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FDA Head Reveals New Details About Agency’s CBD Regulation Plans

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Food and Drug Administration (FDA) Commissioner Scott Gottlieb revealed new details about plans to pursue alternative pathways for CBD regulation and also acknowledged that federal prohibition drives research into medical marijuana overseas on Wednesday.

Gottlieb’s latest comments were in response to questions from Reps. Barbara Lee (D-CA), Chellie Pingree (D-ME) and Mark Pocan (D-WI) during a hearing before a House Appropriations subcommittee.

Among the revelations that came out of the hearing was that Gottlieb will shortly announce that the FDA will hold a public meeting “sometime in April” to hear from stakeholders about how to best regulate CBD derived from hemp, which was legalized late last year as part of the 2018 Farm Bill. He also said he’d be forming a working group comprised of agency experts to inform him on regulatory options for CBD.

Pocan wanted to know “how actively” the FDA was considering different pathways to regulate food and dietary supplements that contain hemp-derived CBD, and he requested a timeline for when the agency expects to release guidance on the issue.

“I’ll say at the outset that we heard Congress loud and clear with respect to that legislation,” Gottlieb said, referring to the Farm Bill. “I understand Congress wants there to be a pathway for CBD to be available.”

But he added that this “is not a straightforward issue.” Not only has the already FDA approved a CBD medication for epilepsy, Epidiolex, which generally means the compound can’t be added to food, but it’s also the “subject of substantial clinical investigation”—another reason it wouldn’t be be allowed in the food supply.

That said, “the law does allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply,” Gottlieb said. Their first step to that end will be a public meeting “sometime in April” that the agency will soon formally announce.

The commissioner offered a theoretical regulatory model that the FDA could implement for CBD.

CBD could potentially exist “in a high concentration, pure formulation as a pharmaceutical product” and also exist “at a different concentration as a food product or dietary supplement.” The reason the agency would want that separation is “because we want to preserve the incentive to study CBD as a pharmaceutical product,” Gottlieb said.

“We believe it does have therapeutic value and has been demonstrated,” he said. “But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”

If the task of developing an alternative regulatory approach for CBD proves “sufficiently complicated,” Gottlieb said the FDA will “come back and have a discussion with Congress about how we might be able to work together on this,” suggesting that further legislative action beyond the Farm Bill may be necessary.

Rep. Andy Harris (R-MD) briefly followed up on Pocan’s questioning and said he goes into markets and see “displays of CBD-containing products, and it’s not at the pharmacy behind the counter obtained with a prescription.”

“I think this is something that crept up on us and I appreciate your answer to Mr. Pocan on that,” Harris said. 

Pingree was the lead author of a bipartisan letter that was sent to the commissioner last week, inquiring about the timeline for the FDA’s guidance on how businesses can lawfully sell hemp-derived CBD products across state lines. At the hearing, the congresswoman said she wanted to “emphasize the need for some sense of urgency” around the issue.

“I will tell you that we’re deeply focused on this. We have taken on other hard challenges before,” Gottlieb said. “I think we have a good track record of trying to come to resolution on other challenges. You have my commitment that I’m focused on this one.”

The commissioner said he will soon announce “a high-level working group that’s going to report to me on this, with some senior officials in the agency who are going to be chairing that.”

“I will tell you that if we make a determination that the pathway here is going to be a multi-year regulatory process that could take two, three, four years, I will come back to Congress to have a discussion about whether or not there are other frameworks that could help address this,” he said. 

Further, the FDA may “need statute that either addresses this as a whole framework or address CBD specifically.”

Lee, who became the first woman and first person of color to co-chair the Congressional Cannabis Caucus in January, said she was excited to have the opportunity to speak about two of her favorite subjects: “Cuba and cannabis.”

For the latter, she focused on the FDA approval of Epidiolex. Specifically, she wanted to point out that a UK-based pharmaceutical company was awarded the drug approval because the UK government licenses them “to privately grow strains of cannabis for the purpose of drug development.”

Is it possible under our US federal system, Schedule I, can a U.S.-based company similarly bring a plant-derived cannabis-based drug to market via the traditional FDA review and approval process?” Lee asked. “Because so many states now have passed medical marijuana initiatives and it’s a shame that we haven’t been able to move forward with the research.”

“With respect to cannabis-derived compounds, it really depends on which active ingredient you’re talking about—whether you’re talking about THC or CBD and whether or not it’s being derived from marijuana or hemp,” Gottlieb said.

He added that it remains an “active question” as to whether hemp-derived CBD was legalized under the 2018 Farm Bill, which would mean the compound “can be studied in a more fluid fashion.” (Some experts don’t see this as an open question, however, as the agriculture legislation did remove hemp-derived products from the Controlled Substance Act.)

The commissioner said he has his “own personal opinion” about the issue but said his lawyers wouldn’t want him to give a “legal opinion.”

I think we’re going to have a resolution on that very soon about whether or not the CBD derived from hemp doesn’t fall under the scheduling process,” he said. 

Finally, Gottlieb conceded that existing federal marijuana laws mean that “the ability to conduct research on marijuana is more restricted, more heavily regulated.” While he said he didn’t know “all of the nuances” around it, one problem is that there’s only one federally authorized marijuana manufacturer in the United States, and that lack of supply has driven some researchers to conduct studies in other countries.

“Over the years, you have seen, in all candor, companies go overseas to conduct research with foreign-grown product that is more easily sourced for the purposes of clinical trials,” he said. “I think the issue you’re getting at is a valid one. The only thing I can say is that the environment here is changing quickly.”

“Very quickly,” Lee agreed.

“We would certainly support more research,” Gottlieb said. 

FDA Is Exploring ‘Alternative Approaches’ To CBD Regulation, Commissioner Says

Photo courtesy of YouTube/House Appropriations Committee.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

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Majority Of Connecticut Residents Back Marijuana Legalization And Expungements, Poll Finds As Reform Bills Advance

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As bills to legalize marijuana in Connecticut move through the legislature, a new poll finds that the reform has strong support among residents.

The survey from Sacred Heart University (SHU), released on Tuesday, found that about 66 percent of people in the state favor legalizing cannabis for adult use, while 27 percent are opposed.

If the policy change is enacted, 62 percent said those with prior marijuana convictions should have their records expunged.

Via SHU.

Younger people and those who identify as Democrats were more likely to back ending prohibition, compared to those 65 and older or Republicans.

Further, the poll asked about perceived harms of cannabis, and 77 percent said they felt the plant carried “fewer effects” or comparable effects as alcohol. About 72 percent drew the same contrast between marijuana and other drugs such as heroin, amphetamines and prescription painkillers.

Via SHU.

These figures are largely consistent with a previous poll that SHU conducted in February.

And like that prior survey, nearly half of Connecticut residents again expressed that they still believe that there are potential negative public safety implications of legalization, even if they support the policy. In this case, 48 percent said they agree that allowing recreational cannabis would lead to a “significant” increase in impaired driving.

Two in five respondents said they agree that marijuana is a gateway to other drugs. The poll involved interviews with 1,000 residents from March 23-31.

But while these figures largely align with the last SHU survey, one thing that has changed is that reform legislation has started to advance in the legislature, including a bill being backed by the governor.

The Judiciary Committee approved Gov. Ned Lamont’s (D) proposal, which was amended to more comprehensively address social equity issues, last week. That said, legislative leaders have indicated that the bill is fluid and will likely see additional revisions down the road.

A competing legalization measure from Rep. Robyn Porter (D) was approved in the Labor and Public Employees Committee last month.

One amendment that was adopted to the governor’s bill would provide for the free erasure of past marijuana convictions for possession or sales of up to four ounces of cannabis or six mature plants—a policy that is evidently backed by most residents in the state.

Lamont, who convened an informal work group in recent months to make recommendations on the policy change, initially described his legalization plan as a “comprehensive framework for the cultivation, manufacture, sale, possession, use, and taxation of cannabis that prioritizes public health, public safety, and social justice.”

For his part, House Speaker Matthew Ritter (D) said last month that “optimism abounds” as lawmakers work to merge proposals into a final legalization bill.

Majority Leader Jason Rojas (D) said “in principle, equity is important to both the administration and the legislature, and we’re going to work through those details.”

To that end, the majority leader said that working groups have been formed in the Democratic caucuses of the legislature to go through the governor’s proposal and the committee-approved reform bill.

In February, a Lamont administration official stressed during a hearing in the House Judiciary Committee that Lamont’s proposal it is “not a final bill,” and they want activists “at the table” to further inform the legislation.

The legislature has considered legalization proposals on several occasions in recent years, including a bill that Democrats introduced last year on the governor’s behalf. Those bills stalled, however.

Lamont reiterated his support for legalizing marijuana during his annual State of the State address in January, stating that he would be working with the legislature to advance the reform this session.

Ritter said in November that legalization in the state is “inevitable.” He added later that month that “I think it’s got a 50–50 chance of passing [in 2021], and I think you should have a vote regardless.” The governor said in an interview earlier this year that he puts the odds of his legislation passing at “60-40 percent chance.”

Should that effort fail, the speaker said he will move to put a constitutional question on the state’s 2022 ballot that would leave the matter to voters. Lamont made similar remarks last week.

The governor has compared the need for regional coordination on marijuana policy to the coronavirus response, stating that officials have “got to think regionally when it comes to how we deal with the pandemic—and I think we have to think regionally when it comes to marijuana, as well.”

He also said that legalization in Connecticut could potentially reduce the spread of COVID-19 by limiting out-of-state trips to purchase legal cannabis in neighboring states such as Massachusetts and New Jersey.

Illinois Gets More Tax Revenue From Marijuana Than Alcohol, State Says

Photo courtesy of Mike Latimer.

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Remembering Cannabis Legalization Pioneer Steve Fox

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This post is a remembrance of longtime cannabis policy activist Steve Fox from his colleagues at VS Strategies and Vicente Sederberg LLP.

Dear Family, Friends, and Colleagues,

We are truly heartbroken to share news of the passing of our partner and dear friend Steve Fox. Steve served as managing partner of VS Strategies since co-founding it in 2013, and he was a leader at Vicente Sederberg LLP since its formation in 2010.

We welcome the celebration of Steve’s life through the sharing of thoughts and memories, and we ask for respect and privacy for his family, friends, and coworkers who are still reeling from this loss. We have also started a GoFundMe page to support Steve’s wife and daughters as they navigate their way through this extremely difficult time—https://www.gofundme.com/f/support-the-family-of-steve-fox

With wisdom beyond his years and a pioneering spirit, Steve was an “old soul” with a knack for seeing things in a new light. He was strongly principled, deeply empathic, and fiercely kind. And despite his usually soft-spoken and lighthearted demeanor, his opinions rarely went unheard and always carried significant weight.

His passion for politics and policy were exceeded only by his passion for people—his family, friends, and colleagues, as well as the multitude of strangers that he knew were being affected every day by politics and policy. He had a burning desire and uncanny ability to envision and effect positive change, both societally and in those closest to him. He was not just a remarkable human being, but a truly transformational leader.

Steve was always the first to volunteer and the last to seek credit. He was beyond generous with his time and patience, and perpetually understanding. He relished opportunities to provide counsel and guidance, and the feeling was mutual for those who received it. He was warmly regarded as a mentor by no fewer than a dozen current and former members of our firm, including all seven of us.

Steve was one of the first political professionals to enter the marijuana advocacy space. At a time when cannabis policy was just a blip on the political radar and most savvy up-and-comers were unwilling to dip a toe into the space, Steve dove in headfirst. While many viewed it as a losing cause that wasn’t worth the fight, he saw it as a cause worth fighting until it was won. And in working to legalize and regulate cannabis for medical and adult use, he found a way to fight simultaneously for several of his core values: To promote justice and compassion, to advance freedom and liberty, and to nurture and inspire the human spirit. Humbly righteous, judiciously aggressive, and relentlessly ethical, he was committed to doing the right thing, doing it the right way, and doing whatever it takes to get it done.

When he joined the Marijuana Policy Project in 2002, Steve was the only full-time cannabis lobbyist on Capitol Hill. He would remain at the forefront of the cannabis policy reform movement for nearly two decades, playing pivotal roles in several major victories at the federal and state levels.

Steve was a lead drafter of Colorado’s historic Amendment 64, which legalized cannabis for adult use, and he managed all aspects of the successful campaign behind its passage and implementation. He also conceptualized and co-founded Safer Alternative For Enjoyable Recreation (SAFER), which laid a lot of groundwork for the legalization effort and contributed to a seismic shift in the U.S. cannabis policy debate. In 2009, he co-authored the book “Marijuana Is Safer: So why are we driving people to drink?,” which is based on the SAFER strategy.

Steve was always thinking step ahead of the rest. Long before cannabis was legalized, he envisioned a legal, organized, and responsible cannabis industry. He played leading roles in conceptualizing and establishing several of the nation’s largest and most influential cannabis trade organizations, including the National Cannabis Industry Association, the Cannabis Trade Federation, and the U.S. Cannabis Council. He regularly led working group meetings and calls, and he was a frequent speaker at cannabis conferences.

Steve’s role in cannabis community cannot be overstated. He was a trailblazer in the movement to end prohibition, and he was an architect and caretaker of the legal industry that is quickly replacing it. He beat the path, built the shelter, and worked tirelessly to make it as welcoming, accessible and beneficial as possible. He always put the mission—the wellbeing of others and the betterment of society—ahead of himself.

No one was more reluctant to sing their own praises while being so deserving of a louder refrain.

In 2013, Steve received a highly esteemed award from the Drug Policy Alliance in recognition of his long-term spearheading of the Colorado legalization effort. With an audience of hundreds and the spotlight squarely on him, he used the better part of his brief acceptance speech to give recognition to the people and organizations who had supported and worked alongside him. He reserved only the final thought for his own personal message and dedication. It was to his parents, for raising him to believe in the Jewish philosophy “Tikkun olam”—to “repair or heal the world” through beneficial and constructive acts. That is what drove Steve to take on the cause of cannabis policy reform. And it was what drove Steve to be the person he was.

Tikkun olam. Mission accomplished, dear friend.

Shawn Hauser
Josh Kappel
Andrew Livingston
Christian Sederberg
Mason Tvert
Brian Vicente
Jordan Wellington

And the entire VSS and VS family

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Biden’s Pick To Lead DEA Voiced Openness To State Medical Marijuana Program

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President Joe Biden’s nominee to lead the Drug Enforcement Administration (DEA) previously described a New Jersey medical marijuana bill as “workable” while serving at the state’s attorney general.

Although the former top state prosecutor, Anne Milgram, doesn’t appear to have publicly detailed her personal views on cannabis reform, the limited comments she made over a decade ago signal that, at the very least, she’s open to allowing states to enact their own marijuana policies despite federal prohibition.

That’d be a big deal, as far as advocates are concerned. Having a DEA administrator who appears flexible with respect to state cannabis reform efforts would be a notable development given the role that the official plays in federal marijuana policy.

However, Milgram’s on-the-record remarks on the issue are admittedly minimal. In 2009, when the New Jersey legislature was considering a medical cannabis legalization bill, she called the proposal “workable,” according to a one-word quote included in an Associated Press report.

After the legislation was amended, a spokesperson for the then-attorney general said the change “tightens up the provisions…that could have become loopholes by people seeking to divert marijuana for illicit purposes.”

Biden announced Milgram as his pick to be the next DEA administrator on Monday, and now her nomination heads to the Senate. It is possible that she will be asked to elaborate on her views during a confirmation hearing before the Judiciary Committee.

Milgram’s prior statements are far from an explicit endorsement of medical cannabis legalization, but they do indicate that the nominee is not vociferously opposed to state-level reforms as has been the case for prior DEA administrators. And in combination with other Biden cabinet picks, that bodes well for advocates.

Attorney General Merrick Garland made clear during his oral and written testimony before the Senate, for example, that he does not feel the Justice Department should use its resources to go after people acting in compliance with state marijuana laws. That stands in contrast with President Donald Trump’s first selection for attorney general, Jeff Sessions, who rescinded Obama-era guidance deprioritizing prosecutions over state-legal cannabis activity.

The DEA, with authority delegated from the Department of Justice, plays an important role in determining the schedule status of marijuana and other drugs. If the agency’s administrator were to acknowledge the medical benefits of cannabis, it would deeply undermine its current classification in Schedule I, which is supposed to be reserved for substances with no therapeutic value.

That said, while the Justice Department and DEA play a key role in federal scheduling, a medical and scientific review by the Department of Health and Human Services (HHS) and the Food and Drug Administration is binding on the attorney general’s classification decision.

To that end, the former attorney general of California, Xavier Bacerra, was confirmed by the Senate to lead HHS, and he has a considerable record supporting cannabis reform and working to protect California’s legal program from federal interference.

Meanwhile, Biden has yet to nominate someone to run the federal Office of National Drug Control Policy (ONDCP), despite earlier reporting that a selection was imminent.

The presumed leading candidate to be White House drug czar—Rahul Gupta, the former chair of the West Virginia Medical Cannabis Advisory Board—has played a critical role in overseeing the implementation and expansion of a state medical marijuana program and has publicly recognized both the therapeutic and economic potential of cannabis reform.

But while any pro-reform appointment is notable in the new administration, the DEA administrator has played a historically antagonistic role opposing federal or state policy changes as they concern cannabis. And so Milgram would stand out as an especially significant pick to that end.

The nominee would be taking over the defense to a number of pending lawsuits from marijuana and psychedelics reform advocates and patients if confirmed.

For example, Seattle doctor hoping to expand access to psilocybin mushrooms for terminally ill cancer patients is taking DEA to court over the agency’s recent denial of an application to legally use the psychedelic in end-of-life treatment.

Scientists and veterans sued the federal agency last year, arguing that the legal basis DEA has used to justify keeping marijuana in Schedule I of the Controlled Substances Act is unconstitutional. They asked for a review of its decisions to reject rescheduling petitions in 2020, 2016 and 1992. DEA subsequently requested that the court dismiss that suit.

The agency has also been taken to court over delays in approving additional cannabis manufacturers for research purposes.

The Scottsdale Research Institute alleged that DEA has been deliberately using delay tactics to avoid approving cultivation applications. A court mandated that the agency take steps to make good on its promise, and that suit was dropped after DEA provided a status update.

In March 2020, 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.

New Mexico Governor Signs Marijuana Legalization Bill, Making State Third To Enact Reform Within Days

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