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DEA Gets Few Comments On Far-Reaching Marijuana Research Proposal With Deadline Looming

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There are less than two weeks left for people to submit comments on the Drug Enforcement Administration’s (DEA) proposed rule change that the agency says will enable it to increase the number of authorized growers of marijuana to be used in scientific studies.

Yet despite this major development, which includes a large-scale overhaul of the federal marijuana research program that grants DEA broadly expanded powers and controls, there appears to be relatively little public interest in providing feedback on the proposal so far—at least compared to previous cannabis-related rule changes that other federal agencies have posted.

When the U.S. Department of Agriculture (USDA) opened a comment period for proposed regulations on hemp last year, for example, more than 4,600 people replied.

But as of Wednesday, just 31 people or organizations have weighed in on the new DEA notice that stands to have a lasting impact on marijuana research in the country and represents the culmination of a years-long conflict between scientists and the agency.

Four years ago, DEA pledged to expand cannabis cultivators for studies. Dozens of research institutions submitted applications, only to hear silence. A lawsuit alleged that DEA was deliberately delaying the process, leading the agency to issue an update last year stipulating that the application procedure had to be revised.

It turns out that there was more to that story. The scientist behind that lawsuit filed another case citing the Freedom of Information Act, requesting the disclosure of a “secret” Justice Department document she claimed was used to justify inaction on the applications. As part of a settlement, the department published a 2018 Office of Legal Counsel memo this month that concluded DEA was in violation of international treaties that dictate how member nations must approach the production of controlled substances.

The office further determined that in order to be in compliance, a single agency needed to control the possession and purchasing of marijuana for research. Currently, DEA registers scientists to obtain cannabis, which is grown by a third-party farm at the University of Mississippi that is overseen by the National Institute on Drug Abuse (NIDA). DEA’s proposed rules would make it the sole agency in charge of research-grade cannabis, a change it says will put it in compliance with treaty obligations.

Generally speaking, researchers applauded the moves to authorize new growers, as it signals that the University of Mississippi monopoly on marijuana for research could soon be ending. That’s especially important given concerns about the quality of cannabis grown at the facility. One study found that its plants are chemically more similar to hemp than marijuana that is available to consumers in state-legal markets.

But not everyone is pleased with the details of the proposed rule change.

With the deadline for public comments fast approaching, here’s a look at what people and organizations are telling DEA about its proposal:

One of the major voices opposing the specifics of the new rules is NORML, which argued in its formal comment that DEA does not have the track record to inspire confidence that the agency is making a good faith effort to expand cannabis research.

“While NORML has long supported facilitating and expanding domestic clinical research efforts, we do not believe that these proposed rules, if enacted, will achieve this outcome,” the group said. “Rather, we believe that the adoption of these rules may further stonewall efforts to advance our scientific understanding of cannabis by unduly expanding the DEA’s authority and control over decisions that ought to be left up to health experts and scientists.”

“NORML opposes the DEA’s proposed rules and, instead, proposes a more practical alternative to facilitate clinical cannabis research in the United States,” the comment continues. “Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, NORML believes that federal regulators should allow investigators to access the cannabis that is currently being produced by the multitude of state-sanctioned growers and retailers throughout the country.”

The National Cannabis Industry Association (NCIA) said it broadly opposes DEA’s proposed regulations, contending that as a law enforcement agency, it would be inappropriate for it to govern production and research into cannabis. NCIA raised a series of concerns and said the rules should either be dramatically amended or withdrawn entirely.

Chief among its recommendations would be for a public health agency like the National Institutes of Health to be responsible for domestic cannabis production for research purposes and to make it so marijuana cultivators that have been operating in compliance with state laws be eligible for grow the plant for studies.

As it stands, DEA’s proposal stipulates that applicants can be denied if they’ve violated the federal Controlled Substances Act—something all existing state-legal marijuana cultivation businesses have technically done.

“The federal government should be incentivizing research, not discouraging it,” NCIA said, adding that it should work to “create a pathway for less restrictive means by which the country can access important information about the medicinal properties of cannabis.”

The advocacy group Americans for Safe Access (ASA) said that while it is “in favor of expanding the production of research grade cannabis and supports research that can potentially lead to the approval by the FDA of cannabis based medicine,” the group is “skeptical of the DEA’s administration of the program and new framework design.”

ASA made several recommendations in the draft comment that has not yet been filed but was shared with Marijuana Moment, including ensuring that there is a “not-for-profit wholesaling scheme to distribute research grade cannabis” and allowing state-legal cannabis producers to participate in the program.

It also wants to remove NIDA from conducting medical cannabis research altogether due to an “unscientific agenda” it has demonstrated over its decades of controlling the process. ASA also suggested that if DEA “should fail to provide adequate licensure or unfairly distributes research grade cannabis (as they have in the past)” the agency should be stripped of its authorities and replaced with a new Office of Medical Cannabis Control.

“Increased access, exposure, and broader normalization of cannabis have deeply affected the American consciousness,” the group said. “Cannabis has become a more popularized form of medicine.”

An individual going by the name of Eric D. offered an interesting perspective in a separate comment, urging DEA to “include provisions to ensure equal opportunity to small- and mid-sized growers.”

“For example, reasonable application and processing fees, especially early in the application process, so the barriers to entry are not insurmountable for some applicants, while being insignificant for others,” the comment states. “Cannabis, unlike other medicines, can be produced by novice growers. It is of great concern that in the event that federal regulations for production become more permissive, a small group of producers will gain control of the entire market.”

Maridose, a company that said was formed because of DEA’s 2016 announcement about research expansion, said it is supportive of the proposed rule changes, though it outlined a series of questions it hoped the agency would clarify.

The company argued it would be helpful if DEA could clarify how the price of cannabis products it purchases will be determined, how it will ensure that there’s competition and availability of different marijuana varieties for researchers and what the packaging and shipping requirements will be for manufacturers.

“While remaining federal compliant and not currently involved in any Federal or State cultivation activities Maridose has developed strategic partnerships with world-renowned researchers and institutions with strong records of legal cannabis cultivation and biopharma research,” the comment states. “If granted a license by the DEA Maridose will be able to provide the highest quality standardized cannabis and cannabis extracts to meet the needs of groundbreaking lines of scientific inquiry.”

Another applicant, Biopharmaceutical Research Company, said it has also been compliant with the Controlled Substances Act by not growing cannabis to date, and argued that it has “undertaken this enterprise as a business, at great risk, because we believe in the importance of compliant and top-quality federal research.” While the company generally supports the agency’s regulations, it recommended making a change so that the current pool of applicants who have had their proposals pending for years are prioritized.

Those comments are some of the very few that have been submitted so far that are specifically responsive to the proposed rule change.

Others put their views more bluntly, calling for the end of prohibition altogether—including one from R. Michelle Anderson that quotes Nixon administration official John Ehrlichman about the racist intent behind marijuana criminalization enforcement.

“Making the rules even more complicated by adding another step just inflates the DEA coffers at the expense of the taxpayer, contributing to our bloated bureaucracy, while adding no needed benefit,” an anonymous commenter said, adding that they feel the rulemaking is the product of DEA’s “unwillingness to accept marijuana reform and impending federal legality, and therefore, are making it more difficult to study in an effort to maintain their position and status.”

North Dakota resident Blaine Hulbert said DEA has “had YEARS to get this done.”

“We would appreciate true action this time as well as DEREGULATING and FREEING of product to be housed at the facilities that are doing the research,” the comment says. “We know once it disappears into your coffers, we never hear any more about it.”

The deadline to submit comments on DEA’s proposed marijuana rule change is May 22.

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Louisiana Senate And House Both Approve Significant Medical Marijuana Expansion

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The Louisiana Senate approved a bill to significantly expand the state’s medical marijuana program on Wednesday, and a committee advanced separate legislation on banking access for cannabis businesses.

The expansion proposal, which the House of Representatives approved last week, would allow physicians to recommend medical cannabis to patients for any debilitating condition that they deem fit instead of from the limited list of maladies that’s used under current law.

The Senate Health and Welfare Committee advanced the proposal last week and now the full chamber has approved it in a 28-6 vote. Before the bill heads to the desk of Gov. John Bel Edwards (D) for signature or veto, the House will have to sign off on an amendment made by the Senate to require dispensaries to record medical marijuana purchases in the state prescription monitoring program database.

As originally drafted, the bill sponsored by Rep. Larry Bagley (R) would have simply added traumatic brain injuries and concussions to the list of conditions that qualify a patient for a marijuana recommendation. But it was amended in a House committee to add several other conditions as well as language stipulating that cannabis can be recommended for any condition that a physician “considers debilitating to an individual patient.”

Under current law there are only 14 conditions that qualify patients for marijuana.

“House Bill 819 is the new standard for medical marijuana programs. The bill allows any doctor who is licensed by and in good standing with the Louisiana Board of Medical Examiners to make medical marijuana recommendations for their patients,” Bagley told Marijuana Moment. “The bill also ends the Legislature’s task of picking medical winners and losers each session, and instead allows doctors to recommend medical marijuana for any condition that a physician, in his medical opinion, considers debilitating to an individual patient.”

Bagley also introduced a House-passed bill to provide for cannabis deliveries to patients, but he voluntarily withdrew it from Senate committee consideration last week and told Marijuana Moment it’s because he felt the medical marijuana expansion legislation would already allow cannabis products to be delivered to patients like other traditional pharmaceuticals.

The delivery bill would have required a government regulatory body to develop “procedures and regulations relative to delivery of dispensed marijuana to patients by designated employees or agents of the pharmacy.”

It’s not clear if regulators will agree with Bagley’s interpretation, as doctors are still prohibited from “prescribing” cannabis and marijuana products are not dispensed through traditional pharmacies. That said, they recently released a memo authorizing dispensaries to temporarily deliver cannabis to patients during the COVID-19 pandemic, so it’s possible officials will be amendable to extending that policy on a permanent basis.

State lawmakers also advanced several other pieces of cannabis reform legislation last week.

A bill introduced by Rep. Edmond Jordan (D) to protect banks and credit unions that service cannabis businesses from being penalized by state regulators cleared the full House in a 74-20 vote.

That measure was approved by Senate Committee on Commerce, Consumer Protection and International Affairs on Wednesday, setting it up for floor action in the chamber.

Also last week, the House Labor and Industrial Relations Committee unanimously approved a resolution to establish “a task force to study and make recommendations relative to the cannabis industry projected workforce demands.”

Text of the legislation states that “there is a need to study the workforce demands and the skills necessary to supply the cannabis industry with a capable and compete workforce, including physicians, nurse practitioners, nurses, and other healthcare practitioners.”

Legislators have until the end of the legislative session on June 1 to get any of the measures to the governor’s desk.

Marijuana Dispensaries Excluded From New York’s Coronavirus Loan Program

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Former Attorney General, Lawmakers And Police Leaders Call For Federal Marijuana Legalization Waivers

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A task force comprised of former lawmakers, federal prosecutors and reform advocates issued a series of recommendations on Wednesday about criminal justice policy changes that should be enacted, and that includes creating a waiver system to allow states to set their own marijuana policies without federal interference.

The Council on Criminal Justice task force was established prior to the coronavirus pandemic, but its new report said the health crisis has “underscored the urgency” of the recommendations. While the group is far from the only criminal justice-minded organization to push for cannabis reform, it’s especially notable because of the backgrounds of its membership.

Sally Yates, who served as deputy attorney general and interim attorney general, is on the task force. So is former Georgia Gov. Nathan Deal (R), former Philadelphia Mayor Michael Nutter and former Washington, D.C. and Philadelphia Police Chief Charles Ramsey. Mark Holden, who was senior vice president and general counsel at Koch Industries, and David Safavian, general counsel of the American Conservative Union, are also members.

Together, the group agreed on 15 reform recommendations.

While they didn’t endorse federally legalizing cannabis outright, the group said the current conflict between local and national policy is untenable and should be addressed in the interim by creating waivers for states to proceed with marijuana legalization without the fear of federal intervention.

“The federal government must act to resolve this conflict and confusion, by creating an environment that respects sovereignty and by providing a responsible framework in which states can make policy choices,” they said. “Without federal action, the cannabis industry will continue to operate without consistent guardrails and guidance for testing, labeling, and marketing—to minors and all consumers.”

“The Task Force concludes that neither a federal crackdown nor a hands-off approach is advisable. In the absence of cannabis rescheduling, or its legalization at the federal level, the Task Force recommends that Congress and the Administration develop a state waiver process or contractual framework. Without it, states and the industry will continue to exist under an illusion of sovereignty where circumstances can change at any moment. A balanced and thoughtful accommodation from the federal government would provide confidence to states, stabilize the market, and help address many of the myriad safety and health problems.”

To implement the recommendation, the group wants the federal government to create an interagency task force including representatives of the Departments of Justice, Treasury and Health and Human Services, among other agencies. Members would be charged with creating policies and standards on best public health practices regarding issues such as product availability, testing, labeling, marketing and child-resistant packaging.

It would also lay out guidelines for banks that work with the cannabis industry as well as guidance, grant funding and assistance to aid law enforcement efforts to crack down on illicit marijuana distribution. Also recommended is an expansion of National Institute on Drug Abuse-supported research on the potential benefits and risks of cannabis as well as the effects of regulatory legal models.

New federal legislation “should provide guidance and assurances to all stakeholders legally operating under the waiver and/or contractual agreement, shielding them from civil and/or criminal liability,” the report says.

Beyond marijuana, the Council on Criminal Justice task force also proposed eliminating mandatory minimum sentences for all federal drug crimes in order to reduce the prison population, automatically sealing public criminal records for non-violent federal convictions “including simple possession of controlled substances, following a conviction-free period of no longer than seven years” and establishing “independent oversight of the federal prison system.”

Due to the high rate of substance use disorders in prisons, the task force also recommended enhancing access “to evidence-based treatment services” that can “help break the cycle of substance use and incarceration.” Medication-assisted treatment would be an example of such a service, the report said.

“The pandemic engulfing the world has exposed more fully than ever the deficiencies in our nation’s criminal justice system, and how those deficiencies endanger people, communities, and public safety,” Nutter said in a press release. “Let us honor the pain, suffering, and loss of life that has occurred during this crisis by sharpening and refocusing our work for change.”

Another task force that advocates are eyeing was recently formed to make criminal justice recommendations to presumptive Democratic presidential nominee Joe Biden. The candidate and Sen. Bernie Sanders (I-VT), who dropped out of the race in April, teamed up to create the group, and most members are in favor of marijuana legalization, in contrast to Biden’s current position. It remains to be seen whether they will formally recommend adopting broader cannabis reform as part of the former vice president’s platform.

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Marijuana Dispensaries Excluded From New York’s Coronavirus Loan Program

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Not only are marijuana businesses excluded from federal coronavirus relief funds, but medical cannabis dispensaries in New York are also ineligible for a new COVID-19 loan program that the state is offering.

Under the New York Forward Loan Fund (NYFLF), marijuana shops are specifically excluded, alongside payday loan providers, pawn shops, strip clubs, liquor stores and astrologers. Information pages about the program don’t provide a reason for why dispensaries are considered ineligible.

“The working capital loans are timed to support businesses and organizations as they proceed to reopen and have upfront expenses to comply with guidelines (e.g., inventory, marketing, refitting for new social distancing guidelines) under the New York Forward Plan,” a description of the program states.

This eligibility requirement restrictions come despite the fact that most states, including New York, have deemed cannabis businesses as essential services that can continue to operate during the pandemic.

For the industry in the Empire State, the loan exclusion is another gut punch in a crisis. There have been widespread calls from stakeholders, advocates and legislatures to provide the market with equitable relief from the federal Small Business Administration and, while that so far has not panned out, there’s been hope that states could help fill the gap.

“Given that cannabis businesses are ineligible for federal relief, it is unconscionable for the state of New York to deny them access to state-based relief efforts,” Morgan Fox, media relations director for the National Cannabis Industry Association, told Marijuana Moment. “These businesses have been going above and beyond to provide continuous healthcare, protect jobs, and generate revenue for the state under terrible conditions just like other essential services.”

“Leaving them in the lurch like this is a tremendous disservice to the people who risked their health to provide medical cannabis to the people that need it, and will stunt the ability of the industry to recover and grow at a time when the economy needs it most,” he said.

Katie Neer, chair of the New York Medical Cannabis Industry Association and director of government relations for Acreage Holdings, told Marijuana Moment that it’s “unfortunate that medical cannabis operators, which are licensed and regulated in New York, and help thousands of patients manage a wide range of ailments, conditions, and illnesses, continue to be lumped in with other so-called ‘sin’ businesses, like pay-day loan stores, massage parlors, and strip clubs.”

“The reality is that New York’s medical cannabis program, established by the governor and Legislature in 2014, is one of the most restrictive in the nation,” she said. “As a result, the industry was struggling prior to the pandemic, even as it was deemed ‘essential’ and continues to serve patients throughout the crisis.”

“While we are eager to participate in the economic recovery at both the state and federal levels, accessing capital has long been a struggle for cannabis operators due to cannabis remaining a federally illegal schedule I drug. We applaud the state’s $100 million New York Forward Loan fund to support small businesses, but we regret not being able to participate due to inconsistencies between state and federal law. To that end, we urge the US Senate to include the SAFE Banking Act in the next federal aid package, which would improve the cannabis industry’s access to capital and ensure that state administered efforts like this one can include state-legal cannabis operators.”

It’s possible that because this loan program is the product of a private-public partnership involving several large national banks, the cannabis exclusion could be related to perceived risks associated with providing financial services to a federally illicit market.

While New York might not be extending state-level relief to cannabis businesses, lawmakers in Massachusetts are actively considering legislation that would establish a coronavirus relief program for marijuana firms and other companies that are left out of federal aid.

In the meantime, at the federal level, the House passed a COVID-19 package that does contain language that would protect banks that service cannabis businesses from being penalized by federal regulators. Advocates argue that this would mitigate the spread of the virus in a heavily cash-based industry.

Rep. Earl Blumenauer (D-OR) also introduced a bill last month that would extend SBA access to marijuana companies.

New York Gov. Andrew Cuomo (D) was recently asked why the state hasn’t legalized cannabis for adult use as a means to generate much-needed tax revenue during the pandemic. He said it’s a policy change he expects will happen, but it’s a “complicated issue and it has to be done in a comprehensive way.”

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