HHS, FDA Commend DEA Action Against Dangerous Enhanced 7-OH Products

WASHINGTON — JULY 1, 2026 — The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today commended the Drug Enforcement Administration's (DEA) issuance of two Notices of Intent to begin the temporary scheduling process for certain kratom-related substances.

One Notice of Intent addresses temporary placement of 7-OH above a specified threshold in Schedule I, while the second would temporarily place three synthetic 7-OH derivatives into Schedule I of the Controlled Substances Act (CSA):

• Mitragynine pseudoindoxyl (MP)
• Dihydro-7-hydroxymitragynine (MGM-15)
• The 9-fluoro derivative of 7-hydroxymitragynine (MGM-16)

Concurrent with DEA's Notice of Intent addressing 7-OH, the Office of the Assistant Secretary for Health (OASH) issued a Request for Information (RFI) on seeking public comment on the proposed 7-OH threshold level in the NOI. The request is limited to obtaining comments on whether: 1) there is additional scientific data to support the proposed or an alternative threshold level – specifically, what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety; and 2) data exist supporting alternative measurement expressions for purposes of specifying the threshold level that is necessary to avoid an imminent harm to public safety.

After the 30-day comment period for the RFI, OASH will provide comments submitted to the RFI public docket to the Attorney General for consideration. Once comments have been considered and at least 30 days have passed since the publication of the NOI, the Attorney General may then issue a temporary scheduling order placing 7-OH above a certain threshold in Schedule I. The CSA provides the Attorney General with the authority to issue a temporary scheduling order placing a substance in Schedule I of the CSA for two years, if such action is necessary to avoid an imminent hazard to public safety.

“I commend the DEA for taking decisive action to address these addictive and harmful substances,” said HHS Secretary Robert F. Kennedy, Jr. “7-OH, MP, MGM-15, and MGM-16 are dangerous opioids that fuel addiction and put American lives at risk. HHS reviewed the science and recommended this action. The Trump Administration will continue using every available authority to stop these deceptive products, hold bad actors accountable, and protect American families.”

These actions are not intended to regulate natural leaf kratom that does not contain enhanced levels of 7-OH. Although 7-OH occurs naturally in trace amounts in the kratom plant, scheduling 7-OH above a certain threshold level does not intend to capture the kratom botanical leaf in the present temporary scheduling recommendation. MP, MGM-15 and MGM-16 do not occur naturally in the plant. MP is a chemical rearrangement product of 7-OH, while MGM-15 and MGM-16 are synthetic derivatives of 7-OH.

“Today’s action targets highly concentrated, synthetic 7-OH products, which pose a growing threat to public safety and health. Temporarily scheduling these substances underscores the emphasis this Administration has put on the safety, health and well-being of the American people,” said DEA Administrator Terrance Cole.  “This action gives law enforcement and public health partners the tools needed to address this emerging threat. We appreciate the FDA's scientific expertise and our continued partnership with HHS to address emerging threats, and we will continue to act aggressively when dangerous substances threaten Americans.”

MP and MGM-15 have been sold online in products including candies, tablets and liquid shots, often marketed as kratom extracts despite containing synthetic opioid compounds.

In July 2025, the FDA issued warning letters to seven companies for marketing and distributing illegal products containing 7-OH, including tablets, gummies, drink mixes and liquid shots. In December 2025, FDA, along with the Department of Justice and U.S. Marshals Service, seized approximately $1 million worth of unlawful 7-OH dietary supplement and food products from three firms in Missouri. Following a comprehensive scientific and medical review, HHS and FDA, in 2025, recommended the DEA begin the process to schedule 7-OH above a certain threshold.

Today's action is part of the Trump Administration's broader effort to combat the opioid epidemic, end addiction, crack down on deceptive products that threaten public health, and protect American families from dangerous synthetic drugs.