There are signs that the U.S. Food and Drug Administration is set to make meaningful progress on cannabidiol, or CBD.
The agency has been tasked with crafting rules for CBD products ever since the 2018 Farm Bill legalized hemp, which is defined as cannabis plants containing .3% THC or less. CBD is just one of many compounds that can be derived from the cannabis plant, which are known as cannabinoids. The popularity of CBD has skyrocketed over the past decade, and it can now easily be found in supermarkets, pet stores, and online. But the FDA has made it clear that they need more research and data before they can approve any products, as Cannabis Wire has reported.
However, the FDA’s new commissioner, Robert Califf, said on Thursday that he is “committed” to doing so. His comments came during a hearing on the FDA’s FY 2023 budget held by the House Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
While the hearing largely focused on the shortage of baby formula, two lawmakers pressed Califf on the FDA’s plans for CBD.
“Since the legalization of hemp and hemp products was made several years ago, I believe we’re still waiting on the FDA for some action to be taken and that currently the industry is in a state of uncertainty because of no direction,” Washington Rep. Dan Newhouse said before asking for an update on the FDA’s work.
Califf first responded by commenting on the “amazing plethora of derivatives of the cannabis plant,” calling it “quite profound and astounding.” He then noted that the FDA’s work to-date has been focused on research to assess risks.
“I am very committed to taking a path on this,” he said. “And just to put a marker down, I don’t think 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.”
Perhaps the biggest sticking point with CBD is that it is the main ingredient in an FDA-approved drug called Epidiolex, which is used to treat seizures. And, generally, compounds approved as medicines cannot be added to foods under the Federal Food, Drug & Cosmetic Act. Yet these products are widely available.
“What is FDA’s plan to clarify that CBD could possibly be regulated as a food or a food additive? And is there any timeline?” Wisconsin Rep. Mark Pocan asked.
“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 said. “I’ve told you and I really mean it, 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.”
Califf then referenced the fact that little has changed with regard to CBD at the FDA since he left six years ago (he returned this year).
“You know, that’s telling you that you can’t just keep trying to do the same thing over and over again,” he said.
And it does seem like some change is afoot at the agency. In recent weeks, the FDA confirmed to Cannabis Wire that the Administration had formed a Cannabis Products Council, to be chaired by Janet Woodcock, the FDA’s Principal Deputy Commissioner.