May 24, 2022
FDA Commissioner Dr. Robert Califf said last week he’s committed to moving forward on a pathway for CBD, but he suggested the agency doesn’t have the current authorities to do so today and will require collaboration with lawmakers on Capitol Hill.
“I don’t think the current authorities we have on the food side, the drug side, necessarily give us what we need to have to get the right pathways forward,” Califf said in response to a question from Rep. Dan Newhouse, R-Wash., during a May 19 hearing held by a subcommittee of the House Committee on Appropriations. “We’re going to have to come up with something new. I’m very committed to do that.”
Rep. Mark Pocan (D-Wis.) then asked Califf about possibly regulating CBD as a food and whether there was any timeline for doing so. The agency has asserted for years it’s unlawful to add CBD to food or market it as a dietary supplement.
“The research so far has shown that there are some risks with CBD, and so we’re going to need a different pathway than just the standard food pathway,” Califf responded.
He added, “I’m committed to do something about this, and it’s going to take some work. I hope that you’ll work with me on that because it’s going to take some creativity.”
Industry stakeholders have been frustrated by the agency’s purported lack of progress in regulating CBD as either a dietary supplement and/or a conventional food, despite the prevalence of CBD in U.S. commerce.
“It’s hard to go anywhere these days without seeing a CBD store on the corner or finding some kind of food or dietary supplement that contains CBD,” Manatt, Phelps & Phillips LLP Partner Rachel Sher said during an April 29 fireside chat she hosted with two FDA officials.
Kimberlee Trzeciak, FDA’s associate commissioner for legislative affairs, described the CBD issues as “complex,” considering the myriad products in the marketplace.
“Whether it’s a personal care product that has the CBD in the lotion, or if it’s something you’re ingesting, whether it’s a dietary supplement or perhaps a food or a beverage, they all are uniquely regulated today, and so it doesn’t fit in a neat square,” she explained.
Califf recalled dealing with CBD issues during his previous stint as FDA commissioner from February 2016 to January 2017, but even he seemed to acknowledge a lack of progress at the agency.
“When you come back six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” he told Pocan.
Former FDA acting commissioner Janet Woodcock, M.D., will chair FDA’s collaborative group on cannabis, which brings together various FDA offices such as the food and drug sides, FDA chief of staff Julia (Julie) Tierney shared during the April fireside chat.
While serving as acting commissioner, Woodcock last year acknowledged a “stalemate” between FDA and companies seeking a lawful pathway to market for CBD in dietary supplements—and she suggested there was no immediate solution on the horizon at FDA.
“In my reading, the law is fairly clear about this, and so it puts us in a stalemate position,” she said during a Sept. 9, 2021, conference hosted by the Consumer Healthcare Products Association (CHPA). “We also need additional data on the safety of lower doses and how that might be controlled, say, in the supplement market. How could you manage exposure of consumers?”
In October, FDA released a “Cannabis-Derived Products Data Acceleration Plan,” which the agency described as “a portfolio of pilot initiatives and partnerships focused on advancing data-driven safety signal detection and building advanced technology capabilities.”
“As you alluded to, you see CBD products everywhere on every corner, and so that is challenging,” Tierney said in her exchange with Sher, the Manatt attorney who focuses on FDA regulations. “This is not a traditional drug product that you just say, ‘Ok, we’ll go through that pipeline and have some approved products on the other side.’”
Tierney added, “And I think we really do owe it to the American people to understand the safety, which is hard when you have a product that is present in lotions and gummy bears, whatever else, things that are quasi-medical, and so that’s a key part of the data acceleration plan.”
FDA has combined the CBD Policy Working Group with the Marijuana Working Group, renaming the group the Cannabis Product Committee in February 2021, according to FDA spokeswoman Courtney Rhodes.
“The reorganization and renaming addressed the overlap between the work of the two groups,” she explained in an email to Natural Products Insider. “The CPC will continue to serve as the FDA’s cross-agency regulatory policy and science committee for cannabis-derived products, including CBD.”
Congress may be part of the broader solution to the complexities around CBD. H.R. 841—The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, which would regulate CBD in dietary supplements—counts more than three dozen bipartisan co-sponsors. Other bills to regulate CBD in dietary supplements and conventional food also have been introduced in Congress.
FDA’s Trzeciak said the agency should focus on better understanding “the science and the safety here, and so that’s going to require additional research and additional work with sponsors.”
“And so hopefully, we’ll find a path forward for these products,” she added, “but it will take work not just within the agency, but also work with the sponsors and [Capitol Hill] to figure out what the best way is to achieve this goal.”
Reaction from U.S. Hemp Roundtable
Jonathan Miller is general counsel to the U.S. Hemp Roundtable, whose members include prominent CBD brands. Miller was encouraged by Califf’s recent remarks.
“Acting Commissioner Woodcock had basically thrown up her hands and said, ‘We’re in a stalemate,’ and now Commissioner Califf is very clear that he’s frustrated that nothing’s happened over the last six years since … he held the office last time, and that he’s committed to developing a pathway for CBD,” Miller said in an interview.
“The words are great; now, we’re hoping for action,” he added. “We’d love to see that action come in the form of something like ‘enforcement discretion’ that the agency just proposed for NAC (N-acetyl-L-cysteine).”
In a May 23 letter to Califf, Miller requested FDA also use enforcement discretion for dietary supplements containing hemp-derived CBD and other legal hemp ingredients. He cited safety studies on CBD, including the second phase of a study completed earlier this year, that he maintained addresses FDA’s safety concerns regarding CBD.
“The Validcare study provides data that addresses FDA’s specific safety concerns regarding CBD, with the results indicating that daily CBD consumption across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels or daytime drowsiness,” Miller wrote to Califf.
In the interview after the letter was sent, Miller also expressed hope that FDA would eventually support a pathway for CBD in legislation.
“To date, from what we hear from congressional staff, FDA’s staff has been opposing our legislative initiatives,” he shared. “And while they’ve sat down with us probably half a dozen times in the last few years, they’ve never been willing to talk about legislation. We’re asking Dr. Califf to break the stalemate here and to get his staff to the table so that we can hammer out a legislative solution if that’s what’s needed.”
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