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.”
Today I asked Commissioner Gottieb about FDA's timeline and resources to develop legal pathways for food products with #CBD. He said the agency is developing a working group focused on this issue, but if it takes too long Congress may need to act. #mepolitics pic.twitter.com/l8TX0DrrVD
— Chellie Pingree (@chelliepingree) February 27, 2019
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.
Photo courtesy of YouTube/House Appropriations Committee.
Austin Police Chief Says Marijuana Arrests Will Continue Despite City Council Vote
Chief Brian Manley said he would continue to enforce marijuana laws the day after the city council unanimously approved stopping arrests and tickets for low-level cases.
The day after the Austin City Council approved a resolution to stop arresting or ticketing people for most low-level marijuana possession offenses, the police chief made clear he had no plans to do so.
“[Marijuana] is still illegal, and we will still enforce marijuana law if we come across people smoking in the community,” Chief Brian Manley said during a news conference Friday afternoon.
Though cracking down on those in possession of small amounts of marijuana has never been a priority for the department, he said, police will continue to either issue tickets under the city’s “cite-and-release” policy or arrest people if officers “come across it.”
The difference, according to City Council member and resolution sponsor Greg Casar, is that the council’s move now guarantees those actions will come with no penalty. Tickets will be meaningless pieces of paper and any arrests will result in a quick release with no charges accepted from prosecutors, he told The Texas Tribune after the news conference.
“What has changed since yesterday is that enforcement, almost in virtually all cases, is now handing someone a piece of paper with no penalty or no court date,” Casar said.
The move by the City Council came as a direct result from Texas’ new hemp law which complicated marijuana prosecution across the state. Last summer, when lawmakers legalized hemp, they also changed the definition of marijuana from cannabis to cannabis that contains more than 0.3% THC, the psychoactive ingredient in the plant.
Many prosecutors, including those in Austin’s Travis County, now won’t accept pot cases based on look and smell alone, requiring lab testing to determine THC levels before accepting a case. Such testing is not yet available in public crime labs, though some counties and cities have spent money to obtain test results from private labs.
The council’s resolution prohibited using city funds or personnel to conduct such testing in non-felony marijuana cases. It also directed the elimination, to the furthest extent possible, of arrests or citations for cannabis possession. As Manley also noted, the resolution clarifies it can’t technically decriminalize marijuana, since that is state law.
The resolution gave the city manager until May 1 to report back to the council on how police were trained in this new resolution, and Casar said he hopes Manley reviews his policies before then.
Manley said in the news conference that he would continue to review the resolution, as well as police policies.
But, he assured, “a City Council does not have the authority to tell a police department not to enforce a state law.”
The Texas Tribune is a nonprofit, nonpartisan media organization that informs Texans — and engages with them — about public policy, politics, government and statewide issues.
Andrew Yang Wants To Legalize Psychedelic Mushrooms For Military Veterans
Andrew Yang says he wants to legalize psilocybin mushrooms for military veterans to help them combat mental health conditions such as post-traumatic stress disorder (PTSD).
During a town hall event at an Iowa college on Thursday, the 2020 Democratic presidential candidate was asked whether he would take initiative and allow veterans to access medical marijuana if elected. Yang replied he “will be so excited to be that commander-in-chief” that he would not only end federal cannabis prohibition but would go one step further by legalizing the psychedelic fungus for veterans as well.
“We need to get marijuana off of the Controlled Substances Act and legalize it at the federal level, make it freely available,” he said. “I say this because I’ve talked to hundreds of veterans and other Americans who benefit from marijuana as a pain relief treatment, and it’s much less deadly than the opiates that many, many people are using for the same conditions.”
“I’ve talked to veterans who’ve also benefited from psilocybin mushrooms,” he added. “They said it was the only thing that actually has helped combat their PTSD. I’m for legalizing psilocybin mushrooms for veterans as well. Pretty much if it’s going to help a veteran, we should make it easier, not harder, for them to get access to it.”
Yang’s drug policy reform platform is unique in that respect. While the majority of Democratic candidates support marijuana legalization, he’s pushed unique proposals such as decriminalizing possession of opioids and making psilocybin mushrooms “more freely available” for therapeutic purposes. The candidate also wants to invest federal funds in safe injection facilities where individuals can use prohibited drugs in a medically supervised environment and receive help getting into treatment.
He hasn’t gone so far as embracing the decriminalization of all drugs, as former South Bend, Indiana Mayor Pete Buttigieg has, however.
That said, Yang did signal that he’s open to legalizing and regulating “certain drugs” beyond cannabis, which he argued would disrupt international drug cartels. Rep. Tulsi Gabbard (D-HI) recently said she backs “legalizing and regulating” currently illegal controlled substances to protect public safety and combat the illicit market.
At the Iowa town hall, Yang went on to say that he’s particularly interested in legalizing marijuana, and he again pledged to “pardon everyone who’s in jail for a non-violent marijuana-related offense because they shouldn’t be in jail for something that’s frankly legal in other parts of the country.”
“And I would pardon them all on April 20, 2021, high-five them on the way out of jail and be like, ‘things got a lot better in the last year,'” he said, referencing the unofficial cannabis holiday 4/20.
Photo element courtesy of Gage Skidmore.
Tom Steyer Calls For Marijuana Legalization And Opioid Decriminalization
Billionaire philanthropist Tom Steyer is calling for the legalization of marijuana and decriminalization of opioid possession.
In a criminal justice reform plan released on Thursday, the 2020 Democratic presidential candidate laid out a vision for ending the drug war, which he said has contributed to mass incarceration and is enforced in a racially disproportionate manner.
“Tom believes we must end the failed War on Drugs. Based on the flawed idea that incarceration is the answer to addiction, federal and state elected officials passed severe sentencing laws that encouraged incarceration for low-level drug offenses,” the plan states. “Unfortunately, communities of color were and continue to be disproportionately affected and targeted by these laws, even when other ethnicities were committing the same drug crimes at the same rates.”
Today @TomSteyer announced a new criminal justice plan to:
– Reform the juvenile system
– Improve prison conditions
– Redirect funds to education
– Eliminate cash bail
– Release more rehabilitated people
– End the war on drugs
And much more! 👉 https://t.co/3VYRw7ioXB
— TeamTom 🌎 (@TomHQ) January 24, 2020
There are six proposals in the drug war section, including legalizing cannabis and expunging prior marijuana convictions, ending mandatory minimum sentences and empowering judges to use more discretion in non-violent drug cases, diverting people convicted of drug offenses to treatment or drug court, ending the sentencing disparity between crack and powder cocaine, sealing the records of certain drug convictions and decriminalizing opioids while investing $75 billion in treatment programs and holding pharmaceutical companies accountable.
Steyer specifically endorsed House Judiciary Committee Chairman Jerrold Nadler’s (D-NY) Marijuana Opportunity Reinvestment and Expungement (MORE) Act, which would deschedule cannabis, expunge prior convictions and set aside tax revenue to support communities most impacted by the drug war.
“Policing marijuana use has led to too many unfair incarcerations and predominantly impacted communities of color,” the plan says. It also criticizes then-Attorney General Jeff Sessions’s 2018 move on “repealing leniency given to states for marijuana laws.”
Today, I'm meeting with formerly incarcerated individuals to talk about transforming the criminal justice system through police accountability, ending cash bail, providing adequate funding to re-entry programs, and so much more. pic.twitter.com/m9lDEKWwwU
— Tom Steyer (@TomSteyer) January 23, 2020
“A Steyer Administration will also open equitable pathways to banking for marijuana businesses,” it continues. “The federal government—including the Federal Deposit Insurance Corporation—should not be a barrier to marijuana businesses receiving support from their local banks.”
“Incarceration is not the answer to addiction, and low-level drug offenses should not carry a severe sentence. Tom will legalize marijuana, let states pass their own policies, expunge past records, and direct the federal government to open banking services to the marijuana industry. Tom’s administration will end the disparity between crack and cocaine sentences, decriminalize opioid possession, and invest $75 billion to address the opioid crisis.”
The opioid decriminalization proposal is similar to that of entrepreneur Andrew Yang, another 2020 candidate who said removing criminal penalties for possessing the substance is necessary in order to help get people into treatment and curb the opioid crisis. Former South Bend, Indiana Mayor Pete Buttigieg and Rep. Tulsi Gabbard (D-HI) have gone further, calling for the decriminalization of all drug possession and, in Gabbard’s case, also the legalization and regulation of illicit drugs.
“Tom supports decriminalizing small amounts of opioid possession for personal use at the federal level,” the plan states. “He will address the opioid crisis through $75 billion in new funding over ten years to resource state and local treatment programs, hold big pharmaceutical corporations and their executives accountable, and strongly enforce laws that end the illicit distribution and sale of opioids.”
This is a notable development for Steyer, who hasn’t discussed drug policy reform as much as many other candidates in the race and whose views on decriminalization of substances beyond marijuana were previously unknown.
Last year, Steyer said he supported creating a national referendum process so that Americans can made decisions about a wide range of policy issues, including cannabis legalization.
He also previously discussed his support for ending marijuana prohibition and providing the industry with access to banking, saying that he and his wife wanted to provide financial services to minority- and women-owned cannabis firms through their community bank, but federal prohibition means the business would be put at risk if they did that.
Steyer’s new plan also calls for juvenile justice reform, ending cash bail, banning facial recognition technology in policing, demilitarizing law enforcement, improving prison conditions and eliminating the death penalty, among other reforms.
Photo courtesy of Flickr/Gage Skidmore.