The Food and Drug Administration (FDA) will hold a public hearing on regulating hemp-derived CBD on May 31, the agency announced in a notice scheduled to be published in the Federal Register on Wednesday.
The much-anticipated hearing will feature testimony from stakeholders and is aimed at informing FDA’s regulatory approach to CBD products. Outgoing FDA Commissioner Scott Gottlieb, who initially said the meeting would take place sometime in April, has repeatedly stressed that while the 2018 Farm Bill federally legalized hemp and hemp-derived products, CBD products remain under the agency’s purview.
Because CBD is an FDA-approved drug in the form of prescription medication Epidiolex and hasn’t been previously introduced into the food supply, regulating CBD products is especially complicated, Gottlieb has said. However, there are alternative pathways the agency can pursue, and the public hearing is one of the first steps in that rulemaking process.
“The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products,” the agency wrote. “FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”
FDA listed a number of “unanswered questions” that it hopes will be addressed at the hearing.
Are there any “particular safety concerns that FDA should consider” as far as regulating CBD products is concerned? Should any specific populations like pregnant women be taken into consideration when developing regulations for CBD? What’s the “maximal acceptable daily intake from all products?”
The notice also discusses why CBD’s status as an approved drug for the treatment of certain forms of epilepsy complicates its regulatory responsibility. If the ingredient is allowed in the food supply or as dietary supplements, there’s a risk that companies will have less of an incentive to conduct additional clinical trials investigating its therapeutic potential, FDA said.
Beyond the public safety issues, FDA listed more questions about the manufacturing and marketing of CBD products. It’s soliciting input on the safest practices for manufacturing CBD and how to properly notify consumers about health risks through labeling, among other topics.
FDA’s steps include a public hearing on May 31 for stakeholders to share experiences/challenges w/ these products, formation of a high-level internal agency working group to explore potential product pathways, web QA updates & new warning letters for unfounded marketing claims.
— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019
“The public hearing will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient,” Gottlieb said in a new statement accompanying the Federal Register notice. “We hope to gain additional information and data for the FDA to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.”
He also provided new details about an FDA working group tasked with exploring “potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
The agency also updated a cannabis products questions-and-answers page on its website with new information.
FDA said it’s aware that there are companies that are already marketing CBD products, including cases where the companies have been formally warned about making unauthorized medical claims about the products. Gottlieb hinted at the agency’s enforcement priorities at a congressional hearing last week.
Hemp cultivators and processors are eager to receive federal guidance on CBD, but the commissioner has tried to temper expectations about the timeline for that guidance. Without congressional action that specifically targets CBD, it may be years before the regulations are enacted, he said.
In the meantime, people interested in shaping the FDA’s CBD regulatory process can submit public comments through July 2. The agency says it will soon make information on how to register for the public hearing available online.
The U.S. Department of Agriculture held a lengthy public hearing last month to receive input from stakeholders about its efforts to implement the Farm Bill’s hemp legalization provisions more generally.
This story was updated to include comments from Gottlieb.
Andrew Yang Contrasts Rampant Opioid Prescribing With Marijuana Criminalization
Andrew Yang contrasted the widespread prescribing of opioids with the ongoing criminalization of marijuana on Wednesday.
In a tweet, the entrepreneur and 2020 Democratic presidential candidate said there were “more opiate prescriptions in the state of Ohio than people in Ohio,” yet “marijuana is still classified as a schedule 1 drug” under the federal Controlled Substances Act.
#DidYouKnow – There were more opiate prescriptions in the state of Ohio than people in Ohio. But marijuana is still classified as a schedule 1 drug.
— Andrew Yang🧢 (@AndrewYang) December 11, 2019
He’s brought that point up before, at a presidential debate in October. Asked about his proposed to decriminalize possession of opioids to combat the drug overdose crisis, Yang brought up the statistic and criticized the government for failing to take action against pharmaceutic companies that aggressively marketed addictive painkillers.
“If the government turned a blind eye to this company, spreading a plague among its people, then the least we can do is put a resource into work in our communities so that people have a fighting chance to get well, even though this is not a money problem,” he said at the time.
— Andrew Yang🧢 (@AndrewYang) October 16, 2019
NBC News confirmed that, in 2010, federal data shows there were 102.4 opioid prescriptions in Ohio for every 100 persons. That’s decreased since then, with 2017 data showing 63.5 opioid prescriptions for every 100 persons in the state.
Yang, who supports comprehensive marijuana legalization, has also embraced other harm reduction policies. Beyond decriminalizing opioids, he said in an interview published last week that he’s in favor of providing federal funding for the establishment of safe injection facilities, where individuals can use illicit drugs under medical supervision and receive assistance getting into treatment.
Yang has not yet called for decriminalization of substances beyond opioids and cannabis, however. That policy is backed by rival contenders South Bend, Indiana Mayor Pete Buttigieg and Rep. Tulsi Gabbard (D-HI).
Sens. Bernie Sanders (I-VT) and Elizabeth Warren (D-MA) and former Housing and Urban Development Secretary Julián Castro, also presidential candidates, have called for the establishment of safe injection sites.
Photo courtesy of ABC News.
Marijuana Legalization Bill Filed In Virginia Ahead Of Attorney General’s Cannabis Summit
The attorney general of Virginia held a cannabis summit on Wednesday, with representatives of states that have legalized marijuana sharing their insights as lawmakers in the Commonwealth prepare to push reform legislation in the coming session.
This event came one day after a lawmaker prefiled a bill to legalize marijuana for adult use and expand the state’s existing limited medical cannabis program.
The event featured panels on marijuana decriminalization, social equity, public health, hemp, CBD and creating a pathway for eventual legalization. The goal was to answer policy questions and inform legislation, which Attorney General Mark Herring (D) hopes will start with decriminalization and expungements and later adult-use legalization.
Herring: “I don’t believe Virginia’s current system of needlessly criminalizing cannabis is working. The negative consequences of the current approach fall disproprtionately on African Americans and other people of color.”
— Martin Austermuhle (@maustermuhle) December 11, 2019
“I don’t believe that Virginia’s current approach of criminalizing cannabis is working,” Herring said in his opening remarks. “It is needlessly creating criminals and burdening Virginians with convictions.”
Today we're bringing together legislators, stakeholders, and policy experts to plot a course for a smarter, fairer, more just cannabis policy in VA. For me, that means decriminalizing now, resolving past convictions, & moving to legal, regulated adult use.https://t.co/aqWxQCVPIg
— Mark Herring (@MarkHerringVA) December 11, 2019
“The human and social costs are enormous, in addition to the millions of dollars it costs Virginia taxpayers. And the negative consequences of the current approach fall disproportionately on African Americans and people of color,” he said. “It’s clear to me that the time for cannabis reform has come. Justice demands it. Virginians are demanding it. And I’m going to help make sure we get this right.”
Watch video of the Virginia Cannabis Summit below:
Representatives from Colorado and Illinois discussed law enforcement and equity in regulated marijuana markets.
The prospects of passing reform measures greatly increased in Virginia after November’s election, which saw Democrats reclaim control of both chambers of the General Assembly for the first time in decades. Herring said the timing is right to “plot a course for a smarter, fairer, more just cannabis policy” in the state.
Sen. Dave Marsden (D), co-founder of the legislature’s recently established Cannabis Caucus, said at the summit that ensuring that the legal market is equitable is paramount.
.@SenDaveMarsden, who co-founded the new Cannabis Caucus, says focusing on equity will be important. “We can’t substitute a civil process for a criminal one and not expect it to lead to disparities,” he says of decriminalization, noting how people of color still impacted most.
— Martin Austermuhle (@maustermuhle) December 11, 2019
“We can’t substitute a civil process for a criminal one and not expect it to lead to disparities,” he said.
“Following several years of forming consensus around medical cannabis products, we have to be ready to take action in the upcoming legislative session to further reform our laws in this arena,” he said in a press release. “This effort will include a more robust medical cannabis program and Attorney General Herring’s summit is a big step in ensuring we are knowledgeable on the issue and prepared to do this right.”
“Virginia is ready for evidence-based reform and that is what we will provide.”
Del. Stephen Heretick (D) said the summit “is a great opportunity for me and my fellow legislators to learn from the experiences of other states as we consider how to create more fair, just, equitable, and effective cannabis laws here in Virginia.”
Decriminalization is the first proposal on the agenda when the next session starts, the attorney general said. That would fulfill a campaign promise of Gov. Ralph Northam (D), who ran on the issue in 2017 and talked about in his State of the Commonwealth address this year.
“It’s time for public policy to catch up with public opinion, and NORML applauds Attorney General Herring for his efforts to foster and advance evidence-based cannabis laws,” Jenn Michelle Pedini, executive director of Virginia NORML said. “We look forward to supporting the attorney general and the Virginia Cannabis Caucus in their work reforming marijuana laws for a safer Commonwealth.”
While Northam hasn’t voiced support for recreational legalization, Herring said last week that Wednesday’s summit is one resource that will help the state move toward comprehensive reform.
“Criminalizing marijuana possession is not working.” Attorney General @MarkHerringVA said he will host a #cannabis summit to advance decriminalization in Virginia. #CheddarLive pic.twitter.com/ecB4BSQo5w
— Cheddar (@cheddar) December 3, 2019
“Based on my conversations, he supports decriminalization,” Herring, who is also running for governor in 2021, said. “Like a lot of people, I think they’d like to get more information about what legalization and what regulated, adult-use would look like.”
A bill to decriminalize marijuana and make possession of up to one ounce punishable by a maximum $50 civil penalty was prefiled in the legislature last month.
This latest legalization bill, introduced by Del. Lee Carter (D), will likely be a heavier lift. It would allow adults 21 and older to possess and purchase cannabis from licensed retailers, and it would impose a 10 percent tax, revenue from which would go toward a veterans fund, transportation and local municipalities that allow marijuana businesses to operate.
“While a majority of Virginians agree with Attorney General Herring that marijuana should be legal for responsible use by adults, it may take a bit more work to convince the Virginia General Assembly to send such a bill to the governor’s desk,” Michelle Pedini told Marijuana Moment. “Todays summit is an important, and historic, step toward that goal, and NORML is proud to be a part of it.”
Photo courtesy of Nicholas C. Morton.
Thailand Prime Minister Uses Medical Marijuana At Event With Ganja Mascot
Top officials in Thailand are getting the word out about medical marijuana—in part by distributing cartoon cannabis dolls and publicly using marijuana oils.
Prime Minister Prayut Chan-o-cha announced the launch of the government’s medical cannabis education site on Wednesday and appeared at an event alongside a person wearing a spectacled marijuana leaf costume called Dr. Ganja. Children were also present, carrying their own Dr. Ganja dolls.
The Thai government officially launches its medical cannabis "educational" website today.https://t.co/zhzZU61q3c
The Prime Minister gets a ganja doll, kids get a ganja doll, everybody gets a ganja doll!
Photo credit: Bhumjaithai Party pic.twitter.com/lVf1WTguqQ
— Prim Chuwiruch (@prim_chuwiruch) December 11, 2019
Prayut argued in favor of the therapeutic use of cannabis, stating that it represents a potential treatment option for low-income people in particular. According to The Nation Thailand, he also demonstrated marijuana products, inhaling an oil and applying some to the back of his ears. The prime minister also said he plans to purchase some oils himself.
The government’s education site features information about where to find cannabis clinics, what kinds of products are available and infographics laying out basic research into marijuana.
Thai lawmakers have made clear their excitement about medical cannabis, with several filmed participating in a ritual dance in August to celebrate the first batch of marijuana oil.
— Reuters Latam (@ReutersLatam) August 8, 2019
Months after Thailand opted to legalize medical marijuana, the ruling party unveiled draft legislation in September that allows individuals to cultivate up to six cannabis plants for personal use.
Photo courtesy of Bhumjaithai Party.