Adam and Shuki had the privilege of partnering with LA NORML to prepare and submit a public comment. The DEA has recently proposed a new set of regulations that would govern cannabis cultivation for research purposes. Concerned about some of the details of the proposed regulations, we submitted a comment recommending several changes to the rules before they are finalized.
See our full comment here.
In 2016, as cannabis legalization was spreading rapidly among states, the demand for cannabis research was increasing as a result of heightened public interest in cannabis’ medicinal benefits. As a result, in August 2016, the DEA published a policy statement announcing that the agency would support the expansion of medical cannabis research by increasing the number of authorizations for cannabis manufacturers supplying researchers. This policy change was designed to allow for a more varied and robust supply of cannabis to support researchers. This announcement was a landmark change in the DEA’s treatment of cannabis research, as it marked the first time the agency expressed support for expanding research into the medical utility of cannabis and its chemical constituents.
Prior to this 2016 policy statement, the agency had consistently treated cannabis as though it had no medical value, despite clear indications to the contrary. The federal government itself has long acknowledged the medical value of certain cannabis compounds. For nearly 20 years, the Department of Health and Human Services has held U.S. Patent No. 6,630,507 (filed Apr. 21, 1999), which covers non-psychoactive cannabinoids, both synthetic and natural. Specific language included in this patent details the medical benefits of cannabinoids, including that “the cannabinoid is used to prevent or treat an ischemic or neurodegenerative disease in the central nervous system of a subject” and details how this can relieve effects of “Alzheimer’s disease, Parkinson’s disease, HIV … etc.” Since the DEA was formed in 1973, it has repeatedly spurned efforts to expand its allowance of cannabis research studies. The agency has authorized only one entity to cultivate cannabis in the U.S. for research purposes: the University of Mississippi’s National Center for Natural Products Research (NCNPR), which cultivates its cannabis pursuant to a contract administered by the National Institute of Drug Abuse (NIDA).
The DEA’s 2016 announcement that it would authorize additional cannabis cultivators thus represented a major departure from its longstanding policy of authorizing only one entity. Studies have revealed that the NCNPR’s cannabis is extremely low in THC content and is more genetically similar to hemp than cannabis, and therefore, is not a representative sample of the commercial cannabis varieties available to medical patients across the country. This unavailability of representative cannabis has been counterproductive to the progress of important clinical studies into the effects of medical cannabis, and raises concerns as to the accuracy of previous studies that have relied on the NCNPR’s cannabis.
Because of these problems, many hailed the 2016 policy announcement as a great development. People predicted that the DEA was about to change its tune on medical cannabis cultivation. Unfortunately that didn’t happen.
The DEA delays again
After announcing its policy change, however, the DEA continued to drag its feet. The agency received over 30 applications for cultivation programs, but to date, has neither approved nor denied a single application. This delay led to widespread confusion amongst the applicants and the industry at large, as it appeared to contradict the DEA’s stated intent to support the expansion of research by approving new registrants.
Last month, however, it became public knowledge that the Department of Justice drafted a legal memo in 2018 that was relied upon by the DEA to stall the processing of those pending cultivation applications. The legal memo, kept from the public view until April 2020, opines that the DEA’s cannabis licensing framework with the NCNPR has been out of compliance with the Single Convention for the past 47 years. The memo also reaches the conclusion that the DEA’s 2016 policy statement that it would approve additional applicants would, if carried out, not comply with the Single Convention, and that changes must be made to the regulatory framework before the new policy is implemented. Critics have argued that the legal memo is fraught with suspect legal reasoning that is designed to buttress a pre-determined decision to delay the applications.
Because it was determined that the DEA needed to fix its regulatory framework, none of the applications could get processed. The delays continued until the DEA finally announced the new proposed rules on March 23, 2020. During the 60 days comment period, there were more than 200 comments submitted. Now that the comment period has passed, the DEA will begin reviewing the comments and amending its regulations before announcing a final rule in the coming months.