President Donald Trump’s Dec. 18, 2025, executive order “Increasing Medical Marijuana and Cannabidiol Research” directs the Attorney General to “take all necessary steps” to move marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA), with the aim of removing research barriers and aligning federal policy with evidence of medical use and state practice. The order cites the HHS’s 2023 recommendation to reschedule; the FDA’s determination of credible scientific support for cannabis in treating pain, anorexia related to certain conditions and chemotherapy-induced nausea; and extensive state-authorized medical use involving millions of patients and tens of thousands of clinicians. The White House emphasized that rescheduling does not legalize cannabis federally but would improve research and allow state-legal operators to access standard federal tax deductions previously barred by the Internal Revenue Code.
The order also addresses hemp-derived cannabinoids, tasking senior White House staff to work with Congress to update the statutory definition of “final hemp-derived cannabinoid products” to preserve access to “appropriate full-spectrum CBD” while restricting unsafe products. It notes that hemp-derived cannabinoids are not controlled substances but exist in a fragmented regulatory landscape. It highlights that some full-spectrum CBD products will again become controlled “marijuana” when a recent law passed as part of the budget bill (section 781 of Public Law 119-37) takes effect due to per-container THC thresholds. Under the order, the HHS, FDA, CMS and NIH are also directed to develop real world evidence research models for legal CBD access and standards of care.
The order is at odds with recent congressional action on marijuana. Congress’s recent budget bill, which Trump signed, established a strict federal cap of a total-THC limit of 0.4 milligrams per container, which would effectively ban most consumable hemp products popular in today’s market. The order indicates that the administration will likely urge Congress to revisit the definition to keep certain full-spectrum CBD available through a narrow legislative fix that preserves medically oriented CBD while restricting products posing health risks to the public. However, Congress has not yet defined the criteria by which a public health risk is defined.
Critically, the order does not itself reschedule marijuana; it accelerates the ongoing DEA process that began with the 2024 proposed rule following the HHS recommendation. Under the CSA, rescheduling generally requires notice-and-comment rulemaking, compilation of an administrative record, potential administrative hearings and publication of a final rule, subject to Office of Management and Budget (OMB) review. Further, any final rule will not legalize recreational use, automatically create FDA‑approved products nor instantly harmonize state and federal systems. The most immediate industry effects would likely include tax relief for state‑licensed operators and improved research access. Broader reforms such as banking, interstate commerce and comprehensive FDA frameworks would still require further agency action and/or legislation.
Practical Implications for Stakeholders
Organizations engaged in cannabinoid research or commercial product development should evaluate existing research pipelines, quality systems and product portfolios against a backdrop of forthcoming federal guidance.
- Research sponsors and academic centers should implement and refine real world evidence methodologies, enhance data governance for long‑term safety tracking and align outcome measures with anticipated HHS/NIH/FDA frameworks focused on dosing and patient‑relevant endpoints. Real world data should be collected and evaluated for specific patient populations and conditions, with particular attention paid to vulnerable patient populations including adolescents and young adults.
- Manufacturers of hemp‑derived CBD products should inventory formulations for THC/CBD ratios and potency, evaluate quality controls and labeling practices, and consider potential adjustments to comply with expected federal definitions and product limits. Manufacturers intending to supply product to support clinical research should become familiar with the FDA’s 2023 guidance document, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.
- Clinician groups and healthcare organizations should integrate evolving clinical evidence into research protocols and patient counseling, especially for pain, nausea and related conditions where the order acknowledges existing clinical support yet calls for more rigorous, standardized data.
Stakeholders should expect interagency activity to define research standards, real world evidence approaches and parameters for product composition and potency. While the order does not itself change the legal status of marijuana or finalize product standards for CBD, it sets in motion processes that could shape clinical practice and the cannabinoid marketplace by elevating evidence quality and standardizing definitions and limits.
McGuireWoods is closely monitoring federal implementation of the executive order and related agency actions by the HHS, NIH and FDA, as well as Congressional engagement on statutory definitions and product parameters for hemp-derived cannabinoids. To learn more about the executive order, how to participate in the EO 12866 regulatory review process and how these updates may impact your existing cannabis business, contact one of the authors of this alert or a member of the Healthcare & Life Sciences Industry Team.