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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

Texas Lawmakers Approve Marijuana Decriminalization In Committee Vote

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A Texas House committee approved a marijuana decriminalization bill on Monday that would make simple possession punishable by a fine, with no jail time, and without having to go on an individual’s criminal record.

The legislation passed in a 5-2 vote out of the Criminal Jurisprudence Committee and now heads to a separate panel responsible for placing bills on the calendar for floor debates.

Possession of one ounce or less of cannabis would be punished with a $250 fine for the first two offenses. After that, possession would be considered a class C misdemeanor, which is still a lesser penalty compared to current law. As it stands, possession of two ounces or less is a class B misdemeanor punishable by a fine of up to $2,000 and up to 180 days in jail as well as a permanent criminal record, which carries steep collateral consequences.

Earlier this month, the committee held a hearing on the legislation and heard testimony about the long-term impacts of having a low-level cannabis conviction on a person’s record and how removing criminal penalties for possession can free up law enforcement resources so that officers can tackle more serious crimes.

Advocates are hopeful that the full House will embrace the modest reform measure, even as the legislature contemplates other cannabis policies such as expanding the state’s limited medical marijuana program.

“We are very optimistic about the chances of HB 63 passing on the floor of the Texas House,” Heather Fazio, director of Texans for Responsible Marijuana Policy, told Marijuana Moment. “Overall, lawmakers on both sides of the aisle agree that we shouldn’t be wasting valuable criminal justice resources arresting and prosecuting people for small amounts of marijuana. Texas is ready.”

While medical cannabis expansion, to say nothing of adult-use legalization, remains a dubious prospect in the conservative stronghold, removing the threat of jail time for possession has gained popularity among Texas Republicans. Delegates for the Republican Party of Texas adopted a platform plank last year that endorses marijuana decriminalization, for example.

“We support a change in the law to make it a civil, and not a criminal, offense for legal adults only to possess one ounce or less of marijuana for personal use, punishable by a fine of up to $100, but without jail time,” the plank states.

What’s more, the policy has even received a tentative green light from Gov. Greg Abbott (R), who has said he is open to legislation that would reduce penalties for simple possession.

During a gubernatorial debate last year, Abbot said he doesn’t want to see “jails stockpiled with people who have possession of small amounts of marijuana” and floated the idea of reducing the penalty for marijuana possession from a class B to a class C misdemeanor.

According to Texans for Responsible Marijuana Policy, the legislation currently has 32 authors or co-authors.

Connecticut Lawmakers Approve Marijuana Legalization Bill In Key Committee

Photo courtesy of Philip Steffan.

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Connecticut Lawmakers Approve Marijuana Legalization Bill In Key Committee

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A key committee in the Connecticut legislature approved a bill to legalize marijuana on Monday.

The General Law Committee, which is one of two panels that heard testimony about legalization legislation last week, voted 10 to 8 to advance the bill.

Beyond legalizing cannabis for adult use, the legislation also includes a number of social equity provisions aimed at encouraging participation in the legal industry by individuals from communities that have been disproportionately impacted by the drug war. A governor-appointed commission would be charged with giving such individuals advance time to apply for a marijuana business license and promote diversity in hiring.

“At the end of the day, if we’re moving, it’s not about revenue. It’s about equity,” Rep. Juan Candelaria (D) said at the meeting. “It’s about ensuring that these communities that have been impacted, that we say we’re not going to stay idle anymore.”

The commission would also be required to study the potential impacts of allowing cannabis microbusinesses and a home cultivation option, which are not currently included in the bill. Delivery would be permitted, however.

While advocates generally support the bill, there are some outstanding concerns about the lack of a home grow option. The lack of specific licenses for delivery services and on-site consumption facilities is another sticking point.

“Marijuana prohibition was borne of misinformation and racism and it continues to be enforced unequally to this day,” Karen O’Keefe, director of state policies at the Marijuana Policy Project, said at last week’s hearing.

It’s not yet clear whether the legislature will ultimately pass this proposal or a separate bill in the Senate, but if either does end up on the desk of Gov. Ned Lamont (D), he’s expected to sign. The governor called legalization one of his “priorities” last year and also discussed the issue during a budget speech last month.

The legislature’s Judiciary Committee is expected to vote on legalization legislation on Thursday.

A separate bill to revise the state’s medical cannabis program by adding opioid use disorder to the list of qualifying conditions and eliminating a registration certification fee for patients and caregivers was also approved by the General Law Committee on Monday.

Connecticut Lawmakers Hold Two Simultaneous Hearings On Marijuana Legalization Bills

This story was updated to note the committee’s vote tally.

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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Marijuana Legalization Vote Cancelled Due To Lack of Support In New Jersey Senate

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Marijuana reform advocates experienced a setback on Monday after bill to legalize cannabis in New Jersey was pulled from the agenda due to a lack of votes to pass the legislation in the Senate.

The proposal would have allowed adults 21 and older to possess, consume and purchase marijuana from licensed retailers. It included a number of social equity provisions meant to encourage participation in the industry by individuals from communities most harmed by the war on drugs, and it also would’ve created a pathway for expedited expungements for prior cannabis convictions.

Two committees—the Assembly Appropriations Committee and Senate Judiciary Committee—approved companion cannabis legalization bills last week.

But while Gov. Phil Murphy (D) and leading lawmakers reached a compromise on certain details on how to carry out legalization earlier this month, the legislation faced resistance and was taken off the table hours before scheduled votes in the Senate and Assembly.

“History is rarely made on the first try,” Murphy said in a press conference. “Certainly I’m disappointed but we are not defeated… We all remain committed to passing this bill and making our state a national model for justice and opportunity because ultimately this is the right thing to do for New Jersey, and we know the people of New Jersey are on our side.”

“While we are all disappointed that we did not secure enough votes to ensure legislative approval of the adult use cannabis bill today, we made substantial progress on a plan that would make significant changes in social policy,” Senate President Stephen Sweeney (D) said in a statement. “This fight is not over. We need to learn from this experience and continue to move forward. While this legislation is not advancing today, I remain committed to its passage.”

“The legalization of adult-use marijuana will get passed in the state of New Jersey, one way or another,” he added at a press conference. “Anybody who thinks this is dead, they’re wrong.”

Assembly Speaker Craig Coughlin (D) echoed those sentiments.

“Today we may not be able to get a bill over the finish line but I’m proud of the effort we made and the discussions we had. It’s a big and complicated issue,” he said in a press conference. “We all remain committed to enacting fair and responsible legislation that will be groundbreaking and a national model.”

According to a whip count tracking tool for the legislation that was created by NJ.com, a majority of senators (23) planned to vote “no” as of Monday morning, compared to just eight who said they’d vote in favor of the bill, with nine others undetermined. Other sources indicated that 18 senators planned to vote “yes.”

In the days leading up to the Monday session, the legislation received a number of high-profile endorsements, including from 2020 Democratic presidential candidate Sen. Cory Booker (D-NJ), Rev. Al Sharpton and CNN host Van Jones. The governor’s office also released a list of quotes supporting the bill from lawmakers, activists and spiritual leaders.

“With this bill, New Jersey legislators can send a strong message to the country that marijuana legalization and social justice must be inextricably linked,” Booker said last week. “I’m hopeful our state will succeed in setting this example.”

Those endorsements were ultimately not enough to convince a sufficient number of on-the-fence state senators, some of whom raised concerns about the potential public health and safety impacts of legalization.

“This is a tragedy for social and racial justice in New Jersey. This legislation was supported by a broad coalition of civil rights, advocacy and faith organizations across the state and the majority of New Jersey voters,” Roseanne Scotti, New Jersey state director for the Drug Policy Alliance, said. “But, we will not give up. We will continue to fight for marijuana legalization legislation centered on racial and social justice. It is only a matter of time before this legislation is enacted and all New Jerseyans can share in the benefits it will create.”

Prohibitionist organization Smart Approaches to Marijuana described the news as a “huge victory for us.”

“They told us legalization was inevitable, and this action proves them wrong, Kevin Sabet, the group’s president, said in a press release.

With the cancellation of the vote, it may be months before lawmakers take up the idea again.

“Voters and lawmakers both agree that the practice of treating marijuana consumers as second-class citizens must end. Unfortunately, legislative intransigence regarding how best to create a regulatory framework has resulted in, at least for now, a continuation of the failed policy of marijuana criminalization in the Garden State,” NORML Political Associate Tyler McFadden said in a press release.

“[I]t should be acknowledged that, to date, no state has taken legislative action to regulate the adult use marijuana market,” she said. “In every jurisdiction where regulations exist, they were enacted by a direct vote of the citizenry. Based on current polling in New Jersey, we have little doubt that, if provided the opportunity, Garden State voters would take similar action.”

A poll last month found that New Jersey adults support legalizing marijuana, 62 percent to 32 percent.

Diversity Provisions Added To Marijuana Banking Bill Up For Congressional Vote This Week

This story was updated to add comment from Sweeney, DPA, NORML and SAM.

Photo courtesy of WeedPornDaily.

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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