The federal drug scheduling system inhibited research into CBD that the Food and Drug Administration (FDA) is now scrambling to conduct following the legalization of hemp and its derivatives, a top agency official said on Tuesday.
Speaking at the National Industrial Hemp Council’s 2019 Hemp Business Summit, FDA Principal Associate Commissioner for Policy Lowell Schiller gave an extensive overview of the agency’s role in regulating cannabis products, repeatedly stressing that FDA is “excited” about cannabidiol’s potential.
That said, Schiller said FDA retains regulatory authority over hemp-derived products and it remains illegal to introduce CBD in the food supply or as dietary supplements unless the agency develops alternative rules, which it is actively exploring. Because CBD exists as an FDA-approved epilepsy drug, Epidiolex, creating a regulatory framework is more complicated.
He also talked about other potential medical benefits of CBD and how the federal ban on hemp and its compounds, which was lifted under a provision of the 2018 Farm Bill that President Donald Trump signed in December, restricted research.
“There’s still a lot we don’t know about the potential therapeutic benefits of CBD, but we’re excited about the possibility that new therapeutic uses of CBD might be demonstrated to be safe and effective,” Schiller said, according to his remarks as prepared for delivery. “The last thing we want to do is to discourage that research, and potentially stunt our knowledge of potential uses of CBD. So we need to be thoughtful in our approach.”
“One thing we realized very early on in evaluating these questions is that there was still far too much we didn’t know about CBD, and about the implications of putting CBD in foods, dietary supplements, and cosmetics,” he said. “This is part of the legacy of almost all CBD being a Schedule I controlled substance until late last year.”
“It was difficult to research, and it hasn’t been studied nearly as much as we would like.”
Schiller said that more studies are needed to determine potential risks associated with consuming large quantities of CBD, interactions with other drugs, using the substance while pregnant and long-term consumption. Resolving those questions will “help to inform our path forward.”
That’s why, he said, FDA is “focusing on a different CBD: Collect Better Data.”
“We want to learn as much as we can, as quickly as we can, to support informed and efficient decision making. If there are data or studies that are relevant to the safety of particular uses of CBD, we want to see them. And if there are gaps in our knowledge, we want to understand how big those gaps are and what can be done—by us and by others—to start filling them.”
Today, FDA Principal Associate Commissioner for Policy Lowell Schiller discussed the agency’s work related to products containing cannabis or cannabis-derived compounds such as cannabidiol at the National Industrial Hemp Council 2019 Hemp Business Summit: https://t.co/LbZ1HEvKH9
— Media Affairs (@FDAMedia) August 13, 2019
Those gaps in knowledge are partially due to the federal drug scheduling system, which has faced bipartisan criticism for hampering research initiatives. The director of the National Institute on Drug Abuse acknowledged in April that continuing to classify drugs like marijuana as Schedule I makes it “very difficult” to research.
But as FDA works to make up for lost time, it has pledged to engage in a transparent rulemaking process that takes into account what Congress and industry stakeholders have called for—namely a regulatory scheme under which hemp and CBD can be lawfully marketed without excessive interference.
FDA said it is speeding up its process to develop regulations and that it plans to release a report on its progress in the fall.
“In closing, I want to reiterate how excited we are about the potential uses of CBD and other hemp and hemp-derived products,” Schiller said. “The hemp industry has come an incredible distance in an incredibly short period of time. And in some cases, the enthusiasm and the commercial appeal have outpaced the scientific research. The science needs to catch up.”
He also told the hemp crowd that as FDA works on its end, “we need your help.”
“As this industry matures, it needs to start taking on more responsibilities—for the safety of consumers, and for the future development of an industry that can meet the same requirements as apply to other industries we regulate,” he said. “We look forward to working together as this industry continues to mature.”
U.S. Department of Agriculture Undersecretary Greg Ibach also spoke at the hemp conference on Tuesday.
“Great opportunity to speak to #hemp farmers and processors about this new market. Hearing from these farmers is key to setting up a successful hemp program.” Under Secretary Ibach at the @NatHempCouncil 2019 Hemp Business Summit pic.twitter.com/wgtwdrtIuw
— USDA Ag Mktg Service (@USDA_AMS) August 13, 2019
Photo courtesy of Brendan Cleak.
Andrew Yang Peddles Marijuana-Themed Presidential Campaign Merchandise
2020 candidate Andrew Yang announced on Saturday that his campaign for the Democratic Party’s presidential nomination is rolling out a line of marijuana-themed merch.
The limited edition products blend Yang’s love of mathematics with his support for cannabis reform. A t-shirt being offered for $30 simply says, “Math. Money. Marijuana.” And a now-sold-out baseball cap says “Math” on the front and displays a cannabis leaf on back. There’s also a bumper sticker that says, “Legalize Marijuana.”
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Buttigieg Pledges To Decriminalize Possession Of All Drugs In First Term As President
South Bend, Indiana Mayor Pete Buttigieg released a comprehensive plan on Friday that calls for “decriminalizing all drug possession” in his first presidential term as a means to combat the opioid epidemic and treat addiction as a public health, rather than criminal justice, issue.
Decriminalization is just one action the 2020 Democratic presidential candidate said he’d pursue in order to reform the country’s mental health care system and bolster substance abuse treatment. His plan also includes proposals to reduce sentences for drug offenses other than possession, increase access to the opioid overdose reversal drug naloxone and make it easier to implement syringe exchange programs.
America’s addiction and mental health care crisis has been building for decades—due to decades of neglect by political leaders in Washington. Today, I’m proposing a new approach that tackles this crisis with the urgency and care it deserves. pic.twitter.com/U8F9DXJPC2
— Pete Buttigieg (@PeteButtigieg) August 23, 2019
Buttigieg’s “Healing and Belonging in America” plan emphasizes the need to divert people suffering from addiction away from prisons and into treatment. He said he’d accomplish that by expanding diversionary programs and evidence-based training “for drug courts, mental health courts, and other alternatives to incarceration for justice-involved persons.”
The goal of decriminalization and diversion is to reduce “the number of people incarcerated due to mental illness or substance use by 75 percent in the first term.”
Our country is in the midst of a mental health and addiction crisis, worsened by decades of stigma and political neglect. I’ll bring a new approach, rooted in commitment and community, to tackle this crisis with the urgency it deserves. https://t.co/spBoh5KH4X
— Pete Buttigieg (@PeteButtigieg) August 23, 2019
Under his plan, sentencing reform for drug offenses other than possession would be applied retroactively and coupled with expungements for past convictions. Buttigieg pointed to research demonstrating that “incarceration for drug offenses has no effect on drug misuse, drug arrests, or overdose deaths” and instead “actually increases the rate of overdose deaths.”
“We cannot incarcerate ourselves out of this public health problem.”
“To ensure that people with a mental illness or substance use disorder can heal, we will decriminalize these conditions,” the proposal states. “When someone is undergoing a crisis or is caught using a drug, they should be treated by a health professional rather than punished in a jail cell.”
“All presidential candidates should join Pete Buttigieg in recognizing that the criminalization of people for their drug use is wrong and simply bad policy,” Maria McFarland Sánchez-Moreno, executive director of the Drug Policy Action, said in a press release. “Possession of drugs for personal use is the single most arrested offense in the United States, eclipsing arrest rates for any other offense. With overdose numbers skyrocketing and entire communities, disproportionately black or brown, suffering from criminalization, it’s time for policymakers to shift gears. Taking an evidence-based, health-centered approach to address this crisis is not only true leadership – it’s common sense.”
The mayor also made harm reduction policies a key component of his strategy. He said take-home naloxone programs would be expanded to all 50 states by 2024 and that harm reduction services would be expanded “to reduce overdose deaths and the spread of infectious diseases related to needle sharing.”
The plan would make naloxone “broadly available in order to reverse overdoses” and remove “legislative and regulatory restrictions on the use of federal funds for syringe service programs.”
Buttigieg said the federal government should provide funding for state and local health departments to purchase the medication, make sure that it’s “available in public spaces and workplaces” similar to first aid kids and encourage “co-prescribing of naloxone with opioids, either by individual physicians or direct dispensing by pharmacists.”
Existing federal law makes it difficult to establish syringe exchange programs, in part because federal funds can’t be used to buy needles. The restrictions “hamper state and local responses, both because they limit resources and because they convey a negative message about the value of these programs, despite overwhelming scientific evidence that they can prevent transmission of HIV and hepatitis.”
In addition to lifting those barriers, the candidate said the Centers for Disease Control and Prevention “would also work with states to remove any criminal liability for those participating in” syringe exchange programs.
“Harm reduction programs are a critical part of any effective response to the opioid and injection drug use crisis. They minimize the negative impact of drug use without encouraging it, while reducing other side effects of drug use. In particular, this means access to syringe service programs for people who inject drugs, that link them to treatment, and provides access to sterile syringes. These programs help prevent transmission of HIV, viral hepatitis, and other infectious diseases associated with needle sharing, and reduce overdoses by deploying medication such as naloxone that help reverse the effects of opioids.”
One harm reduction policy that didn’t make the cut in Buttigieg’s plan is safe injection sites, where people could use illicit drugs under the supervision of medical professionals who could reverse overdoses and recommend treatment options. Sens. Bernie Sanders (I-VT) and Elizabeth Warren (D-MA), who are also running for the Democratic nomination, both proposed legalizing such facilities as part of criminal justice reform plans they released this month.
“Decades of failed mental health and addiction policy, coupled with mass incarceration that criminalized mental illness and drug use, have left us with a mental health and addiction care system so broken that today there are more people with serious mental illness in prisons than in treatment facilities,” Buttigieg said.
The candidate also made ending incarceration for drug possession—as well as legalizing marijuana—central principles of his previously released criminal justice reform plan, which he released last month.
But while the prior plan did not explicitly describe the move as “decriminalizing” drugs, even though advocates commonly use that word to refer to policies that remove the threat of being imprisoned for possession, the new document does use that terminology—signaling a shift in clarity as Buttigieg continues to develop his campaign messaging.
In other instances, he borrowed language from his criminal justice reform plan, specifically as it concerns how criminalizing drug use can increase rates of overdose, for his mental health proposal.
“Despite equal rates of use, Black Americans are nearly four times as likely to be arrested for using marijuana,” the criminal justice plan states. “Research shows that incarceration for drug offenses has no effect on drug misuse, drug arrests, or overdose deaths. In fact, some studies show that incarceration actually increases the rate of overdose deaths.”
Buttigieg mentioned that, as with drug offenses, black people are also more likely to die from overdoses. And that’s due to “the current broken system that criminalizes mental illness and addiction” that was “built during the crack epidemic of the 1980s.”
This story was updated to include comment from the Drug Policy Action.
Photo courtesy of Flickr/Gage Skidmore.
White House Drug Officials Say Legal Marijuana Is Up To States
Two top federal drug officials, including the White House drug czar, recently said that marijuana legalization should be left up to states.
The comments stand out coming from the Office of National Drug Control Policy (ONDCP), which has historically played a central role in defending blanket federal prohibition.
Jim Carroll, the Trump-appointed drug czar who directs the administration’s drug policies, told Fox 59 reporter Kayla Sullivan that he considers legalization a states’ right issue. He added that he’d like to see targeted education campaigns concerning cannabis use during pregnancy and underage usage as well as research into impaired driving.
Got the answer: He believes it should be left up to the state. However, he does want to educate people on the effect marijuana has on young brain development, pregnant women and wants to come up with better guidance & testing for marijuana while driving. https://t.co/eifryNJB1j
— Kayla Sullivan (@KaylaReporting) August 14, 2019
It’s a particularly notable position given that federal law stipulates that the drug czar is required to “take such actions as necessary to oppose any attempt to legalize the use of a substance” listed as Schedule I under the Controlled Substances Act, including marijuana.
Even if Carroll’s remarks arguably don’t directly violate that statute, they are significant in that he doesn’t seem to have taken the opportunity to proactively oppose state legalization efforts when asked by a reporter.
Anne Hazlett, senior advisor at ONDCP, also weighed in on cannabis legalization on Wednesday, telling CentralIllinoisProud.com that marijuana legalization is “a state decision.”
“Marijuana is an ongoing challenge that is being addressed in many of our states,” she said. “This is a state decision, and we would like to see additional research done so that these decisions being made at a state level are being made in a manor that is fully informed.”
Though the comments from Carroll and Hazlett seem to reflect an evolving understanding of the federal government’s role in imposing prohibition on the states, the ONDCP director has previously made clear he’s not enthusiastic about the burgeoning legal market.
During a House Committee on Oversight and Reform hearing in May, Carroll raised concerns about THC potency in marijuana products, saying “the marijuana we have today is nothing like what it was when I was a kid, when I was in high school.”
“Back then the THC, the ingredient in marijuana that makes you high, was in the teens in terms of the percentage,” he said. “Now what we’re seeing is twice that, three times that, in the plant.”
He also said that more research is needed and that the Drug Enforcement Administration as well as the Department of Health and Human Services are “working hard to make sure that we understand the impact of legalization of marijuana on the body.”
Photo courtesy of Philip Steffan.