A bipartisan pair of lawmakers are circulating a sign-on letter asking colleagues to join them in urging the Food and Drug Administration (FDA) to back off companies that are selling CBD products in a responsible manner.
The “Dear Colleague” letter, which is being led by Reps. Chellie Pingree (D-ME) and James Comer (R-KY), emphasizes that hemp and CBD were federally legalized under the 2018 Farm Bill and argues that the lack of regulations for such products is creating industry uncertainty that’s inhibiting economic opportunities.
The letter was first reported by the U.S. Hemp Roundtable, which is asking its supporters to encourage their representatives to sign on.
FDA has said it is in the process of developing rules for the non-intoxicating compound, including a potential alternative regulatory pathway allowing for CBD to be added to the food supply and as dietary supplements. That could take years, however, as former FDA Commissioner Scott Gottlieb has noted.
In the meantime, the agency is being selective about enforcement action against companies that make unsanctioned claims about their products while also maintaining that all businesses selling CBD food items are violating the law.
The lawmakers aren’t satisfied. They described FDA’s regulatory timeframe as “untenable,” particularly because the U.S. Department of Agriculture is expected to release its rules for hemp “any day now,” and an official revealed this month that its draft regulations are currently undergoing final White House and Department of Justice review.
The members of Congress added that FDA’s current approach to CBD has “created significant regulatory and legal uncertainty for participants in this quickly evolving industry.”
“Given the widespread availability of CBD products, growing consumer demand, and the expected surge in the hemp farming in the near future, it’s critical that FDA act quickly to provide legal and regulatory clarity to support this new economic opportunity,” they wrote.
“Please join us in signing this bipartisan letter to Acting FDA Commissioner Ned Sharpless urging the agency to adopt a risk-based policy of enforcement discretion that targets bad actors while eliminating uncertainty for responsible industry stakeholders and consumers. Additionally, we are requesting that FDA to issue an interim final rule to regulate CBD as a dietary supplement and food additive.”
In the letter to Sharpless that Pingree and Comer are asking fellow lawmakers to sign, they laid out two requests for FDA.
First, the agency should “promptly issue guidance announcing a policy of enforcement discretion that maintains FDA’s current risk-based enforcement approach towards hemp-derived CBD products.” And second, it should “consider issuing an interim final rule, pending issuance of a permanent final rule, to establish a clear regulatory framework for CBD as a dietary supplement and food additive.”
The lawmakers added that they appreciate that FDA has pursued “enforcement actions against the worst offenders,” but that “it can do so while eliminating regulatory uncertainty for farmers, retailers, and consumers.”
“Without a formal enforcement discretion policy, anyone participating in the growing marketplace for legal hemp-derived products will continue to face significant legal and regulatory uncertainty,” they wrote.
Though issuing guidance on a “policy of enforcement discretion” wouldn’t be a codified law allowing companies to market CBD in the food supply, it would demonstrate to the industry that some protections are in place while FDA continues to navigate the rulemaking process.
Lawmakers have until Tuesday to sign the letter to FDA.
Read the Dear Colleague invitation and CBD letter to FDA below:
Photo by Kimzy Nanney.
Kansas Medical Marijuana Hearings Cancelled After Senate GOP Leader Reroutes House-Passed Bill
A House-passed bill to legalize medical marijuana in Kansas seems to be in jeopardy, with GOP Senate leadership moving the legislation out of a committee and into a different panel where it may sit in legislative limbo, resulting in the cancellation of hearings that were scheduled to be held this week.
Advocates are concerned about the decision by Senate President Ty Masterson (R), who withdrew the cannabis reform legislation from the Senate Federal and State Affairs Committee days before hearings were to be held on Tuesday and Wednesday. It was then re-referred to the Senate Interstate Cooperation Committee, which Masterson chairs and where the bill’s fate is unclear.
This doesn’t necessarily mean that medical marijuana legalization is off the table for Kansas in 2022, but it does seem to signal that the reform might need to be enacted through another vehicle, either in the legislature or at the ballot, as top Democratic lawmakers in the state are pursuing.
“We certainly hope that this action is just making sure that this bill meets any concerns that Senate leadership may have concerning this historic legislation,” Kevin Caldwell, a legislative manager at Marijuana Policy Project (MPP), told Marijuana Moment. “This bill had widespread bipartisan support in the House last session. We hope Senate President Masterson quickly holds a committee hearing and advances this legislation.”
When the proposal was being advanced in the House last year during the first half of the two-year session, members amended an unrelated bill that previously cleared the Senate to make it the chamber’s vehicle for the policy change. Because of that, it was ruled “materially changed” last May and sent to the Senate for committee consideration.
Now there’s a question of whether lawmakers will be motivated to introduce another separate bill and try to move it through both chambers, requiring another House vote. The Senate president seemed to temper expectations in recent remarks, telling The Kansas City Star that “not a single member” of his caucus has expressed that the issue “was important to them.”
That’s not how Kansas Democrats feel, however. House Minority Leader Tom Sawyer (D) and Assistant Minority Leader Jason Probst (D) said this month that they will be introducing proposals to let voters decide on legalizing medical and adult-use marijuana in the state. At the time, Sawyer said he was “hopeful” that the legislature might separately advance the House-passed legalization measure.
Marijuana Moment is already tracking more than 1,000 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.
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“The people of Kansas deserve to know if senators support the overwhelming majority of people who want to alleviate patients’ suffering with a medical cannabis program,” MPP’s Caldwell said. “Now is the time to show compassion to their fellow citizens and vote this bill out of committee.”
“Kansas is one of fourteen states left without a medical cannabis program,” he said. “We have faith that the Kansas Senate will pass this legislation this session and this is just another step in that process.”
Michael Pirner, Masterson’s communications director, told the Star that “medical marijuana legislation is not a priority of Senate leadership,” but did signal the issue may still be considered before the year is over.
“The subject matter has clearly matured and we expect it to be considered at some level this session,” he said. “There are many more pressing topics on the Senate agenda.”
The bill as drafted contains several significant restrictions, including a ban on smokeable cannabis. Members of the Senate Federal and State Affairs Committee did get a briefing on the issue at a meeting last week ahead of the expected, now-cancelled formal hearings before the panel.
Meanwhile, the constitutional amendment that the Democratic leaders are proposing would provide for a more comprehensive program that lawmakers would need to implement.
Gov. Laura Kelly (D), for her part, wants to see medical cannabis legalization enacted, and she said at a briefing with reporters on Friday that she “absolutely” thinks the bill could pass if “everything else doesn’t take up all the oxygen.”
She previously pushed a separate proposal that would legalize medical cannabis and use the resulting revenue to support Medicaid expansion, with Rep. Brandon Woodard (D) filing the measure on the governor’s behalf.
Kelly has she said she wants voters to put pressure on their representatives to get the reform passed.
The governor also said in 2020 that while she wouldn’t personally advocate for adult-use legalization, she wouldn’t rule out signing the reform into law if a reform bill arrived on her desk.
Photo courtesy of Philip Steffan.
Marijuana Banking Bill Sponsor Says He’s ‘Gonna Get That Darn Thing Passed’ Before Leaving Office
Rep. Ed Perlmutter (D-CO) is retiring from Congress at the end of this session, but he says that he’s going to work to pass his marijuana banking bill before his time on Capitol Hill comes to an end.
The congressman spoke to Colorado Public Radio last week about his decision not to run for reelection this November and his disappointment that, while the House has approved the Secure and Fair Enforcement (SAFE) Banking Act five times now in some form, the Senate has failed to advance it under both Republican and Democratic leadership.
“That one still has me pretty irritated,” Perlmutter said, referring to the fact that Senate Majority Leader Chuck Schumer (D-NY) has effectively blocked his bipartisan legislation. When there was a GOP Senate majority, he was told the bill was “too big and too broad.” Then with a Democratic majority, he’s told that it’s “too narrow and too limited.”
Schumer and his colleagues who are working on a federal legalization bill have repeatedly said that they do not want to see the SAFE Banking Act pass before comprehensive reform is enacted that addresses equity issues. Supporters of the banking bill argue that the incremental policy change is necessary for promote public safety and, importantly, it stands a much stronger chance of getting to the president’s desk with bipartisan support.
Nonetheless, Perlmutter said he plans to spend his remaining months in office pushing to get the job done.
“I have not given up on that one,” he said. “I’m gonna get that darn thing passed this year while I still serve out my term.”
Listen to Perlmutter discuss the marijuana banking legislation, starting around 10:24 into the audio below:
Asked whether he thinks President Joe Biden would be inclined to sign the measure if it did get to his desk, the congressman said “absolutely.”
“Treasury Secretary [Janet] Yellen is somebody who has been talking to me about this for years,” he said. “I feel very good that it would pass. We’re at 47 states that have some level of marijuana use, all the territories and District of Columbia, and they need to have legitimate banking services.”
“It’s just a no brainer in my opinion,” he said. “And yeah, I’m a little bit irritated, but we’re gonna keep working on it and get it passed this year.”
The last attempt that Perlmutter made to enact the reform was by adding its language to a must-pass defense bill, but it was ultimately sidelined following bicameral negotiations and did not make it into the final version. The congressman told Marijuana Moment last month that he sees other potential vehicles to advance the bill and has spoken with House Speaker Nancy Pelosi (D-CA) about it.
Even some Republicans are scratching their heads about how Democrats have so far failed to pass the modest banking reform with majorities in both chambers and control of the White House. For example, Rep. Rand Paul (R-KY) criticized his Democratic colleagues over the issue last month.
Top Federal Drug Official Says ‘Train Has Left The Station’ On Psychedelics As Reform Movement Spreads
A top federal drug official says the “train has left the station” on psychedelics.
National Institute on Drug Abuse (NIDA) Director Nora Volkow said people are going to keep using substances such as psilocybin—especially as the reform movement expands and there’s increased attention being drawn to the potential therapeutic benefits—and so researchers and regulators will need to keep up.
The comments came at a psychedelics workshop Volkow’s agency cohosted with the National Institute of Mental Health (NIMH) last week.
The NIDA official said that, to an extent, it’s been overwhelming to address new drug trends in the psychedelics space. But at the same time, she sees “an incredible opportunity to also modify the way that we are doing things.”
“What is it that the [National Institutes of Health] can do to help accelerate research in this field so that we can truly understand what are the potentials, and ultimately the application, of interventions that are bought based on psychedelic drugs?” Volkow said.
The director separately told Marijuana Moment on Friday in an emailed statement that part of the challenge for the agency and researchers is the fact that psychedelics are strictly prohibited as Schedule I drugs under the federal Controlled Substances Act.
“Researchers must obtain a Schedule I registration which, unlike obtaining registrations for Schedule II substances (which include fentanyl, methamphetamine, and cocaine), is administratively challenging and time consuming,” she said. “This process may deter some scientists from conducting research on Schedule I drugs.”
“In response to concerns from researchers, NIDA is involved in interagency discussions to facilitate research on Schedule I substances,” Volkow said, adding that the agency is “pleased” the Drug Enforcement Administration recently announced plans to significantly increase the quota of certain psychedelic drugs to be produced for use in research.
“It will also be important to streamline the process of obtaining Schedule I registrations to further the science on these substances, including examining their therapeutic potential,” she said.
At Thursday’s event, the official talked about how recent, federally funded surveys showed that fewer college-aged adults are drinking alcohol and are instead opting for psychedelics and marijuana. She discussed the findings in an earlier interview with Marijuana Moment as well.
Don't miss out on the @NIDAnews, @NIAAAnews, & @NIMHgov-sponsored virtual Workshop on Psychedelics as Therapeutics: Gaps, Challenges, and Opportunities, Jan. 12‒13, 2022. Learn more and register: https://t.co/S1zttkoYXq pic.twitter.com/C2Qrk6FN9a
— NIDAnews (@NIDAnews) January 10, 2022
“Let’s learn from history,” she said. “Let’s see what we have learned from the marijuana experience.”
While studies have found that marijuana use among young people has generally remained stable or decreased amid the legalization movement, there has been an increase in cannabis consumption among adults, she said. And “this is likely to happen [with psychedelics] as more and more attention is placed on these psychedelic drugs.”
“I think, to a certain extent, with all the attention that the psychedelic drugs have attracted, the train has left the station and that people are going to start to use it,” Volkow said. “People are going to start to use it whether [the Food and Drug Administration] approves or not.
There are numerous states and localities where psychedelics reform is being explored and pursued both legislatively and through ballot initiative processes.
On Wednesday—during the first part of the two-day federal event that saw nearly 4,000 registrants across 21 time zones—NIMH Director Joshua Gordon stressed that his agency has “been supporting research on psychedelics for some time.”
Tune in today and tomorrow for the @NIH workshop on Psychedelics as Therapeutics, which will examine findings on psychoplastogens for treating depression, post-traumatic stress, and substance and alcohol use disorders. https://t.co/Qzxte5xJt9
— Joshua A. Gordon (@NIMHDirector) January 12, 2022
“We can think of NIMH’s interests in studying psychedelics both in terms of proving that they work and also in terms of demonstrating the mechanism by which they work,” he said. “NIMH has a range of different funding opportunity announcements and other expressions that are priorities aimed at a mechanistic focus and mechanistic approach to drug development.”
Meanwhile, Volkow also made connections between psychedelics and the federal response to the coronavirus pandemic. She said, for example, that survey data showing increased use of psychedelics “may be a way that people are using to try to escape” the situation.
But she also drew a metaphor, saying that just as how the pandemic “forced” federal health officials to accelerate the development and approval of COVID-19 vaccines because of the “urgency of the situation,” one could argue that “actually there is an urgency to bring treatments [such as emerging psychedelic medicines] for people that are suffering from severe mental illness which can be devastating.”
But as Volkow has pointed out, the Schedule I classification of these substances under federal law inhibits such research and development.
The official has also repeatedly highlighted and criticized the racial disparities in drug criminalization enforcement overall.