The Drug Enforcement Administration (DEA) announced on Monday that it is taking steps to expand the number of federally authorized marijuana manufacturers for research purposes.
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 set to be published in the Federal Register on Tuesday, DEA said the “unprecedented” volume of inquiries makes it necessary to develop new regulations before approving pending applications.
.@DEAHQ is moving forward to facilitate and expand scientific and medical research for #marijuana by increasing the number of qualified growers for research. We’ve already increased by 40% in 2 years from 384 to 542. pic.twitter.com/Q26oggZefA
— DEA HQ (@DEAHQ) August 26, 2019
“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.”
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 Announces Steps Necessary to Improve Access to Marijuana Research https://t.co/QY2PoRmRCA
— Justice Department (@TheJusticeDept) August 26, 2019
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,” 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 consumer in legalized state-level 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.”
Acting @DEAHQ Administrator Dhillon: “DEA is making progress…to register additional #marijuana growers for fed. authorized research…We support additional research… and we believe registering more growers will result in researchers having access to a wider variety for study.”
— DEA HQ (@DEAHQ) August 26, 2019
Rep. Matt Gaetz (R-FL), who has repeatedly criticized 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 congressman also introduced legislation that would force the agency to approve additional cannabis growers. A previous version of that bill was approved by the House Judiciary Committee in a voice vote last year.
I'm thrilled to see that after three years, the DEA is finally moving forward with applications to manufacture cannabis for research purposes. During his Senate confirmation, AG Barr said that these applications would be processed, and he has kept his word.https://t.co/vt8mKjBOmO
— Rep. Matt Gaetz (@RepMattGaetz) August 26, 2019
“During his Senate confirmation, AG Barr said that these applications would be processed, and he has kept his word,” he 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.”
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. pic.twitter.com/w1nEQw1My4
— Rep. Matt Gaetz (@RepMattGaetz) August 26, 2019
Other marijuana reform advocates expressed skepticism about the announcement, however.
“Doing more research on the medicinal qualities of cannabis has near universal support, but the Trump administration has been dragging its heels on approving new licenses to produce cannabis for research,” Rep. Earl Blumenauer (D-OR) told Marijuana Moment. “After years of bipartisan pressure, the administration has finally heeded to our demands. I will continue to monitor the DEA to make sure that these licenses actually get approved. This has already taken too long.”
“There is nothing in this new release that provides any sort of time-table 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 NORML, said. “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, 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 flood gates 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 “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,” DEA said.
The note about compliance with treaties references an issue the agency has previously raised when addressing the grower applications. During his 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 “monopoly is broken.”
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 was among those grower applicants listed in the Federal Register notice. Other notable applicants include Columbia Care NY, Confederated Tribes of the Colville Reservation, PharmaCan, the University of California at Davis and the University of Massachusetts.
In addition to moving forward on marijuana grower applications, 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,” DEA 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.”
This story was updated to include reaction from advocates.
Photo courtesy of Evan Johnson.
White House Completes Review Of CBD Guidance From FDA
The White House recently completed its review of pending Food and Drug Administration (FDA) guidance on marijuana and CBD research—though it remains to be seen whether the draft document will ultimately be released to the public.
FDA submitted its proposed plan—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—to the Office of Management and Budget (OMB) in May. Few details are known about its contents, but an FDA spokesperson previously told Marijuana Moment that it could inform the agency’s approach to developing regulations for the marketing of CBD.
OMB finished its review last week, as first reported by InsideHealthPolicy. This comes days after a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
Despite the review being finalized, however, an FDA representative told Marijuana Moment on Friday that the agency “cannot provide an update of when (or even if) this guidance will issue.”
“It will be announced via the Federal Register should it move to publication,” they said.
It’s not entirely clear why the guidance wouldn’t be published in the end, but it may take some time for FDA to implement any edits suggested by the White House over the past month, and it’s possible there are additional layers of review beyond OMB that could determine when and whether it will be finalized.
It also remains to be seen whether FDA plans to wait for this specific guidance to be finalized and for the resulting research to be completed before it gets around to issuing final rules for CBD products in general. Stakeholders have been eagerly awaiting those regulations so they can fully take advantage of the legalization of hemp and its derivatives.
Former FDA Commissioner Scott Gottlieb said in May that White House policies requiring OMB to review scientific documents in the first place represent an onerous step that’s delayed the issuance of guidance.
Beyond sending the draft research plan to the White House for review, FDA is also soliciting public input about the safety and efficacy of CBD in comment period it has decided to keep open indefinitely. The agency said in an update to Congress in March that it has several specific questions it wants answered before deciding whether the cannabidiol can be lawfully marketed. That includes questions about the impact of different methods of consumption and drug interactions.
This week, FDA submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
In the meantime, FDA is maintaining enforcement discretion when it comes to action against companies that sell CBD products regardless of the lack of regulations and has said it is currently targeting sellers that make especially outlandish or unsanctioned claims about the therapeutic value of their products.
It sent a warning letter to a CBD company owned by a former NFL player after advertisements it displayed suggested its products could treat and prevent a coronavirus infection, for example.
FDA sent a letter warning to a company about its marketing of injectable CBD products that led to a voluntary recall in May.
The agency also publicized a voluntary recall of another CBD product from a different company, notifying consumers about potentially high levels of lead in a batch of tinctures.
FDA has previously issued warnings to other CBD companies that have made unsubstantiated claims about the therapeutic potential of their products.
Photo by Kimzy Nanney.
Veterans Working In Marijuana Industry Aren’t Automatically Blocked From Home Loans, VA Says
The U.S. Department of Veterans Affairs (VA) recently clarified to Congress that it does not have a policy automatically barring veterans from receiving home loans solely because they work in the marijuana industry—and now a key House committee is asking the department to better communicate that to lenders and would-be borrowers.
For the past year, Rep. Katherine Clark (D-MA) and other lawmakers have been pressing VA on difficulties some veterans have faced in securing the benefit, with at least one constituent telling Clark that they were denied a home loan because of their work in the state-legal cannabis market. That prompted the congresswoman to circulate a sign-on letter and introduce an amendment to resolve the problem.
However, in a report submitted to Congress last month that was obtained by Marijuana Moment, VA said there is no policy on the books that calls for home loan denials due to employment at a cannabis business. Instead, the department clarified that conflicting state and federal laws makes it “difficult to prove the stability and reliability of cannabis-derived income,” which are key factors in determining loan eligibility.
“VA is committed to working diligently to serve our Nation’s Veterans by providing eligible Veterans with home loan guaranty benefits,” VA said. “There is nothing in VA statutes or regulations that specifically prohibits a Veteran whose income is derived from state-legalized cannabis activities from obtaining a certificate of eligibility for VA home loan benefits. However, given the disparity between Federal and State laws on cannabis, determining whether such a Veteran is able to obtain a loan has become a complex issue.”
A person’s “reliance on [marijuana-derived] income may hinder a Veteran’s ability to obtain a VA-guaranteed home loan, a result that is consistent with other federal housing programs,” the report states. “VA also notes that many lenders have established their own income thresholds and policies on overlays, which are often more stringent than VA’s requirements, to ensure that the VA-guaranteed loan will be purchased by an investor in the secondary mortgage market.”
In other words, individual lending companies may be denying home loans to veterans because the cannabis industry-derived income they would use to pay back loans isn’t necessarily stable and reliable due to the fact that federal officials could shut down their employers at any time.
If that’s the case, then it doesn’t appear it would be necessary to pass legislation targeting the narrow issue in the way lawmakers did last year. Clark’s amendment to address the problem was approved by the House as part of a defense spending bill—though leaders in the chamber agreed to scrap it after the Senate didn’t include it in its version of the legislation.
The House Appropriations Committee also approved report language last year attached to the bill that funds VA expressing concern that the department “has never publicly stated its position on this matter, hindering Veterans’ ability to fully understand and consider how employment decisions could affect future eligibility for earned benefits.”
The newly released explanation from VA is a result of that provision.
Now, for the next fiscal year, a new report attached to the latest Military Construction, Veterans Affairs, and Related Agencies spending bill acknowledges VA’s recent policy clarification—but lawmakers are asking the department to do more.
“The Committee understands that as directed by House Report 116–63, VA has clarified that nothing in VA statutes or regulations specifically prohibits a Veteran whose income is derived from state-legalized cannabis activities from obtaining a certificate of eligibility for VA home loan benefits,” the report states. “The Committee directs the VA to improve communication with eligible lending institutions to reduce confusion among lenders and borrowers on this matter.”
Clark told Marijuana Moment that “no veteran should be denied benefits simply because they work within the legal cannabis industry.”
“This must be crystal clear in our laws and communicated directly to both borrowers and lenders,” the congresswoman said. “By including this language, we’re eliminating any doubt about the rights of our service members and protecting their ability to access what they’ve rightfully earned.”
In other veterans and cannabis news this year, the Congressional Budget Office released an analysis on a marijuana research bill for veterans and determined that it would have no fiscal impact. And a federal commission issued recommendations to promote research into the therapeutic potential of both cannabis and psychedelics such as psilocybin mushrooms and MDMA.
Read VA’s report on its home loan policy for veterans working in the marijuana industry below:
Photo courtesy of Mike Latimer.
Idaho Medical Marijuana Activists Ask State For Electronic Signature Gathering Option Following Court Ruling
Idaho activists have formally requested that the state allow them to collect signatures electronically for a medical cannabis legalization initiative following a series of federal court rulings on the issue in a case filed by a separate campaign.
While the signature submission deadline passed in May, advocates for an education funding campaign filed a suit against the secretary of state, arguing that social distancing restrictions that were put in place due to the coronavirus pandemic meant the state should give them more time to digitally petition. The judge agreed and ordered the state to allow them to do so for 48 days starting Thursday.
The marijuana reform campaign feels that the same relief should be extended to them as well, and an attorney representing the group sent a letter to the secretary of state this week, asking that the Elections Division also provide cannabis activists with the digital petitioning and deadline extension concessions that the federal judge granted to the education funding group.
In one of the latest developments, the state’s request to the U.S. Court of Appeals for the Ninth Circuit to temporarily force the suspension of electronic signature gathering was denied on Thursday, though the appeal on the broader case is ongoing. That’s given the cannabis activists more hope as they pursue legal routes to have the lower court’s ruling apply to them.
BREAKING: State of Idaho's request to block our e-signature drive for K-12 funding DENIED by the Ninth Circuit Court of Appeals. It's time to give Idaho voters a chance to do what those in power refuse to do: Save our schools from deep budget cuts & invest in our children. #idpol
— Luke Mayville (@lukemayville) July 9, 2020
Russ Belville, campaign spokesperson for the Idaho Cannabis Coalition, told Marijuana Moment that the group was “thrilled” to see the appeals court refuse to stay the electronic signature gathering decision.
“Our attorneys are working to convince the state to provide our Idaho Medical Marijuana Act petition the same electronic signature gathering relief, as we have suffered the same infringement of our petitioning rights,” he said. “It’s a shame it takes a pandemic to even consider allowing electronic signatures on petitions. Idaho should make every effort to make exercising our rights as easy as possible, especially for sick, disabled, elderly, infirm and rural folks without easy access to an in-person petitioner.”
In the new letter to Idaho Secretary of State Lawerence Denney, attorney Bradley Dixon said his client “has standing to pursue a remedy given the impact that the COVID-19 restrictions have had upon it.” The campaign “can show (1) they have suffered an injury in fact, which is both concrete and particularized, and actual or imminent; (2) their injury is fairly traceable; and (3) their injury will likely be redressed by a favorable outcome.”
“Moreover, just like Reclaim Idaho, as illustrated above, our client can show that it was diligent in collecting signatures and had adopted a thorough plan to achieve ballot success in advance of the unforeseeable coronavirus outbreak. Considering the merits of a possible case, our client’s First and Fourteenth Amendments rights have been harmed because the State of Idaho and its agents did not provide an alternative means to signature collection during the stay at home order, or during any of the phased reopening stages.”
The state’s stay-at-home order “made it impossible to retrieve all statutorily-required signatures because of both the reduction in time to collect such signatures, and the deadline date to obtain signatures falling on the same day as the end of the stay at home order,” the attorney said.
If the campaign is ultimately allowed to proceed with signature gathering, they will need 55,057 valid signatures to qualify for the November ballot. Activists said they have about 45,000 unverified signatures on hand at this point, and they’re confident that can fill the gap if they get the deadline extension and electronic petitioning option.
The group has indicated it is prepared to seek relief directly from the courts if the secretary of state does not comply with their request to his office.
Under the proposed ballot measure, patients with qualifying conditions could receive medical cannabis recommendations from physicians and then possess up to four ounces of marijuana and grow up to six plants.
Advocates say that passing medical cannabis in one of the remaining states without such policies on the books would be a significant victory for patients in its own right—but it could also have outsized federal implications. A House-passed bill to protect banks that service state-legal cannabis businesses from being penalized by federal regulators is currently pending action in a Senate committee chaired by a senator who represents the state.
Creating a medical marijuana program in Idaho, which is one of small handful of states that don’t yet even have limited CBD laws, could put additional pressure on Senate Banking Committee Chairman Mike Crapo (R-ID) to move the financial services legislation in Congress.
Read the letter to the secretary state on allowing electronic signature gathering for medical marijuana below: