FDA Exploring ‘Flexibilities’ In Marijuana Scheduling Review, But Top Official Says DEA Has ‘Final Word’
A top Food and Drug Administration (FDA) official said on Thursday that the agency is exploring “what flexibilities we might have” when it comes the federal government’s marijuana scheduling review directed by President Joe Biden, which she described as a “very high priority.”
But she said that while FDA will lead the scientific and medical evaluation of cannabis, it is the the Drug Enforcement Administration (DEA) that “has the final word” on any potential scheduling decision. And she pointed out that even doing scientific research into marijuana is “very, very difficult” because of it current restrictive Schedule I status.
Janet Woodcock, FDA’s principal deputy commissioner who formerly served as acting commissioner, spoke about the agency’s role in the scheduling review and the unique challenges of studying Schedule I drugs like marijuana during a webinar organized by the Council for Federal Cannabis Regulation (CFCR) and Thompson Coburn LLP.
She emphasized that FDA conducts “the scientific and medical assessment,” with input from the National Institute on Drug Abuse (NIDA), to develop a scheduling recommendation. And DEA is “not supposed to” second-guess its findings.
That being said, because federal drug scheduling is dictated by DEA statute in the Controlled Substances Act (CSA), it’s the law enforcement agency that gets the final say on whether marijuana is removed from Schedule I. Woodcock also said it’s “very difficult” for scientists to study cannabis under DEA’s current policies.
Don't miss it — perhaps our most dynamic #WEBINAR to date – an in-depth conversation w/ two of the nation's leading cannabis experts from the @US_FDA (#FDA) focusing on the agency’s approach to #cannabis science, policy, and regulation. https://t.co/BMxrp97kHT pic.twitter.com/X1sVkg7sUb
— Council for Federal Cannabis Regulation (@uscfcr) October 15, 2022
The official didn’t offer any particularly specific comments about what she expects to come out of the review or how long it might take, though other top federal agency heads have previously insisted that it will be carried out “expeditiously.” But she stressed that FDA is “agnostic” on cannabis and will work to determine the health risks and benefits of marijuana based on their eight-factor assessment.
If FDA ultimately finds that cannabis has an established medical value, that would directly conflict with its status as a Schedule I drug, which is reserved for substances with no authorized medical use and high abuse potential. Many advocates are hoping that the review will result in a complete descheduling from CSA, which would effectively legalize marijuana under federal law.
Woodcock and FDA Senior Science Advisor Patrick Cournoyer, who also participated in Thursday’s webinar, serve as the chair and lead of FDA’s Cannabis Product Committee, which does cross-agency work to study and craft policies around cannabis.
“We are working diligently on looking at the scheduling of marijuana under the Controlled Substance Act and what flexibilities we might have here,” Woodcock said. “That is a very high priority that the secretary of HHS is very interested in. We’re working closely with our partners at NIDA and also at the assistant secretary for [HHS].”
She didn’t elaborate on what she meant by “flexibilities,” and CFCR did not select a webinar question Marijuana Moment submitted about whether that could mean that the final outcome of the review could be to create an entirely new schedule just for cannabis rather than leaving it in Schedule I, moving it to an existing schedule or descheduling it.
CFCR instructed Marijuana Moment to submit the question directly to FDA press staff, who did not respond to an email.
HHS Secretary Xavier Bacerra said shortly after Biden’s announcement this month that he’d already spoken to FDA Commissioner Robert Califf about the marijuana scheduling review, which he said would be completed “as quickly as we can.”
Other federal officials have similarly committed to quickly proceeding with the review and following up with responsive action, including representatives of the Justice Department and Labor Department.
Rahul Gupta, director of the White House Office of National Drug Control Policy (ONDCP), said on Wednesday that Biden took “historic” action by issuing a mass cannabis pardon and directing the administrative review. And he again said that there’s “clearly” evidence that marijuana has medical value.
But research looking into cannabis has been stymied under federal prohibition, Woodcock said on Thursday, characterizing the challenges of studying Schedule I drugs as “very, very difficult.” NIDA Director Nora Volkow has been especially vocal about the research barriers imposed under the current statute.
Both Woodcock and Cournoyer also dedicated a significant portion of the webinar to talking about hemp and its derivatives like CBD, with the principal deputy commissioner saying that the agency is aware that it’s been “frustrating to people” that it hasn’t released regulations for the marketing of cannabinoids nearly four years since hemp was legalized under the 2018 Farm Bill.
Relatedly, Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to Califf last month, expressing concerns about the protracted timeline for CBD rulemaking since the hemp-derived cannabinoid was federally legalized and the resulting “significant marketplace disruptions and regulatory uncertainly.”
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.
After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said.
At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”
Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. But the agency has generally limited its regulatory enforcement authority to sending warning letters to certain CBD businesses and denying cannabinoid marketing applications.
In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unsanctioned claims about the medical benefits of CBD products they’ve marketed for animals.
FDA also recently warned consumers about marijuana-infused copycat food products that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.
The agency separately issued its first set of warnings to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.
It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.
In May, a top Republican on a key congressional committee also called on leadership to schedule a hearing to hold FDA accountable for its lack of action to set regulations for CBD and delta-8 THC products.
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