President Donald Trump recently announced his intention to make a decision regarding potential changes to marijuana regulation, specifically the possibility of rescheduling marijuana under the Controlled Substances Act (CSA). This renewed focus follows the submission of a proposed regulation for this change in May 2024 by the Department of Justice (DOJ) under the Biden Administration. 

Marijuana is currently classified as a Schedule I controlled substance, meaning it is considered to be a substance that has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks an accepted safety profile for use under medical supervision. The implications of rescheduling marijuana from a Schedule I to a Schedule III would be substantial as it relates to FDA regulations and pharmaceutical development. For example, the Schedule I designation of marijuana severely restricts research opportunities due to the stringent regulations surrounding substances deemed to have a high potential for abuse and no accepted medical use. By reclassifying marijuana as a Schedule III controlled substance, it would be recognized as having a moderate to low potential for dependence and a legitimate medical use. This could facilitate more extensive research and development in the pharmaceutical industry and, in turn, allow for a broader exploration of marijuana’s therapeutic benefits and potential applications in medicine.

While the Trump administration has expressed openness to relaxing regulations surrounding marijuana, it comes with significant opposition that cites concerns about marijuana's abuse potential and public safety. It will be important to assess and prepare for any potential impact the rescheduling of marijuana under the CSA would have on your business. Buchanan’s experienced FDA & Biotechnology Team, Cannabis Industry Group, Life Sciences Industry Group and Government Relations Professionals are here to help.