Last week, the Drug Enforcement Administration (DEA) issued a Federal Notice advising of its intent to issue new regulations for its marijuana growers program for scientific and medical research.
The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marijuana except by persons who are registered under the CSA to do so for lawful purposes. Currently, the DEA allows cannabis — consisting of the marijuana plant, with greater than 0.3 percent THC content — to be grown for research purposes at only one location: The University of Mississippi. This past June, the Scottsdale Research Institute (SRI) challenged this federally imposed limitation in the D.C. Circuit Court on the basis that the limitation to one bulk growing facility is arbitrary and capricious, particularly given espoused shortages and quality issues with product developed at that facility for medical research purposes.
Responding to this concern, the DEA advised of its intent to expand the number of approved bulk manufacturers:
By registering these additional growers in accordance with the criteria of section 823(a), DEA anticipates that additional strains of marihuana will be produced and made available to researchers. This should facilitate research, advance scientific understanding about the effects of marihuana, and potentially aid in the development of safe and effective drug products that may be approved for marketing by the Food and Drug Administration.
The DEA is currently in receipt of 33 applications for registration as bulk manufacturers, some of which the DEA requests be withdrawn in light of the Agriculture Improvement Act of 2018, Public Law 115-334, which excluded hemp from the definition of marijuana under the Controlled Substances Act. The new regulations are intended to govern persons seeking to become registered with DEA to grow marijuana as bulk manufacturers, consistent with applicable law.
This move sends a strong signal of expanding federal interest and oversight of the burgeoning cannabis industry. Frustration is mounting as federal administrative agencies, including the Food and Drug Administration, cite the lack of peer-reviewed studies as a reason to prevent, for example, CBD containing products, from being marketed and sold. Indeed, in a recent alert we advised of FDA’s issuance of warning letters to CBD manufacturers for unapproved and unsubstantiated health claims. Approval of additional sources for cannabis research should help eliminate this barrier and enable continued expansion of the industry.