The Food and Drug Administration’s (FDA) public comment period for CBD regulations closed on Tuesday, with thousands having weighed in on the health and safety effects of the non-intoxicating cannabis compound.
By the end of Wednesday, individuals and organizations filed more than 4,400 submissions, which will be used to inform FDA’s rulemaking process for cannabidiol products. The comment period opened in April and it was followed by a first-ever FDA public hearing on the cannabinoid that involved testimony from numerous industry stakeholders and reform advocates.
The initial deadline was set for July 2, but that was extended by two weeks in response to strong public interest in weighing in on issues FDA requested, including health risks and benefits, manufacturing processes and product quality
The comments run the gamut. Hundreds of people shared personal anecdotes about how CBD had treated symptoms of various conditions such as anxiety and pain, and others said it helped them wean off of other drugs that had damaging side effects.
Several health professionals and medical associations offered their perspective as well, recommending that CBD be regulated as a health supplement that must meet certain quality and labeling standards.
“Our patient community has used non-FDA approved CBD and other cannabis-based products when other options have failed to provide seizure control for their family member with Dravet syndrome,” the Dravet Syndrome Foundation wrote. “Due to reports of extreme variations in product consistency and frequent label misrepresentation, we would welcome standardizing labeling for cannabis based dietary supplements and foods including concentration, ingredients, and stability.”
Some organizations, including advocacy groups and law firms, answered FDA’s questions head-on and went into details about how they feel CBD should be regulated, what its impacts on safety are and best practices for testing and labeling.
The National Cannabis Industry Association, National Association of State Departments of Agriculture (NASDA), New York State Bar Association, National Grocers Association, U.S. Hemp Roundtable, Vote Hemp and Center for Science in the Public Interest (CSPI) were among those groups that provided comprehensive responses to FDA’s request.
A coalition of 37 state attorneys general also submitted comment.
“As the primary enforcers of our respective states’ consumer protection laws, we offer a unique perspective as to the new legalized market of certain cannabis and cannabis-derived compounds, including CBD products,” the state officials wrote. “Although products containing cannabis or cannabis-derived compounds may well offer real benefits to consumers, it is important that consumers have reliable risk and benefit information to make informed choices about initiating and continuing the use of these products.”
The AGs want FDA to continue “to explore manufacturing, testing, and marketing best practices so that consumers are not at risk of misleading advertising or harm to their health from dangerous additives or undisclosed risks of use.”
AG Yost has joined 37 attorneys general in urging federal cooperation with states to protect consumers from false advertising and harms to their health from products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD). Read more: https://t.co/JTgW4yi6yi pic.twitter.com/h1XdByA6d6
— Ohio Attorney General Dave Yost (@OhioAG) July 17, 2019
In its comment, CSPI wrote that it is “critical that FDA assert its authority on behalf of consumers to ensure that products are safe, accurately labeled, and free of adulterants and contaminants, and that consumers are aware of relevant risks.”
“To do so will require that the agency articulate a long-term program to gradually align the state laws that legalize these products with applicable federal health and safety protections, as we propose,” the organization argued.
“NASDA urges FDA to engage with NASDA and NASDA members in meaningful conversations on how this framework can be establish in a manner that will protect public health, while also fostering growth within this new emerging industry,” the agriculture association said.
U.S. Hemp Roundtable said that the organization believes “FDA has all the tools necessary to expeditiously issue a rule allowing CBD in foods and dietary supplements.”
“We believe that a federal regulatory framework, rather than a patchwork of state and local laws, provides the best means for ensuring consumers receive accurate, consistent information about hemp-derived products,” the group added.
Vote Hemp urged FDA not to let the approval of the CBD-based medication Epidiolex prevent it from allowing hemp-derived CBD products into the marketplace.
“Whole-plant hemp extracts can be part of a healthy diet, are beneficial to consumers, and are not pharmaceutical drugs, especially when they are not marketed to have a therapeutic effect on consumers,” the group wrote. “FDA should recognize that whole-plant hemp extracts are distinct from any substance that has been submitted to FDA for approval as a pharmaceutical drug.”
An FDA official said last week that it will be speeding up the rulemaking process for CBD—something that lawmakers and stakeholders have pressured the agency to do since hemp and its derivatives were federally legalized under the 2018 Farm Bill. A report on progress will be released by early fall, she said.
The same official will testify at a Senate hearing on hemp issues next week.
Additional answers could come out of a hemp industry conference in August, where another FDA official is scheduled to speak about the status of developing regulations for CBD.
Photo by Kimzy Nanney on Unsplash.
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.