The Food and Drug Administration (FDA) is releasing new draft guidelines that are meant to streamline approvals for generic oral CBD medications.

In a notice published in the Federal Register on Wednesday, the agency said it is soliciting public feedback on its guidance to researchers who are interested in submitting abbreviated new drug applications (ANDAs) for CBD solutions.

To expedite the approval process, FDA said applicants can request a waiver of an in vivo bioequivalence study if they meet certain requirements. This guidance comes two years after the agency approved the brand-name CBD-based epilepsy medication Epidiolex from GW Pharmaceuticals.

Going forward, if a drug company wants to produce generic versions of that 100 mg/mL cannabidiol solution, they could follow specific rules to skip the in vivo bioequivalence study step if the draft guidance is finalized. The drug would have to be derived from Cannabis sativa L, contain no more than 0.1 percent THC and have “no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”

Researchers must use “appropriate analytical methods” such as macroscopic or microscopic analysis or DNA bar-coding methods to determine that the solution is being made from cannabis sativa.

“Due to the many cultivars within this species, identification and authentication of plant species should be conducted at the cultivar(s) level if the potential cultivar(s) will be used as a natural source of the [botanical raw material],” FDA said.

Further, when collecting that raw cannabis, the agency said applicants must follow “established good agricultural and collection practices (GACP) procedures to minimize variations in BRM and eventually ensure the batch-to-batch consistency of the drug substance.”

A public comment period on FDA’s draft guidance will last until November 23. FDA also recently closed a comment period on separate draft guidance on developing cannabis-derived medications. However, three other federal agencies are currently accepting input on a variety of other proposed cannabis- and drug-related regulations.

While this latest document isn’t the separate comprehensive CBD guidance that advocates and industry stakeholders have been waiting for, it’s another example of how the scientific landscape around cannabis is changing, with a federal agency helping to facilitate the production of cannabidiol-based drugs.

Separately, FDA announced on Tuesday that it will be hosting a public meeting in November to discuss gender and sex differences in the effects of CBD and other cannabinoids.

The agency also recently held a meeting to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant.

It also recently submitted draft guidance on CBD enforcement to the White House Office of Management and Budget—a long-anticipated move that comes after hemp legalization.

The agency was mandated under appropriations legislation enacted late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”

FDA has been using enforcement discretion for CBD in the years since hemp became legal.

The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.

In July, FDA also 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 that month, a congressional spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”

The agency is also actively looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.

Read FDA’s draft guidance on developing CBD medications below: 

FDA CBD guidance by Marijuana Moment

FDA Explains Effects Of CBD And Marijuana Compounds Based On Sex And Gender Differences

Photo by Kimzy Nanney.

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The Centers for Disease Control and Prevention (CDC) has recently been hosting meetings with medical marijuana patients as part of a broader series of listening sessions on alternative pain treatments.

Dustin McDonald, who uses cannabis to treat Lyme disease and also serves as policy director with Americans for Safe Access (ASA), told Marijuana Moment last week that his conversation with the federal agency was productive, with representatives listening attentively as he explained his personal experiences as well as the advocacy work that ASA is involved in.

Beyond simply getting an audience with a main federal health agency, McDonald said what especially stood out to him was that the CDC representatives told him that his wasn’t the first meeting they’ve had with someone who uses medical marijuana as an alternative pain management option. In fact, they said “a lot of the folks that they had spoken with were using cannabis for chronic pain.”

“In addition to my interview and my testimony discussing my experience utilizing medical cannabis for chronic pain and acute pain, there was a large population of people that they spoke with that were doing something similar,” McDonald said, adding that the CDC officials “seemed fairly open-minded” about the subject despite the ongoing federal prohibition of marijuana.

The ASA activist was especially encouraged by the last question the agency put to him, which he said asked “what could CDC do to assist in it advancing the conversation on additional research into medical cannabis applications to human health and health disorders, in talking to the lawmakers about the need to dive more deeply into researching all of these applications.”

ASA wants to take advantage of the opportunity to work with CDC and other related agencies to advocate for “removing roadblocks to research and pushing federal dollars towards combined grant programs for federal government agencies and academic institutions to really take a look at what’s going on with medical cannabis as a medicine,” McDonald said.

While it’s not clear what steps, if any, CDC will take to advance that conversation, McDonald said the fact that the agency heard from a multitude of voices about the therapeutic potential of marijuana could push them to take some action. At the very least, he expects medical marijuana to be discussed at some length in CDC’s forthcoming updated Guideline for Prescribing Opioids for Chronic Pain.

Marijuana Moment reached out to CDC to find out how often cannabis has been brought up in its meetings with stakeholders, but a representative was not immediately available.

The agency said in a notice about the pain management meetings published in the Federal Register in July that the conversations “will help inform CDC’s understanding of stakeholders’ values and preferences related to pain and pain management and will complement CDC’s ongoing work” on updating that guideline.

This comes months after CDC closed a public comment period on pain management that saw over 1,000 submissions advocating for marijuana and kratom as pain relief options.

But while there’s widespread interest in research cannabis as an opioid alternative, federally authorized research has been slow-going because of tight restrictions on who can access the plant for studies and where they can get it. Currently, there’s only one registered manufacturer at the University of Mississippi, and the marijuana they cultivate has been described as chemically closer to hemp than cannabis available in commercial markets.

A House committee last week approved key piece of marijuana research legislation that, among other things, would allow scientists to finally study cannabis from state-legal dispensaries.

In July, the House approved separate legislation that also called for letting researchers study marijuana purchased from businesses in state-legal markets instead of only letting them use government-grown cannabis. The intent of the provision, tucked into a 2,000-plus-page infrastructure bill, was to allow the interstate distribution of such products even to scientists in jurisdictions that have not yet legalized marijuana.

During an Energy and Commerce Subcommittee on Health hearing in January—which was requested by four GOP lawmakers last year—federal health and drug officials, including from the Drug Enforcement Administration (DEA), acknowledged that the current supply of cannabis for research purposes is inadequate and that scientists should be able to access a wider range of marijuana products.

DEA said four years ago that it would be taking steps to expand the number of federally authorized cannabis manufacturers, but it has not yet acted on applications.

Last year, scientists sued the agency, alleging that it had deliberately delayed approving additional marijuana manufacturers for research purposes despite its earlier pledge.

A court mandated that DEA take steps to make good on its promise, and that case was dropped after DEA provided a status update.

In March, 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.

The scientists behind the original case filed another suit against DEA, claiming that the agency used a “secret” document to justify its delay of approving manufacturer applications.

That was born out when the Justice Department Office of Legal Counsel document was released in April as part of a settlement in the case, revealing, among other things, that the agency feels that its current licensing structure for cannabis cultivation has been in violation of international treaties for decades.

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The University of California at Berkeley announced on Monday that it is launching a new center dedicated to psychedelics research and education.

Scientists at the center will use psychedelic substances to “investigate cognition, perception and emotion and their biological bases in the human brain,” according to a press release. At the same time, the new entity will be putting resources toward informing the public about “this rapidly advancing field of research.”

To start, the UC Berkeley Center for the Science of Psychedelics will look at psilocybin, the main psychoactive component of so-called magic mushrooms. This research is being partially funded by an anonymous $1.25 million donation.

“There’s never been a better time to start a center like this,” Berkeley neuroscientist David Presti, a founding member of the center, said. “The renewal of basic and clinical science with psychedelics has catalyzed interest among many people.”

50 years after political & cultural winds slammed shut the doors on psychedelic research, Berkeley is making up for lost time by launching the campus’s first center for psychedelic science & public education. 🍄@UCBerkeleyNeuro https://t.co/lIdtG3KOkR

— UC Berkeley (@UCBerkeley) September 14, 2020

The research is meant to complement studies being conducted at other psychedelics-focused institutions, such as a similar center that launched at Johns Hopkins University last year.

“Some of these studies have produced striking results in cases that are otherwise resistant to more conventional medical treatment,” Berkeley neuroscientist Michael Silver, directer of the new center, said. “This suggests that psychedelic compounds may offer new hope for people suffering from these disorders.”

The researchers will also be partnering with the Graduate Theological Union to create “an immersive learning program on psychedelics and spirituality.” That will involve training individuals to be “facilitators” for psychedelic ceremonies. The training program will look at the “cultural, contemplative and spiritual care dimensions of psychedelics.”

“The training of facilitators is an indispensable part of this project,” Sam Shonkoff, an assistant professor at the Graduate Theological Union, said.

Researchers at the center will attempt to discover potential therapeutic applications of psychedelics for mental health by studying the fundamental mechanisms that go into a psychedelic experience. They plan to explore how visual hallucinations work in the brain, as well as the long-term effects of taking these substances on “social and political attitudes, identity and resilience to stress.”

“Psychedelic medicines can open a doorway to seeing one’s psyche and connection with the world in new and helpful ways,” Presti said. “That’s been appreciated by shamanic traditions for thousands of years. Science is now exploring new ways to investigate this.”

Journalism professor Michael Pollan, author of “How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression and Transcendence,” will also be involved.

Proud to be part of this pioneering project, announced today: UC Berkeley launches new center for psychedelic science and education | Berkeley News https://t.co/stFgv2e2CE

— Michael Pollan (@michaelpollan) September 14, 2020

“We’re really interested in what psychedelics can teach us about consciousness, perception, creativity and learning,” Pollan said. “Psychedelics have a particular value later in life, because that is when you are most stuck in your patterns. They give you the ability to shake them loose.”

This center’s foundation comes in the midst of a national psychedelics reform movement, with activists across the country pushing to end criminalization of entheogenic substances.

In May 2019, Denver became the first U.S. city to decriminalize psilocybin, with the approval of a local ballot measure. Soon after, officials in Oakland, California, decriminalized possession of all plant- and fungi-based psychedelics. The City Council in Santa Cruz, California, voted to make the enforcement of laws against psychedelics among the city’s lowest enforcement priorities in January.

Last month, Canada’s health minister granted exemptions allowing certain cancer patients to legally use psilocybin for end-of-life care.

The Canadian government will have to officially respond to a petition calling for the decriminalization of psychedelics after it recently garnered nearly 15,000 signatures—and there’s legislation in the works that could make the reform happen.

Rep. Earl Blumenauer (D-OR) is formally throwing his support behind an Oregon initiative to legalize psilocybin mushrooms for therapeutic purposes and is helping to raise money for the campaign.

A measure to decriminalize a wide range of psychedelics will appear on the Washington, D.C. ballot—and recent polling indicates that it has strong support.

The Multidisciplinary Association for Psychedelic Studies announced last month that it raised $30 million in donations—including from several notable business leaders outside the drug policy realm—that will enable it to complete a study on using MDMA to treat post-traumatic stress disorder.

Meanwhile, Oregon voters will also see a separate measure on their November ballots to decriminalize drug possession and fund treatment services.

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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.