DEA to Temporarily Schedule 7-OH and Related Substances

The Drug Enforcement Administration (DEA) intends to temporarily place 7-hydroxymitagynine (7-OH) and three related substances into Schedule 1 of the Controlled Substances Act (CSA). Prior, the Department of Health and Human Services (HHS) confirmed that each substance has no accepted medical use and a high potential for abuse. Each of these synthetic opioid-like substances is psychoactive and poses immediate threats to public safety, DEA reported. In botanical forms, 7-OH is found in trace amounts in the kratom (Mitragyna speciosa) plant. The temporary scheduling action doesn’t apply to botanical kratom products containing naturally occurring 7-OH below a specified threshold, instead targeting synthesized products and those containing elevated concentrations of 7-OH.

Products containing semi-synthetic 7-OH are being widely marketed online and sold in gas stations, convenience stores, and smoke shops in a variety of forms, including powders, tablets, capsules, gummies, and dissolvable strips, DEA reported.

The agency filed two notices of intent that respectively address 7-OH above a specified threshold and moving 7-OH-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16) into Schedule 1.

“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.”

“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.”

The Natural Products Association (NPA) commended DEA for its intent to schedule these synthetic substances, agreeing with the determination that these substances pose significant risks to consumer health and safety.

“The science clearly establishes that 7-OH is found in trace amounts in the Mitragyna speciosa plant,” said Daniel Fabricant, PhD, president and CEO of NPA. “We remain consistent in our position that highly concentrated amounts of 7-OH are falsely marketed as kratom and have not demonstrated pre-market safety through FDA’s new dietary ingredient notification process.”

Fabricant previously directed FDA’s Division of Dietary Supplement Programs; he emphasized that forms of kratom intended for dietary supplements in the U.S. market must be supported by evidence of safety and comply with acceptable regulatory requirements.

“Intoxicating products, or those that get a person ‘high,’ are not dietary supplements,” he said. “We applaud DEA’s leadership and encourage continued coordination with FDA to remove synthetic 7-OH and related substances that put American consumers at risk. Products with a high potential for abuse have no place in the dietary supplement marketplace.”