SIMSA Act of 2025
Summary
What This Bill Does
The bill creates a new Schedule A under the Controlled Substances Act for imported synthetic drug analogues that have chemical structures and central nervous system effects substantially similar to existing schedule I-V, establishes criminal penalties for violations involving Schedule A substances: up to 20 years imprisonment and fines up to $1 million for individuals ($5 million for organizations), enhanced to 30 years and $2 million, and requires IUPAC (International Union of Pure and Applied Chemistry) nomenclature labeling on all imported or exported Schedule A substances. It relies on compliance mandates, exemptions, definition changes, and product standards. The main policy areas are Trade, Drug Enforcement, Criminal Justice, and Healthcare.
Who Benefits and How
Individuals convicted of Schedule A offenses whose substances are later rescheduled could see lower costs, Pharmaceutical companies with FDA-approved products could face lower compliance burdens, and Existing Schedule I/II registered importers/exporters could face lower compliance burdens.
Who Bears the Burden and How
Persons importing, manufacturing, or distributing Schedule A substances could face higher costs, Illicit synthetic drug importers and manufacturers could face higher barriers, and Legitimate importers/exporters of Schedule A substances for research and industry would take on compliance duties.
Key Provisions
- Creates a new Schedule A under the Controlled Substances Act for imported synthetic drug analogues that have chemical structures and central nervous system effects substantially similar to existing schedule I-V...
- Establishes criminal penalties for violations involving Schedule A substances: up to 20 years imprisonment and fines up to $1 million for individuals ($5 million for organizations), enhanced to 30 years and $2 million...
- Requires IUPAC (International Union of Pure and Applied Chemistry) nomenclature labeling on all imported or exported Schedule A substances.
- Establishes registration requirements for importing or exporting Schedule A substances for legitimate research, analytical, or industrial purposes.
- Expands makes conforming amendments throughout the Controlled Substances Import and Export Act to extend existing import/export controls for Schedule I and II substances to also cover Schedule A substances.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
The bill creates a new Schedule A under the Controlled Substances Act for imported synthetic drug analogues that have chemical structures and central nervous system effects substantially similar to existing schedule I-V, establishes criminal penalties for violations involving Schedule A substances: up to 20 years imprisonment and fines up to $1 million for individuals ($5 million for organizations), enhanced to 30 years and $2 million, and requires IUPAC (International Union of Pure and Applied Chemistry) nomenclature labeling on all imported or exported Schedule A substances.
Key Policy Areas
Trade, Drug Enforcement, Criminal Justice, Healthcare
Primary Purpose
The bill creates a new Schedule A under the Controlled Substances Act for imported synthetic drug analogues that have chemical structures and central nervous system effects substantially similar to existing schedule I-V, establishes criminal penalties for violations involving Schedule A substances: up to 20 years imprisonment and fines up to $1 million for individuals ($5 million for organizations), enhanced to 30 years and $2 million, and requires IUPAC (International Union of Pure and Applied Chemistry) nomenclature labeling on all imported or exported Schedule A substances.
Policy Domains
SIMSA Act of 2025 - Stop the Importation and Manufacturing of Synthetic Analogues
Identified Gains
- Individuals convicted of Schedule A offenses whose substances are later rescheduled
- Pharmaceutical companies with FDA-approved products
- Existing Schedule I/II registered importers/exporters
- Law enforcement agencies
- Clinical trial sponsors with active INDs
Identified Costs
- Persons importing, manufacturing, or distributing Schedule A substances
- Illicit synthetic drug importers and manufacturers
- Legitimate importers/exporters of Schedule A substances for research and industry
- Importers and exporters of Schedule A chemical substances
- Academic and pharmaceutical researchers
Sponsors
Legislative Progress
In CommitteeMr. Grassley (for himself, Ms. Hassan, Ms. Ernst, Mrs. Shaheen, …
Read twice and referred to the Committee on the Judiciary.
Introduced in Senate
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Clinical trial sponsors with active INDs, Existing Schedule I/II registered importers/exporters, Importers and exporters of Schedule A chemical substances
Positive-direction: Clinical trial sponsors with active INDs, Existing Schedule I/II registered importers/exporters, Pharmaceutical companies with FDA-approved products
Negative-direction: Importers and exporters of Schedule A chemical substances, Importers and exporters of controlled substances, Legitimate importers/exporters of Schedule A substances for research and industry
Drug Enforcement Administration, Federal courts, Federal courts and prison system
Positive-direction: Law enforcement agencies
Negative-direction: Drug Enforcement Administration, Federal courts, Federal courts and prison system
Illicit synthetic drug importers and manufacturers, Persons importing, manufacturing, or distributing Schedule A substances
Academic and pharmaceutical researchers, Researchers already registered for Schedule I/II substances
Positive-direction: Researchers already registered for Schedule I/II substances
Negative-direction: Academic and pharmaceutical researchers
Individuals convicted of Schedule A offenses whose substances are later rescheduled
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "secretary"
- → Secretary of Health and Human Services
- "attorney_general"
- → Attorney General of the United States (DOJ/DEA)
- "comptroller_general"
- → Not applicable
Key Definitions
Terms defined in this bill
An offense involving a schedule A substance for which the penalty was established under section 4 or 5 of this Act.
A drug or substance that (i) is or has been imported, or is offered for import, into the United States; (ii) has a chemical structure substantially similar to a controlled substance in schedule I-V AND an actual or predicted stimulant, depressant, or hallucinogenic effect on the CNS substantially similar to or greater than that of a schedule I-V controlled substance; and (iii) is not listed in any other schedule.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology