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.”
Today I asked Commissioner Gottieb about FDA's timeline and resources to develop legal pathways for food products with #CBD. He said the agency is developing a working group focused on this issue, but if it takes too long Congress may need to act. #mepolitics pic.twitter.com/l8TX0DrrVD
— Chellie Pingree (@chelliepingree) February 27, 2019
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.
Photo courtesy of YouTube/House Appropriations Committee.
Feds Award $3 Million In Grants To Study Marijuana Ingredients As Alternatives To Opioids
The federal government has awarded $3 million in grants for research into the therapeutic benefits of ingredients in marijuana other than THC, emphasizing their potential as alternatives to prescription opioids.
In a notice published on Thursday, the National Institutes of Health (NIH) explained why the studies were necessary and listed grant recipients and the subjects they will investigate. That includes research into the use of CBD for arthritis pain, which will be led by New York University School of Medicine.
“The treatment of chronic pain has relied heavily on opioids, despite their potential for addiction and overdose and the fact that they often don’t work well when used on a long-term basis,” Helene Langevin, director of the National Center for Complementary and Integrative Health (NCCIH), said in a press release. “There’s an urgent need for more effective and safer options.”
A total of nine grants were issued, with NIH stating that the funds will help identify alternative treatment options for pain and provide information about the impact of consuming cannabis compounds such as CBD and other lesser-known cannabinoids as well as terpenes found in the plant.
“The cannabis plant contains more than 110 cannabinoids and 120 terpenes, but the only compound that’s been studied extensively is THC,” the press release said.
But while THC is known to treat certain forms of pain, NIH is concerned that its intoxicating effects limit its medical applicability.
“THC may help relieve pain, but its value as an analgesic is limited by its psychoactive effects and abuse potential,” David Shurtleff, deputy director of NCCIH, said. “These new projects will investigate substances from cannabis that don’t have THC’s disadvantages, looking at their basic biological activity and their potential mechanisms of action as pain relievers.”
Just released: Nine new research awards, funded by our Center, will investigate the potential pain-relieving properties and mechanisms of actions of the diverse phytochemicals in cannabis, including both minor cannabinoids and terpenes. https://t.co/03MxrycfFa
— NIH NCCIH (@NIH_NCCIH) September 19, 2019
NIH first announced that it would be issuing grants for studies into minor cannabinoids and terpenes last year.
Federal health agencies aren’t the only institutions interested in learning about marijuana compounds other than THC. On Wednesday, a Senate committee issued a spending report that called for research into CBD and CBG while also criticizing the federal drug scheduling system for inhibiting such research.
Read descriptions of the federal cannabinoid and terpene research grant awards below:
Mechanism and Optimization of CBD-Mediated Analgesic Effects; Boston Children’s Hospital, Boston,; Zhigang He, Ph.D., B.M., and Juan Hong Wang, Ph.D. This project will investigate how the pain-relieving effects of cannabidiol (CBD) and other minor cannabinoids may be modulated by the activity of potassium-chloride cotransporter 2 (KCC2), a chloride extruder expressed in most neurons. (Grant 1R01AT010779)
Neuroimmune Mechanisms of Minor Cannabinoids in Inflammatory and Neuropathic Pain; University of California, San Francisco; Judith Hellman, M.D., and Mark A. Schumacher, M.D., Ph.D. This project will explore the effects of minor cannabinoids on inflammatory and neuropathic pain in vitro and in vivo, focusing on the interactions of the cannabinoids with the peripheral receptor called TRPV1 and a cannabinoid receptor, CB1R. (Grant 1R01AT010757)
Minor Cannabinoids and Terpenes: Preclinical Evaluation as Analgesics; Research Triangle Institute, Research Triangle Park, North Carolina; Jenny L. Wiley, Ph.D. This project will evaluate purified biosynthesized minor cannabinoids and selected terpenes alone and in planned combinations to determine their potential efficacy as pain relievers against acute thermal, inflammatory, neuropathic, and visceral pain. (Grant 1R01AT010773)
Identifying the Mechanisms of Action for CBD on Chronic Arthritis Pain; New York University School of Medicine, New York City; Yu-Shin Ding, Ph.D. This project will use neuroimaging studies and behavioral assessments to investigate the mechanisms of action of CBD in the modulation of chronic pain associated with osteoarthritis in a mouse model. (Grant 1R21AT010771)
Synthetic Biology for the Chemogenetic Manipulation of Pain Pathways; University of Texas, Austin; Andrew Ellington, Ph.D. This project will use a novel method to evolve individual variants of cannabinoid receptor type 2 (CB2) that interact with high affinity with minor cannabinoids and evaluate the new variants in a mouse model of pain. (Grant 1R21AT010777)
Exploring the Mechanisms Underlying the Analgesic Effect of Cannabidiol Using Proton Magnetic Resonance Spectroscopy; University of Utah, Salt Lake City; Deborah A. Yurgelun-Todd, Ph.D. This project will use proton magnetic resonance spectroscopy (1H-MRS) to evaluate changes in brain chemistry in critical pain-processing regions after short-term administration of a cannabis extract enriched in CBD. (Grant 1R21AT010736)
Mechanistic Studies of Analgesic Effects of Terpene Enriched Extracts from Hops; Emory University, Atlanta; Cassandra L. Quave, Ph.D. This project will take a multidisciplinary approach to investigate the analgesic effects of terpenes from Humulus lupulus (hops), a plant that is closely related to cannabis and has a very similar terpene profile. (Grant 1R21AT010774)
Systematic Investigation of Rare Cannabinoids With Pain Receptors; University of Illinois at Urbana-Champaign; David Sarlah, Ph.D. This project involves synthesizing several classes of rare phytocannabinoids, systematically evaluating their anti-inflammatory potential, and examining the effects of the compounds with the strongest anti-inflammatory potential on the major receptors involved in pain sensation. (Grant 1R21AT010761)
Analgesic efficacy of single and combined minor cannabinoids and terpenes; Temple University, Philadelphia; Sara J. Ward, Ph.D. This project will use rodent models of pain to evaluate the effects of four biologically active components of cannabis that may act synergistically to protect against pain development and to assess the interactions of these four substances with morphine. (Grant 1R01AT010778)
Beto O’Rourke Proposes Drug War Reparations Funded By Marijuana Taxes
Marijuana would not only be legalized under a plan proposed on Thursday by Democratic presidential candidate Beto O’Rourke, but cannabis tax revenue would be used to directly repay formerly incarcerated people through a new “Drug War Justice Grant” program.
Unlike other contenders who have come around to supporting marijuana legalization in just the past couple of years, the former Texas congressman has long called for ending prohibition—and his new plan in many respects goes further than those rolled out by other campaigns.
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Support Grows For Marijuana Legalization Bill In Colombia
Colombia’s legislature will soon take up a bill to legalize and regulate the production and consumption of marijuana for adults.
The legislation, which is being filed by Sen. Gustavo Bolivar of the opposition Colombia Humana party, seeks to end prohibition as a means of curtailing crime and supporting a public health-focused approach to drug policy.
Bolivar, an author who has written several books centered on drug trafficking, has characterized the bill as being about “regularization, not legalization,” but it would provide for legal sales to adults with restrictions similar to those imposed for tobacco and alcohol. There would be penalties for selling to underage individuals and smoking wouldn’t be permitted in public spaces.
The senator pointed to Uruguay, Canada and states in the U.S. as regulatory models for legalization.
“It has been proven that crime levels are lowered and public health is improved,” he said, according to Colombia Reports.
Sen. Alberto Castilla Salazar of the leftist Polo Democrático party said that his coalition supports the reform measure.
Colombia debe superar el prohibicionismo y romper los vínculos de los grupos ilegales con el control del Cannabis, para que sea el Estado quien regule, defina las formas y entienda el consumo como problema de salud pública. Como @PoloDemocratico respaldamos está iniciativa. pic.twitter.com/YBDHqojENJ
— Alberto Castilla Salazar (@CastillaSenador) September 17, 2019
“Colombia must overcome prohibitionism and break the ties of illegal groups with the control of cannabis, so that it is the State that regulates, defines the forms and understands consumption as a public health problem,” he said on Tuesday.
Sen. Julián Gallo Cubillos of the FARC party said his coalition supports the legislation and that it represents “a new way to fight the scourge of drug trafficking.”
— Senado Colombia (@SenadoGovCo) September 18, 2019
The proposal has also garnered the support of former President Juan Manuel Santos, who has been an outspoken advocate for ending the war on drugs. His Liberal party could make or break the legislation depending on where members fall.
While left and center-left lawmakers seem largely united around legalizing marijuana, the issue will likely face resistance from President Ivan Duque, who last year signed a decree banning low-level possession of cannabis and cocaine despite court rulings that such activity is permissible.
As Colombia Reports noted, however, Duque’s far-right Democratic Center party is in the minority.
“We’ll have to see how many senators are left to former president Juan Manuel Santos and see how public opinion receives the idea that marijuana can be consumed in public spaces,” Sen. Paloma Valencia, a member of the president’s party, said.
If the country does opt to pursue a regulated cannabis program, it will join Mexico, where lawmakers are readying legislation to legalize marijuana for adult use following a Supreme Court ruling establishing that a ban on possession and cultivation for personal use is unconstitutional.
Photo courtesy of Brian Shamblen.