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FDA Releases Guidelines On Cannabis Research Following White House Review

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The Food and Drug Administration (FDA) published draft guidance on developing cannabis-based drugs on Tuesday.

This comes weeks after the White House completed its review of the document, clearing its path for public release.

FDA is still in the process of developing regulations that could allow for CBD to be marketed as a food item or dietary supplement, but in the meantime it has worked to create these new research guidelines for drug manufacturing.

Much of the guidance—which is “limited to the development of human drugs and does not cover other FDA-regulated products”—covers the basics of conducting federally authorized research for drug development purposes such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.”

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” FDA Principal Deputy Commissioner Amy Abernethy said in a press release. “As that body of research progresses and grows, the FDA is working to support drug development in this area.”

The chief legislative change she referenced is the 2018 Farm Bill, which federally legalized hemp and its derivatives such as CBD.

For researchers, that reform means they are no longer bound to certain restrictions that exist for marijuana. For example, FDA noted in the new document that as long as a manufacturer produces hemp products that meet the federal definition of containing no more than 0.3 percent THC, scientists can use that for studies rather that rely on the nation’s only federally authorized marijuana manufacturer at the University of Mississippi.

“This change gives sponsors and investigators of clinical studies new options that do not involve the [National Institute on Drug Abuse Drug Supply Program],” FDA wrote.

Because excess THC concentrations could render hemp illicit under federal law, FDA dedicated a section to testing standards for hemp-derived products.

“Sponsors and investigators proposing drug development activities involving controlled substances should consult with [Drug Enforcement Administration] about the applicable requirements,” it said. “Sponsors and investigators may find it useful to calculate the level of delta-9 THC in their proposed investigational drug product early in the development process to gain insight into the potential control status of their product.”

“Regardless of whether cannabis or a cannabis-derived compound meets the definition of hemp, sponsors and applicants should work with reliable laboratories for analytical testing,” it continued.

Applicants for an investigational new drug should submit information to FDA that includes “quantitative data, such as a certificate of analysis from a laboratory” on THC content and “detailed descriptions of testing methods used to evaluate the level of delta-9 THC.” They should also provide “quantitative data regarding phytochemicals that are present in their proposed product, including but not limited to, cannabinoids, terpenes, and flavonoids.”

“Many sponsors initiating clinical research for drugs containing cannabis and cannabis-derived compounds may be unclear regarding, or unfamiliar with, applicable drug quality expectations,” FDA said.

The agency discussed how calculating dry weight for hemp is unique in that it should be based on “the calculation of delta-9 THC percentage on the composition of the formulation with the amount of water removed, including any water that may be contained in excipients.” It’s not clear if that standard would prove burdensome for hemp producers, but it is the case that many farmers have already complained about existing stringent THC testing policies under U.S. Department of Agriculture guidance.

The new FDA guidance gives a step-by-step overview of how to test for THC on a dry weight basis in a way that meets their standards.

“We recommend that you consult DEA regarding the control status of cannabis or cannabis-derived materials or products that are under development,” the document states. “We note that intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight, even if the starting materials meet the definition of hemp, may no longer meet the definition of hemp and may be considered a Schedule I controlled substance.”

“We invite comment from the public on this recommended approach,” the agency said in a Federal Register notice accompanying the new draft guidance. “In addition, FDA invites public comment on the appropriate manufacturing controls over materials that cross under the 0.3 percent delta-9 THC by dry weight threshold during the production of a drug that contains cannabis or cannabis derived compounds.”

A 60 day public comment period will be opened for stakeholders to weigh in on the proposed research guidelines. At the same time, the agency has a separate comment period indefinitely open for information on the safety and efficacy of CBD.

FDA stressed that guidance documents such as this one “do not establish legally enforceable responsibilities.”

“Instead,” it said, “guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

The agency said researchers should take other non-cannabis-specific past guidance on the development of botanical drugs into account as well and laid out several other considerations.

“Cannabis is held to the same regulatory standards as any other botanical raw material, botanical drug substance, or botanical drug product,” the guidance states. To that end, researchers should be doing things like chemical fingerprinting to ensure consistency and testing for residual pesticides. FDA also noted that any drug products that require a device like an inhaler fall under their own category with its own set of requirements.

Further, researchers should “consider selection of a container closure system carefully.”

The agency also emphasized that “a naturally occurring compound isolated from a botanical source would be expected to have a different impurity profile from the corresponding synthetically produced cannabis related compound, and impurities for the naturally occurring compound should be controlled accordingly” as opposed to “synthetic single-chemical active pharmaceutical ingredients.”

Advocates, industry representatives, regulators, health professionals and marijuana legalization opponents stood up before FDA last year at a historic public hearing to share their perspectives on how to best approach regulating CBD.

“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis,” the agency’s Abernethy said. “The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.”

“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes—and one key element of this support involves development of guidance, like this one,” she said.

FDA also recently submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.

Also this month, a spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”

Read FDA’s draft guidance on cannabis research below: 

FDA cannabis research guide… by Marijuana Moment on Scribd

Justice Department Demands Marijuana Documents From California Officials In Federal Court Filing

Photo courtesy of Philip Steffan.

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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State Of Montana Launches Online Hemp Marketplace To Connect Buyers And Sellers

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Say you’re a Montana farmer who has planted acres of industrial hemp. As harvest nears, you’re looking to offload it. Where do you go to find a buyer?

Montana’s Department of Agriculture says it has the answer.

The state this week announced the launch of an online “Hemp Marketplace,” unveiling an online portal meant to connect the hemp farmers with buyers in search of seeds, fiber and derivatives such as cannabidiol, or CBD.

“The Hemp Marketplace concept originated from the same idea as the department’s Hay Hotline,” the Agriculture Department says on its website, “only instead of hay and pasture, the online tool connects buyers and sellers of hemp and hemp derivatives.”

Listings are free of charge.

Montana online Hemp Marketplace screenshot

Montana Department of Agriculture

Montana farmers have embraced industrial hemp since the state legalized its production under a federal pilot program. The first legal crop was planted in 2017, and in recent years the state has led the country in terms of space dedicated to the plant. In 2018, for example, licensed farmers in Montana grew more acreage of hemp than any other U.S. state. While other states have since eclipsed the state’s hemp production—the crop became broadly federally legal through the 2018 Farm Bill—Montana remains an industry leader.

But to make revenue, farmers have to be able to sell their crop. That’s where the new hemp marketplace comes in. The online portal is essentially a sophisticated bulletin board for buyers and sellers, split into “Hemp for Sale” and “Hemp to Buy” categories.

“With hemp being a relatively new crop grown in Montana, the department recognizes that these markets are still developing,” Department of Agriculture Director Ben Thomas said in a statement. “The Hemp Marketplace was designed to help facilitate connections between buyers and sellers. I’m looking forward to seeing how the marketplace will continue to advance the industry.”

Listings include what type of products are on offer (or being sought), whether a given crop is organic and even whether laboratory testing data is available. The portal also organizes products into one of four varieties based on whether the hemp seeds have been certified by regulators. None of the products may contain more than 0.3 percent THC—the upper limit for what qualifies as hemp under both state and federal law.

Meanwhile, Montana voters are set to decide on Tuesday whether the state will legalize hemp’s more infamous cousin, high-THC marijuana. According to a poll released this week, passage looks likely: The survey, conducted by Montana State University at Billings, found that 54 percent of likely voters plan to support legal cannabis on the ballot. Another 38 percent said they were opposed, while 7 percent remained undecided.

At the federal level, officials at the Drug Enforcement Administration are still working to revise rules around marijuana and hemp to reflect Congress’s move to legalize hemp broadly in 2018. While the public comment on the proposals closed earlier this month, nine members of Congress cautioned the agency against adopting its proposed changes, warning some could put hemp producers at risk of criminal liability. Already a number of arrests and seizures have been made by law enforcement officers confused whether products were legal hemp or illicit marijuana.

The U.S. Department of Agriculture (USDA), meanwhile, has faced separate criticism over its own proposed hemp rules, though it has been more proactive in addressing them. Following significant pushback from the industry over certain regulations it views as excessively restrictive, the agency reopened a public comment period, which closed again this month.

USDA is also planning to distribute a national survey to gain insights from thousands of hemp businesses that could inform its approach to regulating the market.

Montana Marijuana Legalization Ballot Measure Has Solid Lead In New Poll

Photo courtesy of Brendan Cleak

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New Jersey Governor Steps Up Marijuana Legalization Push As New Ad Touts Economic Benefits Days Before Election

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With just a few days to go before Election Day, New Jersey Gov. Phil Murphy (D) is continuing to stump for marijuana legalization in that state, extolling the economic and social justice benefits he says the change would bring. His latest comments came shortly after the release of a new campaign ad focusing on legalization’s economic impact.

“We’ll build an industry, it would be a revenue-generator,” Murphy said in an interview with Yahoo Finance. “I think at first it would be modest, but ultimately will grow, I think, into several hundred million dollars in the state budget.”

“Along with social justice,” he added, “that’s a pretty good, winning combination.”

Recent polling suggests voters are mostly on board with legalization, with surveys showing upwards of 60% support for Public Question 1, a referendum to legalize and establish a commercial industry around the drug. If it passes, some lawmakers hope legal sales to adults 21 and older could begin as soon as next month, though regulators and some advocates have pushed back on the plan to start sales in existing medical cannabis dispensaries, saying that it could lead to access and supply issues for patients.

Legalization would indeed likely bring in millions of dollars to the state budget, hit hard by the coronavirus pandemic and ensuing economic downturn. But Murphy claims his chief motivation for supporting the measure is racial justice.

“When I became governor, we had the widest white–nonwhite gap of persons incarcerated, believe it or not, of any American state. The biggest reason was low-end drug offenses,” he said. “So I get there first and foremost because of social justice.”

Meanwhile, on Wednesday, one of the campaign committees behind New Jersey’s legalization effort, NJ CAN 2020, released a new 30-second ad emphasizing the economic benefits legalization could bring the cash-strapped state.

“At a time when this crisis has created challenges we all face—a budget deficit and a lack of funding for services we need—New Jersey could raise hundreds of millions of dollars to support our local schools, vital health care services and community programs, by simply voting yes on Public Question 1,” the ad says.

Earlier this week, U.S. Sen. Cory Booker (D-NJ) also filmed a video in support of the measure. Appearing in a NJ CAN campaign video released Wednesday, he said prohibition “has not been a war on drugs, but a war on people.”

“Veterans, for example, are more likely to be arrested for drug use or possession of marijuana. Instead of getting help, they’re often hurt by a system that piles upon them criminal charges for doing things that two of the last three presidents admitted to doing,” he said.

Black, Latino and low-income communities are also disproportionately targeted by enforcement of drug laws, Booker added. “We can do this as a state so much more responsibly, and instead of destroying lives we can get more resources to help to empower the well-being of all New Jerseyans.”

In other legal states, cannabis has been a rare bright spot in terms of tax revenue. Oregon, for example, saw record sales this summer even as other areas of the economy slowed. State budget analysts said last month that they expect the strong sales to continue.

“Since the pandemic began, the increase in recreational sales have been more than 30 percent above forecast,” Oregon’s Office of Economic Analysis said in a recent report. “Expectations are that some of these increases will be permanent.”

Other established markets, such as Washington state, Colorado and Nevada, have also seen “strong gains” in marijuana sales amid the pandemic, Oregon’s budget office noted.

Big money has also been flowing into New Jersey’s legalization campaign itself. A report released Thursday by the state Election Law Enforcement Commission (ELEC) shows that committees supporting the referendum have raised more than $2 million in campaign contributions. That’s compared to just $9,913 brought in by opponents.

“Assuming all available funds are spent, the marijuana ballot question already ranks eighth among the top ten most expensive public referenda in the Garden State,” ELEC Executive Director Jeff Brindle said. “Keep in mind that marijuana interests already have spent $4.1 million on lobbying between 2017 and 2019. So the industry’s overall political investment in New Jersey already has topped $6 million.”

If voters approve the referendum, lawmakers will still need to pass a bill to establish a framework for the state’s legal marijuana market. A legislative hearing to get a head start on planning was scheduled for last week, but that was canceled when a state senator leading the proposal went into quarantine after being exposed to the coronavirus.

Friday’s appearance by Murphy is the latest effort by the governor to encourage voters to back legalization. He also recorded a video that was released by NJ CAN 2020 earlier this month and recently called on voters to support the proposal in an email blast circulated by the New Jersey Democratic State Committee.

In July, Murphy described legalizing cannabis is “an incredibly smart thing to do” both from an economic and social justice perspective.

The governor isn’t alone in his attempts to get out the vote for cannabis reform. Filmmaker Kevin Smith earlier this month urged his Twitter followers to “VOTE YES when you see State Public Question Number 1: Constitutional Amendment to Legalize Marijuana.”

Also this month, the NJ CAN campaign scaled up its advertising push, releasing a series of English- and Spanish-language videos.

In June, the state Assembly passed a cannabis decriminalization bill that would make possession of up to two ounces of marijuana a civil penalty without the threat of jail time. The bill hasn’t advanced in the Senate.

Arizona Marijuana Opponents Release Five Misleading Attack Ads Ahead Of Legalization Vote Next Week

Photo courtesy of Gov. Phil Murphy

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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Oregon Psilocybin Ballot Measure Can Help Dying People Find Peace, Doctor Says In TV Ad

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Oregon’s first-of-its-kind ballot measure to legalize psilocybin therapy has the potential to help ease mental suffering for terminally ill people, a medical doctor says in a new TV ad for the initiative.

“I’ve worked in end-of-life care for 28 years. In hospice, we believe when people are dying, we should treat their pain—physical or mental distress,” Dr. Nick Gideonse says in the 30-second spot. “There’s often mental suffering that comes with a terminal diagnosis.”

“So I support Measure 109 to allow psilocybin therapy for terminally ill people suffering from depression. It’s humane,” he said. “Yes on 109 will help those near death come to terms with their diagnosis and find peace.”

If approved by voters, 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.

A previous ad released earlier this month by the campaign featured a state senator who is also a medical doctor saying that the measure “promotes safety for a therapy that can help people who are suffering.”

That followed an independent spot by the nonprofit Heroic Hearts Project going on the air in Oregon to tout the benefits of psilocybin therapy, but it didn’t mention the specific ballot measure.

A campaign working to pass a separate measure on the Oregon ballot to decriminalize drug possession and expand substance misuse treatment also recently released a series of ads.

The Oregon Democratic Party formally endorsed both measures last month.

Meanwhile, the psychedelic reform measure has drawn opposition from an unlikely source. Decriminalize Nature, which has led efforts to pass local policies reducing criminal enforcement against psilocybin and other entheogens, has argued that it could threaten equitable access to the substance.

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. In August, 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.”

Arizona Marijuana Opponents Release Five Misleading Attack Ads Ahead Of Legalization Vote Next Week

Photo courtesy of Wikimedia/Workman.

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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