The SIMSA Act of 2025 establishes a new Schedule A for synthetic analogues of controlled substances, outlines strict penalties for violations, and sets registration and labeling requirements for these substances.
Charles "Chuck" Grassley
Senator
IA
The SIMSA Act of 2025 establishes a new Schedule A within the Controlled Substances Act to specifically target synthetic analogues that are structurally or functionally similar to existing controlled substances. This legislation grants the Attorney General authority to temporarily or permanently schedule these substances, imposing strict penalties for trafficking and mandatory labeling requirements. Furthermore, the Act outlines specific registration processes for handling Schedule A substances and provides a mechanism for sentence review if a substance is later descheduled.
The Stop the Importation and Manufacturing of Synthetic Analogues Act of 2025, or the SIMSA Act, is a major overhaul of how the government controls designer drugs. Right now, the Controlled Substances Act (CSA) uses five schedules (I through V). This bill adds a sixth one: Schedule A. This new schedule is specifically designed to catch synthetic drugs—think fentanyl analogues, synthetic cannabinoids, or bath salts—that are chemically similar to existing controlled substances and have similar psychoactive effects.
This is the government’s attempt to play catch-up with chemists who constantly tweak drug molecules to stay ahead of the law. A substance gets put into Schedule A if it’s imported, has a chemical structure substantially similar to an existing controlled drug, and has a similar or greater effect on the central nervous system (Sec. 2). Crucially, the Attorney General (AG) can determine the predicted effect based on chemical structure and scientific data, not just confirmed clinical trials. This gives the AG significant power to control substances before they cause widespread harm, which is the clear benefit here. However, relying on a “predicted effect” based on chemical structure alone is a broad definition, and it could potentially sweep in many compounds very quickly.
To address emerging threats quickly, the bill gives the AG the authority to issue a temporary scheduling order for up to five years if the substance meets the Schedule A criteria and the ban would help prevent abuse (Sec. 3). Here's the catch: these temporary orders are not subject to judicial review. If you’re a researcher or a small business dealing with chemicals, your substance could be banned overnight without a court being able to weigh in immediately. The AG must notify the Department of Health and Human Services (HHS) first, but the AG is not required to follow HHS’s advice. This concentrates immense, rapid regulatory power in the Department of Justice, which is great for speed but less so for scientific oversight.
If you deal with a Schedule A substance illegally, the penalties are severe, mirroring those for Schedule I and II drugs. A standard violation carries up to 20 years in prison. If the violation results in death or serious bodily injury, the penalty is life imprisonment (Sec. 4). Furthermore, the fines are massive: up to $1 million for individuals and $5 million for entities. For repeat offenders, those fines double. This section also imposes mandatory minimum supervised release terms (at least three years for a standard offense), overriding the court’s usual discretion. For individuals, especially those caught on the distribution end, this means the courts have less flexibility to consider the specific circumstances of the case, potentially leading to disproportionately long sentences.
For legitimate businesses, the bill tightens up labeling rules. Any imported or exported Schedule A substance must be labeled using the precise IUPAC nomenclature (the standard scientific naming system) (Sec. 5). If you’re a manufacturer or importer, this means strict adherence to chemical naming conventions unless your product is already FDA-approved or in an investigational clinical trial. Failure to comply is a violation of the CSA. Researchers are also impacted. If you’re already studying a substance that gets added to Schedule A, you have 30 days to apply to modify your registration, or you risk being in violation of the law (Sec. 6). This adds a layer of administrative burden and complexity for the scientific community.
One critical provision offers a path for justice if the science changes. If a Schedule A substance is later de-scheduled (removed entirely) or moved to a schedule with lower penalties, individuals convicted of offenses involving that substance can petition the court for a sentence reduction hearing (Sec. 8). The court must hold this hearing quickly—within 30 days—and can modify the sentence as if the new, lower penalty schedule was in place when the original crime occurred. This provides a necessary safety net against long-term sentences for substances that scientific review later deems less dangerous than initially predicted.