At his final hearing before a Senate appropriations subcommittee on March 28, 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.”
As Gottlieb has explained to lawmakers a number of times this year, part of the reason that regulating CBD products is especially complicated is that CBD currently exists as an approved drug in the form of the epilepsy medication Epidiolex, and is also “under substantial clinical investigation.”
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