Another Long Strange Trip
In 1970, the U.S. Congress enacted the Controlled Substances Act (CSA) to establish a federal drug policy regulating the manufacture and distribution of regulated substances. The CSA classified cannabis (the CSA schedule refers to marijuana and cannabis interchangeably.) as a Schedule I controlled substance. Schedule I substances are considered to have no currently accepted medical use and a high potential for abuse. Possession and sale of cannabis is illegal under U.S. federal law despite the fact that 38 states have legalized medical cannabis. Prior to the passage of the CSA, cannabis had been used medically and was in the U.S. Pharmacopeia from 1851 until 1941. Now, it appears that the federal pendulum with respect to cannabis may have begun to move ever so slowly back in that direction. On May 21, 2024, more than 50 years after the passage of the CSA, the US Department of Justice (DOJ) published a proposal in the Federal Register to transfer marijuana from Schedule I to Schedule III. The DOJ based its conclusion on a report prepared by the Department of Health and Human Services (HHS) regarding marijuana rescheduling at the request of President Biden in 2022. (Letter for Anne Milgram, Administrator, DEA, from Rachel L. Levine, M.D., Assistant Secretary for Health, HHS (Aug. 29, 2023)}
By way of background, the Drug Enforcement Administration (DEA), a federal agency under the DOJ responsible for combating illicit drug distribution, classifies drugs into five schedules based on the drug’s acceptable medical use and potential for use or dependency. As noted above, Schedule I controlled substances are considered to have no currently accepted medical use and a high potential for abuse. Other Schedule I controlled substances include heroin, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone (Quaalude), and peyote. In contrast, Schedule III substances are defined as drugs with a moderate to low potential for physical and psychological dependence. Examples of Schedule III substances include ketamine, anabolic steroids, and testosterone, all of which are legally available by prescription.
The HHS report reviewed extensive scientific and technical literature and reports from states that have legalized medical cannabis and concluded that cannabis has a currently accepted medical use at the very least, for treatment of anorexia related to a medical condition, nausea and vomiting, and pain. The HHS report also concluded that although abuse of cannabis produced clear evidence of a risk to public health, that risk was relatively lower than that posed by most other comparator drugs. These conclusions led HHS to recommend rescheduling cannabis to Schedule III.
It may be more than a year before the rescheduling takes effect. The DEA is accepting public comments up through July 22, 2024. At the completion of the comment period, there will be a review of the proposal by an Administrative Law Judge. Assuming the proposal is approved without any litigation, the DEA will then publish the final rule.
The likely impact of rescheduling on the cannabis industry and patenting will be discussed next month in Part II of this article.
— Gretchen Temeles, Esq.