HHS Recommends Science-Based Thresholds to Target Dangerous Enhanced Kratom Products

DEA takes action based on updated recommendation from HHS

WASHINGTON—OCTOBER 9, 2026—The U.S. Department of Health and Human Services (HHS) provided a new recommendation to the Drug Enforcement Administration (DEA) that establishes science-based thresholds for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI), potent opioid compounds associated with products marketed as kratom.

The Department of Justice today announced that DEA issued new Notices of Intent reflecting HHS’ updated scientific analysis and recommendations, including a new Notice of Intent for 7-OH and MGPI incorporating HHS’ recommended concentration and ratio thresholds.

Following a review of available scientific data and comments, HHS Assistant Secretary for Health Admiral Brian Christine, M.D., recommended that DEA use concentration or ratio-based thresholds to determine which products containing 7-OH and MGPI are subject to Schedule I control for purposes of temporary scheduling of these substances under the Controlled Substances Act.

The recommendation is designed to target concentrated or chemically altered products while distinguishing them from natural botanical kratom products, which may contain trace amounts of 7-OH and MGPI.

“We are drawing a clear line between natural kratom and dangerous, enhanced opioid products,” said HHS Secretary Robert F. Kennedy, Jr. “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.”

Under the recommendation, 7-OH and MGPI would be controlled in Schedule I for purposes of temporary scheduling when either substance alone, or their combined amount when both are present:

• Exceeds 1 milligram per gram in solid powders, encapsulated material, or other solid forms, or exceeds 1 milligram per milliliter in liquid preparations; or
• When the mass of mitragynine present divided by the mass of 7-OH, or MGPI, or the combined amount of 7-OH and MGPI if both present, is less than 100.

The ratio-based approach reflects the alkaloid composition of natural kratom products and provides a way to identify products intentionally enhanced or concentrated with 7-OH or MGPI. Available scientific data indicate that 7-OH occurs naturally in botanical kratom at relatively low or trace levels, while some evidence reviewed by FDA suggests MGPI may also occur at trace levels in some natural or kratom-derived products.

FDA's scientific review found that 7-OH is substantially more potent than morphine in preclinical studies, with available data indicating approximately two to nine times greater potency depending on the study. FDA also identified evidence supporting a meaningful risk of opioid-like physical dependence and withdrawal from MGPI.

“Our recommendation gives DEA a scientifically supportable framework to distinguish natural botanical kratom from products that have been concentrated or manipulated to deliver dangerous levels of potent opioid compounds,” said Assistant Secretary for Health Admiral Brian Christine, M.D. “This approach allows us to focus on the products that pose the greatest threat to public health.”

In July 2025, following an FDA scientific and medical evaluation, HHS recommended that 7-OH above a specified threshold be placed in Schedule I of the Controlled Substances Act. In July 2026, DEA announced its intent to temporarily schedule 7-OH above a specified threshold, and HHS simultaneously sought public comment on the proposed threshold.

DEA subsequently temporarily placed MGPI and two synthetic 7-OH derivatives, MGM-15 and MGM-16, in Schedule I. Since then, questions have emerged about how scheduling could affect natural botanical kratom products potentially containing trace amounts of MGPI.

The new HHS recommendation responds to those concerns by providing DEA with a more precise threshold based on both the concentration of 7-OH and MGPI and their relationship to mitragynine, the predominant alkaloid in kratom.

HHS and FDA will continue working with DEA to protect Americans from dangerous concentrated and synthetic opioid products while ensuring federal policy is grounded in the best available science.