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FDA Head Reveals New Details About Agency’s CBD Regulation Plans

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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.”

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. 

FDA Is Exploring ‘Alternative Approaches’ To CBD Regulation, Commissioner Says

Photo courtesy of YouTube/House Appropriations Committee.

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 Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

Congresswoman Wants Ban On DC Marijuana Sales Lifted Through Coronavirus Legislation

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A congresswoman is calling on the government to end a policy prohibiting Washington, D.C. from legal marijuana sales, arguing that the jurisdiction is in particular need of tax revenue from cannabis commerce due to the coronavirus outbreak.

Rep. Eleanor Holmes Norton (D-DC) has repeatedly condemned the congressional rider barring the District of Columbia from allowing retail sales that has been extended each year since 2014, shortly after local voters approved a ballot measure to legalize low-level possession and home cultivation. But given the need for resources to combat the pandemic, she said a reversal of the provision should be included in the next COVID-related relief bill.

“At this moment of unparalleled need, D.C. should be able to collect tax revenue from all available sources, like every other jurisdiction, including from recreational marijuana, which is believed to be widely used in the District,” the congresswoman said in a press release on Friday, adding that D.C. was shorted in the last stimulus because Congress treated it as a territory rather than a state.

“While I am working for a retroactive fix in the next coronavirus bill, it is imperative that Congress also repeal the D.C. recreational marijuana commercialization rider in the next bill to help D.C. shore up its finances,” she said. “It is beyond unreasonable that congressional interference keeps only the District from commercializing recreational marijuana, while all other jurisdictions are free to do so.”

“Bringing the District in line with other jurisdictions would create a critical source of tax revenue in our time of need.”

Last year, the House approved an appropriations bill that excluded the D.C. rider, but it was included in the Senate version and ultimately made its way into the final package that the president signed. The cannabis commerce ban was also included in President Trump’s budget proposal earlier this year.

“True to form, Representative Eleanor Holmes Norton continues to be one of the best allies to the cannabis reform movement,” Justin Strekal, political director for NORML, told Marijuana Moment. “During this unprecedented COVID-19 outbreak, it is critical that lawmakers analyze and reform any and every aspect of public policy to mitigate the health crisis and build a foundation for a strong recovery.”

“As the majority of states that regulate cannabis have deemed the industry essential to the continued functioning of their jurisdictions, the continued congressional prohibition of the District of Columbia enacting it’s own adult-use program becomes even more ridiculous,” he added.

Norton, in an interview about her push, said that the congressionally mandated prohibition on sales doesn’t prevent people from accessing cannabis but does block the city from collecting tax revenue.

“You can buy two ounces but, by the way you’ve got to do that on the black market,” she told WUSA-TV. “But there’s nobody to tax it. And I’m simply trying to get the taxes the District is due for merchandise, in this case marijuana that’s being consumed readily in the District of Columbia.”

Legislative priorities for Congress have shifted significantly as lawmakers attempt to address the outbreak, and that’s meant putting some reform efforts on hold. However, the issue isn’t being ignored entirely, and it’s possible that other members may look to attach modest marijuana proposals to additional coronavirus legislation.

For example, Rep. Katherine Clark (D-MA) said this week that U.S. Department of Veterans Affairs policy preventing its doctors from recommending medical cannabis in legal states puts service members at risk in Massachusetts because the state is shuttering recreational shops (but not medical dispensaries) and some veterans fear registering as patients out of concern that they could lose federal benefits.

Eleven senators wrote a letter to Appropriations Committee leadership asking that they allow small cannabis businesses to access federal loans and disaster relief programs. While the lawmakers said it should be enacted through an annual spending bill, advocates have argued that the policy change should be pursued through coronavirus legislation since these businesses are facing challenges just like those experienced by many other companies during the pandemic.

Eleven Senators Push To Let Marijuana Businesses Access Federal Loan Programs

Photo courtesy of WeedPornDaily.

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North Dakota Activists Say Marijuana Legalization Initiative Unlikely In 2020 Due To Coronavirus

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North Dakota activists announced on Thursday that they are suspending their campaign put marijuana legalization on the November ballot due to the coronavirus outbreak.

In a Facebook post, Legalize ND said “we are going to have to face a few hard realities going forward” as businesses are shuttering, public events are being cancelled and individuals are encouraged to shelter in place. The pandemic means in-person signature gathering can’t take place, and the state does not allow for alternative signing options such as by mail or online.

“Due to the virus all of our major avenues for signature collection have been cancelled or indefinitely postponed, and going door to door is not safe for both those knocking and those getting knocked,” the group said. “Businesses will continue to collect, but we don’t want to create another vector for the coronavirus. As a result, at this time if something major doesn’t change we will not be able to make the 2020 ballot.”

Legalize ND said there’s no way for state policies related to signature gathering to be changed ahead of the November election. They needed to collect 13,452 valid signatures from voters before July 6 in order to qualify. In all likelihood, the campaign said it would have to shift its focus to the July 2022 primary election.

“This isn’t the solution we want, but given the situation it is what will have to happen,” the post states. “Stay safe, and hopefully we can make a major push when the quarantine ends.”

The proposed initiative would allow individuals to purchase and possess up to two ounces of cannabis. Unlike a much more far-reaching measure the same group pushed in 2018 that included no possession or cultivation limits, which voters rejected, this version would prohibit home growing, impose a 10 percent excise tax and establish a regulatory body to approve licenses for marijuana businesses.

North Dakota voters approved a medical cannabis initiative in 2016.

The coronavirus outbreak has dealt several blows to drug policy reform efforts in recent weeks.

California activists for campaigns to amend the state’s legal cannabis program and legalize psilocybin mushrooms are asking for a digital signature option.

Likewise in Washington, D.C., advocates for a measure to decriminalize psychedelics asked the mayor and local lawmakers to accept online signatures for their ballot petition.

An effort to legalize medical cannabis in Nebraska is facing similar signature gathering challenges. A campaign to legalize cannabis in Missouri is also in jeopardy.

In Oregon, advocates for a measure to decriminalize drug possession and a separate initiative to legalize psilocybin for therapeutic purposes have suspended in-person campaign events amid the pandemic.

In New York, Gov. Andrew Cuomo (D) recently conceded that legalization was “not likely” going to happen through the budget, as he hoped. Coronavirus shifted legislative priorities, and comprehensive cannabis reform seems to have proved too complicated an issue in the short-term.

Idaho activists announced on Thursday that they are suspending their campaign, though they are still “focusing on distributing petitions through online download at IdahoCann.co and encouraging every volunteer who has downloaded a petition to get them turned in to their county clerk’s office by mail, regardless of how many signatures they have collected.”

Finally, in Arizona, a legalization campaign is petitioning the state Supreme Court to instruct the secretary of state to allow individuals to sign ballot petitions digitally using an existing electronic system that is reserved for individual individual candidates seeking public office.

Virginia Groups Push Governor To Amend Marijuana Decriminalization Bill On His Desk

Photo courtesy of Philip Steffan.

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.
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Arizona Legal Marijuana Campaign Asks Supreme Court To Allow Electronic Signatures Amid Coronavirus

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Several campaigns to put initiatives on Arizona’s November ballot—including one to legalize marijuana—are asking the state Supreme Court to allow electronic signature gathering amid the coronavirus pandemic, which has made in-person ballot petitioning all but impossible.

Smart and Safe Arizona, the group behind the cannabis measure, along with three other campaigns, filed a petition with the court on Thursday, requesting that it direct the secretary of state to let them digitally collect signatures. They stressed that the infrastructure already exists, as residents are able to use a system called E-Qual to sign ballot petitions for individual candidates running for office.

While the marijuana campaign has already gathered more than 320,000 signatures, which is well over the required 237,645 signatures for statutory proposals, they have yet to be verified and activists would like to continue collection efforts to ensure that they qualify for the ballot.

In the filing, the groups argued that limiting the E-Qual system to office seekers is unconstitutional. However, state law stipulates that it can only be used for that purpose, so it remains to be seen whether court action will produce the intended result. There was a bill filed last year to expand its utility to allow digital signature gathering for initiatives, but it has not advanced in the legislature.

“Legal access to E-Qual for these citizen initiatives is the right thing for public health and democracy,” attorneys representing the groups said in a statement. “Following Governor Doug Ducey’s stay-at-home order issued Monday and current CDC recommendations, gathering hundreds of thousands of signatures on paper, at people’s homes, or in public spaces, is impossible to do safely and responsibly during this pandemic. E-Qual is a very reasonable remedy.”

The legalization petition would allow individuals 21 and older to possess and purchase cannabis from licensed retailers. People could possess up to an ounce of marijuana at a time and cultivate up to six plants for personal use.

The measure also contains several restorative justice provisions such as allowing individuals with prior marijuana convictions to petition the courts for expungements and establishing a social equity ownership program

Cannabis sales would be taxed at 16 percent. Tax revenue would cover implementation costs and then would be divided among funds for community colleges, infrastructure, a justice reinvestment and public services such as police and firefighters.

The Department of Health Services would be responsible for regulating the program and issuing cannabis business licenses. It would also be tasked with deciding on whether to expand the program to allow for delivery services.

“The Committees have explored potential alternatives, such as mailing petitions to interested persons to circulate within their families,” Smart and Safe Arizona Campaign Manager Stacy Pearson said in a declaration filed with the court. “This, however, is expensive, inefficient, and has no realistic likelihood of permitting the Committees’ to gather large numbers of valid petition signatures.”

The legalization group was joined by campaigns to limit school vouchers, provide sentencing reform and increase taxes on the wealthy to fund public education in the petition. Separately, two other campaigns—to enact voting reform and end surprise hospital billings—filed a similar lawsuit in a federal court on Thursday.

Smart and Safe Arizona is not the only drug policy reform campaign to request electronic signature gathering since the COVID-19 outbreak.

Activists in California released a video last month asking officials to allow digital signatures for a petition to revise the state’s adult-use marijuana program. In Washington, D.C., advocates for a measure to decriminalize psychedelics similarly wrote to the mayor and local lawmakers, imploring them to accept online signatures for their ballot petition.

Another California campaign to legalize psilocybin mushrooms is struggling and asking for electronic signature gathering to qualify for the ballot.

Others have generally shut down campaign activities in light of the pandemic, which has resulted in shutter businesses and shelter-in-place orders across the country.

An effort to legalize medical cannabis in Nebraska is facing similar signature gathering challenges. A campaign to legalize cannabis in Missouri is also in jeopardy.

In Oregon, advocates for a measure to decriminalize drug possession and a separate initiative to legalize psilocybin for therapeutic purposes have suspended in-person campaign events amid the pandemic.

In New York, Gov. Andrew Cuomo (D) recently conceded that legalization was “not likely” going to happen through the budget, as he hoped. Coronavirus shifted legislative priorities, and comprehensive cannabis reform seems to have proved too complicated an issue in the short-term.

Idaho activists announced on Thursday that they are suspending their campaign, though they are still “focusing on distributing petitions through online download at IdahoCann.co and encouraging every volunteer who has downloaded a petition to get them turned in to their county clerk’s office by mail, regardless of how many signatures they have collected.”

Idaho Activists Suspend Campaign To Legalize Medical Marijuana Due To Coronavirus

Photo courtesy of Mike Latimer.

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.
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