For more than fifty years, the Controlled Substances Act has required the federal government to evaluate drugs according to scientific standards before determining whether they should be placed in, removed from, or transferred between the schedules established by Congress. Those standards exist for one reason: to ensure that scientific evidence—not politics, public opinion, or commercial interests—guides decisions affecting public health.

The federal government’s proposal to move marijuana from Schedule I to Schedule III has been widely described as an effort to “follow the science.” Yet one of the most important witnesses to appear during the Drug Enforcement Administration’s administrative hearing presented scientific testimony that raises serious questions about whether the government’s proposal is consistent with the standards traditionally applied under the Controlled Substances Act.

The scientist was not an outside advocate or political opponent of marijuana legalization. She was Dr. Luli Akinfiresoye, a Ph.D. pharmacologist employed by the Drug Enforcement Administration. Dr. Akinfiresoye has worked for more than a decade in the DEA’s Drug and Chemical Evaluation Section, the office responsible for evaluating controlled substances for scheduling under the Controlled Substances Act.

More importantly, she identified herself as the author of the DEA’s official scientific review of marijuana completed in December 2024. She testified that the report was prepared in coordination with colleagues in the Drug and Chemical Evaluation Section, approved within the section, submitted as an official DEA document, and represented the consensus work of that office. This was not simply the opinion of an individual scientist. It was testimony explaining the DEA’s own scientific review of marijuana.

Filling the Gaps

One of the most revealing moments occurred early in Dr. Akinfiresoye’s testimony. She explained that the DEA prepared its scientific review because the Notice of Proposed Rulemaking lacked information necessary to complete a proper scientific evaluation.

“The NPRM had gaps in data,” she testified.

She explained that, ideally, the DEA publishes an Eight-Factor Analysis together with a proposed scheduling action. In this case, however, the scientific analysis had not been completed because additional information was needed. Her review was prepared to provide the scientific information sought by the proposed rulemaking.

If the DEA’s own scientists believed additional scientific information was necessary before evaluating marijuana, it raises an obvious question: Was the scientific record complete when the rescheduling proposal was issued?

Two Different Scientific Standards

Perhaps the most significant issue addressed during the hearing concerned the standard used to determine whether marijuana has a “currently accepted medical use.” The Department of Health and Human Services recommended rescheduling using a two-part analysis.

Dr. Akinfiresoye testified that the DEA’s Drug and Chemical Evaluation Section instead applied the traditional five-factor analysis that the agency has historically used when evaluating drugs under the Controlled Substances Act. She explained that this decision was made collectively by the scientists within her section because the five-factor approach was the more comprehensive scientific framework.

When asked whether the two-factor approach made scientific sense to her as a pharmacologist, she answered simply:

“Scientifically, no.”

She then explained why. According to her testimony, the two-factor approach lacked consideration of chemistry, safety, and efficacy. Those three elements are fundamental to modern drug evaluation.

The scientific framework relied upon by the DEA’s own pharmacologists differed from the framework that ultimately supported the government’s proposed rule.

The Problem of Reproducibility

The testimony became even more significant when Dr. Akinfiresoye described marijuana itself. She testified that marijuana is not a single molecular entity. Rather, it is composed of numerous cannabinoids and other compounds whose concentrations vary substantially from one strain to another. As a consequence, she testified, it is not possible to derive a standardized dose, and marijuana does not possess a consistent and reproducible chemical profile capable of producing predictable clinical effects.

Modern medicine depends upon reproducibility. Every FDA-approved prescription medicine is expected to have a defined chemical identity, consistent manufacturing, standardized strength, predictable dosing, demonstrated safety, and demonstrated effectiveness.

Dr. Akinfiresoye testified that marijuana, as generally available today, does not satisfy those characteristics.

What DEA’s Scientific Review Found

According to Dr. Akinfiresoye’s testimony, the review found that marijuana lacks reproducible chemistry necessary for standardized dosing. It concluded that adequate and well-controlled studies demonstrating efficacy were lacking. It identified important concerns regarding safety, diversion from state marijuana programs, cannabis use disorder, psychiatric complications, and the absence of meaningful standardization among products marketed as marijuana.

She also testified that the review included information concerning diversion from state marijuana programs that had not been included in the HHS analysis, including diversion from licensed purchasers and dispensaries.

Equally noteworthy was her testimony regarding state “medical marijuana” programs. She agreed that dispensary employees should not be providing medical advice because they lack the information necessary to evaluate drug interactions, patient histories, pharmacokinetics, and other safety considerations. She further agreed that such advice can be harmful to patients.

Why This Matters

This hearing is about far more than marijuana. It is about whether the federal government continues to apply the same scientific standards to every substance considered under the Controlled Substances Act. No one disputes that individual cannabinoids may have therapeutic potential. Several cannabinoid-based medications have already been approved through the FDA’s rigorous review process. Those products possess defined chemistry, standardized manufacturing, demonstrated safety, approved labeling, and reproducible dosage.

The question presented by the current proceeding is different. It is whether marijuana itself—a highly variable botanical material sold in thousands of differing chemical compositions—meets the scientific standard historically required before the federal government recognizes a substance as having a currently accepted medical use.

According to the DEA’s own pharmacologist, significant scientific questions are unanswered

The integrity of the Controlled Substances Act depends upon one simple principle—that every substance is evaluated according to the same scientific standards.

Whether that principle has been followed in the current rescheduling proceeding is a question the hearing record itself may further answer. The official position of the DEA’s Drug and Chemical Evaluation Section is that marijuana has not met the standard, yet the DEA recklessly wants to proceed to satisfy the Administration’s political agenda.