A two-week DEA hearing on cannabis rescheduling opened June 29 in Arlington, Va., with seven anti-rescheduling groups challenging the Biden-administration proposal to move cannabis from Schedule I to Schedule III. The opening sessions on June 29–30 focused on cross-examinations of Dominic Chiapperino, Ph.D., the FDA’s director of controlled substance staff, and on procedural objections to the rulemaking process.
The notice of proposed rulemaking (NPRM) stems from a 10-month FDA and HHS scientific and medical evaluation completed in August 2023 and summarized in a 252-page HHS analysis. The DOJ published the NPRM after HHS recommended rescheduling; a 2024 Office of Legal Counsel opinion upheld HHS’s authority to use a new two-part test to determine currently accepted medical use (CAMU). The DEA convened an administrative law judge (ALJ) hearing to allow parties who oppose the NPRM to present evidence and legal arguments.
FDA witness and evaluation
Chiapperino testified that his team reviewed epidemiological databases and health outcomes for the U.S. population rather than conducting drug-approval labeling work. He noted the agency’s evaluation considered harms across categories of cannabis use, not separate, product-specific findings. Chiapperino has led the FDA controlled substances staff since 2018 and said he has overseen about 40 review evaluations for roughly 120 substances.
Key numbers and procedural limits: the evaluation ran about 10 months and concluded in August 2023; the HHS report totals 252 pages of analysis and citations. The FDA’s testimony was limited under a Touhy letter restricting Chiapperino to topics within that scientific review.
NDASA cross-examination and legal challenges
David Evans, representing the National Drug & Alcohol Screening Association (NDASA), pressed Chiapperino on whether political considerations influenced the review. Evans documented that President Joe Biden ordered the FDA/HHS review and that President Trump later directed his administration to finish rulemaking expeditiously via a December executive order.
Evans attempted to question Chiapperino about outside influences, including a reference to a $750,000 inaugural donation, but DEA counsel objected and ALJ Derek C. Julius sustained the objection because it fell outside the FDA’s evaluative scope. Evans also raised potential recusal issues tied to Julius’ prior DOJ role, but Julius denied involvement with the OLC opinion and did not recuse himself.
Evans moved to dismiss the NPRM, calling the evaluation “shoddy” and arguing it failed to analyze specific harms—such as cannabis exposure in utero—separately. Julius denied the motion, explaining the judge lacks authority to withdraw an NPRM issued by DOJ. Julius instructed counsel repeatedly to keep questions focused on evidence rather than argument.
Tennessee Bureau of Investigation (TBI) cross-examination
Reed Smith, assistant attorney general for Tennessee, focused on diversion, links to violent crime, and delta-8 THC. Smith highlighted that the HHS/FDA evaluation did not analyze diversion from state-licensed programs in detail and did not directly connect cannabis to violent crime in the materials cited.
Smith emphasized cannabis’ botanical variability, presenting evidence that the plant is “highly polymorphic” and that chemovars show widely varying cannabinoid profiles. Under the DEA’s historical five-part CAMU test, a drug’s chemistry had to be reproducible; HHS adopted a new two-part test in 2023 that removes that reproducibility requirement for cannabis as a category. The OLC’s 2024 opinion found the new two-part test legally sufficient.
Smith also pointed to the 2018 Farm Bill’s change to the legal definition of hemp and marijuana. Chiapperino said that the Farm Bill expanded the market for hemp-derived cannabinoid products—such as synthesized delta-8 THC—which may have affected epidemiological databases and health-intervention counts used in the 2023 evaluation. He said HHS focused primarily on delta-9 THC because it occurs in far greater abundance and is likely determinative of most intoxicating effects unless a product is chemically manipulated.
DUID Victim Voices and data currency
Patrick Kenneally, representing Driving Under the Influence of Drugs (DUID) Victim Voices, argued the 2023 evaluation relied on dated survey data and did not interview families of people who suffered psychosis or died in crashes involving suspected cannabis impairment. Kenneally repeatedly asked whether the FDA would update the recommendation for 2026; Chiapperino replied that the 2023 recommendation remains in effect and that findings depend on the quality and timing of available data.
Points of contention
– Test standard: Prosecutors and prohibitionist groups argued the government changed the CAMU standard midstream by adopting a two-part test in 2023 instead of the long-used five-part test. Supporters of rescheduling counter that a plant-based category cannot meet the reproducibility element unless a compound is isolated as a pharmaceutical.
– Scope of evaluation: Opponents said the HHS/FDA review failed to analyze specific subpopulations (pregnant people, adolescents ages 18–25) and certain product types (delta-8 THC) separately. Government witnesses said the review prioritized population-level epidemiology.
– Process and politics: Lawyers for anti-rescheduling groups framed the NPRM as political, citing executive-branch directions and timing. DEA counsel and the ALJ limited cross-examination to the scientific analysis scope and procedural record.
What happens next
The hearing is scheduled to continue for two weeks, with additional testimony and cross-examination from parties that opposed the NPRM. After the ALJ completes the record, he will issue a recommended decision to the DEA. The DEA will then consider the recommendation along with public comments and legal analyses before issuing a final scheduling decision. Rescheduling to Schedule III would remove cannabis from Schedule I, recognize medical use at the federal level, and change federal prosecutorial and research frameworks, but it would not automatically legalize state-regulated products or alter state licensing systems.
The hearing’s record centers on the 252-page HHS analysis, the FDA’s 10-month review, the OLC opinion affirming the two-part CAMU test, and contested gaps flagged by state law enforcement and advocacy groups. Parties opposing rescheduling seek to use the hearing record to persuade the DEA and courts that the NPRM lacks adequate scientific support; the government is defending the HHS/FDA methodology and the 2023 recommendation.
Observers should expect the ALJ’s recommended decision several weeks after the hearing ends and the DEA’s final administrative timeline to depend on legal review and possible litigation.
