Cannabis has been on a steady march toward mainstream acceptance and legalization on a state-by-state basis for more than two decades. According to the National Conference of State Legislatures, cannabis has been legalized for medicinal purposes in 37 states, and 19 of those states, plus the District of Columbia, have legalized cannabis for adult-use, nonmedical purposes. National polling shows that nearly 70 percent of Americans believe cannabis should be legal at the national level. Both the U.S. House of Representatives and the Senate have introduced bills with substantial support that would federally legalize and regulate cannabis.
It is clear a tremendous amount of momentum is behind the cannabis legalization effort. However, when it comes to universities, as well as their researchers and students, evolving regulations and bureaucratic scrutiny present significant barriers to cannabis.
Because cannabis is designated as a Schedule I controlled substance under the Controlled Substances Act of 1970, universities that accept federal funding have limited options when it comes to cannabis and its use on campus, whether for recreational, medical, or even research purposes.
Even in states where it is fully legal for recreational purposes, such as New Jersey, New York, and Colorado, cannabis is still strictly prohibited on college campuses, to avoid issues arising under federal law. However, cannabis research serves a vital function in a rapidly growing industry, and there is a process for schools to safely pursue this important work without losing their federal funding.
Any college looking to conduct legally sanctioned cannabis research should expect significant bureaucratic scrutiny across government and seek the legal and regulatory guidance needed to navigate the many requirements. At the federal level alone, any research on cannabis or cannabis products will require interaction with the National Institute on Drug Abuse (NIDA), the Drug Enforcement Agency (DEA), and the Food and Drug Administration (FDA).
The FDA treats any research on cannabis as research into an investigational new drug, which requires a formal application to the agency. The university would also be required to obtain a letter of authorization from NIDA, which is the only source for legally obtaining a supply of cannabis for study. This authorization letter will include information about the researcher’s facilities, as well as any important characteristics of the cannabis product at issue. Finally, the university would also need to seek registration with the DEA and a license for the specific facilities where the research would be conducted. The DEA may also require a review of the documentation submitted to NIDA and the FDA, as well as physical site inspections and a security protocol review. Any deficiency detected by these agencies could freeze or end a cannabis research effort.
States—including those that have already legalized cannabis for medical and recreational use— have also taken an interest in regulating the research of cannabis. Many universities would need to seek approval from state cannabis regulators, medical boards, or advisory panels, which is often a prerequisite for submitting a compliant application to the FDA or DEA.
Failing to comply with the rules and regulations of cannabis research could be absolutely fatal to a university, and no school wants to be the example. Universities with the wherewithal and competent advisors will be able to find success navigating this vast bureaucratic landscape. Many schools are already doing so and have created research centers dedicated to cannabis and hemp. Starting with hemp research may also be a good launching point for a larger research program in the future, but with far less risk in the present. Following the passage of the 2014 Farm Bill, universities were permitted to grow and possess hemp and hemp-derived products—essentially, cannabis with 0.3% or less THC by dry weight—for research purposes. With the passage of the 2018 Farm Bill just a few years later, hemp was removed from Schedule I of the Controlled Substances Act and fully legalized on the federal level.
As cannabis continues to gain in popularity and acceptance, the hope is that similar legislation will legalize cannabis research, and ultimately cannabis itself, to allow university-level research to grow with far less risk and far fewer bureaucratic road blocks to the important work yet to be done.
Brian M. McGovern is a partner at Archer in Voorhees, New Jersey, where he is an active member of the firm’s Business Counseling and Cannabis Law Groups. Brian can be reached at 856- 673-3923 or bmcgovern@archerlaw.com.
Natalie M. Brennan is an associate in Archer’s Cannabis Law and Health Care Law Groups. Contact Natalie at 856-673-7155 or nbrennan@archerlaw.com.
Learn more about Archer at https://www.archerlaw.com/.
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