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FDA Chief Warns CBD Rulemaking Could Take Years Without Congressional Action

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The outgoing head of the Food and Drug Administration (FDA) suggested on Tuesday that it would take several years for the agency to come up with rules around allowing hemp-derived cannabidiol (CBD) in food products—unless Congress steps in.

At a Brookings Institution event, FDA Commissioner Scott Gottlieb recognized that there’s strong interest among the cannabis industry and lawmakers in developing a regulatory framework through which CBD from hemp could be extracted, sold and introduced into the food supply. The problem is that “CBD didn’t previously exist in the food supply, and it exists as a drug under the statute.”

“It can’t just be put into the food supply,” he said, arguing that current law only allows the FDA to “contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.”

That rulemaking process can take two to three years for conventional products, and so because CBD is “more complex”—due to its association with marijuana—and has already been approved by the FDA as a drug to treat epilepsy (in the form of Epidiolex), it could theoretically take much longer to develop those regulations.

“We’ve never done this before,” Gottlieb said. “It would be a highly novel rulemaking process.”

In the meantime, the FDA is putting together a “high-level work group” that will work to identify “some potential legislative pathways might be to create a framework for allowing CBD into the food supply.”

Gottlieb said he expects the group to release some recommendations by the summer, as Business Insider first reported.

The commissioner said the work group will be formally announced within the next week and would involve a public meeting to solicit comments from stakeholders.

While Congress might have intended to permit the marketing of hemp-derived CBD through the 2018 Farm Bill, the commissioner indicated that additional legislation that specifically addresses CBD regulations would be necessary to allow the ingredient in the food supply. He said there’s precedent for such actions, citing legislation around human growth hormone and fish oil.

“I think you need to come up with a framework that defines concentration levels, where you would create some kind of cut off, and that would be up to the agency to do,” he said. “Congress would obviously give directions to the agency to do that.”

“CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe—I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value. But this is a process that the agency would have to work through. I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation that would specifically address CBD.”

Gottlieb made similar comments in response to questions from members of a House Appropriations subcommittee last month, where he announced that the agency would hold a public meeting in April to gather input from stakeholders on CBD regulation.

In the new comments, the commissioner also added that he felt the Drug Enforcement Administration (DEA) would have to “formally de-schedule” hemp-derived CBD before moving forward with regulatory changes, in spite of the fact that the agriculture legislation shifted regulatory responsibility for the crop and its derivatives from the Justice Department to the U.S. Department of Agriculture.

“I think the prevailing view is that the plain language of the statute [of the Farm Bill] intended for that, but I’m not sure that DEA has done that yet,” he said. “But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”

The desire for clarity around CBD’s legality post-Farm Bill passage has been widespread. For example, the U.S. Postal Service issued an advisory earlier this month spelling out rules for mailing hemp-derived CBD. Representatives from state agriculture departments also heard talk about “alternative approaches” to regulating the compound at a conference last month.

In his remarks at Brookings, Gottlieb announced that the CBD work group would be co-chaired by Amy Abernethy, FDA’s principal deputy commissioner, and Lowell Shiller, the agency’s acting associate commissioner for policy.

In the meantime, it is clear that lawmakers want FDA to move on the issue.

“Every meeting I go into on Capitol Hill, almost every meeting, I get asked about this,” Gottlieb said.

U.S. Postal Service Issues Advisory On Mailing Hemp-Derived CBD

Photo courtesy of YouTube/Brookings Institution.

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 Sacramento-based senior editor. His work has also appeared in High Times, VICE and attn.

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Bipartisan Lawmakers Push VA To Allow Medical Marijuana Access For Veterans ‘As Soon As Possible’

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The U.S. Department of Veterans Affairs (VA) must urgently institute a policy change to ensure that military veterans can access cannabis for therapeutic use, a bipartisan coalition of congressional lawmakers said in a new letter.

Writing to VA Secretary Denis McDonough on Wednesday, the co-chairs of the Congressional Cannabis Caucus urged the official to consider “a change in policy to allow access to medical cannabis fro VA patients” and to “act swiftly and implement this change as soon as possible.”

The lawmakers pointed to surveys showing high rates of opioid addiction and post-traumatic stress disorder (PTSD) among the veteran community.

“Research has shown that cannabis can be safe and effective in targeted pain-management. Additionally, cannabis has proven benefits in managing PTSD and other health issues, including multiple sclerosis (MS) and seizure disorders,” the letter states. “Despite its efficacy, antiquated bureaucratic red-tape continues to deny veterans these life-altering treatments.”

“Congress and several administrations have enacted various well-intentioned intervention attempts, however, over twenty veterans continue to die by suicide each day—it is past time we stop barring access from these innovative therapies. We therefore respectfully urge you to ensure no veteran can be denied medically prescribed cannabis treatments.”

The letter comes weeks after McDonough participated in a Veterans Day Q&A where he said that VA officials are “looking at” the possibility of an internal policy change and have discussed it with the White House and Department of Justice. The secretary also talked about being personally moved by stories from veterans who’ve found relief using medical marijuana.

“We’re trying to explore what more we can do,” he said at the time. “And I’ve talked to our friends in the rest of the federal government, including the Department of Justice, on what we can do on this, and with the White House.”

The Congressional Cannabis Caucus co-chairs—Reps. Earl Blumenauer (D-OR), David Joyce (R-OH), Barbara Lee (D-CA) and Don Young (R-AK)—want McDonough to speed up the policy change process.

“America’s veterans have risked life and limb to preserve our freedoms, so we must not allow the unnecessary politicization of medical cannabis to hinder their lifesaving therapies,” they wrote. “We stand ready to work with you and your administration in advancing these necessary treatments.”

While congressional lawmakers are working to advance legislation to end marijuana prohibition, McDonough’s department has resisted even modest proposals meant to promote veteran access and clinical research into the medical value of cannabis.

One such research bill was approved by the House Veterans Affairs Committee earlier this month, despite testimony from the department opposing the reform. VA’s David Carroll told lawmakers that the legislation was overly prescriptive and argued that the department is already conducting robust research into marijuana.

Some had held out hope that VA would back the reform this session after the sponsor, Rep. Lou Correa (D-CA), said that he’d had a conversation with McDonough about the issue of marijuana and veterans.

On the Senate side, a coalition of lawmakers recently filed an amendment to the National Defense Authorization Act (NDAA) that would federally legalize medical cannabis for military veterans who comply with a state program where they live. VA doctors would also be explicitly allowed to issue marijuana recommendations.

Read the letter to the VA secretary on marijuana access below: 

Click to access caucus-letter-to-va-secretary-december-2021.pdf

Biden Treasury Secretary Says ‘Of Course’ Marijuana Banking Would Make IRS’s Job Easier

Photo courtesy of Chris Wallis // Side Pocket Images.

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Biden Treasury Secretary Says ‘Of Course’ Marijuana Banking Would Make IRS’s Job Easier

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The secretary of the U.S. Treasury Department said on Wednesday that freeing up banks to work with state-legal marijuana businesses would “of course” make the Internal Revenue Service’s (IRS) job of collecting taxes easier.

At a hearing before the House Financial Services Committee, Rep. Ed Perlmutter (D-CO) referenced recent comments from an IRS official about the “special type of collection challenge the IRS undertakes regarding tax collection from cannabis-related businesses forced to operate in cash only.”

“Do you agree if these business were simply allowed to access the banking system and didn’t have to transact business only in cash it would make the IRS job easier?” Perlmutter asked Secretary Janet Yellen.

“Yes, of course it would,” she replied matter-of-factly.

The congressman also talked about his bill—the Secure and Fair Enforcement (SAFE) Banking Act—which has passed the House in some form five times now and would resolve the issue by protecting financial institutions that service state-legal cannabis businesses.

Numerous financial, labor and insurance associations, as well as key lawmakers, are pushing the Senate to attach the measure to must-pass defense spending legislation, as the House already has. Bipartisan members of the Senate Armed Services Committee, as well as senators representing Colorado, made the same request in recent letters.

While Yellen’s response was quick, it’s yet another example of a federal official recognizing the untenability of the status quo.

Steven Mnuchin, the Treasury secretary under the Trump administration, repeatedly addressed the issue, saying the current policy conflict creates “significant problems” for IRS and financial regulators. It “creates significant risk in the communities for collecting this amount of cash. It’s problematic,” he said last year.

IRS, for its part, said in September that it expects the cannabis market to continue to grow, and it offered some tips to businesses on staying compliant with taxes while the plant remains federally prohibited.

With respect to the SAFE Banking Act, a bipartisan coalition of two dozen governors recently 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 recent Marijuana Moment op-ed 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.

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.

Texas Activists Turn In Signatures To Put Marijuana Decriminalization On Austin’s 2022 Ballot

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Texas Activists Turn In Signatures To Put Marijuana Decriminalization On Austin’s 2022 Ballot

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Texas activists on Wednesday turned in signatures to place a marijuana decriminalization initiative on Austin’s 2022 ballot.

Ground Game Texas, a progressive organization that was established earlier this year, submitted more than 30,000 signatures to qualify the local measure to go before voters in the May 7 election next year.

While Austin, as well as other Texas cities like Dallas, have already independently enacted law enforcement policy changes aimed at reducing arrests for cannabis-related offenses by issuing citations and summons, the Austin Freedom Act of 2021 would take the reform a step further.

The initiative seeks to end arrests and citations for misdemeanor marijuana possession within Texas’s capital city. Also, it says police cannot issue citations for residue or paraphernalia in lieu of a possession charge.

“Thanks to the tireless efforts of on-the-ground organizers from Ground Game Texas and partner organizations, Austin residents will soon have the ability to make lasting change to our antiquated and racist criminal justice laws,” Mike Siegel, political director of Ground Game Texas, said in a press release. “With successful campaigns like these, Ground Game Texas will continue to empower and excite communities around progressive change—and deliver for the marginalized communities that too often get left behind.”

The measure would further prohibit the use of city funds to request or test cannabis to determine whether it meets the state’s definition of a lawful product. Hemp is legal in the state, creating complications for law enforcement, as they are now tasked with determining if seized cannabis products are in compliance with state statute.

Under the initiative, the execution of no-knock warrants would also be prohibited in the city—a policy that generated significant national attention last year after it led to Kentucky officers entering Breonna Taylor’s apartment and fatally shooting her in a botched drug raid.

Activists were joined by Austin City Council members Greg Casar and Vanessa Fuentes for Wednesday’s signature turn in.

Game Ground Texas previously attempted to place the measure on this year’s ballot, but they did not meet the signature turn-in deadline and shifted their attention to 2022.

While the measure is now set to appear on the May ballot, it’s also possible that the Austin City Council could independently move to adopt the ordinance prior to the election.

“Austinites continue to work towards reducing the decades of negative impacts prohibition has caused by any means available,” Jax Finkel, executive director of Texas NORML, told Marijuana Moment.  “During the interim, local actions like this create pressure for more action during the next legislative session. With a majority of Texans supporting the creation of a regulated cannabis market, it is important to continue pushing this conversation forward.”

Elsewhere in the state, activists in San Marcos launched a campaign in September to put marijuana decriminalization on the November ballot next year.

Ground Game Texas told Marijuana Moment on Wednesday that it is also planning to place a cannabis decriminalization measure before voters in Killeen next fall.

There is no statewide, citizen-led initiative process that would enable advocates to put an issue like decriminalization or legalization on the Texas ballot. But at the local level, there are limited cases where activists can leverage home rule laws that allow for policy changes.

A recent poll found that a strong majority of Texans—including most Republicans—support even broader reform to legalize marijuana for adult use.

The survey from the University of Houston and Texas Southern University found that 67 percent of Texas residents back the broad reform. Fifty-one percent of participants who identified as Republican said they back legalization.

In Texas, drug policy reform did advance in the legislature in the latest session, but not necessarily at the pace that advocates had hoped to see.

A bill to expand the state’s medical cannabis program and another to require a study into the therapeutic potential of certain psychedelics for military veterans were enacted.

Advocates remain disappointed, however, that lawmakers were unable to pass more expansive cannabis bills—including a decriminalization proposal that cleared the House but saw no action in the Senate.

The House approved a cannabis decriminalization bill in 2019, but it did not advance in the Senate that session.

The Texas Republican Party adopted a platform plank endorsing decriminalization of marijuana possession in 2018.

Another Texas poll that was released over the summer found that 60 percent of voters in the state support making cannabis legal “for any use.”

Jamaican Government Launches ‘Good Ganja Sense’ Campaign To Debunk Marijuana Myths

Photo courtesy of Brian Shamblen.

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