The Drug Enforcement Administration (DEA) announced on Friday that it will be taking significant steps to expand marijuana research.
The agency is proposing a rule change that would enable it to approve additional cannabis growers and diversify the types of marijuana available to be used in studies. The move comes more than three years after the agency initially said it was accepting applications for additional marijuana manufacturers.
DEA stressed throughout the new notice that it will have sole ownership over any marijuana that’s cultivated for research purposes. That includes any cannabis that’s stored at cultivation facilities. This appears to be a fundamental change in policy. As it stands, a single facility in Mississippi is authorized to grow cannabis through a contract with the National Institute on Drug Abuse (NIDA), and DEA does not maintain ownership over its products.
“The Drug Enforcement Administration continues to support additional research into marijuana and its components, and we believe registering more growers will advance the scientific and medical research already being conducted,” Acting Administrator Uttam Dhillon said in a press release. “DEA is making progress to register additional marijuana growers for federally authorized research, and will continue to work with other relevant federal agencies to expedite the necessary next steps.”
A 60-day public comment period will be open for individuals to provide feedback on the proposal, which will be formally published in the Federal Register on Monday.
After DEA said in 2016 that it would allow more cannabis cultivators, 37 institutions submitted applications. Many applicants grew frustrated with inaction on their proposals, and one filed a lawsuit alleging that the agency was deliberately avoiding making good on its pledge. The plaintiff won a procedural victory in that case, with the court mandating that DEA take action.
However, because the agency did provide an update on the status of its process, the suit was dismissed last year. DEA argued that the high volume of applicants to manufacture cannabis, as well as what it saw as complications arising from international drug treaties to which the U.S. is a party, meant that it would have to develop new regulations to approve them.
“This is an important step and a byproduct of the legal action we filed last summer,” Sue Sisley, a researcher with the institution that filed the suit, told Marijuauna Moment. “The agency indicated it would propose new rules to govern approving new applicants to manufacture marijuana for research, and these appear to be those rules.”
Lawmakers have repeatedly pressured the agency to expedite the process of allowing more cannabis to be grown for studies. Last year, thirty bipartisan members of the House and Senate sent a letter to the Justice Department, urging officials to approve additional applications.
Attorney General William Barr has said he favors expanding research opportunities and testified at a Senate Appropriations Committee hearing last year that it’s something he’s “ been pushing very hard over the last few weeks.” He also said at that meeting that he’d prefer some level of federal regulations over cannabis as opposed to maintaining the status quo of prohibition.
His interim predecessor, Matthew Whitaker, had previously told Congress that international treaty obligations were complicating efforts to authorize more marijuana manufacturers—a point that’s was disputed by the U.S. State Department’s Bureau of International Narcotics and Law Enforcement in a 2016 letter to senators.
President Trump’s first attorney general, Jeff Sessions, had reportedly interfered in the process during his time in office. The anti-cannabis official also rescinded Obama era guidance laying out enforcement guidances on marijuana for federal prosecutors.
With respect to international treaty obligations, DEA said there are five requirements that countries allowing marijuana cultivation for research must adhere to in order to maintain compliance with United Nations rules. The agency already follows three of the five, but the “proposed rule would amend DEA’s regulations so that DEA directly carries out these remaining two functions.”
Those functions are: 1) requiring cultivators to deliver their cannabis directly to a government agency in a timely manner, but no longer than four months after harvest, and 2) ensuring that the agency holds the “exclusive right of importing, exporting, wholesale trading, and maintaining stocks of cannabis and cannabis resin,” except as it concerns medical marijuana preparations.
“DEA may accept delivery and maintain possession of such crops at the registered location of the registered manufacturer authorized to cultivate cannabis consistent with the maintenance of effective controls against diversion,” the notice states. “In such cases, DEA shall designate a secure storage mechanism at the registered location in which DEA may maintain possession of the cannabis, and DEA will control access to the stored cannabis.”
Further, the agency said it will control “importing, exporting, wholesale trading, and maintaining stocks,” and it may “exercise its exclusive right by authorizing the performance of such activities by appropriately registered persons.” It will also require written notice from cultivators about their estimated harvest date. That notice should be submitted at least 15 days prior to harvest.
“It should be noted that the timing of when DEA would take physical possession of the crops, if delayed, would not only increase the risk of diversion, but would also adversely impact the quality of the crop,” DEA said.
“If this proposed rule is promulgated, the following key changes are anticipated: more persons will be authorized to grow marihuana, DEA will purchase and take title to the crops of marihuana, and DEA will, with respect to marihuana, have the exclusive right of importing, exporting, wholesale trading, and maintaining stocks,” the notice states. “These changes would mean that authorized purchasers of bulk marihuana to be used for research, product development, and other purposes permitted by the CSA may only purchase from DEA, except that DEA’s exclusive rights would not extend to medicinal cannabis or cannabis preparations.”
DEA said this notice, which also lays out criteria for eligible cultivation applicants, “is the latest and most significant action taken to expand the number of registered marijuana growers in the United States and underscores the federal government’s support for scientific and medical research with marijuana and its chemical constituents.”
Corey Cox, a senior associate at Vicente Sederberg LLP, told Marijuana Moment that DEA’s application approval process has been “very slow” so far, but that the new filing is a positive sign.
“Given this history, even if the rules leave significant room for improvement, their publication in the Federal Register represents meaningful movement beyond the stalling tactics DEA has employed to date,” he said.
The agency said the proposed rule would increase the diversity of cannabis grown for research purposes—including products of varying quality and potency—which could produce “more effective research” and facilitate possible development of Food and Drug Administration-approved medicines.
There’s been widespread criticism over the quality of cannabis produced at the only federally authorized cultivation facility at the University of Mississippi. Studies have indicated that the institute’s products are chemically more similar to hemp than marijuana available in state-legal markets, raising questions about the applicability of studies that have relied on the government’s cannabis on real consumers.
The head of the federal cultivation facility said last year that he couldn’t understand demand for marijuana with higher THC concentrations, arguing that even eight percent THC (significantly lower that most products in commercial markets) is “extremely” potent.
Unlike the current system, DEA would have a much more hands-on role under the proposed rule.
For example, “DEA would travel to the National Center at the time of harvest and take title and possession to the crop.” After that point, the material would be maintained, under seal, in DEA’s possession in the National Center’s schedule I vault until such time that a distribution to another DEA registrant is authorized.”
It remains unclear how many cultivator applications will be approved. An economic analysis the agency will conduct will consider two hypothetical scenarios. Under the first, DEA would consider the impact of approving three additional growers. Under the second, it would look at the effects of approving 15 more. However, the agency said that “this range of potential registrants is not necessarily reflective of the actual number of applications that DEA will grant.”
The agency also described how it will judge various manufacturer applications, explaining that it would consider their “ability to consistently produce and supply marihuana of a high quality and defined chemical composition” and also look into whether “the applicant has demonstrated prior compliance with the CSA and DEA regulations.”
That second criterion could pose problems for several companies that have filed applications—such as Columbia Care and The Giving Tree Wellness Center—which operate cannabis dispensaries in defiance of federal marijuana prohibition.
Individuals with prior cannabis convictions may also be adversely impacted in the application process, as the proposed rule states that the agency will take into account violations of federal or state law “relating to the manufacture, distribution, or dispensing of such substances.”
Another provision of the rule concerns pricing for cannabis sold or purchased by DEA for research purposes. The agency said it will negotiate a fee based on “market forces” and also potentially add an administrative cost “to add onto the sales price of the marihuana it sells to end users.”
“DEA believes that economic forces will not only drive the types, varieties and strains of marihuana materials that will be produced by growers, but that such forces will also drive the fees that DEA-registrants will be willing to pay for marihuana used for research purposes,” it states.
The agency also said it anticipates “minimal procedural change for authorized researchers who plan to acquire bulk marihuana for research” as compared to current policy and that the “only anticipated procedural change is that some researchers would acquire the bulk marihuana from DEA, rather than from NIDA.”
This story has been updated to include additional information about the proposed rule change.
Photo courtesy of Philip Steffan.
Missouri Marijuana Legalization Campaign In Jeopardy Due To Coronavirus
Coronavirus has dealt another blow to the marijuana reform movement. This time, activists in Missouri announced on Saturday that their effort to put a cannabis legalization measure on the ballot has “no practical way” of succeeding amid the pandemic.
In recent weeks, the outbreak of COVID-19 has resulted in business closures and increased calls for social distancing in states across the country. That has made mass signature gathering for drug policy reform measures virtually impossible.
“Unfortunately, while there is widespread support from Missourians to tax and regulate marijuana, there is currently no practical way during the COVID-19 outbreak to safely, publicly gather the 170,000 plus signatures needed over the remaining 6 weeks to put this on the Missouri ballot in 2020,” John Payne, campaign manager for Missourians for a New Approach, said.
He added that the group is still “exploring our options at this point” but if it ultimately cannot find a path to the ballot for this November, “our supporters from every corner of this state will be back next cycle to put this on the 2022 ballot and finally bring Missouri the benefits of a safe, adult-use marijuana program.”
A total of 160,199 valid signatures from registered voters are needed in order to qualify the measure for this year’s ballot, and the campaign says it has so far collected roughly 80,000—though it is unclear how many of those have been validated. Organizers have aimed to collect more than needed in case some submissions are not accepted.
In a separate email circulated to supporters earlier on Saturday, Dan Viets, coordinator for Missouri NORML and an advisory board member for Missourians for a New Approach, said the “status of the effort to legalize adult use of marijuana in Missouri this year is unclear.”
“No official decision has yet been made regarding whether to suspend the campaign,” he said. “If we do so, it is likely we will return to pursue this goal in 2022.”
“It is, of course, virtually impossible to effectively gather signatures on petitions given the response to the coronavirus pandemic. Gatherings of more than a very few people in any one place have been banned. Almost all colleges and universities have switched to online teaching. No large meetings, conferences, or other gatherings are taking place. We should know within a very short time whether the campaign will be continuing this year or not.”
The language of the campaign messages indicates that activists aren’t entirely throwing in the towel just yet. But that’s a change of tone compared to a message sent to key organizers earlier this month by Graham Boyd, director of the national New Approach PAC, which has been a chief funder of the Missouri effort.
Boyd wrote in the March 17 email obtained by Marijuana Moment that after “much deliberation, we’re making the very difficult, but ultimately unavoidable, decision to end our 2020 adult-use legalization effort in Missouri.”
“As you can imagine, the onset of the coronavirus situation has made that already difficult process essentially impossible,” he said at the time, adding that after discussing the issue with reform campaigns in other states, it “seems likely that the situation will get much worse in many more states before it gets better.”
Since then, organizers have worked to try to salvage the effort.
Activists officially started signature gathering for the Missouri campaign in January, and they were optimistic that voters in the state would embrace the reform move. The proposed initiative would allow adults 21 and older possess and purchase cannabis from licensed retailers and cultivate up to three plants for personal use.
Additionally, it would impose a 15 percent tax on marijuana sales, with revenue going toward veterans services, substance misuse treatment and infrastructure projects. Individuals with cannabis convictions would be empowered to petition for resentencing or expungements.
Boyd stressed in his email that cancelling the campaign would be a “temporary setback” and that it’s “clear from the work and polling we’ve done so far that voters in Missouri are ready to approve a marijuana legalization law.”
Beyond Missouri, coronavirus has already proven to be a formidable presence in 2020 politics, with multiple drug policy reform campaigns having been impacted by the public health crisis.
Activists in California recently released a video asking California officials to allow digital signatures for a petition to revise the state’s adult-use marijuana program. In Washington, D.C., advocates for a measure to decriminalize psychedelics similarly wrote to the mayor and local lawmakers, imploring them to accept online signatures for their ballot petition.
Another California campaign to legalize psilocybin mushrooms is struggling and asking for electronic signature gathering to qualify for the ballot. An effort to legalize medical cannabis in Nebraska is facing similar signature gathering challenges.
In Oregon, advocates for a measure to decriminalize drug possession and a separate initiative to legalize psilocybin for therapeutic purposes have suspended in-person campaign events amid the pandemic.
Arizona activists shared some more positive news this week, however, announcing that they have collected more than enough signatures to qualify for the state’s November ballot—though they have not yet been submitted to or verified by the state.
Photo courtesy of Philip Steffan.
Scientists Sue DEA Over Alleged ‘Secret’ Document That Delayed Marijuana Research Expansion
The Drug Enforcement Administration (DEA) is finding itself in court over marijuana again after scientists filed a lawsuit against the agency, requesting “secret” documents that they allege DEA used to delay action on expanding cannabis research.
The Scottsdale Research Institute (SRI) is behind the suit. It’s one of more than 30 organizations that have submitted applications to DEA to become licensed cannabis manufacturers for research purposes.
Some background should be noted: In 2016, DEA announced it would expand marijuana research by approving additional growers beyond the sole source that has existed for half a century at the University of Mississippi. But after more than three years, applicants heard silence, and SRI filed an initial lawsuit alleging that the agency was deliberately holding up the process. A court mandated that it take steps to make good on its promise, and that case was dropped after DEA provided a status update.
This month, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party. A public comment period is now open, after which point the agency says it will finally approve an unspecified number of additional growers.
But what really accounted for the delay?
According to the plaintiffs in this new suit, after DEA said it would accept more cultivators, the Justice Department’s Office of Legal Counsel (OLC) secretly issued an opinion that interprets international treaty obligations as making it impossible to carry out the 2016 proposed rule while maintaining compliance.
The new revised rule aims to address the problem, in part by shifting jurisdiction over the cannabis to a single agency, DEA, which would purchase and technically own all of the cannabis grown by approved cultivators, and would then later sell the product directly to researchers.
That OLC document, which is not public, is the basis of SRI’s Freedom of Information Act (FOIA) complaint. The case was filed with the U.S. District Court for the District of Arizona on Wednesday and requests that the Justice Department be found guilty of unlawfully failing to make records available related to its interpretation of the Single Convention treaty, including the OLC opinion. It further states that DEA should release those documents and pay the plaintiff’s attorney fees.
Matt Zorn, an attorney working the case, told Marijuana Moment in a phone interview that it’s not clear what’s contained in the OLC opinion and that the uncertainty is “entirely the point” of the suit.
“I think we all know vaguely what it says—the subject matter of it—but we don’t know what it actually says,” he said. “That’s important because you need to know what that instruction was or what their interpretation of the law is to assess whether what they’re doing now is appropriate.”
The suit claims that SRI, “as a non-commercial company dedicated to advancing the state of medical care through clinical research, is directly harmed by this unlawful secrecy.”
“Because Defendants have failed to fully disclose their re-interpretation of federal law and treaty obligations as the law requires, Plaintiff lacks information necessary to protect its legal rights, including the right to have its application to manufacture marijuana for research processed in compliance with the Administrative Procedure Act and the [Controlled Substances Act],” the filing states.
SRI’s research objective for cannabis is to determine potential therapeutic benefits for veterans suffering from conditions such as post-traumatic stress disorder. “While DEA’s unlawful and dilatory conduct harms the public generally, the secrecy and delay have been especially harmful to our nations’ veterans,” the suit says.
“We deserve not only to know the scientific truth about medical marijuana use, but candor from our government, which includes disclosure of the ‘secret law’ the agency continues to rely on as a basis to delay and ultimately revamp the process for researching and manufacturing marijuana in this country,” the filing says. “Plaintiff brings this FOIA action so can understand the legal basis—if there is one—for the government’s conduct surrounding the Growers Program.”
While SRI acknowledged that DEA last week announced its revised rule change proposal, the suit states that the explanation about how it arrived at its determination “leaves Plaintiff and the public in the dark with respect to several critical considerations.” For example, it alleges, the notice doesn’t account for how the Justice Department advised the agency on the matter and which parts of the amended proposal would make the action compliant with international treaties.
“The answer to these questions and others presumably lies in the undisclosed OLC Opinion and related records that animated DOJ’s decision to sideline the Growers Program and prompted DEA to embark on this notice-and-comment rulemaking in the first place… In sum, using a secret OLC Opinion interpreting the CSA and a 1961 international treaty, DEA delayed processing applications to cultivate marijuana for research and now proposes to radically revamp federal law through rulemaking—rules which will loom large over the future of medical marijuana research, manufacture, and distribution going forward.”
The plaintiffs argue that DEA violated federal statute that prohibits the creation of a “secret law.” The statute says that federal agencies must make records—including final opinions and policy interpretations not published in the Federal Register—public.
“To block the Growers Program, DOJ formulated—through the OLC Opinion and related records—and DEA adopted to an undisclosed interpretation of the Single Convention and federal law contrary to the view espoused and published by DEA in the August 2016 Policy Statement, and contrary to the view of the State Department,” it continues, apparently referencing a letter the State Department sent to a senator in response to questions about the role of international treaties as it concerns expanding cannabis cultivation facilities.
In that letter, the department said nothing about the Single Convention prevents member nations from increasing the number of such facilities. “If a party to the Single Convention issued multiple licenses for the cultivation of cannabis for medical and scientific purposes, that fact alone would not be a sufficient basis to conclude that the party was acting in contravention of the Convention,” it read.
Read the State Department’s responses on international treaties and marijuana below:
If the new lawsuit’s allegations prove accurate, it could help explain the role of former Attorney General Jeff Sessions, the anti-marijuana official who was reportedly involved in blocking research expansion.
The suit, which was first reported by Politico, goes on to say:
“For more than three years, Defendants relied on this undisclosed interpretation, contained in the OLC Opinion and related records, to make an end-run around the Administrative Procedure Act by unlawfully withholding and unreasonably delaying agency action on marijuana cultivation applications. The OLC Opinion has guided DEA’s actions—and its inaction… The government’s unlawful conduct under FOIA prevents Plaintiff and those similarly situated from timely and effectively vindicating legal rights under the Administrative Procedure Act, effectively rendering its protections and judicial review provisions meaningless.”
To resolve the issue, SRI said it wants DEA to be held accountable for violating federal law, release the documents and compensate them for the legal action. While this is a FOIA-related suit, the institute didn’t first seek the documents through a standard document request but instead filed the case under the law’s “Reading Room provision” that allows courts to force federal agencies to put records online, according to a Ninth Circuit ruling last year.
Sue Sisley, a researcher with SRI, told Marijuana Moment that the institute has generally had a good relationship with DEA over the years and doesn’t expect that it would unduly deny their application in retaliation for the institute’s repeated legal actions against the agency.
“I couldn’t fathom that that would happen, but I hope that the merits of our application are so clear that it would carry us forward,” she said. However, these licensing agreements are “not always a merit-based process so it is possible that if politics get deeply involved here that there could be a situation where licenses are awarded to friends of the government. We’re still praying that there is some merit-based system.”
Researchers and lawmakers have made clear that the current availability of federally authorized cannabis for research raises questions about the accuracy of tests that rely on it, as the quality is insufficient. As of now, there’s only one facility at the University of Mississippi that’s authorized to grow cannabis for researchers. The products developed at the university have been widely criticized by scientists and lawmakers. A study indicated that the facility’s cannabis is chemically more similar to hemp than marijuana available in state-legal markets.
“If adopted, these proposed rules would radically overhaul how medical marijuana manufacture and research will proceed in this country,” the plaintiffs wrote. “Better supply is needed for better research, and better research is needed not only because millions use medical marijuana every day, but also to facilitate informed policymaking at the federal and state levels, including legislation and drug scheduling decisions.”
Read the full lawsuit against DEA below:
Photo courtesy of Mike Latimer.
First Legal Marijuana Home Deliveries Begin In Colorado
For the first time, people in Colorado will be able to legally have marijuana products delivered directly to their homes starting on Friday.
The launch of the limited program focused on medical cannabis patients comes one week after the dispensary chain Native Roots announced that its Boulder location The Dandelion had received the state’s first marijuana delivery license. And while the license wasn’t related to the coronavirus outbreak, the timing is opportune, as officials have increasingly cautioned against leaving home to avoid catching or spreading the virus.
The delivery service will be limited to patients living in either Boulder or Superior. They must also be registered with the dispensary, and those who are not already signed up must do so in-person for the time being—though Native Roots said it is “looking into a compliant, remote solution for patient registration.”
Native Roots said there is a $100 minimum purchase, and they’re encouraging patients to pay with a debit card rather than cash, presumably because drivers could be targets of burglaries if they’re transporting large amounts of cash or because of concerns that money changing hands could further the spread of COVID-19.
Cannabis delivery services are a new feature of Colorado’s legal marijuana program. Gov. Jared Polis (D) signed legislation last year allowing the option, though individuals jurisdictions must proactively opt-in, so as of now that number of cities permitting deliveries is limited. Native Roots said it’s been engaging with local governments about the issue for months.
Deliveries for recreational cannabis consumers won’t begin until January 2021 under the law.
As more businesses shutter as a result of the pandemic, there’s growing demand for alternative means of obtaining marijuana products, and several states have taken steps to address that concern by encouraging deliveries and curbside pickup, for example.
For patients and reform advocates, that represents an ideal solution compared to closing dispensaries altogether. Numerous legal states have categorized cannabis shops as essential services that are exempt from mandates to close down. And according to a poll released this week, a majority of Americans agree with that decision.
But while the market remains largely operational in the midst of this health crisis, reform advocates across the U.S. are feeling the impact and struggling to continue campaign activities, including in-person signature gathering.
Campaigns to change state marijuana programs, legalize psilocybin mushrooms, legalize psilocybin for therapeutic purposes, legalize medical and recreational cannabis, decriminalize psychedelics and broadly decriminalize drug possession have all faced challenges amid the pandemic, and several have implored officials to allow electronic signature gathering to overcome the barrier.
An exception to this appears to be Arizona, where activists recently said they’ve collected more than enough signatures at this point to qualify for the state’s November ballot.
Photo courtesy of Philip Steffan.