Scott Gottlieb, the Food and Drug Administration’s Commissioner who is stepping down soon, spoke at his final hearing before a Senate appropriations subcommittee on Thursday.
The outgoing chief discusses the agency’s plan to regulate hemp-derived CBD products.
Sen. Patrick Leahy (D-VT) asked Gottlieb how he thinks the FDA should use discretion in its enforcement efforts.
“We’re using enforcement discretion right now,” said Gottlieb. “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over-the-line claims.”
According to Gottlieb, people who market CBD and claim “that it can cure cancer or prevent Alzheimer’s disease” will be subject to enforcement action “because that can mislead a patient into forgoing otherwise effective therapy.”
“But there are products on the market right now that, given our enforcement priorities and our limited resources, we haven’t taken action against,” he added. “That’s not an invitation for people to continue marketing these products—we’re concerned about it—but we heard Congress loud and clear here.”
“Even if it wasn’t an approved drug, because it was never previously in the food supply, we don’t have a clear route to allow this to be lawfully marketed short of promulgating new regulations,” he also said.
“There is precedent for Congress legislating in the context of a single ingredient,” Gottlieb said to Sen. John Hoeven (R-ND). “You could, for example, contemplate a scheme here where Congress gave FDA authority to contemplate CBD as a food ingredient at certain concentrations and potency and purity and then have it exist separately as a drug product at a different concentration, different potency and purity.”
“Fish oil, for example, exists that way in the marketplace,” he said. “But fish oil, we didn’t need to come up with a legislative option to do that because it was previously in the food supply. CBD, obviously, it was not.”
