New measure aligns with HHS and FDA recommendation by targeting lab-made opioids

WASHINGTON, DC, March 26, 2026 (EZ Newswire) -- The Global Kratom Coalition (GKC) today endorsed a new bill by U.S. Rep. Gus Bilirakis that would amend the Controlled Substances Act to schedule concentrated synthetic 7-hydroxymitragynine (7-OH) as a Schedule I controlled substance.

The measure was considered Thursday at a hearing of the House Energy and Commerce Committee’s Health Subcommittee, titled “Policies to Protect Our Communities From Illicit Drug Threats.”

H.R. 8000 — also known as the “End Needless Distribution of 7-OH Act” or the “END 7-OH Act” — aligns with the July 2025 recommendation of the Food and Drug Administration (FDA) to classify concentrated synthetic 7-OH as a Schedule I substance. The Drug Enforcement Administration (DEA) still has not adopted that recommendation.

Meanwhile, states such as Florida and Kentucky have followed the FDA’s lead by moving in recent months to emergency-schedule concentrated synthetic 7-OH as a Schedule I narcotic, making it illegal to sell, possess, or distribute the substance in those states.

“We thank Rep. Bilirakis for introducing this important piece of legislation, which embraces existing federal health policy and widespread scientific consensus on the dangers posed by concentrated synthetic 7-OH opioid products,” said Matthew Lowe, GKC’s Executive Director.

Crucially, Rep. Bilirakis’ bill would schedule 7-OH’s “synthetic equivalents” but would not affect 7-OH “naturally contained in the plant of the genus and species name: Mitragyna speciosa, also known as kratom.”

In recommending concentrated synthetic 7-OH for scheduling last year, FDA officials emphasized that the agency’s action did not apply to natural kratom leaf, which contains only trace amounts (less than 0.04 percent by weight) of the 7-OH alkaloid and presents minimal health concerns to consumers.

By contrast, concentrated synthetic 7-OH products act like prescription opioids and pose significant risks of dependence, overdose, and respiratory suppression. Research published in Drug Alcohol and Dependence have found these products to be up to 13 times more potent than morphine, and their availability in gas stations, vape shops, and convenience stores is fueling a new wave of America’s opioid epidemic.

About Global Kratom Coalition

The Global Kratom Coalition is an alliance of natural kratom consumers, experts, and industry leaders dedicated to protecting access to natural leaf kratom while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers. To learn more about the Global Kratom Coalition and its mission, visit globalkratomcoalition.org.

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