Government prepares to ease federal restrictions on marijuana

Justice Department begins process to reclassify drug from Schedule I to Schedule III

Nearly three decades after California became the first state to legalize marijuana, the U.S. Department of Justice (DOJ) announced its intent to ease federal restrictions on marijuana—decriminalized in two dozen states already—by downgrading the drug’s status on the Controlled Substances Act (CSA) from Schedule I to Schedule III.

The May 16 announcement is the result of an October 2022 directive from President Joe Biden to the U.S. attorney general and the secretary of the U.S. Department of Health and Human Services (HHS) to conduct a scientific and medical review of how marijuana is scheduled under federal law. Based on its review, the HHS has recommended that marijuana be reclassified to a less restrictive category.

Drugs, substances, and certain chemicals used to make drugs are classified into five categories or schedules based on the drug’s medical value and potential for abuse. Schedule I is the most restrictive of the categories, reserved for drugs with no known medical use and a high potential for dependance. Heroin, ecstasy, and illegally manufactured forms of fentanyl are examples of Schedule I drugs.

A bottle surrounded by cannabis flower buds is filled with Cannabid oil via a syringe
The U.S. Department of Justice has begun the process to reschedule marijuana from a highly restricted Schedule I drug to a less tightly regulated Schedule III controlled substance.

Schedule III drugs, such as ketamine and anabolic steroids, are considered as a having a moderate to low potential for physical and psychological dependence.

Marijuana has been categorized as a schedule I drug since 1970, when Congress first enacted the CSA. Conventional wisdom at the time was marijuana was a dangerous, highly addictive drug with zero therapeutic benefits.

Public attitudes evolve, however. In 1996 California voters approved Proposition 215, which made medical marijuana legal with a doctor’s prescription. Twenty-four U.S. states and the District of Columbia have since legalized marijuana, for medicinal or recreational purposes, or both, even as the federal prohibitions have remained in place (see sidebar).

As explained in the May 21 Federal Register notice, the authority to schedule, reschedule, or decontrol drugs is vested in the U.S. attorney general by the CSA. While the attorney general has delegated this authority to the administrator of the U.S. Drug Enforcement Administration (DEA), an agency within the DOJ, the attorney general retains authority to schedule drugs.

The Federal Register goes on to explain how, in a letter dated August 29, 2023, Adm. Rachel Levine, MD, HHS’s assistant secretary for health, recommended to the DEA administrator that marijuana be controlled in Schedule III of the CSA.

“HHS found that marijuana has a potential for abuse less than the drugs or other substances in Schedules I and II; that marijuana has a currently accepted medical use in treatment; and that the abuse of marijuana may lead to moderate or low physical dependence or high psychological dependence. These findings correspond to the criteria for placement of a substance in Schedule III,” the notice reads.

As of press time in June, the DEA had not yet made a determination on the appropriate schedule for marijuana.

If marijuana is made a Schedule III drug, the regulatory controls applicable to Schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations, according to the DOJ’s proposal.

Additionally, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA’s definition of “marijuana” would also remain subject to the applicable prohibitions in the federal Food, Drug, and Cosmetic Act.

Public comments on the DOJ proposal must be submitted to the DEA electronically or postmarked on or before July 22.

The AVMA has released an updated version of a report meant to help veterinarians and pet owners better understand the laws, science, and research concerning cannabis and companion animals.

Published in April, the updated report, titled “Cannabis in Veterinary Medicine” highlights research into the effects of cannabidiol on cats and dogs conducted since the original report’s release in 2020. This includes preclinical pharmacokinetic data and potential adverse effects of CBD-rich hemp products in a small number of peer-reviewed studies.

Additionally, the AVMA report updates the regulatory landscape governing the use of cannabis-derived products in dogs and cats. (Note: This report was published prior to the U.S. Department of Justice’s announcement it would seek to reclassify marijuana from a schedule I to schedule III drug on the federal Controlled Substances Act.)

The report is broken into six sections:

  • Historical perspective on cannabis in the United States
  • Cannabis pharmacology and the endocannabinoid system
  • Clinical research investigating therapeutic potential and pharmacokinetics in companion animals
  • Analytic testing and quality control in the cannabis industry
  • Cannabis toxicosis in companion animals
  • Regulatory overview of the use of cannabis-derived products in animals

Covered are cannabis and two of its types: marijuana and hemp. Cannabis refers to “plants that are further defined as either ‘hemp’ or ‘marijuana,’ depending on their ∆9-tetrahydrocannabinol (THC) concentration. Marijuana is “cannabis that has a THC concentration exceeding 0.3% and classified as a Schedule I controlled substance regulated by the (Drug Enforcement Administration). Hemp “is defined in the 2018 Farm Bill as the plant species Cannabis sativa L. and any part of that plant, including the seeds and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a ∆9-THC concentration of not more than 0.3% on a dry weight basis.”

Regarding the clinical research portion of the cannabis report, data are derived almost entirely from dogs and cats because “well-controlled clinical studies for other species are sparse.”

Several areas of research are covered by the AVMA report. These include pharmacokinetic studies involving administration of CBD or CBD-rich hemp products to dogs; pharmacokinetic and safety studies of CBD or CBD-rich hemp products in cats; clinical investigations of CBD-rich hemp products to manage pain in dogs with osteoarthritis; clinical investigations using CBD for seizure management; and clinical investigations involving CBD to manage pain in cats following dental extractions.

Dr. Dharati Szymanski, an assistant director in AVMA’s Division of Animal and Public Health, oversaw the update of the report. She said the original 2020 report was published in response to a flood of inquiries the AVMA was fielding about the efficacy, safety, and legality of cannabis-derived products.

Importantly, this latest iteration features an updated review of state and federal regulations that impact the potential use of primarily hemp-derived products in animals, Dr. Szymanski explained.

“AVMA continues to work to support veterinarians in maintaining a current understanding of the many aspects of cannabis-derived products in veterinary medicine,” Dr. Szymanski said.