S. 3228 — SIMSA Act of 2025

This section designates the Act as the “Stop the Importation and Manufacturing of Synthetic Analogues Act of 2025” or the “SIMSA Act of 2025” and sets forth the table of contents.

This section establishes a sixth schedule of controlled substances, designated Schedule A, under the Controlled Substances Act (CSA), increasing from five schedules (I-V) to six (I-V and A). As background, the CSA classifies substances into schedules based on potential for abuse, accepted medical use, and dependence risk, with Schedule I having the highest abuse potential and no accepted medical use and Schedule V the lowest. Schedule A covers substances that are or have been imported or offered for import into the United States, have a chemical structure substantially similar to a substance in schedules I-V along with an actual or predicted stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than such a scheduled substance (based on factors including chemical structure and structure-activity relationships, binding assays, abuse potential, clandestine activity, or dependence capacity), and are not otherwise scheduled; the Attorney General may temporarily or permanently place such substances in Schedule A pursuant to CSA section 201(k).

This section establishes procedures for the temporary and permanent scheduling of schedule A substances under the Controlled Substances Act. The Attorney General may issue a temporary scheduling order—effective 30 days after Federal Register notice—if the substance meets schedule A criteria and scheduling will help prevent abuse; such orders last up to 5 years (extendable by 180 days during proceedings), are not subject to judicial review, and are vacated upon issuance of a permanent order or other scheduling action. Not earlier than 3 years after a temporary order, the Attorney General may issue a permanent order adding the substance to schedule A if it meets the criteria; however, if the Secretary of Health and Human Services determines—based on scientific studies—that it lacks sufficient abuse potential for any schedule and provides 30 days' notice, the Attorney General must terminate the temporary order within 30 days. Before a temporary order, the Attorney General must notify the Secretary of Health and Human Services and consider any comments received. (As background, the Controlled Substances Act currently uses schedules I-V to classify drugs by abuse potential and medical use; schedule A appears designed for expedited control of particularly dangerous substances.)

This section amends penalties under the Controlled Substances Import and Export Act (21 U.S.C. 960) for offenses involving schedule A substances by (1) inserting references to such substances in subsection (a), and (2) adding subsection (b)(8) that imposes imprisonment for up to 20 years (up to 30 years after a prior felony drug conviction), or any term of years or life if death or serious bodily injury results; fines up to the greater of the statutory maximum under 18 U.S.C. or $1 million for individuals ($5 million for others), doubled after a prior conviction; and minimum supervised release terms of 3 years without a prior conviction (6 years with a prior conviction) notwithstanding 18 U.S.C. 3583. Subsection (b)(8) further prohibits probation or sentence suspension for violations resulting in death or serious bodily injury.

This section establishes labeling requirements for schedule A substances (analogous to existing requirements for anabolic steroids under CSA §305(e)), prohibiting their import or export with intent to manufacture, distribute, or dispense unless the substance or product bears a label identifying it using International Union of Pure and Applied Chemistry (IUPAC) nomenclature. Products approved under Federal Food, Drug, and Cosmetic Act §505(b) or (j), or exempt for investigational use in clinical trials under §505(i) with an effective investigational new drug application, are exempt if labeled per that Act. The section also amends CSA §402 to add violations of these requirements as an offense under subsection (a)(17), subjecting violators to the civil and criminal penalties specified in subsection (c).

This section establishes registration requirements under the Controlled Substances Import and Export Act for importers and exporters of schedule A substances (i.e., substances temporarily placed in a new schedule due to high abuse potential), requiring the Attorney General to register applicants demonstrating use for research, analytical, or industrial purposes approved by the Attorney General and consistent with the public interest—considering factors such as controls against diversion, compliance with state law, and applicant history—and exempting those already registered for schedule I or II substances from separate registration. This section further amends the Controlled Substances Act to (1) exempt research on substances newly added to schedule A from registration requirements if conducted pursuant to an investigational new drug exemption under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); (2) permit persons registered for schedule I or II research to continue such research on newly added schedule A substances for up to 30 days pending submission of a registration application or modification, with continuation allowed until an order to show cause is issued and expedited hearings within 45 days if requested; (3) allow schedule A research registrants to conduct schedule I research upon application modification, verification by the Secretary of Health and Human Services of a meritorious protocol, and an Attorney General determination within 30 days of consistency with the 1961 Single Convention on Narcotic Drugs; and (4) preserve the Attorney General's authority to deny, suspend, or revoke registrations.

This section amends the Controlled Substances Import and Export Act to extend import prohibitions and exceptions applicable to schedule I or II controlled substances (and, separately, narcotic drugs in schedules III, IV, or V) to also include drugs or substances in schedule A. The amendments apply to provisions governing (1) importation of such substances, (2) exportation generally and during emergencies, (3) transshipment and in-transit shipments, (4) possession with intent to import or export, and (5) distribution outside the United States.

This section establishes a sentencing review process for individuals convicted of a covered offense (i.e., an offense involving a schedule A substance for which the penalty was established under section 4 or 5 of this Act). If such a substance—temporarily or permanently scheduled under new section 201(k) of the Controlled Substances Act—is later descheduled or rescheduled to a lower-penalty schedule, an individual awaiting sentencing or serving a prison term for the offense on the date of that change may petition the sentencing court for a reduction hearing. The court must hold the hearing not later than 30 days after the petition is filed and may modify the sentence as if the descheduling or rescheduling had applied at the time of the offense.

This section provides that nothing in this Act or its amendments limits (1) the prosecution of offenses involving controlled substance analogues under the Controlled Substances Act; or (2) the Attorney General's authority under section 201 of the Controlled Substances Act (21 U.S.C. 811)—as in effect the day before enactment—to temporarily or permanently schedule, reschedule, or decontrol controlled substances. (Section 201 authorizes the Attorney General, after receiving a scientific and medical evaluation from the Secretary of Health and Human Services, to add substances to or remove them from the five schedules of controlled substances based on factors such as potential for abuse and accepted medical use.)