DEA Urges Judge to Move Marijuana to Schedule III as Final Rescheduling Briefs Set Stage for Decision

The Drug Enforcement Administration (DEA) is formally urging the judge overseeing the federal marijuana rescheduling case to recommend moving marijuana from Schedule I to Schedule III, arguing that the evidence presented during the nearly three-week hearing shows the drug no longer meets the requirements for the nation’s most restrictive drug category.

The government laid out its position in a post-hearing brief filed August 17 with Chief Administrative Law Judge Derek Julius. The filing came alongside a series of briefs from parties opposing rescheduling, including Smart Approaches to Marijuana (SAM), the states of Idaho, Indiana and Nebraska, the Tennessee Bureau of Investigation (TBI), the National Drug and Alcohol Screening Association (NDASA), DUID Victim Voices, Dr. Kenneth Finn and Dr. Phillip Drum.

The filings represent the closing arguments in a hearing that ran from June 29 through July 15. Julius had given designated parties until August 17 to submit proposed findings of fact, conclusions of law and closing arguments.

The government’s position is unambiguous.

“Marijuana most appropriately belongs in Schedule III because its abuse potential and dependency profile most align with those substances in Schedule III,” DEA attorneys wrote. The government asked Julius to recommend that marijuana be transferred from Schedule I to Schedule III.

Central to the government’s case is the Department of Health and Human Services’ 2023 scientific and medical review.

HHS concluded that marijuana has a currently accepted medical use in the United States for at least three conditions: chronic pain, anorexia associated with a medical condition, and nausea and vomiting associated with chemotherapy.

The government says that finding alone prevents marijuana from continuing to meet the statutory requirements of Schedule I, which requires a drug to have no currently accepted medical use.

Federal attorneys also pointed to the scale of state medical marijuana programs. According to the filing, more than 30,000 health care practitioners were authorized to recommend marijuana to more than six million patients across 43 U.S. jurisdictions, which the government argues undermines the contention that marijuana lacks accepted safety when used under medical supervision.

Another major dispute involves how the federal government determines whether a substance has a “currently accepted medical use,” commonly referred to as CAMU.

Opponents have argued that marijuana fails the five-part test historically used by DEA. The government counters that an Office of Legal Counsel (OLC) opinion found that test impermissibly narrow because it effectively ignored widespread medical use occurring through state-regulated programs.

Under the newer two-part approach used by HHS, regulators examine whether there is widespread current medical experience with the drug under state-authorized programs and whether there is credible scientific evidence supporting at least one of those medical uses.

The government notes that OLC found the newer approach legally sufficient even for a drug that has not received Food and Drug Administration approval and would not satisfy the older five-part test. The OLC opinion also concluded that while DEA is not automatically bound by HHS’ ultimate CAMU recommendation, DEA must give “significant deference” to HHS’ underlying scientific and medical determinations after formal rulemaking begins.

DEA attorneys also highlighted testimony from witnesses called by opponents who acknowledged evidence of therapeutic benefits.

The government’s brief notes that Finn has previously recommended marijuana for pain patients, while Dr. Bertha Madras acknowledged evidence involving neuropathic pain, severe nausea and cachexia or wasting syndrome. Dr. Deepak D’Souza also discussed research finding a beneficial effect from a standardized cannabis extract for pain. The government argues those concessions further support the conclusion that marijuana has at least one accepted medical use.

Beyond medical use, the government argues marijuana’s relative abuse potential and dependence risks are more consistent with Schedule III than Schedule I or II.

The HHS analysis compared marijuana with substances including heroin, fentanyl, cocaine, oxycodone and other controlled drugs using data involving emergency room visits, hospitalizations, poison center reports, substance use disorders and overdose deaths.

DEA’s brief acknowledges that marijuana can be abused and can cause psychological dependence. The agency is not advocating that marijuana be removed from the Controlled Substances Act.

Instead, the government argues that the severity of marijuana-related outcomes generally falls below those associated with Schedule I and II comparator drugs and that marijuana produces low-to-moderate physical dependence, with withdrawal generally less severe than that associated with heroin and opioids.

The government therefore says marijuana should remain federally controlled, but at Schedule III.

SAM and the states of Idaho, Indiana and Nebraska reached the opposite conclusion in their joint filing.

They argue that the government has failed to establish that marijuana has lower abuse potential than Schedule I and II substances, has a currently accepted medical use or meets Schedule III’s standards concerning dependence.

A major target of their brief is HHS’ two-part CAMU test.

The parties argue that the framework was developed specifically for the marijuana review and represents an unjustified departure from the five-part test used in previous scheduling proceedings. They contend that state medical marijuana programs do not themselves establish acceptance within the medical profession and that national statistics concerning doctors and patients do not establish widespread use for a particular medical condition.

They also challenge HHS’ evaluation of marijuana’s risks, pointing to cannabis use disorder, psychosis and schizophrenia, while arguing that the federal analysis relied too heavily on comparisons with drugs associated with extremely high overdose rates.

The filing further argues that marijuana products covered by federal law vary dramatically in potency and composition, making it inappropriate to extrapolate results from controlled studies involving specific preparations to marijuana generally.

The group ultimately told Julius that the government “has not carried its burden” and should recommend keeping marijuana in Schedule I.

TBI’s filing attacks the rescheduling process from a different angle, arguing that the underlying notice of proposed rulemaking was legally invalid because it was issued by the attorney general rather than the DEA administrator.

TBI argues that although the Controlled Substances Act originally gives scheduling authority to the attorney general, federal regulations delegated that authority to the DEA administrator. According to TBI, that delegation deprived the attorney general of authority to personally issue the rescheduling proposal.

The agency also argues that HHS’ eight-factor analysis failed to adequately consider diversion from state-regulated markets, marijuana-associated violent crime and traffic fatalities, products containing psychoactive cannabinoids other than delta-9 THC, and increased accidental exposures involving children.

TBI’s filing concludes that DEA has not met its burden and asks for marijuana to remain in Schedule I.

NDASA focused heavily on what it says could be an unintended consequence of Schedule III: federal workplace and transportation drug testing.

The organization argues that Executive Order 12564, which forms part of the legal framework for federal workplace testing, defines illegal drugs for purposes of the program as controlled substances in Schedule I or II. HHS workplace testing guidelines similarly reference Schedule I and II substances.

NDASA therefore contends that moving marijuana to Schedule III could eliminate existing federal authority to require marijuana testing under programs that depend on those rules, potentially affecting airline pilots, commercial truck drivers, locomotive engineers, school bus drivers, transit operators, maritime workers and other safety-sensitive employees.

The government rejects that argument as a reason to keep marijuana in Schedule I, saying concerns involving transportation, employment and law enforcement do not overcome the scientific and medical evidence relevant to marijuana’s proper placement under the Controlled Substances Act.

DUID Victim Voices and Finn filed a joint brief arguing that the government’s case underestimates marijuana’s potential effects on impaired driving, mental health and public safety.

Their filing challenges both HHS’ CAMU analysis and its method for comparing marijuana’s abuse potential with other drugs.

They argue that the government relied on comparisons with pharmacologically different substances, including alcohol, and failed to adequately weigh evidence involving psychosis, schizophrenia, suicidality, cardiovascular risks, impaired driving and diversion.

The parties also argue that studies involving standardized or lower-potency marijuana preparations cannot necessarily establish the safety or effectiveness of the much wider range of high-potency marijuana products included under federal law.

They asked Julius to recommend against rescheduling.

Drum, a pharmacist participating as an individual designated party, similarly argues marijuana should not move to Schedule III.

His filing focuses extensively on the lack of standardized dosing, variations among marijuana products, state testing and labeling systems, youth access and product contamination. He argues that botanical marijuana should not be moved to Schedule III without full FDA approval and standardized labeling comparable to other medications.

The government disputes the relevance of several of Drum’s arguments. Its brief also notes that Drum testified during the hearing that Schedule II could potentially be a more appropriate classification for marijuana, and says much of his testimony dealt with federal oversight, testing and labeling rather than whether marijuana has a currently accepted medical use.

With the August 17 briefing deadline now passed, the case moves to Julius.

Under DEA regulations, the administrative law judge is required “as soon as practicable” to prepare a report containing recommended rulings on the parties’ proposed findings, his own recommended findings of fact and conclusions of law, and a recommended decision.

The parties then have 20 days after receiving the report to file exceptions to Julius’ findings or recommended decision. No sooner than 25 days after serving the report, Julius is to certify the complete administrative record to the DEA administrator.

DEA Administrator Terrance “Terry” Cole currently leads the agency.

Once the record reaches the administrator, federal regulations call for a final order to be published in the Federal Register setting out the final rule and the findings supporting it. The regulations do not establish a specific deadline for Julius to issue his recommended decision or for the administrator to issue the final order.