Yesterday, the U.S. Drug Enforcement Administration (DEA) took a number of actions regarding the federal control of marijuana, including denying a citizen petition to transfer the substance out of Schedule I, issuing a policy change to expand the number of entities the federal government will allow to grow marijuana for research, and concurring in a USDA statement of principles regarding industrial hemp.
DEA’s decision to decline to reclassify marijuana was published in response to two petitions requesting DEA transfer marijuana out of Schedule I, filed in 2009 and 2011, respectively. In response to the petitions, DEA requested a scientific and medical evaluation and scheduling recommendation from the Department of Health and Human Services (HHS), which was conducted by the U.S. Food and Drug Administration (FDA) in consultation with the National Institute on Drug Abuse (NIDA). DEA concluded “[b]ased on the legal standards in the CSA, marijuana remains a schedule I controlled substance because it does not meet the criteria for currently accepted medical use in treatment in the United States, there is a lack of accepted safety for its use under medical supervision, and it has a high potential for abuse.” See DEA, Press Release at 1.
DEA found that the existing body of data did not meet these thresholds. It elaborated, “the DEA and the FDA continue to believe that scientifically valid and well-controlled clinical trials conducted under investigational new drug (IND) applications are the most appropriate way to conduct research on the medicinal uses of marijuana. Furthermore, DEA and FDA believe that the drug approval process is the most appropriate way to assess whether a product derived from marijuana or its constituents is safe and effective and has an accepted medical use. This pathway allows the FDA the important ability to determine whether a product meets the FDA criteria for safety and effectiveness for approval.” Id.
However, DEA also expanded the number of entities that may become DEA registered to cultivate marijuana in the United States. In a policy statement, DEA explained that persons may become registered with DEA to grow marijuana not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development. This marks a significant change from DEA’s historic policy to only permit the cultivation of marijuana from one federal source, the University of Mississippi under contract with the National Institute of Drug Abuse. DEA’s limitation on growth for research has been alleged as posing an unreasonable impediment to research on potential legitimate and therapeutic uses of the marijuana. DEA also explained in its statement that “under the new approach, should the state of scientific knowledge advance in the future such that a marijuana-derived drug is shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States—independent of the NIDA contract process.” DEA’s statement elaborates on the factors that it will consider both under the CSA and the Single Convention on Narcotic Drugs in determining whether to grant an entity a registration to cultivate marijuana.
Simultaneous with these actions, the U.S. Department of Agriculture (USDA), in concurrence with FDA and DEA, issued a statement informing the public of how federal law applies to activities involving industrial hemp. The statement suggests the clarification should resolve open questions regarding the application of federal law created by the enactment of section 7606 of the Agricultural Act of 2014. The statement clarifies, among other things that “Section 7606 specifically authorized certain entities to “grow or cultivate” industrial hemp but did not eliminate the requirement under the Controlled Substances Import and Export Act that the importation of viable cannabis seeds must be carried out by persons registered with the DEA to do so.”