Federal Cannabis Research and Scheduling Policy: CSA, DEA, FDA and NIDA

Executive Summary

Federal cannabis policy now runs on three parallel tracks (rescheduling, research access and drug approval), and the American Medical Association's November 2026 intervention pulls the debate toward the third. On November 2, 2026, Marijuana Moment reported that the AMA urged federal officials to uphold "known and widely accepted scientific and clinical standards for testing safety and efficacy" for botanical drug products. The AMA named cannabis, kratom and other plant-derived substances. According to that report, it warned that political and commercial interests should not circumvent the standard approval process, and it called for a "special schedule" to support research.

The statement lands in a policy fight that has run since the Controlled Substances Act of 1970 placed marijuana in Schedule I under 21 U.S.C. § 812. In August 2023, the Department of Health and Human Services recommended moving marijuana to Schedule III. In May 2024, the DEA published a notice of proposed rulemaking (NPRM) to do so. The administrative hearing before an administrative law judge (ALJ) was stayed in January 2025. In December 2025, President Trump signed an executive order directing the Attorney General to expedite the rescheduling process. Readers should confirm the final-rule status in the Federal Register docket (DEA-1362) before relying on any schedule designation.

The key points:

• Schedule III would not legalize cannabis. It would remove Section 280E tax treatment for plant-touching operators and ease some research barriers.
• Research access is a separate bottleneck. It is governed by DEA registration, FDA investigational new drug rules and a historically narrow federal supply of research cannabis.
• The AMA's position is that botanicals should clear FDA-grade evidence standards, and that a purpose-built schedule could enable research without implying medical acceptance.

Why This Matters

The research-and-scheduling question touches roughly every licensed U.S. cannabis operator, tens of millions of consumers and the clinicians who field patient questions with limited trial data.

Three stakeholder groups carry the most exposure.

Patients and clinicians

Most U.S. states run medical cannabis programs, yet physicians lack the randomized, controlled trial data they get for FDA-approved drugs. Dispensary products such as Wedding Cake, OG Kush and Northern Lights vary in cannabinoid and terpene content (including myrcene and limonene). That variation makes it hard to translate research findings into clinical guidance. The AMA's concern reflects this gap: patients use products that never passed the evidence screen applied to pharmaceuticals.

Operators and investors

The tax stakes are concrete. Under Internal Revenue Code Section 280E, businesses trafficking in Schedule I or II substances cannot deduct ordinary business expenses. Schedule III placement would end that treatment for state-licensed cannabis businesses. For multi-state operators (MSOs), effective tax rates are often a central valuation issue. The research-access side is less visible but still matters, because studies determine which claims, formulations and products can be defended.

Regulators and the botanical drug sector

The AMA's letter reaches beyond marijuana to kratom and other botanicals. That framing signals that any research-specific schedule would likely be written as a category rule, not a cannabis carve-out. A kratom decision, such as the FDA's 2025 recommendation to schedule the concentrated alkaloid 7-hydroxymitragynine, would run on the same regulatory machinery.

Background and History

Federal cannabis scheduling began as a 1970 legislative compromise, not a scientific finding, and every reform effort since has run into the gap between that placement and the research record.

1970: The Controlled Substances Act

Congress enacted the Controlled Substances Act in 1970 and placed marijuana in Schedule I on a provisional basis. Schedule I requires a "high potential for abuse," "no currently accepted medical use in treatment in the United States" and a lack of accepted safety under medical supervision. The same law created a commission, led by former Pennsylvania Governor Raymond Shafer, to study marijuana. The Shafer Commission's 1972 report recommended decriminalizing personal possession. The Nixon administration did not act on it.

1968 onward: A single federal supply

The National Institute on Drug Abuse (NIDA) arranged for the University of Mississippi to grow research cannabis, an arrangement dating to 1968. For decades that single source supplied federally authorized researchers. Investigators often complained that the material did not resemble commercial products, which tend to be higher in THC and more varied in terpene profile.

1985-1999: Dronabinol and the first split

The FDA approved dronabinol (Marinol), a synthetic THC capsule, in 1985. It was placed in Schedule II in 1986 and moved to Schedule III in 1999. That sequence showed a cannabinoid could be a legitimate medicine even while the whole plant stayed in Schedule I.

1996-2016: State programs and failed petitions

California voters approved Proposition 215 in 1996, launching state medical programs. Federal petitions to reschedule marijuana were repeatedly denied, including a 2016 denial by the DEA, which relied on FDA and HHS analyses. In August 2016, the DEA also announced it would expand the number of registered cannabis growers for research. Applications piled up for years, and the agency took no meaningful action until a 2020 push led by applicants and Congress.

2018-2020: Hemp and Epidiolex

The 2018 Farm Bill removed hemp, defined as cannabis with no more than 0.3 percent delta-9 THC by dry weight, from the Controlled Substances Act. In June 2018, the FDA approved Epidiolex, a plant-derived CBD medicine for certain seizure disorders. That approval stands as the botanical-drug template the AMA invokes today: a standardized extract, controlled trials and a defined indication. The DEA descheduled Epidiolex in 2020.

2022: The research expansion law

President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454, Public Law 117-215) on December 2, 2022. It created a registration pathway for manufacturers and growers of research cannabis and instructed agencies to streamline research-protocol review. It did not change the schedule.

2022-2024: The Biden review

In October 2022, Biden directed HHS and the Attorney General to review marijuana's scheduling. HHS delivered its recommendation to the DEA in August 2023: move marijuana to Schedule III. HHS concluded there was "currently accepted medical use" based on evidence from state programs and limited clinical data, and that marijuana's abuse potential was lower than that of Schedule I and II substances. On May 21, 2024, the DOJ and DEA published the NPRM proposing the move.

2025: Hearing stay and executive order

An ALJ hearing was set for January 2025. It was stayed amid an interlocutory appeal over the DEA's handling of participants, and the change in administration compounded the delay. In November 2025, Congress passed a spending package that redefined hemp. That law targeted intoxicating hemp products, counting total THC including THCA, with a one-year effective date running to November 2026. In December 2025, President Trump signed an executive order on medical marijuana and CBD research that directed the Attorney General to expedite rescheduling to Schedule III, according to the White House text.

November 2026: The AMA statement

The AMA statement, reported November 2, 2026, adds the physician community's evidence-standard concerns to a debate largely framed around taxes and enforcement.

Key Players

Six institutions hold decisive influence: the DEA, HHS and FDA, NIDA, Congress, the physician lobby and the industry.

Drug Enforcement Administration

The DEA holds final scheduling authority under 21 U.S.C. § 811, subject to a binding HHS scientific and medical evaluation. It also administers researcher and manufacturer registrations under 21 CFR Part 1301. Its handling of the stalled hearing is the most scrutinized variable in the process.

HHS and the FDA

The FDA performs the eight-factor analysis that drives HHS recommendations and regulates drug approval under the Federal Food, Drug, and Cosmetic Act. Its 2016 Botanical Drug Development guidance shapes how complex plant mixtures can qualify for approval. The AMA's letter implicitly asks the FDA to hold that line.

National Institute on Drug Abuse

NIDA's Drug Supply Program remains the legacy source of federally supplied research cannabis. It also funds much of the federally sponsored cannabis science, and its mandate to study abuse and harm shapes the research portfolio.

Congress

Congress has acted on research access (the 2022 law) and hemp (the 2018 and 2025 laws). Bills to deschedule cannabis outright, or to move it to Schedule III legislatively, have stalled repeatedly. Appropriations riders have long shielded state medical programs from DOJ enforcement.

American Medical Association

The AMA is the largest U.S. physician organization. According to the Marijuana Moment report, it argues that standard approval pathways should not be bypassed for botanicals and supports a "special schedule" to enable research. Its voice matters because the DEA must weigh medical consensus when it asserts "accepted medical use."

Industry and advocates

Trade groups, MSOs and patient-advocacy organizations have pushed for Schedule III or full descheduling, with differing levels of enthusiasm. Some advocates oppose Schedule III because it could entrench pharmaceutical-style regulation of the plant. Kratom advocates and hemp-industry groups have separate positions on any botanical framework.

Legal and Regulatory Framework

Scheduling is a statutory process with fixed criteria, and a research-specific schedule would need either new legislation or novel use of existing authority.

The Controlled Substances Act

21 U.S.C. § 812 defines five schedules. Schedule I requires no accepted medical use and a high abuse potential. Schedule III requires a potential for