The Department of Justice today announced the emergency scheduling of three highly potent opioid compounds that pose an imminent hazard to public safety: mitragynine pseudoindoxyl, commonly known as MGPI, and two synthetic compounds known as MGM-15 and MGM-16.
“The Justice Department is acting before these dangerous compounds become a broader threat,” said Attorney General Todd Blanche. “These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks. This action will protect our nation’s children and communities from the dangers of drug addiction and abuse.”
The Drug Enforcement Administration is temporarily placing the three 7-hydroxymitragynine-related substances in schedule I of the Controlled Substances Act. Preclinical evidence indicates that all three are potent mu-opioid receptor agonists and may present risks associated with other mu-opioid agonists, including dependence and respiratory depression. MGPI and MGM-15 are manufactured and marketed in products sold for their opioid effects. MGM-16 has not been confirmed in the consumer market but is a highly potent compound that could emerge as a substitute for related substances.
The emergency scheduling action subjects the manufacture, distribution and possession of these substances to the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances. It allows the federal government to respond to a rapidly developing market for products containing these manufactured opioid compounds.
This action is directed at deliberately manufactured and concentrated opioid products, not traditional botanical kratom. The published scientific literature has not established MGPI as a naturally occurring kratom alkaloid. However, scientific and analytical questions remain about whether MGP1 may be reported at incidental trace levels in some botanical products as a result of processing, storage or analytical conditions.
In light of these unresolved questions, the Department of Justice will exercise enforcement discretion when only incidental trace amounts of MGPI are confirmed in a product otherwise consistent with botanical kratom. This policy does not create a legal exemption and does not change MGPI’s status as a schedule I controlled substance.
This enforcement policy does not apply to MGM-15 or MGM-16, or products containing manufactured, concentrated, fortified or intentionally added MGPI.
The policy does not change the scheduling status of any other substance or limit the authority of the Food and Drug Administration under federal law.