FDA Chief Clarifies Enforcement Priorities For CBD Products

FDA Chief Clarifies Enforcement Priorities For CBD Products

At his final hearing before a Senate appropriations subcommittee on Thursday, outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb was again pressed on the agency’s plan to regulate hemp-derived CBD products.

Sen. Patrick Leahy (D-VT) voiced concerns about the “significant regulatory and enforcement uncertainty” surrounding marketing CBD, which has been raised at several hearings since industrial hemp and its derivatives were federally legalized under the 2018 Farm Bill. The senator asked Gottlieb how he thinks the FDA should use discretion in its enforcement efforts.

“We’re using enforcement discretion right now,” the commissioner said. “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over-the-line claims.”

But what constitutes an “over-the-line” claim?

Gottlieb specified that people who are marketing CBD and “claiming 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 said. “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.” Read more

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