SIMSA Act of 2025

Summary#

This bill creates a new category called "Schedule A" for certain imported or offered-for-import drugs. A substance can be placed in Schedule A if it is not already scheduled, has a chemical structure substantially similar to a scheduled drug, and has actual or predicted stimulant, depressant, or hallucinogenic effects similar to or greater than a scheduled drug. The Attorney General (AG) may issue temporary orders to place drugs in Schedule A (after a 30-day public notice) that last up to 5 years, with a possible 180-day extension. Temporary scheduling orders are not subject to judicial review. The AG may later make scheduling permanent after three years unless the Secretary of Health and Human Services (HHS) finds the substance does not have sufficient abuse potential and notifies the AG to stop scheduling.

The bill adds new criminal penalties for import or export offenses involving Schedule A substances, including higher maximum prison terms, larger fines, and required terms of supervised release. It requires imported or exported Schedule A substances and products containing them to use International Union of Pure and Applied Chemistry (IUPAC) names on labels, with exemptions for certain FDA-approved or investigational products. The AG must register importers and exporters of Schedule A substances if the use is for approved research, analytical, or industrial purposes and registration is consistent with public interest and international treaty obligations. The law also adds rules to let researchers already working with a substance continue research while they apply for registration. The bill makes related edits to import-and-export statutes and allows people convicted under these new penalties to seek a sentence review if the substance is later descheduled or placed on a schedule with lower penalties. It also states that existing authority to prosecute analogues and to schedule or reschedule controlled substances remains in effect.

What it means for you#

• Importers or exporters of synthetic analogues will generally need AG registration and must show the substance will be used for approved research, analytical, or industrial purposes.
• Products containing Schedule A substances must use IUPAC names on labels unless they are FDA-approved or covered by a clinical-trial investigational exemption.
• Researchers already working with a substance that becomes Schedule A may continue research while applying for or modifying registration, but must meet new timelines and application rules.
• People who import, export, or distribute Schedule A substances can face much higher criminal penalties, including longer prison terms and larger fines; courts must impose minimum supervised release terms in many cases.
• If a substance is later removed from Schedule A or moved to a lower-penalty schedule, some people already convicted can petition for a sentence reduction.

Expenses#

No publicly available information.

Proponents' View#

The bill aims to stop the importation and manufacture of synthetic analogues, tighten controls to prevent abuse and diversion, require clear chemical labeling, and provide registration rules for legitimate research and industry use.

Opponents' View#

No publicly available information.