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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

Where Presidential Candidate Deval Patrick Stands On Marijuana

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Former Massachusetts Gov. Deval Patrick (D) announced on November 14, 2019, that he is seeking the 2020 Democratic presidential nomination.

The latecomer to the race does not have an especially reform-friendly record on drug policy issues compared to many of his rival contenders, and questions remain about where he stands on legalization for adult-use—or even medical use for that matter.

During his time as governor, he voiced opposition to a marijuana decriminalization proposal and raised concerns about a medical cannabis legalization measure. After voters approved that latter initiative, he said he wished the state didn’t have the program, and his administration faced criticism over its implementation.

That said, Patrick, who also served as the U.S. assistant attorney general for the civil rights division, does not appear to have expressed hostility to marijuana reform in recent years and during his time in office did take action in support of modest proposals such as resentencing for people with non-violent drug convictions. Here’s where the former governor stands on cannabis:

Legislation And Policy Actions

Patrick’s administration said that despite a marijuana decriminalization policy going into effect following the passage of a 2008 ballot initiative, law enforcement should be able to continue to search people suspected of possession. However, his office declined to approve a request from prosecutors to delay the implementation of the voter-approved policy change.

After the decriminalization proposal passed, Patrick directed the Executive Office of Public Safety and Security (EOPSS) to develop an implementation plan.

“Our office will continue to work collaboratively with EOPSS and the district attorneys and law enforcement agencies on implementation,” a spokesperson said. “It’s an ongoing process.”

The then-governor said he would work to toughen up enforcement of fines levied against people possessing marijuana.

“The bottom line is the governor believes that if people are fined they should pay the fines,” a spokesperson for his administration said.

Following the passage of a 2012 medical cannabis initiative in Massachusetts, Patrick said simply that the “voters have voted,” and pledged that he wouldn’t seek to repeal the law.

But there were some complications that arose during his administration’s medical marijuana licensing approval process.

In February 2014, Patrick contradicted the state health department, which had recently announced that 20 business licenses had been accepted.

“No licenses have been given. No provisional licenses have been given. What we have is a multi-step process of screening out applicants,” he said. “Don’t get ahead of where we are. There was a balance struck here about trying to let the public in through transparency to the process even though the process was unfinished.”

When reports emerged that certain medical cannabis applicants had apparently provided false or misleading information in their application forms, Patrick said “[n]o good dead goes unpunished.”

“Rather than wait till the end when all that vetting and screening had been done, we’re going to do that first cut from 100 [applicants] down to 20, and we’re going to tell everybody,”

The next month, he dismissed requests for a review of the licensing process by applicants who the health department had rejected.

“I don’t think we gain anything by starting over,” he said. “We are in the middle of a process. Nobody has a license, no one is going to get a license until we meet the standards of the application process.”

Patrick was also criticized for failing to follow up with patient advocates who urged him to effectively implement the program.

“It appears the governor wants to skip out of office without addressing medical marijuana because he doesn’t want to talk about it and he doesn’t want to deal with it,” Massachusetts Patient Advocacy Alliance Executive Director Matthew Allen said in 2014.

Patrick’s successor, Gov. Charlie Baker (R), overhauled the his predecessor’s medical cannabis licensing process to create “a more streamlined, efficient, and transparent process that allows the Commonwealth to maintain the highest standards of both public safety and accessibility.”

Despite opposing marijuana decriminalization and expressing concerns about medical cannabis legalization, the governor did sign several drug policy reform bills during his time in office.

Patrick signed legislation in 2012 that reduced mandatory minimum sentences for people with non-violent drug convictions. He’d introduced a package of bills that included a call for the repeal of such mandatory minimums the previous year, earning praise from reform advocates.

“We need an effective and accountable re-entry program for those leaving the criminal justice system,” Patrick said in a statement. “Combining probation and parole, and requiring supervision after release, takes the best practices from other states to assure both public safety and cost savings.”

Another piece of legislation the then-governor proposed was to reduce the scope of “drug-free school zones,” where people charged with drug crimes would face mandatory minimum sentences. He recommended reducing the size of these zones from within 1,000 feet of a school to 100 feet.

Patrick signed off on a bill in 2014 to expand access to drug treatment.

“This bill creates some new rules and new tools for us to use together to turn to our brothers and sisters who are dealing with these illnesses and addiction and help them help themselves,” he said.

But in 2012, Patrick signed a bill prohibiting certain synthetic drugs called “bath salts.”

On The Campaign Trail

So far, Patrick has not made drug policy a center-stage issue in his campaign. However, his website says his agenda involves “making meaningful fixes to the big systems that consistently fail to meet modern needs.”

“This means a justice system that focuses less on warehousing people than on preparing them to re-enter responsible life,” the site says.

Previous Quotes And Social Media Posts

In 2007, a spokesperson for Patrick’s office said the governor would veto a proposed marijuana possession decriminalization bill. Patrick told the Associated Press that he had other priorities when asked whether he would sign the legislation.

He was listed as a supporter for a campaign that opposed the 2008 decriminalization ballot measure that voters later approved.

Several news reports from the time also noted that Patrick stood opposed to the modest proposal to remove criminal penalties for low-level cannabis possession.

Oddly, two years earlier, Patrick was asked about a decriminalization proposal during a debate and said that while he’s “very comfortable with the idea of legalizing marijuana,” he doesn’t “think it ought to be our priority.” He went on to say that he would veto a proposed decriminalization measure in the legislature.

Massachusetts voters also approved a 2012 medical cannabis initiative while Patrick was in office—in spite of the fact that he declined to endorse the measure.

Asked about the proposal during a radio interview with WBZ, the then-governor first cited an argument in support of legalization made by conservative author William F. Buckley Jr., who said regulating drug sales would remove a profit motive for illicit dealers. Yet he went on to say that “I’m not endorsing” the initiative.

“I’m not expressing a point of view and I’m not dodging, it’s just I’ve got so much else I’m working on,” he said.

The host asked if Patrick would implement the law if voters approved it and he said “that’s, I think, what we’re supposed to do.”

In September 2012, he said that he doesn’t “have a lot of enthusiasm for the medical marijuana” measure, which was set to go before voters two months later.

“I mean I have heard the views on both sides and I’m respectful of the views of both sides, and I don’t have a lot of energy around that,” he said. “I think California’s experience has been mixed, and I’m sympathetic to the folks who are in chronic pain and looking for some form of relief.”

“I really have to defer to the medical views about this and individuals will get a chance to vote on this,” Patrick said in April 2012. “I haven’t been paying much attention to it.”

While his administration struggled to implement the program after voters had approved it, Patrick said in August 2014 that “I wish frankly we didn’t have medical marijuana.”

Patrick doesn’t appear to have publicly weighed in during the Massachusetts campaign about legalizing marijuana for adult-use, which voters approved in 2016 after he had left office.

In 2012, Patrick said during a State of the State Address that Massachusetts should reevaluate how it treats people convicted of non-violent drug offenses.

“In these cases, we have to deal with the fact that simply warehousing non-violent offenders is a costly policy failure,” he said. “Our spending on prisons has grown 30 percent in the past decade, much of that because of longer sentences for first-time and nonviolent drug offenders. We have moved, at massive public expense, from treatment for drug offenders to indiscriminate prison sentences, and gained nothing in public safety.”

“We need more education and job training, and certainly more drug treatment, in prisons and we need mandatory supervision after release,” he said. “And we must make non-violent drug offenders eligible for parole sooner.”

He also said that the “biggest problem is that our approach to public safety has been to warehouse people,” and that the “answer is new policies, not bigger warehouses.”

“We’ve been warehousing people for whom what they really need is treatment and not just time,” he said during a town hall event in 2009.

Patrick voiced support in 2006 for a bill that would legalize the over-the-counter sale of needles in order to prevent the spread of disease.

“Deval Patrick supports this legislation because he believes it will reduce dangerous diseases in our state,” a campaign spokesperson said. “Studies in other states have shown that programs such as these decrease the rates of disease infection without increasing drug use.”

Patrick later criticized then-Gov. Mitt Romney (R) for vetoing the legislation, stating that the official “put misguided ideology before leadership in public health.”

Personal Experience With Marijuana

Patrick said in 2012 that he has never “experienced marijuana myself” but that during his school years there “was probably enough around me that there was a second-hand, a contact-high.”

Marijuana Under A Patrick Presidency

It is difficult to assess how Patrick would approach federal marijuana policy if elected president, but his vocal opposition to decriminalization in Massachusetts and his administration’s troubled implementation of medical cannabis legalization is likely to give advocates pause. While his current position on legalizing marijuana for adult-use is unclear, given that drug policy reform has become a mainstream issue that candidates are routinely pressed on, it is likely the former governor will be asked to weigh in on the campaign trail.

But for the time being, it appears that Patrick would not make marijuana reform a priority and, in fact, might prove more resistant to policy changes such as descheduling that the majority of candidates now embrace.

Where Presidential Candidate Mark Sanford Stands On Marijuana

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Postal Service Unveils ‘Drug Free USA Forever’ Stamp Commemorating 1980s Anti-Drug Program

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The U.S. Postal Service (USPS) is rolling out a new stamp design that pays tribute to 1980s-era drug prevention programs and promotes a “drug-free USA.”

The stamps, which will go on sale starting in October 2020, were announced at the conclusion of this year’s Red Ribbon Week last month, an annual occurrence first launched under the Reagan administration.

“This Drug Free USA Forever stamp will help further raise awareness about the dangers of drug abuse, and the toll it is taking on families and communities around our country,” Robert Duncan, chairman of the USPS Board of Governors, said in a press release. “The Postal Service is glad to do its part in marking Red Ribbon Week, and renewing our commitment to helping these efforts to educate youth about the dangers of illegal drugs.”

Via USPS.

USPS explained that Red Ribbon Week originated after a Drug Enforcement Administration (DEA) agent was tortured and killed in Mexico while investigating drug traffickers in 1985.

“I am very pleased that the U.S. Postal Service will issue a stamp affirming our commitment to a drug-free America,” DEA Acting Administrator Uttam Dhillon said. “This stamp will help raise awareness of the fight against drug addiction and honor those who have dedicated their lives to that cause.”

A description of the design states that the stamp “features a white star with lines of red, light blue and blue radiating from one side of each of the star’s five points, suggesting the unity necessary at all levels to effectively address drug abuse.”

USPS isn’t applying anti-drug messaging to the cannabis component CBD anymore, however. In September, the agency clarified that hemp-derived CBD products can be mailed under certain circumstances since the crop and its derivatives were federally legalized under the 2018 Farm Bill.

For those with mailing needs who aren’t interested in supporting the notion of a “Drug Free USA,” USPS does have another stamp that recognizes the 50-year anniversary of the drug-fueled 1969 counterculture music festival Woodstock.

Via USPS.

The stamp “features an image of a dove along with the words ‘3 DAYS OF PEACE AND MUSIC,’ evoking the original promotional poster for the festival,” USPS says.

Another option is a John Lennon Forever stamp, celebrating the iconic Beatles member and marijuana enthusiast who famously got “high with a little help” from his friends.

Via USPS.

“Still beloved around the world, Lennon’s music remains an anchor of pop radio and continues to speak for truth and peace,” USPS wrote.

Top CDC Official Suggests Legal Marijuana Regulations Can Mitigate Vaping Injuries

Photo courtesy of Wikicommons.

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New Congressional Resolution Calls For Marijuana Legalization And Drug Expungements

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Rep. Ayanna Pressley (D-MA) released a congressional resolution on Thursday that calls for a fundamental reshaping of the criminal justice system, in part by legalizing marijuana and expunging all drug-related convictions.

The congresswoman’s “People’s Justice Guarantee” resolution outlines “a bold, new vision for justice in the American criminal legal system” that’s designed to “transform the U.S. criminal legal system to one that meets America’s foundational yet unfilled promise of justice for all.”

The ultimate goal of the measure is to reduce mass incarceration in the country through a series of reform steps that includes ending for-profit prisons, decriminalizing certain non-violent offenses, imposing caps on criminal sentences, abolishing the death penalty, expanding access to mental health services in prisons and reinvesting in communities that have been most impacted by “tough of crime” criminal policies.

Some have characterized the resolution as the “Green New Deal” of criminal justice reform, comparable in scope and ambition to the climate change plan championed by fellow “Squad” member Rep. Alexandria Ocasio-Cortez (D-NY).

Drug policy reform isn’t the main feature of the resolution, but it does call for “decriminalizing addiction, homelessness, poverty, HIV status, and disabilities, including mental health diagnosis, by legalizing marijuana and overdose prevention sites, declining to criminally prosecute low-level offenses such as loitering and theft of necessity goods, and expunging the records of individuals for all drug-related offenses.”

Interestingly, an earlier draft of the measure reportedly contained language specifying that law enforcement should “use civil citations instead of arrests for drug possession,” according to a paraphrase by a reporter with The Appeal who reviewed the document but later updated her story to reflect the version that was actually filed. A call for an 80 percent reduction in the prison population was also removed from the text.

It’s not clear if the provision on “decriminalizing addiction” in the final resolution would involve all drug possession offenses, or why Pressley apparently decided to scale back the scope of the measure from the draft her staff circulated to reporters. Marijuana Moment reached out to the congresswoman’s office for clarification but a representative was not immediately available.

The ACLU, Color of Change and National Immigrant Law Center are among several civil rights groups that have endorsed the resolution, which was created in concert with advocates from the National Immigration Law Center, Immigrant Legal Resource Center, Immigrant Defense Project, UndocuBlack Network and others.

“You cannot have a government for and by the people if it is not represented by all of the people,” Pressley said in a press release. “For far too long, those closest to the pain have not been closest to the power, resulting in a racist, xenophobic, rogue, and fundamentally flawed criminal legal system.”

“The People’s Justice Guarantee is the product of a symbiotic partnership with over 20 grassroots organizations and people impacted by the discriminatory policies of our legal system,” she said. “Our resolution calls for a bold transformation of the status quo—devoted to dismantling injustices so that the system is smaller, safer, less punitive, and more humane.”

While the freshman congresswoman declined to endorse a 2016 marijuana legalization measure that was ultimately approved by Massachusetts voters, she’s since positioned herself as a champion for reform, including by voting against an amendment barring people with drug convictions from working in child care services with the U.S. Department of Veterans Affairs.

She also voted in favor of amendments to protect all state marijuana programs from federal intervention and another introduced by Ocasio-Cortez to remove a budget rider that she argued inhibited research into the therapeutic potential of psychedelics.

In addition, Pressley has cosponsored bills concerning marijuana descheduling, research on the benefits of medical cannabis for military veterans and banking access by state-legal businesses.

Read the full text of Pressley’s justice reform resolution below: 

Pressley_The People’s J… by Marijuana Moment on Scribd

Kamala Harris Jokes About CBD Body Rubs To Make A Serious Point On The Marijuana Industry

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