DOJ orders emergency Schedule I ban on three synthetic opioid compounds

The Department of Justice announced the emergency scheduling of three potent opioid compounds that it says pose an imminent hazard to public safety, according to a DOJ press release. The compounds are mitragynine pseudoindoxyl, known as MGPI, and two synthetic substances designated MGM-15 and MGM-16.

Attorney General Todd Blanche said the department is “acting before these dangerous compounds become a broader threat.” Blanche said the substances are potent opioids “being manufactured and sold in consumer products, often under labels that obscure their true risks,” and that the action is intended to protect children and communities from 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, the DOJ said. Preclinical evidence indicates all three are potent mu-opioid receptor agonists that may carry risks associated with other mu-opioid agonists, including dependence and respiratory depression, according to the release. MGPI and MGM-15 are being manufactured and marketed in products sold for their opioid effects, while MGM-16 has not been confirmed in the consumer market but is described as a highly potent compound that could emerge as a substitute for related substances.

The emergency scheduling subjects the manufacture, distribution and possession of the three compounds to the regulatory controls and administrative, civil and criminal sanctions applicable to Schedule I substances, according to the DOJ. The department said the move allows the federal government to respond to a rapidly developing market for products containing these manufactured opioid compounds.

The department emphasized that the action targets deliberately manufactured and concentrated opioid products rather than traditional botanical kratom. The DOJ noted that published scientific literature has not established MGPI as a naturally occurring kratom alkaloid, though unresolved questions remain about whether MGPI could be reported at incidental trace levels in some botanical products because of processing, storage or analytical conditions.

Because of those questions, the DOJ said it will exercise enforcement discretion when only incidental trace amounts of MGPI are confirmed in a product otherwise consistent with botanical kratom. The department stressed that this discretion does not create a legal exemption or alter MGPI’s status as a Schedule I controlled substance. The policy does not extend to MGM-15 or MGM-16, or to products containing manufactured, concentrated, fortified or intentionally added MGPI, according to the release. The DOJ added that the policy does not change the scheduling status of any other substance or limit the FDA’s authority under federal law.