Federal Laws & Cannabis Scheduling

“Scheduling” refers to the federal classification of drugs, Schedules I-V, created by Congress in 1970 through the Controlled Substances Act (CSA). A substance’s designated schedule determines how it is regulated (prohibited, prescription, or over-the-counter) and the severity of associated criminal penalties for unregulated possession, production, or sales.  

Cannabis is classified at the most restrictive level, Schedule I. This schedule is reserved for substances that have been deemed to have a high potential for abuse and have no “accepted medical use in the United States,”  and are essentially banned. Over the past 50+ years, the Schedule I status of Cannabis has been responsible for the imprisonment of millions of Americans and barri

ers to research and development and is at the heart of the struggle for access to cannabis therapeutics. 

The scheduling of a substance is determined by a process defined in the CSA that includes a medical and scientific review confined by an “Eight Factor Analysis” and a “five-element test” for determining whether the drug has a currently “accepted m

edical use in treatment in the United States”  conducted by Health and Human Services (HHS) and the Department of Justice (DOJ) and a review of the United Nation’s classification to ensure compliance with International Drug Treaties. 

Over the last 50 years, HHS and DOJ have conducted five scheduling reviews of cannabis, initiated by the petition process defined in the CSA. The last review concluded in 2016 with the DEA’s issuing “Denial of Petition to Initiate Proceedings to Reschedule Marijuana.”

Congress can override this process and schedule or change the scheduling of a substance without HHS or DOJ. 

In 2020, the United Nations adopted the World Health Organization’s (WHO) 2015 recommendations and changed the classification of cannabis to recognize its medical use. This change frees any signatory countries to international drug treaties to change their classification and facilitate access. Today, over 60 countries now have federal medical cannabis programs. 

In 2022, President Biden initiated the rescheduling process by issuing a statement calling on Health and Human Services (HHS) and the Department of Justice (DOJ) to revisit the scheduling of cannabis. 

On August 30, 2023, HHS confirmed that it had recommended a Schedule III status after conducting its review. 

On May 1st, 2023 DOJ confirmed that are moving the forward the rescheduling process with HHS's  Schedule III recommendation. 

That’s right, HHS & the FDA has confirmed that cannabis has accepted medical use in the United States and DOJ agrees!

On August 30, 2023, HHS confirmed that it had recommended a Schedule III status after conducting their review, and on January 12, 2023, the report HHS sent to DEA their recommendation was made public through a FOIA request. Americans for Safe Access (ASA) provided guidance and data to the Food & Drug Administration (FDA), which was incorporated into their approach to the scheduling process and to utilize in reaching their conclusion that cannabis does, in fact, have accepted medical use.

The full implications of rescheduling will be determined ultimately by the executive branch. However, one certainty is that cannabis will no longer fall solely under the jurisdiction of the DOJ and the CSA. Currently, state-level cannabis programs operate outside the CSA, making it reasonable to expect that the DOJ would refrain from enforcing drug trafficking statutes for unregulated Schedule II/III substances when cannabis is rescheduled. However, these substances are still illegal and carry significant penalties akin to Schedule I substances. 

The definition of all the other schedules (II-V) includes a finding that the substance has “accepted medical use in treatment in the United States,” but this does not mean that the federal government recognizes cannabis as a medicine. This definition is reserved for products that have achieved FDA approval, a process ill-suited for herbal products with multiple active compounds like cannabis. The FDA categorizes “herbal medicines” as dietary supplements that cannot make health claims and are primarily absent from curricula for medical professionals and insurance coverage.

Most products intended for human consumption in the U.S. fall under the guidelines of the Food, Drug, and Cosmetic Act (FDCA) or the Dietary Supplement Health and Education Act (DSHEA), both regulated by the FDA. However, in January 2023, the FDA declared its inability to regulate cannabinoid products despite their removal from the CSA  through the Hemp Authorization of the 2018 Farm Bill. The FDA has urged Congress to create a new pathway with extended authority for this purpose. 

State programs operate outside the Controlled Substance Act (CSA), medical cannabis programs will continue to be protected from federal interference of the Justice Department (DOJ)  as long as the medical cannabis amendment to the Commerce-Justice-Science (CJS) budget is reauthorized every year.

When the DEA finalizes their review, it will be posted to the federal registry, accompanied by a timeframe for public comment. 

At that time, stakeholders can request a hearing to present the DEA with additional information in pursuit of a different outcome. If granted, a non-binding hearing will be conducted by an administrative law judge. The last hearing in 1985 concluded with the DEA rejecting the rescheduling petition in defiance of the judge’s findings in 1988.

If there is no hearing, the Department of Justice will confirm the DEA’s scheduling recommendation. 

LIVING IN A WORLD THAT ACCEPTED MEDICAL USE!

No matter what happens next, the FDA has confirmed that cannabis has accepted medical use in the United States. This will no doubt have an impact on attitudes about medical cannabis, reducing stigma and increasing the acceptance of cannabis for medical professionals, employers, state regulators, and hopefully Congress.

Take A Bow Patients! The federal prohibition of cannabis sent medical cannabis advocates to their states for legal protection and, eventually, access. Through state programs, we were able to develop regulations for various stages of the supply chain, train a workforce, stimulate interest in cannabis research, and, as HHS has concluded, establish “accepted medical use in the United States.”