FDA Releases Its Scientific Support for Rescheduling Marijuana to Schedule III

January 18, 2024

On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration’s (FDA) reasons for recommending that the Drug Enforcement Administration (DEA) reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).

FDA scientists conducted an eight-factor analysis (8FA) wherein the scientists concluded that marijuana has acceptable medical uses and a moderate to low risk of physical dependence compared to other Schedule I drugs like LSD and heroin. McGuireWoods previously reported on HHS’ April 2023 letter to DEA; however, the supporting documentation was not made public until the Jan. 12 release. On Dec. 19, 2023, the DEA advised it was reviewing HHS’ recommendation, signaling DEA may be prepared to reschedule marijuana in the near future, as McGuireWoods noted earlier this month. While the DEA maintains final authority to reschedule marijuana, under the CSA, HHS’ recommendations “shall be binding … as to [] scientific and medical matters.”

FDA’s 8FA analysis concluded that marijuana has less potential for abuse than other Schedule I or II substances and has a clinically accepted medical use in the United States (including for nausea and lack of appetite associated with chemotherapy and for pain management). FDA added that even for heavy chronic users, “marijuana withdrawal syndrome appears to be relatively mild compared to the withdrawal syndrome associated with alcohol, which can include more serious symptoms such as agitation, paranoia, seizures and even death.”

Importantly, FDA noted that “[the] risks to the public health posed by marijuana are lower compared to other drugs of abuse (e.g., heroin, oxycodone, cocaine), based on an evaluation of various epidemiological databases for emergency department (ED) visits, hospitalizations, unintentional exposures, and most importantly, for overdose deaths.” It is also worth noting that the studies largely focus on effects of delta-9 THC, though FDA acknowledges delta-8 THC also “produces marijuana’s psychoactive effects.” It remains to be seen whether the lack of studies on delta-8 THC may further complicate its legal status should DEA decide to reschedule based on the delta-9 THC scientific evidence.

This development is another step toward the potential federal legalization of marijuana, although 24 states, two U.S. territories and Washington, D.C., have already legalized marijuana for adult recreational use, and 38 states and D.C. have legalized medical marijuana. If DEA reschedules marijuana to Schedule III, the industry may experience relief from certain tax burdens it currently faces under Section 280E of the Internal Revenue Code and it might make banking easier. However, rescheduling would bring many products and manufacturers more squarely within FDA’s regulatory authority, likely leading to new regulations and guidance that could take years to implement, leaving the industry in legal limbo for the foreseeable future.

McGuireWoods attorneys are experienced in representing and advising investors, manufacturers and vendors in the marijuana industry and marijuana-related industries. If you have questions about navigating current complex regulations or how rescheduling may impact your business, please contact one of the authors of this article.