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Congressional Hearing Exposes Marijuana Research Limitations Imposed By Federal Law

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At a congressional hearing on Wednesday, federal regulators recognized that valuable research into marijuana is being inhibited cannabis’s current legal status and described previously unreported steps they’re taking to resolve the issue.

The Energy and Commerce Subcommittee on Health held the meeting to discuss six cannabis reform proposals, including two that would federally legalize marijuana. Most of the hearing involved lawmakers pressing witnesses from the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and National Institute on Drug Abuse (NIDA) on the obstacles to marijuana studies that those officials claim are needed before pursuing broader policy reform.

Conversation was more limited when it came to legalization bills such as Judiciary Chairman Jerrod Nadler’s (D-NY) Marijuana Opportunity, Reinvestment and Expungement (MORE) Act, which was approved by his panel last year. That said, formerly anti-reform Rep. Joe Kennedy III (D-MA) did lead a powerful discussion about the failures of prohibition and the need to deschedule cannabis.

Kennedy announced that panel leadership has agreed to hold a second hearing featuring the voices of people negatively impacted by marijuana prohibition, which he said “has failed.”

Energy and Commerce Committee Chairman Frank Pallone (D-NJ) said in his opening statement that “while state laws and public perception around cannabis and its derivatives have evolved over the years, much of the federal framework that regulates cannabis has stayed the same.”

Watch the hearing, titled “Cannabis Policy For the New Decade,” below:

After being repeatedly asked about the limited supply of research-grade cannabis and the lack of chemical diversity in those plants cultivated at the nation’s only federally authorized manufacturer, DEA Senior Policy Advisor Matthew Strait said the agency is aware of the issue and is actively developing regulations to address the problem by licensing additional growers.

“We actually have a draft regulation in place,” he said, adding that it’s currently being reviewed by the White House Office of Management and Budget (OMB) and that regulators have a call scheduled for Thursday to discuss the proposed rule.

“We know that we have to probably do notice and comment rulemaking to implement regulations on two matters: one is how we’re going to evaluate all of our pending applications and two what additional types of regulations might need to be in place in order to impose on those that would grow,” he said. “That regulation is in draft form. I can’t talk too much about it, but rest assured, we have submitted to OMB, it’s been drafted and tomorrow some of us will be getting on a call to talk through it.”

DEA, FDA and NIDA witnesses all agreed under questioning that the current supply of cannabis for study purposes is inadequate and that researchers should be able to access a wider range of marijuana products.

Kennedy, who recently became a cosponsor of the MORE Act, followed up on his opening remarks with a brief statement on his personal evolution on the issue and frustration over policies inhibiting research.

“Meanwhile, millions of Americans—mostly black and brown—have been locked up for non-violent drug offenses. Meanwhile, desperate parents are forced to turn to a black market with no concern for patient safety to get their children the relief that they need. Meanwhile our cities and states are trying, and at times stumbling, to put in place thoughtful and thorough regulatory frameworks with zero support from federal partners. And meanwhile, a brand new corporate industry is rising up, rife with predictable economic injustices that spring up whenever government fails to regulate. Prohibition has clearly failed and America isn’t waiting for its government anymore.”

He then asked NIDA Director Nora Volkow and FDA Deputy Director for Regulatory Programs Douglas Throckmorton whether removing cannabis from the Controlled Substances Act (CSA) would make it easier for researchers to obtain and study it. Both said that the policy change would in fact simply research, though Volkow said it “may have unintended negative consequences.”

FDA and NIDA said their agencies would not be impacted if marijuana was descheduled, and DEA’s Strait acknowledged that his agency would because of its responsibility to enforce the CSA.

Subcommittee Chairwoman Anna Eshoo (D-CA) said researchers are “are in a catch-22” under the current regulatory scheme because they “can’t conduct research until they show cannabis has a medical use, but they can’t demonstrate cannabis has a medical use until they can conduct research.”

“It doesn’t make sense—at least to me,” she said.

Rep. Tony Cardenas (D-CA) said that the “United States Congress made a mistake, and every Congress since has not had honest hearings and honest dialogue and has not allowed—truly allowed—the researchers in this great country to do the true research that needs to be done for us to properly categorize cannabis in this country.”

“As a result of that, we have millions of individuals in this country who have been subjected to incarceration and a criminal record that otherwise they would have a much more productive and better life and that as a society, we would be much better off, including the taxpayers, if we were to actually get this right,” he said.

There were several exchanges throughout the hearing—which was requested by four Republican members last month—where lawmakers opposed to comprehensive reform argued that cannabis is a gateway drug and that legalization represents a public health threat.

Rep. Greg Walden (R-OR) brought cookies in plastic baggies and distributed them to members. He then pointed to an image of a THC-infused cookie that looks similar that are available in Oregon.

“Each of you, by the way, has a cookie in front of you. I have a pizza stand opening in an hour out in the hallway,” he quipped. “Now don’t worry, I didn’t get that carried away. You can actually eat these. The question is, how do you know if your child stumbled upon it?”

The congressman went on to say that descheduling marijuana “is a step too far and is something I cannot support.”

But there were other members who shared anecdotes about the consequences of prohibition, particularly on patients who stand to benefit from medical cannabis.

Rep. Morgan Griffith (R-VA), for example, recalled that in the 1980s, he knew friends who would smuggle cannabis into a hospital for a man suffering from cancer and who wanted to improve his quality of life to spend time with his son. Rep. Debbie Dingell (D-MI) said her late husband, former Rep. John Dingell (D-MI) experienced “great pain” and was told that cannabis might treat it, but he declined in part because of its status as a federally illicit substance.

Several other lawmakers, including Cannabis Caucus Co-Chair Barbara Lee (D-CA), highlighted the hearing and remarked on its significance.

“Today, my [Energy Commerce] colleagues are holding a hearing on legislation to remove marijuana from the list of Schedule I drugs and allow for more research on the uses, impacts, and health benefits of cannabis,” Rep. Mike Doyle (D-PA) said. “Looking forward to their discussion on these bills!”

“After years of working to advance cannabis reform in Congress, this critical hearing is an important milestone where another major congressional committee focused time and attention on our movement,” Rep. Earl Blumenauer (D-OR), who spoke to Marijuana Moment on Tuesday about his expectations for the hearing, said in a press release. “It was important to hear a number of senior members of Congress affirming the change that is taking place at the state level and affirming the contradictions that are created by the federal government being out of step and out of touch.”

Pro-legalization group NORML also submitted written testimony for the hearing, stating that as “evident by the title of this hearing, our federal marijuana policies are stuck in the past.”

“It is time for Congress to amend them in a manner that comports with our current political and cultural reality,” the organization said. “For some 50 years, the cannabis plant has been improperly categorized and criminalized by federal law. It is time to re‐examine and amend this longstanding failed policy.”

Ahead of the hearing, a coalition of cannabis reform groups—including the National Cannabis Industry Association, Cannabis Trade Federation and Minority Cannabis Business Association—sent a letter to subcommittee leadership ahead of the meeting, encouraging members to take action on the various pieces of legislation.

“As organizations that collectively represent thousands of state-legal cannabis businesses around the country, ancillary industries, and our communities, we applaud your decision to hold a hearing on cannabis policy so early in the new legislative session,” the groups wrote. “This is a wonderful opportunity to continue the robust and groundbreaking discussion on this issue that took place in Congress last year and we commend your leadership in carrying it over into 2020.”

“As an industry, we understand that many lawmakers have concerns about the impact of the changing legal status of cannabis. We do not take these concerns lightly. These concerns underscore the need to establish a legal federal cannabis framework, as current federal policies can cause and exacerbate these concerns. We welcome the opportunity to work with lawmakers and regulators to determine the best paths forward as state and federal cannabis policy evolves.”

In their written testimony, DEA, FDA and NIDA representatives generally described the current state of federal marijuana policy, unsurprisingly without advocating for changes to cannabis’s current criminal status. That said, both DEA and NIDA seemed to at least recognize that existing policies are inhibiting research into the plant and signaled that changes are on the horizon.

Volkow wrote that the growing availability of cannabis products, particularly with high concentrations of THC, “raise serious public health concerns.” At the same time, however, “despite the public health urgency, legal and regulatory barriers continue to present challenges to advancing cannabis research.”

“Obtaining or modifying a Schedule I registration [for researchers to study marijuana] involves significant administrative challenges, and researchers report that obtaining a new registration can take more than a year,” she said. “Adding new substances to an existing registration can also be time consuming.”

“It would be useful to clarify aspects of the [Controlled Substances Act] that have been sources of confusion and administrative burden for the research community,” she said.

Additionally, Volkow acknowledged that the current situation, where the government has only authorized one facility to cultivate cannabis for researchers, “limits the diversity of products and formulations available to researchers and slows the development of cannabis-based medications.”

“Although the University of Mississippi supplies cannabis for clinical trials, it does not have the capacity to manufacture a broad array of cannabis-derived formulations for research or to supply these cannabis products for commercial development,” she said.

Strait wrote that his agency remains committed to expanding the number of federally authorized cannabis manufacturers for research purposes, noting that DEA is reviewing the situation but that ” adjustments to DEA’s policies and procedures may be necessary under applicable U.S. law to be consistent with certain treaty functions.”

“In the near future, DEA intends to propose regulations that would govern persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, consistent with applicable law, taking into account recent changes in the Controlled Substances Act,” he said. “At present, a notice of proposed rulemaking is under review by the Office of Management and Budget.”

Volkow raised another issue, which other federal agencies have previously recognized, noting that “researchers supported by NIDA and other federal agencies are unable to access marketed cannabis products through state marijuana dispensaries.”

“There is a significant gap in our understanding of their impact on health,” she said. “The recent outbreaks of e-cigarette or vaping product use associated lung injury (EVALI), which has been linked to informally-sourced THC-containing vape products, underscores the critical importance of facilitating researcher access to different product sources.”

A NIDA staffer told Marijuana Moment in an email last week that “rigorous research is essential for understanding how the changing cannabis landscape will affect public health, for guiding evidence-based policy, and advancing therapeutics.”

“However, there are significant regulatory challenges to conducting research with marijuana and other Schedule I drugs,” the official said. “NIDA [has] been working with the DEA and FDA on ways to ameliorate these challenges, but there is nothing publicly available to share at this time.”

This story has been updated to include details and quotes from the hearing.

Leading Marijuana Reform Advocate In Congress Weighs In On This Week’s Legalization Hearing

Image element courtesy of Tim Evanson

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The White House Is Reviewing CBD And Marijuana Research Guidance From FDA

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The White House is currently reviewing a federal plan for marijuana and CBD research.

The Food and Drug Administration (FDA) submitted draft guidance on the issue last week to the White House Office of Management and Budget (OMB).

Details about the document—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—are sparse. But an FDA spokesperson indicated to Marijuana Moment that it’s related to the agency’s ongoing work to develop broader CBD regulations that could eventually allow for the marketing of cannabis products as dietary supplements or food items.

“We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress,” FDA said in a statement. “There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.”

“As part of our work, the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed,” the statement continues. “An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform our consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards.”

What remains to be seen is 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.

“We will continue to update the public about our path forward as our work progresses, and provide information that is based on sound science and data,” FDA said.

While sending the guidance to OMB could be interpreted as a positive development signaling that FDA is making progress on the development of regulations, former FDA Commissioner Scott Gottlieb said on Saturday 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.

The FDA spokesperson declined to comment on the former commissioner’s statement.

The agency first announced in January that it planned to publish guidance on cannabis research this year. It’s not clear how long the OMB review will take or when the document will be finalized for public release.

In addition to sending the guidance 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.

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 last month.

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.

Scientists And Veterans File Lawsuit Challenging DEA’s Marijuana Rescheduling Denials

Photo by Kimzy Nanney.

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Marijuana Legalization And The Fight For Racial Justice (Op-Ed)

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“Black and brown lives matter and we owe it to our country and to ourselves to take tangible steps toward dismantling many of the power structures that perpetuate injustice. Marijuana prohibition is simply one of them.”

By Erik Altieri, NORML

On May 25th, George Floyd was killed on camera by officers affiliated with the Minneapolis Police Department. As were many Americans, we were shocked and disheartened by this tragic and needless loss of life.

As the events of the past few days have unfolded, it is clear that America is in the midst of a long overdue reckoning with itself. Since 1619, when the first ships arrived on the coast of Virginia with enslaved Africans in chains, our country has long had to struggle to address the inequality and structural racism embedded within our public institutions—particularly within the criminal justice system.

From slavery and the Civil War, to the battles to end Jim Crow laws, to the marches for civil rights, to the protests against mass incarceration, to the Black Lives Matter movement, each generation of Americans has stepped up to take action to fight to end racial injustice.

As protests continue to take place across our nation, more Americans are beginning to publicly demand action from their local, state and federal leaders to end the policies and practices that promote, enable and drive systemic racial injustice. In these conversations about policy solutions, many will include in their demands an ending to the war on drugs—or, at a minimum, an ending to marijuana criminalization. But while ending cannabis prohibition is both important and necessary, we must also recognize that doing so is but a single piece of a much larger puzzle.

Will legalizing marijuana reform alone solve the problem of racial injustice? No.

Is ending cannabis prohibition going to fix all of America’s social ills? No.

After we legalize adult-cannabis use, will we see an end to discriminatory policing against communities of color and other marginalized groups? No.

Will end marijuana prohibition be a small step toward the greater goal of promoting justice? Without a doubt, yes.

And the majority of Americans agree.

Our decades-long prohibition of marijuana was founded upon racism and bigotry. Look no further than the sentiments of its architect, Harry J. Anslinger, Commissioner of the Federal Bureau of Narcotics, who declared: “[M]ost [marijuana consumers in the US] are Negroes, Hispanics, Filipinos and entertainers. … [M]arijuana causes white women to seek sexual relations with Negroes. … Reefer makes darkies think they’re as good as white men.”

These racial biases were later exploited by the Nixon administration when it ramped up the drug war in 1970 and declared cannabis to be “public enemy #1.” As former Nixon adviser John Ehrlichman later acknowledged: “The Nixon campaign in 1968, and the Nixon White House after that, had two enemies: the antiwar left and black people. You understand what I’m saying? We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news. Did we know we were lying about the drugs? Of course we did.”

Today, the modern era of marijuana prohibition continues to be disproportionately applied. Annually, over 650,000 Americans are arrested for violating marijuana laws. Yet, according to an analysis of these arrests released earlier this year by the ACLU, “In every single state, Black people were more likely to be arrested for marijuana possession, and in some states, Black people were up to six, eight, or almost ten times more likely to be arrested. In 31 states, racial disparities were actually larger in 2018 than they were in 2010.”

Of course, marijuana prohibition isn’t the sole cause of America’s racial inequities, nor is it the sole reason why certain members of the police continue to engage in racially-aggressive policing and misconduct. But its criminalization is one of the tools commonly used to justify and perpetuate these injustices.

For example, marijuana enforcement was the pretext in the fatal law enforcement shooting of another Minnesotan just a few years before George Floyd’s murder: Philando Castile. The officer in this case alleged that he feared for his life simply because he believed that Mr. Castille had been smoking marijuana, stating: “I thought I was gonna die. And I thought if he’s, if he has the guts and the audacity to smoke marijuana in front of the 5-year-old girl and risk her lungs and risk her life by giving her secondhand smoke and the front seat passenger doing the same thing then what, what care does he give about me. And, I let off the rounds and then after the rounds were off, the little girl was screaming.”

Even in those jurisdictions where adult-use cannabis is legal, we know that there still remains much work to be done to address continuing racial inequities. For instance, African Americans and Latinos continue to disproportionately be targeted for traffic stops in Colorado and Washington even after legalization.

Then there is the question of the cannabis industry itself. We advocates need to continue to push for inclusion and equity within this space. We must not ignore the reality that while a handful of venture capitalists are now engaging in licensed cannabis sales in systems that largely exclude minority ownership while millions of others—most of them young, poor and people of color—continue to face arrest and incarceration for engaging in much of the same behavior.

There is no doubt that our national discussion over matters of race and policing will continue long after these public protests have ceased. NORML believes that calls for cannabis legalization need to be an important part of this emerging discussion—but only a part. Black and brown lives matter and we owe it to our country and to ourselves to take tangible steps toward dismantling many of the power structures that perpetuate injustice. Marijuana prohibition is simply one of them.

We are at a crossroads in this country and it is time for all of us to march as allies in the fight for racial justice and equality. It is important during this process for those of us not from these marginalized communities to truly listen to those who are facing this oppression and support them in this struggle. Let us take this moment in time to pledge to put in the work necessary in order to make America the better and more just nation that we know it can be.

Erik Altieri is executive director of NORML.

Cory Booker Cites Marijuana Enforcement As Example Of Racial Injustice That Is Motivating Protests

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Two-Thirds Of Arizona Voters Support Marijuana Legalization Ballot Measure, Poll Shows

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If Arizona marijuana activists succeed in placing a legalization initiative before voters this November, it will likely pass by a wide margin, according to a new poll.

In a survey of likely voters, about two-thirds (65.5 percent) of respondents said they would support the proposed measure, the Smart and Safe Arizona Act. That’s a notable shift since residents were surveyed late last year in a poll that showed 54 percent in favor of the policy change.

The survey described the legalization initiative, which would make it legal for adults 21 and older to purchase and possess cannabis and also impose taxes on legal sales, and asked 400 respondents if they would vote yes or no on the proposal

Forty-seven percent said they would “definitely” back it and 18.5 percent said they “probably” would. Nineteen percent said they “definitely” would not vote for it, while six percent said they “probably” wouldn’t.

The campaign behind the initiative, Smart and Safe Arizona, said in April that it had collected enough raw signatures to qualify for the ballot. However, those haven’t been verified by the state yet and the group said it plans to continue petitioning to ensure success. Stacy Pearson, campaign manager for the organization, told Marijuana Moment on Tuesday that they’re “on track to turn in more than 400,000 signatures by the July 2 deadline.”

“The HighGround poll is encouraging and tracks with what our internal polling shows—Arizonans are ready to legalize marijuana,” she said. “Particularly in this economic environment, new jobs and tax revenue are important to voters.”

Activists asked the state Supreme Court to allow electronic signature gathering given challenges presented by the coronavirus pandemic, but that request was rejected.

In the poll, which was conducted from May 18-22, the only group that appears divided on the issue are those who identify as “very conservative.” They were evenly split—47.6-47.6 percent—on whether or not they’d vote in favor of legalization. All other demographics were solidly in favor of the proposal.

Via Higherground.

“As long as Smart and Safe Arizona can qualify for the ballot, all signs point to 2020 being the year that recreational marijuana finally becomes legal in Arizona,” Paul Bentz, senior vice president of research and strategy at HighGround, said in a press release. “Of course, there is still strong opposition among some of those who represent the most conservative segments of the electorate. We should expect a legal challenge coming from that audience because at this point, that’s the likely the only way they can defeat this issue.”

Under the measure, adults could possess up to an ounce of marijuana at a time and cultivate up to six plants for personal use.

The initiative also contains several restorative justice provisions such as allowing individuals with prior marijuana convictions to petition the courts for expungements and establishing a social equity ownership program

Cannabis sales would be taxed at 16 percent. Tax revenue would cover implementation costs and then would be divided among funds for community colleges, infrastructure, a justice reinvestment and public services such as police and firefighters.

The Department of Health Services would be responsible for regulating the program and issuing cannabis business licenses. It would also be tasked with deciding on whether to expand the program to allow for delivery services.

A 2016 legalization proposal was rejected by Arizona voters. But in the four years since, more states have opted to legalize and public opinion has continued to shift in favor of reform.

“Clearly, the initiative backers have learned from the mistakes of the past and have done everything they can to put together a more palatable proposal,” Bentz said. “In particular, they were wise to make this proposition more ‘family friendly’ by banning smoking in public and ensuring products cannot resemble children’s candy. Ultimately, that’s likely what got them over the hump with a majority of Republicans.”

Michigan Bill To Let Elected Officials’ Spouses Obtain Marijuana Licenses Advances While Equity Issues Persist

Photo courtesy of Brian Shamblen.

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