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

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Massachusetts Lawmakers Discuss Drug Decriminalization And Safe Injection Sites At Hearing

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Massachusetts lawmakers on Monday heard testimony on separate proposals to decriminalize drug possession and establish a pilot program for safe injection facilities where people could use illicit substances in a medically supervised environment to prevent overdose deaths and facilitate treatment.

The state legislature’s Joint Committee on Mental Health, Substance Use and Recovery held a hearing on the harm reduction proposals, with experts and people personally impacted by substance misuse advocating for new approaches to drugs that destigmatize addiction and offer people resources outside of a criminal justice context.

The decriminalization bill would replace criminal penalties for the possession of any controlled substance with a civil fine of up to $50. To avoid the fine, individuals could enroll in a “needs screening to identify health and other service needs, including but not limited to services that may address any problematic substance use and mental health conditions, lack of employment, housing, or food, and any need for civil legal services.”

For the safe injection site legislation, the state would establish a 10-year pilot program where at least two facilities would “utilize harm reduction tools, including clinical monitoring of the consumption of pre-obtained controlled substances in the presence of trained staff, for the purpose of reducing the risks of disease transmission and preventing overdose deaths.”

A separate, less far-reaching bill that was added to the agenda in a late addition would direct the Department of Public Health to simply “evaluate the feasibility” of safe consumption sites and then report back to lawmakers by July 31, 2022..

The joint committee listened to academics, health professionals, lawmakers discuss the reform proposals but did not take immediate action on any of the legislation. It’s unclear when the bills will be taken up again for further consideration.

“By every metric, the war on drugs has been a catastrophic failure,” Rep. Mike Connolly (D) said. “In the United States and here in Massachusetts, the criminalization of drug possession is a major driver of mass incarceration. We know that black people have been incarcerated at a rate eight times higher than white people, and there’s no question that the criminalization of substance use issues has contributed to these terrible disparities.”

Connolly is also the sponsor of legislation that received a Joint Judiciary Committee hearing in July on  studying the implications of legalizing psychedelics like psilocybin and ayahuasca.

Officials with at least one Massachusetts city, Somerville, said that there are plans in the work to launch a safe injection facility in the jurisdiction. And they want to see the statewide bill pass to provide additional protections against being federally penalized.

“State legislation, wielding its constitutionally granted powers to enact laws for public health and safety, has the ability to greatly minimize these risks through legislation authorizing a pilot of safe consumption sites,” Hannah Pappenheim, assistant city solicitor at the City of Somerville, said. “In addition, state legislation would also minimize the risk of costly—but more importantly, lengthy—litigation.”

The official noted that a separate, Pennsylvania-based case on the legality of safe injection sites has been ongoing in federal courts for years at this point.

A coalition of 80 current and former prosecutors and law enforcement officials—including one who is President Joe Biden’s pick for U.S. attorney of Massachusetts—recently filed a brief urging the Supreme Court to take up the case.

Xavier Bacerra, the Biden administration’s secretary of health and human services, was among eight top state law enforcement officials who filed an earlier amicus brief in support of the Philadelphia-based Safehouse’s safe injection site plan when he served as California’s attorney general.

“State legislation paves the way for a more expedient process in Somerville, and of course elsewhere in the Commonwealth,” Pappenheim said.

Somerville Mayor Joseph Curtatone (D) said at Monday’s hearing that “it’s important for Massachusetts to finally lead—not just compiling, but implementing a strategy that reduces harm and save lives.” He conceded that he previously opposed the concept of allowing safe consumption sites; but his personal experience knowing people in his immediate family who suffered from addiction—as well as his own review of the scientific literature on harm reduction alternatives to criminalization—led him to embrace the reforms.

Massachusetts lawmakers advanced similar legislation last year, but it was not ultimately enacted.

The governor of neighboring Rhode Island signed a bill in July to establish a safe consumption site pilot program where people could test and use currently illicit drugs in a medically supervised environment. It became the first state in the country to legalize the harm reduction centers. It’s not clear whether the Department of Justice will seek to intervene to prevent the opening of such facilities in that state.

Oamshri Amarasingham, deputy legislative director of the ACLU of Massachusetts, voiced support for both reform proposals at Monday’s hearing and told WGBH that establishing a safe injection site pilot program “is one piece of that puzzle” that is “critically important and that’s had great success in other countries.”

Shaleen Title, a former Massachusetts cannabis commissioner who now heads the Parabola Center, juxtaposed how laws handle substances like caffeine, alcohol and nicotine differently from currently illegal drugs.

“What separates that from when we have these illicit drugs, where handcuffs and cages are involved, and what led that to be? The reason has nothing to do with science, or evidence or the relative dangers of those drugs,” she said. “The reason is because—and this is well-documented—those drugs could be scapegoated and blamed on their association with indigenous and Indian and Mexican and Chinese and other cultures, and then used to target communities of color, particularly black and Latino people nationally and here in Massachusetts.”

At the same time that Massachusetts legislators are looking into harm reduction and broad drug decriminalization, local activists in the state have also been pursuing psychedelics reform.

Three Massachusetts cities—Northampton, Somerville and Cambridge—have each passed resolutions to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics and other drugs. The Easthampton City Council is also exploring a resolution to decriminalize a wide range of entheogenic substances, with a meeting set for Friday.

Marijuana Arrests Dropped Sharply In 2020 As Both COVID And Legalization Spread, FBI Data Shows

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Marijuana Arrests Dropped Sharply In 2020 As Both COVID And Legalization Spread, FBI Data Shows

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Marijuana arrests declined significantly in 2020 amid the coronavirus pandemic, newly released FBI data shows.

There were 1,155,610 drug-related arrests overall last year, with cannabis sales and possession busts accounting for just over 30 percent (or 350,150) of those cases. The vast majority were for marijuana possession alone.

The agency’s data shows that there was a cannabis arrest every 90 seconds in the country in 2020, and there was a drug-related arrest every 27 seconds.

While these figures still highlight the rampant, ongoing criminalization of cannabis in states across the U.S., it’s a substantial deescalation compared to 2019, when FBI reported a total of 545,601 marijuana arrests. That amounted to a cannabis bust every 58 seconds.

Put another way, there was a 36 percent decrease in cannabis cases from 2019 to 2020. And while the federal agency doesn’t attempt to explain the statistical shift, there are a number of factors that could help explain it.

One of the more obvious societal changes during that timeframe is the COVID-19 health crisis, which involved social distancing requirements and generally discouraged people from being out in public where they might be at higher risk of being arrested for simple possession.

But advocates have also pointed out that the marijuana reform movement could be playing a role. Illinois’s adult-use cannabis law took effect at the beginning of 2020, for example. Hawaii, New Mexico and North Dakota also enacted decriminalization of marijuana possession in 2019, and Virginia followed suit the next year.

In Arizona, limited cannabis possession was legalized for adults starting on November 30, 2020 following voter approval of a reform initiative earlier that month.

“As more states move toward the sensible policy of legalizing and regulating cannabis, we are seeing a decline in the arrest of non-violent marijuana consumers nationwide,” NORML Executive Director Erik Altieri told Marijuana Moment. “The fight for legalization is a fight for justice. While these numbers represent a historic decline in arrests, even one person being put into handcuffs for the simple possession of marijuana is too many.”

Despite the decline in cannabis busts, the new data shows that American law enforcement still carried out more arrests for marijuana alone last year than for murder, rape, robbery, burglary, fraud and embezzlement combined.

It should be noted that not all local police participate in FBI’s reporting program, so these figures are not holistic and are estimates the agency makes based on those that do submit data.

The country had seen a consistent decline in cannabis arrests for roughly a decade prior to 2016, when those cases started to rise up until 2019.

Observers expect to see the downward trend in cannabis busts continue as more states move to end prohibition and law enforcement deprioritizes marijuana-relate cases. In New York, for example, police received new guidance this year stipulating that adults 21 and older can possess certain amounts of marijuana and consume it in places where tobacco use is permitted.

That directive alone seems to have led to a dramatic decrease in cannabis arrests in New York City.

Federal marijuana trafficking cases also continued to decline in 2020 as more states have moved to legalize, an analysis from the U.S. Sentencing Commission (USSC) that was released in June found.

Federal prosecutions of drug-related crimes overall increased in 2019, but cases involving marijuana dropped by more than a quarter, according to an end-of-year report released by Supreme Court Chief Justice John Roberts in December.

A study released by the Cato Institute in 2018 found that “state-level marijuana legalization has significantly undercut marijuana smuggling.”

New York Governor Says Marijuana Legalization Will Create ‘Thousands’ Of Jobs And Touts Regulatory Appointments

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New York Governor Says Marijuana Legalization Will Create ‘Thousands’ Of Jobs And Touts Regulatory Appointments

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The governor of New York says marijuana legalization will generate “thousands and thousands of jobs” in the state, and she’s touting her recent actions to make regulatory appointments for the industry to get implementation underway.

At the Business Council of New York State’s annual meeting on Friday, Gov. Kathy Hochul (D) talked about the state’s business ethic and the importance of supporting markets of all sizes, including cannabis companies.

“We do want to go big or go home, and I want to help you get there,” she said. “I need you to survive because you’re the identity of New York that people create jobs and opportunities. You are who we are as New Yorkers. Your success means the success of this entire state.”

“So count me in as an ally—someone who’s going to be there for you, who will fight for you to make sure that we do not lose out to any competition, whether it’s in the space of cannabis, where I believe there’s thousands and thousands of jobs and new industries, to be created that were not even focused on,” Hochul said.

The governor has made a point of emphasizing her support for adult-use legalization and standing up the industry since replacing former Gov. Andrew Cuomo (D), who resigned amid a sexual misconduct scandal last month.

At Friday’s meeting, she said, “I had to unleash this opportunity that had been stifled for the first five months [after legalization was signed into law] because a few appointments hadn’t been made. Got that done.”

Hochul named two additional Cannabis Control Board members last week, which followed the Senate confirmation of previous appointees earlier this month. The newly named regulators do not require confirmation by lawmakers.

According to The New York Post, the governor reportedly recently dismissed Norman Birenbaum, director of cannabis programs under Cuomo, whom advocates had opposed becoming the head of the new Office of Cannabis Management.

Under New York’s legalization law, the independent Office of Cannabis Management within the New York State Liquor Authority was established and will be responsible for regulating the recreational cannabis market as well as the existing medical marijuana and hemp programs. It will be overseen by a five-member Cannabis Control Board.

Three members have now been appointed by the governor, and the Senate and Assembly have also appointed one member each.

As it stands, adults 21 and older can possess up to three ounces of cannabis or 24 grams of concentrates in New York—and they can also smoke marijuana in public anywhere tobacco can be smoked—but there aren’t any shops open for business yet.

The first recreational marijuana retailers in New York may actually be located on Indian territory, with one tribe officially opening applications for prospective licensees earlier this month.

In July, a New York senator filed a bill to create a provisional marijuana licensing category so that farmers could begin cultivating and selling cannabis ahead of the formal rollout of the adult-use program. The bill has been referred to the Senate Rules Committee.

Because the implementation process has been drawn out, however, one GOP senator wants to give local jurisdictions another year to decide whether they will opt out of allowing marijuana businesses to operate in their area—a proposal that advocates say is unnecessary and would create undue complications for the industry.

Under the law as enacted, municipalities must determine whether they will opt out of permitting marijuana retailers or social consumption sites by December 31, 2021. Sen. George Borrello (R) introduced legislation earlier this month that would push that deadline back one year.

Legalization activists aren’t buying the argument, however.

Adding pressure to get the market up and running is the fact that regulators in neighboring New Jersey recently released rules for its adult-use marijuana program, which is being implemented after voters approved a legalization referendum last year.

The state comptroller recently projected that New York stands to eventually generate $245 million in annual marijuana revenue, which they say will help offset losses from declining tobacco sales.

For the first year of cannabis sales, the state is expected to see just $20 million in tax and fee collections. That will be part of an estimated $26.7 billion in new revenues that New York is expected to generate in fiscal year 2021-2022 under a budget that the legislature passed in April.

Meanwhile, a New York lawmaker introduced a bill in June that would require the state to establish an institute to research the therapeutic potential of psychedelics.

Florida Would Study Psychedelics’ Medical Benefits Under Top Senate Democrat’s New Bill

Photo courtesy of Mike Latimer.

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