Legal Background
As the US government has removed certain restrictions on the use and distribution of specific aspects of the cannabis plant, the cannabis-derived products marketplace has expanded.
The Agricultural Act of 2014 defined “industrial hemp” as any part of the Cannabis sativa L. plant with a delta-9 tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis. This allowed it to be used for research purposes only in limited situations. The Agricultural Improvement Act of 2018 (also known as the 2018 Farm Bill) again relaxed federal restrictions on hemp by removing hemp from the Controlled Substances Act statutory definition of marijuana, resulting in interstate commerce of hemp. The 2018 Farm Bill also preserved the US Food and Drug Administration’s (FDA’s) authority to regulate products containing cannabis and cannabis-derived products under the Federal Food, Drug, and Cosmetic Act and § 351 of the Public Health Service Act.
To this point, the FDA has approved one cannabis-derived drug product and three synthetic cannabis-related drug products for humans. There are currently no FDA-approved, conditionally approved, or indexed animal drugs that contain cannabidiol (CBD). Under the Animal Medicinal Drug Use Clarification Act of 1994 and its implementing regulations, however, veterinarians can prescribe approved human drugs for use in animals in an extralabel manner under certain conditions.
The FDA may be trying to change this. On January 16, 2025, the FDA’s Center for Veterinary Medicine (CVM) under the Biden administration released a request for information (RFI) soliciting comments from the public, with a focus on practicing veterinarians, related to the use of cannabis-derived products in veterinary medicine. The RFI is focused primarily on CBD products and other hemp-derived products. The FDA also stated in the RFI that regulation of the CBD market is a priority and thus the information gathered will guide the FDA in its future regulatory action. Stakeholders have until April 16, 2025, to submit comments to CVM. However, as discussed below, the change in administration may result in updated priorities.
Implications of Administration Change
The recent change in presidential administration has created some uncertainty regarding agencies’ current cannabis-related positions and priorities.
President Donald Trump became the first major-party presidential nominee to endorse a state adult-use legalization campaign when he voiced his support for Amendment 3 to Florida’s constitution in September 2024. President Trump also stated his intention to “focus on research to unlock medical uses of marijuana to a Schedule 3 drug, and work with Congress to pass common sense laws.” However, President Trump has not addressed the issue since his September 2024 statement.
Trump’s selections to lead relevant agencies such as the DOJ and DEA will likely have a sizable impact on the future of marijuana rescheduling. Cannabis was not a topic of discussion at the confirmation hearings for Attorney General Pam Bondi. On February 11, 2025, Trump announced his nomination of Terrance C. Cole for DEA administrator. Cole has expressed opposition to cannabis reform. The current acting administrator of the DEA, Derek Maltz, has similarly voiced opposition to cannabis reform.
The topic received little attention at newly confirmed US Department of Health and Human Services Secretary Robert F. Kennedy Jr. (RFK)’s nomination hearings, with RFK Jr. stating that he would defer to the DEA on marijuana rescheduling. Although RFK has previously called for cannabis decriminalization, he has recently been silent on rescheduling efforts and instead has said that he will defer to the DOJ and DEA in the allocation of their resources and development of their priorities.
Next Steps
Given the mixed signals offered by current and future members of the Trump administration, it remains difficult to predict exactly where cannabis-related reform is headed in the near future. However, as federal cannabis regulations undergo significant changes, stakeholders should stay informed and involved in the rulemaking process, and businesses should continue to adapt to the evolving landscape to remain competitive and compliant.
If you would like to submit comments to the CVM or require guidance on navigating cannabis regulation, please contact one of the authors or any other member of McDermott’s Cannabis Regulatory Practice Group and Food, Drug & Medical Device Regulatory Practice Group. McDermott will continue to monitor cannabis regulation as it develops.