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Biden’s FDA Pick Prescribed Cannabinoid Medicine And Recognized Marijuana’s Therapeutic Potential

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President Joe Biden announced on Friday that he intends to nominate a new Food and Drug Administration (FDA) commissioner who has acknowledged the potential medical benefits of marijuana and says he actually prescribed a cannabinoid drug as a doctor.

Robert Califf, who previously served a short stint as the FDA head under the Obama administration, hasn’t been especially vocal about marijuana issues. But at a 2016 federally hosted research summit on cannabis, he recognized various therapeutic applications for the plant and its components and emphasized that the agency is interested in promoting research and development.

“We understand that people have identified a number of possible uses of marijuana and marijuana-derived products. For example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, cancer and chemotherapy-induced nausea,” Califf said. “And I had the chance to prescribe some of this in my cardiology practice in people with extreme heart failure who get a wasting cachectic syndrome.”

Notably, he also said that while FDA had yet to find that botanical marijuana is “safe and effective for any indication,” that’s not to say there aren’t any good uses for it, and additional studies could shed light on the situation.

FDA’s position on cannabis is “not because we’ve had a ton of applications to look at,” he pointed out. “It’s because we haven’t gotten them into the pathway,” Califf said. “What this means is that no one has demonstrated to FDA that any such product is safe or effective for the treatment of any disease or condition. To change that we need studies conducted using marijuana to rigorously assess the safety and effectiveness of marijuana for medical use.”

Watch Califf discuss marijuana issues, around 5:03:00 into the video below:

“Then we need to get those studies submitted to FDA and a marketing application for review under the legal standard set out in the federal Drug and Cosmetic Act,” he said. “This assures that the drug product meets the statutory standards for approval.”

“This is what we really want and we actively encourage it and want to work with people to make this happen,” he added. “To do this, we know we need to facilitate the work of companies interested in appropriately bringing safe, effective and quality products to market, including scientifically based research concerning these medicinal uses.”

“We believe this process, which includes collaboration with other federal and state agencies, researchers and manufacturers working on issues related to the use of cannabidiol and other constituents of marijuana in the U.S. remains the best way to identify new treatments that are safe and effective for patients and to protect patients from products that are not what they purport to be.”

At the summit, Califf also noted that FDA has approved synthetic cannabis products like Marinol for the treatment of anorexia associated with AIDS and nausea related to chemotherapy treatment.

The approval of these substances “supports the point I made earlier that our decisions on the approval of any medicine relies on the science to determine the safety and effectiveness of new medicines. And it’s also consistent with the approach we’ll continue to take going forward in this area,” he said.

Overall, the remarks suggest that, if confirmed, it doesn’t seem that Califf wouldn’t be hostile toward attempts to explore the therapeutic potential of cannabis. But he does seem to defer to statutory processes within FDA that favor pharmaceutical approaches to these medicines that have so far kept marijuana in a tightly regulated drug category.

Separately, some vaping stakeholders have raised concerns about the prospective nominee, pointing to a 2019 op-ed he authored that advocated for a ban on flavored vape products as a way to mitigate the risks of the e-cigarette or vaping use-associated lung injury (EVALI) crisis.

“I believe that we should move to enact strict regulation to limit the harm done by vaping products, augmented by an aggressive public education program that is particularly aimed at vulnerable young people, but not excluding adults,” Califf wrote at the time.

However, he acknowledged that an “outright prohibition of vaping products seems impracticable on several grounds,” adding that the “regime of legal prohibition also dissuades people from seeking help with addiction for fear of stigma that might negatively affect future employment and social mobility.”

If Califf does become commissioner, he’ll have his work cut out for him on the cannabis front.

For example, industry stakeholders are eagerly awaiting action by the FDA to allow CBD to be marketed as a food item or dietary supplement. The agency has said that it is exploring regulatory pathways to allow for such cannabidiol commerce, but bipartisan lawmakers have introduced legislation this session to force a change.

FDA was mandated under appropriations legislation enacted in 2019 to provide an update on its regulatory approach to CBD, and it did so in March of last year. 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.”

Another issue that FDA is focusing on concerns delta-8 THC products that are made through a synthetic process using hemp-derived CBD. The agency issued warnings to consumers about the potential risks of the cannabinoid in September.

FDA also recently announced that it plans to use Reddit and other “novel” data sources to gain a better understanding of public health issues surrounding use of CBD and other “emerging” marijuana derivatives like delta-8 THC.

With respect to broader marijuana policy, FDA would play a critical role in any moves to reschedule or deschedule cannabis. If a scheduling petition is accepted, the agency would need to assess the scientific, medical and public health implications before submitting that review to the Justice Department with its recommendations.

FDA Acting Commissioner Janet Woodcock, meanwhile, frustrated advocates earlier this year after dodging a congressman’s question about whether marijuana is more harmful than tobacco.

DEA Boosts Psilocybin, MDMA And DMT Production Levels Again In Final Quotas For 2021

Photo courtesy of Brian Shamblen.

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Credit Unions Urge Congress To Pass Marijuana Banking Reform Through Defense Bill

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Major associations representing U.S. credit unions are calling on Congress to pass marijuana banking reform through must-pass defense legislation.

It’s the latest in a series of requests from lawmakers, stakeholders and advocates to advance legislation to protect financial institutions that work with state-legal cannabis businesses from being penalized by federal regulators.

Specifically, they want to see the Senate follow the House’s lead in attaching language from the Secure and Fair Enforcement (SAFE) Banking Act to the National Defense Authorization Act (NDAA).

“We take no position on legalizing or decriminalizing medicinal or recreational cannabis at either the state or federal level,” the associations said in a letter to key committee leadership. “However, credit unions operating in states where it is legal have members and member businesses involved in the cannabis market who need access to traditional depository and lending services, the absence of which creates a significant public safety issue.”

The Credit Union National Association, Defense Credit Union Council and National Association of Federally-Insured Credit Unions signed the letter, which also touches on non-cannabis issues.

The groups, which wrote that they “strongly support” attaching SAFE Banking to NDAA, also stressed that “financial institutions that choose not to bank the cannabis industry still risk unknowingly serving those businesses in states where cannabis is legal.”

“Indirect connections are often difficult to identify and avoid because like any other industry, those offering cannabis-related services work with vendors and suppliers,” the letter continues. “Under the existing status quo, a credit union that does business with any one of these indirectly affiliated entities could unknowingly risk violating federal law.”

“Inclusion of the SAFE Banking Act puts in place necessary protections to bring revenue from state-sanctioned cannabis businesses into the financial services mainstream and, as a result, keeping communities safe,” it concludes.

While the Senate has yet to independently add the banking reform language to its version of NDAA, supporters want to see the provisions adopted by negotiators in conference for the final legislation sent to President Joe Biden’s desk.

Bipartisan members of the Senate Armed Services Committee recently sent their own letter urging leaders to include the SAFE Banking Act in the final NDAA. Shortly thereafter, U.S. senators representing Colorado made the same request in a separate letter.

The SAFE Banking Act has been approved in some form in the House five times now, but it’s so far languished in the Senate. Stakeholders have held out hope that the chamber would advance the legislation with a Democratic majority, but some key players like Senate Majority Leader Chuck Schumer (D-NY) have insisted on passing comprehensive legalization—like a reform bill he’s finalizing—first.

That said, Schumer has signaled that he’s open to enacting banking reform through NDAA if it contained social equity provisions.

Earlier this month, a bipartisan coalition of two dozen governors implored congressional leaders to finally enact marijuana banking reform through the large-scale defense legislation.

A group of small marijuana business owners also recently made the case that the incremental banking policy change could actually help support social equity efforts.

Rodney Hood, a board member of the National Credit Union Administration, wrote in a Marijuana Moment op-ed last month that legalization is an inevitability—and it makes the most sense for government agencies to get ahead of the policy change to resolve banking complications now.

Meanwhile, an official with the Internal Revenue Service said last month that the agency would like to “get paid,” and it’d help if the marijuana industry had access to banks like companies in other legal markets so they could more easily comply with tax laws.

Federal data shows that many financial institutions remain hesitant to take on cannabis companies as clients, however, which is likely due to the fact that the plant is a strictly controlled substance under federal law.

Read the letter from the credit union associations on marijuana banking below: 

Click to access 110421_ndaa_joint-trade.pdf

 

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Marijuana Had ‘Unprecedented’ Success In State Legislatures In 2021, NORML Report Shows

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Lawmakers across the U.S. proved again in 2021 that marijuana reform will continue to advance on the state level despite the recalcitrance of Congress to end federal prohibition.

As more eyes turn to 2022 legislative sessions, a report from NORML that was released on Monday details advocates’ progress on the cannabis front this year in more than 25 states, where over 50 pieces of marijuana reform legislation were enacted.

Most notably, legislatures and governors in five states enacted recreational legalization—a notable trend given that the reform has historically been decided by voters as ballot initiatives. But 2021 has also seen more modest policy changes related to medical cannabis, decriminalization and social equity.

“State lawmakers took unprecedented steps this year to repeal marijuana prohibition laws and to provide relief to those millions of Americans who have suffered as a result of them,” NORML Deputy Director Paul Armentano said in a press release.

Of course, one of the primary objectives of reform advocates is to comprehensively end prohibition. To that end, the legislatures of Connecticut, New Jersey, New Mexico, New York and Virginia each legalized marijuana for adult use this year. (New Jersey’s action came months after voters approved a referendum on the issue during last November’s election.)

In Rhode Island, the Senate approved a marijuana legalization bill in June. While legislative leaders discussed holding a special session to send a final measure to the governor’s desk, it now appears more likely that the issue will be taken up again in 2022.

North Dakota’s House also passed a recreational legalization bill, but it was later rejected in the Senate.

Louisiana lawmakers, meanwhile, passed legislation this year that decriminalizes possession of up to 14 grams of cannabis.

With respect to expungements for prior marijuana convictions, reform measures meant to help provide people with relief were approved in Colorado, Delaware, New Mexico and Virginia, NORML reported.

As an example, the governor of Colorado signed a bill in May to double the marijuana possession limit for adults in the state—and he also directed state law enforcement to identify people with prior convictions for the new limit who he may be able to pardon.

Separately, Alabama’s governor signed legislation that same month to legalize medical cannabis in the state.


Marijuana Moment is already tracking more than 1,200 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.

Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

At least 15 states took steps to expand existing medical marijuana programs. They range from California, where hospitals will now be required to permit medical cannabis use by certain patients, to Texas, where patients can now qualify for low-THC marijuana products if they suffer from post-traumatic stress disorder or cancer.

As state markets have continued to evolve, some lawmakers have turned their attention to enhancing social equity in the industry. And to that end, five state legislatures advanced reform this year.

For example, Illinois passed a bill to create additional marijuana licensing lotteries to expand business opportunities. And in Michigan, the governor signed a bill this month that makes it so people with cannabis-related felony or misdemeanor convictions on their record are no longer disqualified from obtaining a medical cannabis business license.

NORML also documented other reform bills related to the business industry, driving/DUI policies, juvenile justice and more. One miscellaneous measure that was enacted in California, for example, makes it so non-intoxicating cannabinoids, including CBD, can be sold as dietary supplements and as ingredients in food and beverages.

“As we approach the 2022 legislative session and the elections next November, it is important for lawmakers of all political persuasions to recognize that advocating for marijuana policy reforms is a political opportunity, not a political liability,” NORML’s Armentano said. “These policies are popular among voters, regardless of political party.”

Activists and lawmakers have made clear that the cannabis reform momentum will continue through the new year.

On Monday, for instance, a Kentucky lawmaker announced that she is pre-filing bills to legalize possession, limited sales and home cultivation of marijuana in the state for the 2022 session.

In the South Dakota legislature, a cannabis reform bill has been formally recommended by a leadership panel for the upcoming session. And activists will also continue collecting signatures for a 2022 ballot initiative—though they hope to work with lawmakers to advance reform legislatively ahead of next year’s election.

The Indiana Democratic party is mounting a push for marijuana legalization and calling on state lawmakers to enact the reform in 2022.

Arkansas activists are also hoping to place marijuana legalization on the state’s 2022 ballot.

Last month, Oklahoma activists filed a pair of 2022 ballot initiatives to legalize adult-use marijuana and remodel the state’s existing medical cannabis program.

In Nebraska, advocates unveiled the language of a pair of initiatives to legalize medical marijuana in the state last month.

This summer, New Hampshire lawmakers discussed a new strategy to legalize marijuana in the state that involves putting a proposed constitutional amendment on the ballot for voters to decide on in 2022.

Wyoming activists, meanwhile, are working to collect signatures for 2022 ballot initiatives to legalize medical marijuana and decriminalize cannabis possession.

A Maryland House working group has been tasked with studying marijuana and preparing a legalization referendum that the speaker wants to put on next year’s ballot.

Just months ago, Ohio activists were cleared to begin collecting signatures for a 2022 ballot initiative to legalize marijuana in the state. And the campaign says it expects to have enough valid signatures by the end of this month.

Idaho advocates are also pursuing a 2022 cannabis legalization ballot initiative as well as a separate proposal focused on medical marijuana.

Kentucky Lawmaker Pre-Files Marijuana Legalization Bills For 2022 Session

Photo courtesy of Mike Latimer.

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Kentucky Lawmaker Pre-Files Marijuana Legalization Bills For 2022 Session

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A Kentucky lawmaker announced on Monday that she is pre-filing bills to legalize possession, limited sales and home cultivation of marijuana in the state for the 2022 session, with endorsements from several leading advocacy groups.

Rep. Nima Kulkarni (D) is taking a dual-track approach to the reform, with one bill to have the legislature adopt the policy as a statutory measure and another to enact legalization through a constitutional amendment that would go before voters.

Generally speaking, the measures would accomplish the same central objective of ending prohibition, but Kulkarni said they’re meant to complement each other by giving lawmakers an opportunity to pass legalization in the short-term while allowing voters to constitutionally enact the reform as a “more permanent fix that gives cannabis use the constitutional protection it deserves.”

“I am sponsoring these bills for several reasons, any one of which should be enough for them to become law,” the sponsor said in a press release.

“First, current cannabis statutes have needlessly and tragically ruined many lives, especially people of color who have suffered because of unequal enforcement,” she said. “Second, thousands of citizens, from cancer patients to veterans suffering from PTSD, should have the right to use something that gives them the mental and physical relief they deserve without relying on stronger, potentially addictive medicine. Third, cannabis decriminalization would give the state a much-needed source of reliable revenue without raising current taxes a single cent.”

Kulkarni further noted that polls “have repeatedly shown a majority of Kentuckians backs decriminalization and allowing cannabis to be used responsibly by adults.”

Under one of the lawmaker’s pre-filed bills, a constitutional amendment would be placed on the ballot if three-fifths of the House and Senate approve it during next year’s legislative session. If passed by voters, adults 21 and older would be able to possess, purchase and sell up to one ounce of cannabis. They could also grow up to five plants for personal use.

The measure would task the General Assembly with coming up with regulations on matters such as licensing and taxes.

The separate statutory proposal would similarly remove criminal penalties for low-level possession, cultivation and sale of cannabis. It would also amend state statute so that marijuana paraphernalia would no longer be criminalized and create a pathway for people to have their cannabis convictions expunged.

Neither measure creates a regulatory structure for commercial marijuana sales, something that would be subject to separate legislation.


Marijuana Moment is already tracking more than 1,200 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.

Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

“Because of outdated and ill-enforced laws, thousands of Kentuckians have lost time and opportunities due to criminal convictions, and thousands more have suffered needlessly because Kentucky blocks cannabis’ medicinal use,” ACLU of Kentucky said. “It is past time for the commonwealth to join the 36 other states that have removed most if not all of these barriers, which is why we are proud to add our name to those supporting Rep. Nima Kulkarni’s legislation.”

While Kentucky is well-known for its hemp industry, broader reform has consistently stalled.

The Republican sponsor of a bill to legalize medical marijuana in Kentucky said last month that he made multiple revisions to the legislation to scale it back and add restrictions to garner more support from colleagues—and he said he’s confident it would pass if legislative leaders had the “courage” to simply allow a vote on it.

Rep. Jason Nemes (R) filed a medical legalization bill that soundly passed the House last year but later died in the Senate without a vote amid the early part of the coronavirus pandemic. He reintroduced the legislation in January for the 2021 session but it did not advance this year. Now he’s working to build support for a new version for 2022.

Gov. Andy Beshear (D) is in favor of medical marijuana legalization and called on lawmakers to pass the reform during a State of the Commonwealth address in January.

Passing an adult-use marijuana legalization bill would presumably be a much larger challenge in the conservative legislature, but the proposal has the backing of several prominent groups.

Mike Conway, state director for Americans for Prosperity-Kentucky, said the pre-filed bills “would move Kentucky away from the harmful policies that have criminalized the use and possession of marijuana.”

“Criminal enforcement of marijuana possession has unnecessarily brought thousands of Kentuckians into the criminal justice system while diverting law enforcement resources away from public safety priorities such as violent crime reduction,” he said.

Matthew Bratcher, executive director for Kentucky NORML, said the group “commends Representative Kulkarni in her efforts to reform the cannabis possession laws in our commonwealth, and we encourage other legislators from both sides of the aisle to join her in making a difference in the lives of many of Kentuckians.”

“We’re at the precipice of the opening of the cannabis industry here in Kentucky,” C.J. Carter, Kentucky state director for Minorities for Medical Marijuana, said. “This is indeed a dangerous moment in time for Black and Brown people. There’s a new multi-billion dollar industry that will soon open on both the Federal and State level while simultaneously, people who look like me remain criminalized behind bars and are once again being left out of the conversation.”

“We now have the opportunity to write a different narrative in Kentucky that would benefit us first and foremost,” he said. “The State of Kentucky and its history as it relates to cannabis owes a tremendous debt to the Black Community and that starts with this legislation that is being introduced by Rep. Kulkarni.”

Read the text of the pre-filed Kentucky marijuana legalization bills below: 

Click to access kentucky-cannabis-bills.pdf

Florida Lawmaker Files Bill To Decriminalize All Currently Illicit Drugs

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