SIMSA Act of 2025
Sponsored By: Senator Grassley, Chuck [R-IA]
Introduced
Summary
Creates a new Schedule A for synthetic drug analogues.
Show full summary
This bill would add a sixth schedule to the Controlled Substances Act for imported or import-offered substances that are chemically similar to scheduled drugs and that produce similar or greater stimulant, depressant, or hallucinogenic effects.
- Researchers and labs: Registered researchers may continue work under investigational exemptions and can seek expedited modifications or hearings to study Schedule A substances. They must file appropriate amendments within 30 days and may continue research while applications are pending.
- Importers, exporters, and manufacturers: New registration and labeling rules would require proof of legitimate research, analytical, or industrial use and labels aligned to IUPAC naming. False labeling and import/export violations carry fines up to $1 million for individuals and prison up to 20 years, with life sentences if death or serious injury results.
- People prosecuted for trafficking: The bill creates new Schedule A offenses and tougher penalties, including enhanced terms for repeat felons up to 30 years or life and higher fines. It also lets convicted people petition for a sentencing-reduction hearing if the substance is later descheduled or moved to a lower schedule.
- Enforcement tools: The Attorney General could issue temporary scheduling orders that take effect 30 days after notice and last up to five years, with a possible short extension. Temporary orders would not be subject to judicial review.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 0 benefits, 2 costs, 2 mixed.
Tough penalties for Schedule A trafficking
If enacted, the bill would add Schedule A violations to federal criminal penalties. Trafficking could bring up to 20 years in prison, or life/term-of-years if death or serious injury results. Fines could reach $1,000,000 for individuals and $5,000,000 for entities. Higher penalties apply after a prior felony (up to 30 years; fines up to $2,000,000 for individuals and $10,000,000 for entities). Sentences must include supervised release of at least 3 years (no prior) or 6 years (with prior). People serving time or awaiting sentence could petition for resentencing if the substance is later descheduled or moved to a lower-penalty schedule; courts must hold a hearing within 30 days of the petition.
New federal Schedule A for imports
If enacted, the bill would create a new federal "Schedule A" for some drugs that are imported or offered for import. A substance could be listed if its chemical structure is substantially like a schedule I–V drug and it has similar or stronger stimulant, depressant, or hallucinogenic effects. The bill would allow scientific tests, structure–activity relationships, receptor assays, and other evidence to predict effects. The Attorney General could temporarily place substances on Schedule A and use a special timeline for temporary and permanent scheduling.
New import and export rules for businesses
If enacted, the Attorney General would have to register people who want to import or export Schedule A substances for approved research, analytical, or industrial uses. The AG would weigh diversion controls, prior convictions, state law compliance, and other public‑interest factors. If you already have a Schedule I or II import/export registration, you would not need a separate Schedule A registration. The bill would also require labels to show the chemical name in IUPAC format for imports/exports made with intent to manufacture, distribute, or dispense, with narrow FDA-approved and clinical-trial exemptions. The bill would add Schedule A to existing import/export criminal rules.
Research rules and continuity protections
If enacted, researchers could continue investigational studies on a substance after it is added to Schedule A if the study is under an IND or FDA section 505 investigational exemption. People already registered for Schedule I or II research must submit an application or modification within 30 days of scheduling, but they may continue work until the application is withdrawn or the AG takes action. If the AG serves an order to show cause and the applicant asks for a hearing, the hearing must be held quickly (within 45 days unless delayed by the applicant). To work with a Schedule I drug while registered for Schedule A, researchers must get HHS verification of a meritorious protocol and an AG consistency finding within 30 days.
Sponsors & CoSponsors
Sponsor
Grassley, Chuck [R-IA]
IA • R
Cosponsors
Sen. Hassan, Margaret Wood [D-NH]
NH • D
Sponsored 11/20/2025
Sen. Ernst, Joni [R-IA]
IA • R
Sponsored 11/20/2025
Sen. Shaheen, Jeanne [D-NH]
NH • D
Sponsored 11/20/2025
Shelley Capito
WV • R
Sponsored 11/20/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov