July 1, 2026
Washington, D.C. — The Natural Products Association (NPA), the nation’s leading trade association representing the natural products industry, commended the U.S. Drug Enforcement Administration for its announcement today that it plans to temporarily place 7-hydroxymitagynine (7-OH) and three related substances (mitragynine pseudoindoxyl, MGM-15 and MGM-16) into Schedule I of the Controlled Substances Act (CSA).
NPA fully supports DEA’s action targeting highly concentrated, synthetic 7-OH products and agrees with the agency that these substances pose significant risks to consumer health and safety. One year ago, NPA publicly supported FDA warning letters issued against products containing concentrated amounts of 7-OH.
“The science clearly establishes that 7-OH is found in trace amounts in the Mitragyna speciosa plant,” said Daniel Fabricant, Ph.D., 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.”
Dr. Fabricant, who previously directed FDA’s Division of Dietary Supplement Programs, emphasized that all forms of kratom intended for the U.S. market must be supported by evidence of safety and comply with applicable regulatory requirements.
“Intoxicating products, or those that get a person ‘high,’ are not dietary supplements,” he said.
According to DEA, once the temporary scheduling orders take effect, the manufacture, distribution, sale, and possession of covered 7-OH substances will become subject to criminal, civil, and administrative provisions of the Controlled Substances Act.
“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,” Dr. Fabricant said. “Products with a high potential for abuse have no place in the dietary supplement marketplace.”
