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.
Trade Associations And Civil Rights Groups Send Mixed Messages On Marijuana Banking To Senate
A coalition of trade associations sent a letter to Senate Banking Committee leadership on Thursday, urging a vote on legislation to protect financial institutions that service state-legal marijuana businesses.
But those senators are also feeling pressure from leading civil rights groups like the ACLU and Human Rights Watch, which sent an earlier letter insisting that they not allow cannabis banking to detract from more comprehensive reform that addresses social equity.
The organizations involved in the latest letter—including the American Bankers Association and Credit Union National Association—said that advancing the Secure and Fair Enforcement (SAFE) Banking Act or similar legislation is pivotal to ensuring that stakeholders receive needed clarity and are shielded from being penalized by federal regulators.
The letter, addressed to Banking Chair Mike Crapo (R-ID) and Ranking Member Sherrod Brown (D-OH), emphasized the bipartisan nature of the House passage of the bill in September and the growing movement at the state level to legalize cannabis for medical or recreational purposes.
“Our organizations support an initial legislative step that allows the legal cannabis industry into the banking system,” the groups, which also include the Council of Insurance Agents and Brokers, International Council of Shopping Centers and National Association of REALTORS, wrote. “Ultimately, protecting law-abiding financial institutions and ancillary businesses from their currently untenable position and addressing increasing public safety concerns.”
As more states reform their marijuana laws, however, “distribution, sale, possession, research, transaction, housing, employment, and a broader landscape of cannabis is becoming increasingly problematic” for stakeholders under federal prohibition.
“Ultimately, this creates more legal and security concerns that impact the operations and safety of businesses and consumers,” they said. “Finally, the lack of an available safe harbor for cannabis will continue to challenge the full adoption and deployment of the legal hemp and CBD products market in the U.S. due to the inextricable link between hemp and cannabis.”
“To resolve this, we urge the Committee to vote on the SAFE Banking Act or similar measures. Such measures are meant to create a safe harbor for depository institutions that provide a financial product or service to businesses in a state permitting the use of cannabis. A safe harbor will enable law enforcement and states to effectively monitor and regulate businesses while simultaneously bringing billions into the regulated banking sector.”
12 groups including ABA just wrote @MikeCrapo @SenSherrodBrown @senatemajldr @SenSchumer urging a vote on the #SAFEBanking Act. It's time to end the legal limbo over banking cannabis in the growing number of states where it's legal. Read the letter: https://t.co/1529vIHawq
— American Bankers Association (@ABABankers) December 12, 2019
The letter, also signed by Americans for Prosperity and R Street, recognizes that creating a federal regulatory scheme for marijuana will take time but says that the SAFE Banking Act represents “a critical first step to ensure that legal cannabis marketplaces are safe, legal, and transparent.”
Crapo has said that he’s interested in holding a vote on resolving the cannabis banking issue in his panel before the year’s end, but so far nothing has been scheduled. The chairman told Marijuana Moment in earlier interviews that there are several changes to the House-passed bill that he’d like to see but that he’s worried impeachment proceedings against the president will interfere with plans to hold a vote.
All that said, pressure from civil rights advocacy groups could complicate congressional efforts to get the banking bill approved. In October, several organizations including the ACLU, Drug Policy Alliance, Human Rights Watch and Center for American Progress sent a letter to Senate leadership, as well as Crapo and Brown, demanding that “marijuana legislation considered in the Senate include provisions that will guarantee equity in the industry.”
The letter, which doesn’t appear to have been previously reported and was obtained by Marijuana Moment, states that while the coalition agrees the SAFE Banking Act “is an incremental step toward rolling back the federal prohibition of marijuana, it fails to help communities that have been historically and disproportionately devastated by United States’ punitive drug laws.”
“As the Senate Committee on Banking, Housing, and Urban Affairs considers similar legislation, we insist that the legislation include provisions that ensure equity in the marijuana industry by creating opportunities for individuals who have been prohibited from this growing business either by legal or financial means,” the letter, which was also signed by the Immigrant Legal Resource Center, Leadership Conference on Civil and Human Rights and National Association of Social Workers, states.
“Indeed, this Congress has shown it understands the economic impact of legalization. But while progress on the business side of legalization is promising, it is not sufficient. Federal marijuana legislation must be comprehensive and lead with equity, addressing past and current harms to communities of color and low-income communities who bore the brunt of the failed war on drugs. We demand that any marijuana reform or legalization bill considered by the Senate] include robust provisions addressing equity. More than simply adding equity provisions to bills that address industry concerns, we need comprehensive reform that deschedules marijuana and addresses the inequities and harms continually inflicted by the failed war on drugs.”
In other words, the groups are insisting on broad reform prior to a vote on a bill viewed as largely beneficial to the cannabis industry—similar to a request they made of House members prior to the legislation’s passage in the chamber.
Read the marijuana banking letters from the trade associations and civil rights groups below:
GOP Congressman Knocks His Party For Failing To Pass Marijuana Reform
A Republican congressman says that whichever party is responsible for passing federal marijuana reform will “instantly” shoot up in the polls, while lamenting the fact that the GOP failed to do so when they controlled the House.
Rep. Thomas Massie (R-KY), a vocal advocate for hemp, was asked by Fox Business host Kennedy on Wednesday whether cannabis should be rescheduled under federal law.
“Absolutely,” he said. “The first party that does this—and I don’t understand why either party won’t do it—is going instantly gain 10 points in the general poll on which party versus the other.”
“We should have done it when we were in the majority,” he added. “The liberals should be asking Pelosi why she hasn’t put it on the floor yet.”
The House Judiciary Committee approved legislation last month to end federal marijuana prohibition, but it hasn’t yet been scheduled for floor action.
Massie made similar points during an interview with Marijuana Moment earlier this year, stating that if Republicans had advanced states’ rights-focused marijuana legislation, “I think we might still be in the majority.”
Of course, while Massie has supported legislation to allow states to set their own cannabis policies without federal intervention, as well as other more modest reform measures such as protecting banks that service marijuana businesses, he’s so far declined to cosponsor any bills that seek to deschedule cannabis.
The congressman has also expressed interest in changing federal gun control laws to allow cannabis consumers to purchase firearms.
Though it’s not clear exactly how much of a boost either party would get by passing a marijuana reform bill, a Pew poll released last month does show that there’s majority support for legalization among those who lean Republican (55 percent) as well those who lean Democratic (78 percent).
Photo courtesy of YouTube/Rep. Massie.
State Department Warns Travelers About Flying With Cannabis Oil Internationally
The U.S. State Department is warning international holiday travelers that while hemp-derived CBD might be legal in the U.S., it can land you in trouble if you take it certain places abroad.
“Make sure your gift isn’t a fa la la la la la la la la fail,” the department said in a tweet on Thursday. “Bringing along gifts like drones, CBD oils, and firearms can land you in trouble in foreign countries. Research what is and isn’t allowed before you travel.”
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Photo courtesy of Flickr/DHS.