In the three years since DEA first said it would be accepting applications for cannabis manufacturers, the agency has received 33 submissions. In a notice of applications that were for publication in the Federal Register on Aug. 27, 2019, the DEA said the “unprecedented” volume of inquiries makes it necessary to develop new regulations before approving pending applications.
“DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law,” the notice states, adding that the agency recognizes “the need to move past the single grower system and register additional growers.”
The DEA will also open a public comment period for individuals interested in weighing in on the rulemaking process.
“I am pleased that DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research,” Attorney General William Barr, who previously voiced support for increasing the number of marijuana manufacturers, said in a press release.
“The Department of Justice will continue to work with our colleagues at the Department of Health and Human Services and across the Administration to improve research opportunities wherever we can.”
DEA said that approving applications for cannabis growers will produce “additional strains of marihuana” that will be “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 [FDA],” the agency wrote.
That's precisely what researchers have been asking for. Lawmakers and scientists alike have complained that the current source of federally authorized research-grade cannabis — which is produced at a single facility at the University of Mississippi — is inadequate, with a chemical composition that's closer to hemp than the marijuana that's available to consumers in legalized state markets.
“DEA is making progress in the program to register additional marijuana growers for federally authorized research, and will work with other relevant federal agencies to expedite the necessary next steps,” DEA Acting Administrator Uttam Dhillon said. “We support additional research into marijuana and its components, and we believe registering more growers will result in researchers having access to a wider variety for study.”
Republican Rep. Matt Gaetz of Florida, who has repeatedly criticized the DEA for delaying the application approval process, told Marijuana Moment that he's “thrilled to see that after three years, the DEA is finally moving forward with applications to manufacture cannabis for research purposes.”
The Florida representative also introduced legislation that would force the agency to approve additional cannabis growers. A previous in 2018last year.
“During his Senate confirmation, AG Barr said that these applications would be processed, and he has kept his word,” Gaetz said. “Having additional cannabis manufacturers will greatly aid American scientists and researchers. Today's announcement is a victory for science, and brings us one big step closer to unlocking cures for America's most vulnerable populations.”
Legalization advocates expressed skepticism about the announcement, however.
“There is nothing in this new release that provides any sort of timetable as to when the agency intends to license these pending applications, some of which have been pending for well over two years,” Erik Altieri, executive director of the National Organization for the Reform of Marijuana Laws (NORML), told Marijuana Moment. “At this point, the DEA has had over three years to move forward with their initial promise to expand the number of licensed cultivators for marijuana research and the news today only reveals that in that time they have essentially achieved zero progress.”
“This is the very definition of kicking the can further down the road since they have indicated none of this will move forward without the finalization of new regulations, which is essentially the same thing they told the public in 2016,” he said.
Queen Adesuyi, policy coordinator for the Drug Policy Alliance (DPA), said that for decades “the greatest harm associated with marijuana use has been from its criminalization and overenforcement—not the substance itself.”
“The DEA's proposed steps toward expanding marijuana research opportunities are modest steps in the right direction at best. The most critical way to open the floodgates of much needed and wanted marijuana research is to deschedule marijuana,” she said. “For as long as marijuana remains a scheduled drug, there will continue to be significant federal restrictions and barriers to research, in addition to the continued individual and community-level harms of maintaining federal criminalization.”
The agency said that the number of individuals who are registered to conduct cannabis research “has increased by more than 40 percent from 384 in January 2017 to 542 in January 2019” and similarly, the “DEA has more than doubled the production quota for marijuana each year based on increased usage projections for federally approved research projects.”
“DEA anticipates evaluating the applications and, of those applications that it finds are compliant with relevant laws, regulations, and treaties, granting the number that the agency determines is necessary to ensure an adequate and uninterrupted supply of the controlled substances at issue under adequately competitive conditions,” the DEA said.
The note about compliance with treaties references an issue the agency has previously raised when addressing the grower applications. During his three-month stint as acting attorney general, Matthew Whitaker blamed the delay on international treaties that he said “may not allow the way that marijuana has been handled from the grow facilities to the researchers.”
But those international agreements don't actually prohibit the government from expanding marijuana manufacturers for research purposes, the State Department said in 2016.
The new notice says DEA has been consulting with other federal agencies “engaged in a policy review process to ensure that the marihuana growers program is consistent with applicable laws and treaties.”
“That review process remains ongoing; however, it has progressed to the point where DEA is able to issue Notices of Application,” it says. “Over the course of this policy review process, the Department of Justice has also determined that adjustments to DEA's policies and practices related to the marihuana growers program may be necessary. Accordingly, before DEA completes this evaluation and registration process, DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law.”
The announcement comes days before DEA was required under a federal court order to respond to a lawsuit concerning its inaction on cannabis manufacturer applications.
Dr. Sue Sisley, who belongs to the research facility that filed the lawsuit, told Marijuana Moment in a text message that the National Institute on Drug Abuse (NIDA) “monopoly is broken.”
The DEA “didn't want to explain themselves to D.C. Circuit Court, and there is little chance they can deny ALL 33” applications. So somebody NEW is FINALLY going to get to grow for research in U.S. after 51+ year government-enforced monopoly,” she said.
Sisley's Scottsdale Research Institute in Arizona was among those grower applicants listed in the Federal Register notice. Other notable applicants include Columbia Care NY; Confederated Tribes of the Colville Reservation in Washington; PharmaCan; the University of California, Davis; and the University of Massachusetts.
In addition to moving forward on marijuana grower applications, the DEA also clarified that hemp manufacturers “no longer require DEA registration for that purpose” since the crop was federally legalized under the 2018 Farm Bill and so “these applicants may respond in writing with a request to withdraw their applications.”
“Upon receipt of a request to withdraw an application that is received no later than November 1, 2019, DEA will refund all related application fees paid by the applicant,” the agency wrote.
“In addition, any listed applicants who no longer wish to obtain registration for any other reason may also request to withdraw their application in writing, and DEA will refund all related application fees paid by the applicant, provided the withdrawal is received no later than November 1, 2019.”
Feature image: The DEA says it will register additional cannabis growers to supply government research, though few specifics about the process were offered. Cannabis research has been stymied for decades in part because of a stranglehold on growers for federal research. (Photo by Gina Coleman/Weedmaps News)
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