FDA Commissioner Dr. Robert Califf said last week hes committed to moving forward on a pathway for CBD, but he suggested the agency doesnt have the current authorities to do so today and will require collaboration with lawmakers on Capitol Hill.

"I dont 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. "Were going to have to come up with something new. Im 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 its 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 were going to need a different pathway than just the standard food pathway," Califf responded.

He added, "Im committed to do something about this, and its going to take some work. I hope that youll work with me on that because its going to take some creativity."

Industry stakeholders have been frustrated by the agencys 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.

"Its hard to go anywher 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, FDAs associate commissioner for legislative affairs, described the CBD issues as "complex," considering the myriad products in the marketplace.

"Whether its a personal care product that has the CBD in the lotion, or if its something youre ingesting, whether its a dietary supplement or perhaps a food or a beverage, they all are uniquely regulated today, and so it doesnt 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, thats telling you that you cant just keep trying to do the same thing over and over," he told Pocan.

Former FDA acting commissioner Janet Woodcock, M.D., will chair FDAs 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 everywher 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, well 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 thats 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 FDAs 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.

FDAs Trzeciak said the agency should focus on better understanding "the science and the safety here, and so thats going to require additional research and additional work with sponsors."

"And so hopefully, well 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 Califfs recent remarks.

"Acting Commissioner Woodcock had basically thrown up her hands and said, Were in a stalemate, and now Commissioner Califf is very clear that hes frustrated that nothings happened over the last six years since … he held the office last time, and that hes committed to developing a pathway for CBD," Miller said in an interview.

"The words are great; now, were hoping for action," he added. "Wed 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 FDAs safety concerns regarding CBD.

"The Validcare study provides data that addresses FDAs 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, FDAs staff has been opposing our legislative initiatives," he shared. "And while theyve sat down with us probably half a dozen times in the last few years, theyve never been willing to talk about legislation. Were 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 thats whats needed."