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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.

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Senate Schedules Hearing On Marijuana Business Banking Access

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In one of the clearest signs of marijuana reform’s growing momentum on Capitol Hill, a Republican-controlled Senate committee has scheduled a hearing for next week that will examine cannabis businesses’ lack of access to banking services.

The formal discussion in the Senate Committee on Banking, Housing and Urban Affairs on Tuesday comes as legislation aimed at resolving the marijuana industry’s financial services problems is gaining momentum. A House cannabis banking bill that cleared that chamber’s Financial Services Committee with a bipartisan vote in March now has 206 cosponsors—nearly half the body—while companion Senate legislation has 32 out of 100 senators signed on.

Please visit Forbes to read the rest of this piece.

(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)

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Congressman Files Marijuana Bill After Leaving Republican Party

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In one of his first legislative acts since leaving the Republican Party earlier this month amid a feud with the president, Rep. Justin Amash (I-MI) filed a bill on Monday that would let states set their own marijuana policies without federal interference.

If that sounds familiar, it’s because bipartisan legislation that would accomplish the same goal has already been filed this Congress.

But unlike the nearly identical Strengthening the Tenth Amendment Through Entrusting States (STATES) Act, Amash’s new bill excludes one provision that would require the Government Accountability Office (GAO) to study the effects of cannabis legalization on road safety and issue a report on its findings within a year of the law’s enactment.

That language states that the GAO must study “traffic crashes, fatalities, and injuries” in legal cannabis states, actions taken by those states to “address marihuana-impaired driving,” testing standards being used to detect impaired driving and federal initiatives “aiming to assist States that have legalized marihuana with traffic safety.”

Given Amash’s libertarian leanings, it stands to reason that he opposes spending government dollars to conduct the research and simply supports the broader states’ rights intent of the original legislation.

That would also put him at odds with social justice advocates who feel that the STATES Act itself doesn’t go far enough and are pushing for more comprehensive legislation that includes additional provisions addressing social equity and restorative justice for people harmed by drug law enforcement.

Members of the House Judiciary Crime, Terrorism and Homeland Security Subcommittee heard that debate play out during a historic hearing on ending federal marijuana prohibition last week.

A newly formed coalition of civil rights and drug reform organizations, including the ACLU, is also insisting on passing wide-ranging legislation to deschedule cannabis entirely that also invests in communities that have been disproportionately impacted by prohibition.

Amash is a long-standing critic of the war on drugs and earlier this year signed on as a cosponsor of a separate bill that would federally deschedule marijuana. Rep. Tulsi Gabbard (D-HI), a 2020 Democratic presidential candidate, filed that legislation, which is also silent on social equity provisions.

Gabbard also introduced a separate bill that would require the U.S. Department of Health and Human Services and other federal agencies to study the impacts of legalization. True to form, Amash declined to add his name to that measure as well.

Read the text of Amash’s new cannabis bill below:

AMASH_038_xml by Marijuana Moment on Scribd

Former GOP Congressman Explains Why Broad Marijuana Reform Is Achievable In 2020

Photo courtesy of Kyle Jaeger.

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Berkeley City Council Considers Decriminalizing Psychedelics This Week

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A resolution to decriminalize psilocybin and other psychedelics will go before a Berkeley, California City Council committee on Wednesday.

Decriminalize Nature, the group behind the measure, also led the charge to successfully get a measure decriminalizing entheogenic plants and fungi approved by the City Council in neighboring Oakland last month.

In Berkeley, the Public Safety Committee will discuss the proposal and can either decide to hold it for a future meeting or advance it to the full Council. The public is able to attend Wednesday’s special meeting and share their perspective on the resolution, but Decriminalize Nature stressed in a tweet that this “is a small meeting, so you do NOT need to attend.”

However, city residents are being encouraged to write to their Council members and urge them to vote in favor of the measure, which would codify that “no department, agency, board, commission, officer or employee of the city, including without limitation, Berkeley Police Department personnel, shall use any city funds or resources to assist in the enforcement of laws imposing criminal penalties for the use and possession of Entheogenic Plants by adults of at least 21 years of age.”

The resolution defines the covered substances as “plants and natural sources such as mushrooms, cacti, iboga containing plants and/or extracted combinations of plants similar to ayahuasca; and limited to those containing the following types of compounds: indoleamines, tryptamines, phenethylamines.”

Councilmembers Rigel Robinson and Cheryl Davila are sponsoring the resolution, which does not allow for commercial sales or manufacturing.

The lawmakers provided background information on the measure in a report to their colleagues and the mayor, describing the medical potential of various psychedelics as well as the success of decriminalization measures in Denver and Oakland.

“It is intended that this resolution empowers Berkeley residents to be able to grow their own entheogens, share them with their community, and choose the appropriate setting for their intentions instead of having to rely exclusively on the medical establishment, which is slow to adapt and difficult to navigate for many,” they wrote.

While efforts to eliminate criminal penalties associated with psilocybin and other psychedelics have so far centered in jurisdictions that have historically embraced marijuana legalization and broader drug reform, the conversation around decriminalizing psychedelics is spreading nationally.

Shortly after Oakland approved its measure, Decriminalize Nature received inquiries from activities in cities from across the country. The group has kept track of each city where organizers are pursuing decriminalization.

On Monday, a conversation around changing laws governing psychedelics reared during a City Council meeting in Columbia, Missouri. One resident implored the body to take up a resolution to decriminalize the natural substances, pointing to their therapeutic benefits.

Councilmember Mike Trapp said that the student’s proposal should be considered and that a government advisory board on public health should provide input on the medical potential of psychedelics, describing it as “very promising.”

Hawaii Governor Vetoes Two Cannabis Bills While Letting Decriminalization Become Law

Photo elements courtesy of carlosemmaskype and Apollo.

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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