unwieldy black market.
“For years, the people who study kratom most closely have said what federal regulators are now acknowledging: natural kratom leaf is not the same as concentrated synthetic 7-OH and other novel synthetics, and they shouldn’t be treated the same way,” said Matthew Lowe, Executive Director of the Global Kratom Coalition. “This paper gives lawmakers a ready-made, science-based roadmap: regulate real kratom responsibly and treat lab-made synthetics as the dangerous drugs they are. Blanket bans get both of those wrong.”
Meanwhile, states and counties are considering how to regulate natural kratom leaf, which an estimated 23 million Americans consume. Twenty three states have chosen to regulate natural kratom leaf and ban concentrated synthetic derivatives – that is the right approach and aligned with both federal action and science.
The federal government and leading scientists have laid out a clear road map: regulate natural kratom leaf products in a way that allows adults access to safe consumer products, and ban the dangerous synthetic opioid products that masquerade as natural kratom. A new video at expertsonnaturalkratomleaf.co shows just how closely federal officials and these researchers are aligned on the differences between natural kratom leaf and concentrated synthetic 7-OH and other other synthetic alkaloid products.
About the Global Kratom Coalition
The Global Kratom Coalition is an alliance of natural kratom consumers, experts, and industry leaders dedicated to protecting access to natural kratom leaf while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers. For more information, visit globalkratomcoalition.org.
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Last modified: October 29, 2026
