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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.

Politics

Oregon Psilocybin Initiative Gets Boost From New TV Ad But Draws Opposition From Unlikely Source

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An Oregon ballot initiative to legalize psilocybin for therapeutic purposes is getting a boost from a nonprofit veterans group’s new TV ad. But meanwhile, the campaign is seeing pushback from an unexpected source.

On the one side, the Heroic Hearts Project—which helps connect veterans to entheogenic-based healing and provides complementary counseling—is airing an advertisement in the state that highlights the therapeutic potential of taking psilocybin in a clinical setting.

The 30-second spot doesn’t explicitly mention the reform measure that will appear on Oregon’s November ballot, but it could help inform how voters approach that question when they head to the polls nonetheless. According to the group, it will play on television frequently enough that the average viewer should see it about seven or eight times.

Here’s the script of the ad: 

“As a scientist, I’m impressed by the research. Major universities findings show psilocybin therapy can be effective for depression and anxiety.

It’s plant medicine [the Food and Drug Administration] calls breakthrough therapy, meaning it can be an improvement over available options.

The psilocybin therapy program: Research-based with patient safety top of mind, strictly regulated.

We’re in a mental health crisis. The science is real, the restrictions smart. Psilocybin therapy: Healing, providing hope.”

Heroic Hearts Project is largely focused on the plant ayahuasca. But the group says psilocybin is another treatment option that’s shown promise in mitigating symptoms of post-traumatic stress disorder.

“In Oregon and across the country there has been a big decriminalization movement, there’s been a big push to do similar to what we’re doing but also allow for access within the U.S. because there’s a lot of people that understand the power and the efficacy of these treatments,” Jesse Gould, founder of the organization, told Marijuana Moment.

“Within Oregon, there is this historic opportunity where they’re trying to create licensed and regulated psilocybin and therapy—and there’s a lot of veterans in Oregon—so just having that availability of it in a place that they can rely on, that they know it’s safe, is a tremendous value to the veterans in Oregon,” he said. “I think it will also be a model for other states and other localities to adopt it.”

Again, the ad doesn’t explicitly promote the psilocybin legalization initiative that will appear on Oregon’s November ballot—but there has been a strong push from a wide range of experts and advocates to pass the historic measure. The Oregon Democratic Party also formally endorsed the psychedelic therapy proposal earlier this month.

“Oregonians are suffering from the most severe mental health crisis in the country,” Sam Chapman, campaign manager for the psilocybin measure, told Marijuana Moment. “We know that if we want to help terminally ill cancer patients, veterans, and so many others who are struggling to combat depression and anxiety due to COVID, we need a licensed and regulated system that people can trust.”

But while these developments could help bolster the campaign, there’s also been surprising dissent from certain psychedelics reform advocates who argue that the proposed legal therapeutic model for psilocybin would threaten equitable access to entheogens.

Decriminalize Nature (DN), the group advancing a localized psychedelics decriminalization movement across the country, is urging Oregonians to vote “no” on the initiative.

“M109 threatens equitable access by not ending the prohibition of personal use and establishing supremecy [sic],” DN said in a tweet.

The group’s Portland chapter, which said earlier this year that it would pursue psychedelics decriminalization through the City Council, announced last week that it’s now against the psilocybin measure and declining to endorse a separate proposal to decriminalize possession of all currently illicit drugs and fund treatment services that will also appear on the state’s ballot.

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Decrim Nature Oregon Groups Encourage No on M109 Oregon Psilocybin Services Measure . . DN Nature lovers, When Oregon first created it’s statewide initiative, decriminalization language was included and all signatures were accounted for. After a sizeable donation, the #Oregon Psilocybin Service measure removed the decriminalization language thereby continuing the prohibition of psilocybin mushroom gathering, growing, or having an experience in the safety of one’s own home. Negotiations broke down with the key sponsor of this initiative last week to ensure the protection of equitable access to entheogenic plants for the most vulnerable. M109 threatens this due to sections that do nothing to end the prohibition of personal use and also establishes statewide supremacy. Therefore, Decrim Nature groups in Oregon are taking a No position on the Oregon Psilocybin Service measure. In solidarity with our local groups in Oregon, we share this with our DN network.

A post shared by Decriminalize Nature (@decriminalizenature) on

DN Portland said they are “advocating that all people who care about ensuring access to entheogenic medicines for all people regardless of financial status, those who care about protecting these medicines from the profit motives of capital, and those who wish to see big money removed from the equation of psychedelic medicines.”

David Bronner, CEO of the soap company Dr. Bronner’s, has helped finance a slew of marijuana and psychedelics reform campaigns for years, including the psilocybin legalization initiative. Private messages that DN decided to release show the executive expressing concern about certain internal politics within the movement, including disputes between DN and the Indigenous Peyote Conservation Initiative about including peyote within the scope of decriminalization measures.

In a blog post, he wrote that Dr. Bronner’s “is fully committed to the Decriminalize Nature (DN) movement, but have recently lost faith in its national leadership.” Regardless, “we still fully support regional DN campaigns such as DC’s effort to decriminalize plant medicines.”

In turn, DN alleged that Bronner “is resorting to divide and conquer tactics to control the Decriminalize Nature movement. ”

Under the Oregon psilocybin ballot measure, adults would be able to access the psychedelic in a medically supervised environment. There aren’t any limitations on the types of conditions that would make a patient eligible for the treatment.

Rep. Earl Blumenauer (D-OR) told Marijuana Moment in January that he was in favor of the psilocybin reform proposal and that he would be working to boost the campaign as the election approaches. Last month, he wrote in an email blast that passing the measure is necessary “because it tackles an important issue in our community, mental health, and it does so in an innovative and responsible way.”

The campaign behind the separate drug decriminalization and treatment funding initiative recently released its first ad urging Oregonians to support it.

Montana Marijuana Legalization Initiative Endorsed By Environmental Conservation Groups

Photo courtesy of Wikimedia/Mushroom Observer.

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Colorado Governor Grants Thousands Of Marijuana Pardons With New Clemency Powers

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The governor of Colorado on Thursday signed an executive order granting nearly 3,000 pardons for people convicted of possession one ounce of less of marijuana.

Pursuant to a new law that he signed in June, Gov. Jared Polis (D) made the pardons on the first day the policy took effect. While the law gives him authority to grant clemency for cases of possession of up to two ounces, his office explained that he limited it to one ounce because that’s the legal possession limit under Colorado’s cannabis program.

“We are finally cleaning up some of the inequities of the past by pardoning 2,732 convictions for Coloradans who simply had an ounce of marijuana or less,” Polis said in a press release. “It’s ridiculous how being written up for smoking a joint in the 1970’s has followed some Coloradans throughout their lives and gotten in the way of their success.”

Convictions impacted by the governor’s action range from those that took place in 1978 though 2012.

“Too many Coloradans have been followed their entire lives by a conviction for something that is no longer a crime, and these convictions have impacted their job status, housing, and countless other areas of their lives,” he added. “Today we are taking this step toward creating a more just system and breaking down barriers to help transform people’s lives as well as coming to terms with one aspect of the past, failed policy of marijuana prohibition.”

The new law allows the governor to use his clemency power for cannabis offenses without consulting with prosecutors and judges involved in the cases, as is typically required under statute.

“For the individuals pardoned in this Executive Order, all rights of citizenship associated with the pardoned conviction are restored in full without condition,” the order states. “All civil disabilities and public sufferings associated with the pardoned conviction are removed.”

People who are eligible for the pardons don’t have to do anything to clear their own records; it’s automated, and individuals can check a website to see if they’ve been processed.

Those who have municipal marijuana convictions, or who were arrested or given a summons, don’t qualify for the pardon. The action only applies to state-level convictions.

A frequently asked questions document states that while Polis has declined for now to use the full extend of his pardon power by applying it to people with convictions of up one to two ounces, the “administration will continue to evaluate” cases that could receive clemency. A representative from the governor’s office did not immediately respond to a question from Marijuana Moment about whether plans are imminent to expand the pardon pool.

The governor’s action also calls on the state Department of Public Health to “develop a process to indicate on criminal background checks which individuals’ convictions have been pardoned pursuant to this Executive Order.”

Colorado isn’t alone in pursuing opportunities to enact marijuana-focused restorative justice policies.

In June, more than 15,000 people who were convicted for low-level marijuana possession in Nevada were automatically pardoned under a resolution from the governor.

The governors of Washington State and Illinois have both issued pardons for cannabis offenses since their states legalized the plant.

Polis told Westword that beyond the practical benefits of having these records cleared, the move is “also symbolically important, because it shows that as a state and nation, we’re coming to terms with the incorrect discriminatory laws of the past that penalized people for possession of small amounts of marijuana.”

Marijuana Arrests Decline Nationally For First Time In Four Years, FBI Data Shows

Photo courtesy of Martin Alonso.

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.
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Marijuana Arrests Decline Nationally For First Time In Four Years, FBI Data Shows

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Marijuana arrests in the U.S. declined in 2019 for the first time in four years, a new federal report shows.

While many expected the state-level legalization movement to reduce cannabis arrests as more markets went online, that wasn’t the case in 2016, 2017 or 2018, which each saw slight upticks in marijuana busts year-over-year. But last year there was a notable dip, the data published this week shows.

There were a total of 545,601 marijuana arrests in 2019—representing 35 percent of all drug arrests—according to FBI’s Uniform Crime Reporting program. That’s down from 663,367 the prior year and 659,700 in 2017.

Via FBI.

Put another way, police across the country made a cannabis bust every 58 seconds on average last year. Of those arrests, 500,394 (92 percent) were for possession alone.

“A decline in cannabis related arrests is better than seeing an increase for a fourth year in a row, but the amount of these arrests is still abhorrent,” Marijuana Policy Project Executive Director Steve Hawkins told Marijuana Moment. “There is no reason to continue punishing adults for consuming a substance that is less harmful than alcohol. Arresting adult cannabis consumers has a dramatically disproportionate impact on communities of color, is a massive waste of law enforcement officials’ time and resources and does nothing to improve public health or safety.”

Overall, arrests for drug sales, manufacturing and possession amounted to 1,558,862 for the year—approximately 15 percent of all busts reported to FBI from local and state law enforcement agencies. That’s one new drug case every 20 seconds.

Before 2016, the country had seen a consistent decline in marijuana arrests for roughly a decade. It should be noted, however, that not all local police participate in the federal agency’s program, so these figures are not holistic.

Nonetheless, this data shows that American law enforcement carried out more arrests for marijuana alone than for murder, rape, robbery, burglary, fraud and embezzlement combined.

“At a time when a super-majority of Americans support marijuana legalization, law enforcement continues to harass otherwise law abiding citizens at an alarming rate,” NORML Political Director Justin Strekal told Marijuana Moment. “Now is the time for the public to collectively demand that enough is enough: end prohibition and expunge the criminal records to no longer hold people back from achieving their potential.”

While there’s no solitary factor that can explain the recent downward trend in cannabis cases, there are one-off trends that could inform the data. For example, marijuana possession arrests fell almost 30 percent in Texas from 2018 to 2019, and that seems to be connected to the legalization of hemp and resulting difficulties police have had in differentiating the still-illegal version of the cannabis crop from its newly legal non-intoxicating cousin.

At the federal level, prosecutions for marijuana trafficking declined in 2019, and drug possession cases overall saw an even more dramatic decline, according to a report published by the U.S. Sentencing Commission in March.

Federal prosecutions of drug-related crimes increased in 2019, but cases involving marijuana dropped by more than a quarter, according to an end-of-year report released by Supreme Court Chief Justice John Roberts in December.

A study released by the Cato Institute in 2018 found that “state-level marijuana legalization has significantly undercut marijuana smuggling.

Mixed Arizona Marijuana Polls Raise Questions About Legalization Ballot Measure’s Prospects

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