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.
Bipartisan Lawmakers Circulate Letter Urging FDA To Back Off CBD Companies
A bipartisan pair of lawmakers are circulating a sign-on letter asking colleagues to join them in urging the Food and Drug Administration (FDA) to back off companies that are selling CBD products in a responsible manner.
The “Dear Colleague” letter, which is being led by Reps. Chellie Pingree (D-ME) and James Comer (R-KY), emphasizes that hemp and CBD were federally legalized under the 2018 Farm Bill and argues that the lack of regulations for such products is creating industry uncertainty that’s inhibiting economic opportunities.
The letter was first reported by the U.S. Hemp Roundtable, which is asking its supporters to encourage their representatives to sign on.
FDA has said it is in the process of developing rules for the non-intoxicating compound, including a potential alternative regulatory pathway allowing for CBD to be added to the food supply and as dietary supplements. That could take years, however, as former FDA Commissioner Scott Gottlieb has noted.
In the meantime, the agency is being selective about enforcement action against companies that make unsanctioned claims about their products while also maintaining that all businesses selling CBD food items are violating the law.
The lawmakers aren’t satisfied. They described FDA’s regulatory timeframe as “untenable,” particularly because the U.S. Department of Agriculture is expected to release its rules for hemp “any day now,” and an official revealed this month that its draft regulations are currently undergoing final White House and Department of Justice review.
The members of Congress added that FDA’s current approach to CBD has “created significant regulatory and legal uncertainty for participants in this quickly evolving industry.”
“Given the widespread availability of CBD products, growing consumer demand, and the expected surge in the hemp farming in the near future, it’s critical that FDA act quickly to provide legal and regulatory clarity to support this new economic opportunity,” they wrote.
“Please join us in signing this bipartisan letter to Acting FDA Commissioner Ned Sharpless urging the agency to adopt a risk-based policy of enforcement discretion that targets bad actors while eliminating uncertainty for responsible industry stakeholders and consumers. Additionally, we are requesting that FDA to issue an interim final rule to regulate CBD as a dietary supplement and food additive.”
In the letter to Sharpless that Pingree and Comer are asking fellow lawmakers to sign, they laid out two requests for FDA.
First, the agency should “promptly issue guidance announcing a policy of enforcement discretion that maintains FDA’s current risk-based enforcement approach towards hemp-derived CBD products.” And second, it should “consider issuing an interim final rule, pending issuance of a permanent final rule, to establish a clear regulatory framework for CBD as a dietary supplement and food additive.”
The lawmakers added that they appreciate that FDA has pursued “enforcement actions against the worst offenders,” but that “it can do so while eliminating regulatory uncertainty for farmers, retailers, and consumers.”
“Without a formal enforcement discretion policy, anyone participating in the growing marketplace for legal hemp-derived products will continue to face significant legal and regulatory uncertainty,” they wrote.
Though issuing guidance on a “policy of enforcement discretion” wouldn’t be a codified law allowing companies to market CBD in the food supply, it would demonstrate to the industry that some protections are in place while FDA continues to navigate the rulemaking process.
Lawmakers have until Tuesday to sign the letter to FDA.
Read the Dear Colleague invitation and CBD letter to FDA below:
Photo by Kimzy Nanney.
Marijuana Banking Bill Will Get A Full House Floor Vote This Month
A bipartisan bill to protect banks that service marijuana businesses will get a House floor vote by the end of the month, the office of Majority Leader Steny Hoyer (D-MD) confirmed to Marijuana Moment on Friday.
House leadership announced the decision to Democratic lawmakers at a closed-door meeting on Thursday.
“Mr. Hoyer said at the Whip meeting yesterday that he intends to move it this month,” a Hoyer staffer said in an email. “We’re discussing it with Members, but it hasn’t been scheduled just yet.”
Prior to confirmation from Hoyer’s office, four sources initially described the development to Marijuana Moment, with some saying the vote would be made under suspension of the rules—a procedure that is generally reserved for non-controversial legislation.
Voting on suspension would require two-thirds of the chamber (290 members) to vote in favor of the Secure and Fair Enforcement (SAFE) Banking Act in order for it to pass. The bill, which cleared the House Financial Services Committee in March, currently has 206 cosponsors, including 26 Republicans.
No amendments would be allowed to be added on the floor under the suspension process.
Problems could arise if lawmakers aren’t able to rally additional votes from conservative members or if there’s pushback over the strategy from progressive lawmakers, though it is unlikely Democratic leadership would advance the bill if they didn’t believe they have the votes for passage.
While interest in resolving the banking issue is generally bipartisan, it’s within reason to assume that lawmakers on both sides of the aisle might have wanted the opportunity to offer provisions such as extending protections to hemp businesses or adding language promoting social equity policies. That said, it is possible that leadership could file an entirely new piece of legislation that is similar to the SAFE Banking Act but contains modified provisions negotiated with key members and use that as the vehicle for floor action.
Many expected cannabis banking legislation to receive a floor vote before the August recess, but that did not come to fruition.
In any case, the development comes as the Senate Banking Committee is also preparing to hold a vote on marijuana banking legislation, with Chairman Mike Crapo (R-ID) announcing on Thursday that his panel is “working to try to get a bill ready.” He didn’t offer a timeline, however, other than saying he hoped to advance the legislation by the end of the year.
While sources told Marijuana Moment that Hoyer made his decision to allow cannabis banking vote following an earlier Wednesday meeting on the issue, it is likely that building momentum in the GOP-controlled Senate added to pressure on the House to act so that Democrats wouldn’t be seen as lagging behind Republicans on cannabis reform, an issue the party has sought to take political ownership of.
Following Crapo’s statement on advancing the banking legislation, Rep. Ed Perlmutter (D-CO), chief sponsor of the SAFE Banking Act, told Marijuana Moment that he welcomes the senator’s “commitment to resolve the banking conflicts that have been created by the misalignment in state and federal law on the issue of cannabis.”
“I remain focused on passing the SAFE Banking Act out of the House and look forward to working with my colleagues in the Senate as they take up the SAFE Banking Act or work to develop and pass similar legislation,” he said.
Banking access is largely seen as one of the most achievable pieces of cannabis legislation that stands to pass this Congress. Advocates and reform-minded lawmakers view it as one of the first steps on the path toward ending federal marijuana prohibition.
“We are seeing the blueprint in action and moving forward on critical legislation to protect state legal cannabis banking,” Rep. Earl Blumenauer (D-OR) told Marijuana Moment, referring to a memo he sent to House leadership last year outlining a committee-by-committee process for passing incremental cannabis bills leading up to major legislation to end federal prohibition. “Earlier this summer, the House passed protections for state and tribal cannabis laws. In the most cannabis friendly Congress in history, we need to keep up this momentum. There is still much to be done.”
There has been some disagreement within advocacy circles about whether it’s prudent to pass legislation viewed as primarily favorable to the industry before advancing comprehensive legislation that deschedules cannabis and takes steps to repair the harms of prohibition enforcement.
“It is our hope that after the successful passage of the SAFE Banking Act in the House, we will be able to advance legislation that ends the federal criminalization of cannabis once and for all,” Justin Strekal, political director of NORML, told Marijuana Moment. “Now is our time to demonstrate that marijuana law reform is both good policy and good politics.”
“We will not stop until otherwise law-abiding Americans are no longer discriminated against or criminalized due to the past or future choice to consume cannabis,” he said.
Neal Levine, CEO of the Cannabis Trade Federation, told Marijuana Moment that the group is “delighted that the U.S. House of Representatives is on the brink of passing a landmark piece of cannabis policy legislation that modernizes our antiquated banking laws to reflect the will of the people.”
“This is welcomed and long overdue news for the over 200,000 employees that work in the industry, cannabis businesses, and for public safety in the communities in which we operate,” he said. “Once the SAFE Banking Act passes the U.S. House, we call on the U.S. Senate to move quickly to protect our businesses and our workers.”
Pressure has been building all year from stakeholders and policymakers alike to get the legislation passed. Endorsements aren’t just coming from reform groups, either; 50 state banking associations, the National Association of State Treasurers, the top financial regulators of 25 states, a majority of state attorneys general and bipartisan governors of 20 states have also voiced support for the SAFE Banking Act.
Earlier this month, the head of the American Bankers Association predicted that the bill would be passed in the House “as early as September.”
This story was updated to add comment from Perlmutter and Hoyer’s office.
New ‘Marijuana 1-to-3 Act’ Would Reclassify Cannabis Under Federal Law
Another bill to reschedule marijuana was filed in Congress on Thursday.
Rep. Greg Steube (R-FL) introduced the legislation, which is titled the “Marijuana 1-to-3 Act.” True to its name, the bill would simply require the attorney general to move cannabis from Schedule I to Schedule III under the Controlled Substances Act, with the aim of increasing research on the drug’s effects.
“As marijuana is legalized for medical and recreational use across the United States, it is important that we study the effects of the substance and the potential impacts it can have on various populations,” Steube said in a press release. “By rescheduling marijuana from a schedule I controlled substance to a schedule III controlled substance, the opportunities for research and study are drastically expanded.
Today, I introduced a bill to reschedule marijuana from a schedule I to a schedule III controlled substance. The Marijuana 1-to-3 Act will allow additional research to be done on the benefits of marijuana by removing bureaucratic red tape. https://t.co/w45WAKHBr9
— Congressman Greg Steube (@RepGregSteube) September 12, 2019
“With this rescheduling, researchers can now access federal funds to research this substance and determine its medical value,” he said.
The press release came hours after a bipartisan pair of lawmakers introduced separate legislation to reschedule marijuana, also to Schedule III.
That bill contained additional provisions that would require federal agencies to develop research agendas for marijuana within one year of its enactment and also establish a system whereby universities could be designated as “Centers of Excellence in Cannabis Research” if they conducted comprehensive studies on issues related to marijuana.
Rep. Matt Gaetz (R-FL), who is a sponsor of the broader research bill, is also cosponsoring Steube’s more focused rescheduling proposal.
It’s not clear why Steube chose to file his own reclassification bill or whether the other legislation’s additional provisions were a factor.
The congressman’s two-page bill states that “the Attorney General of the United States shall, by order not later than 60 days after the date of enactment of this section, transfer marijuana…from schedule I of such Act to schedule III of such Act.”
“We hear every day about the positive health benefits of marijuana,” Steube said. “Whether it’s young children with seizure disorders, or veterans suffering from chronic pain, it is clear that there are medical benefits to marijuana and I think it’s time we remove the bureaucratic red tape that prevents us from thoroughly studying this substance.”
While he emphasized that the intent of his legislation is to encourage research into marijuana, placing cannabis in Schedule III would also have implications for marijuana businesses, who are currently ineligible for federal tax deductions under an Internal Revenue Code section that applies to anyone “trafficking in controlled substances” in Schedule I or II.
Read the full text of the bill below:
Photo by Ndispensable.