FDA to Reset its Tobacco Program

February 24, 2023

The Food and Drug Administration on Friday announced a plan to improve its tobacco program, responding to criticisms that its lack of direction has hampered regulation efforts.

The head of the FDA’s tobacco center pledged to deliver a five-year strategic plan outlining priorities surrounding the regulation of cigarettes, vape devices and other products. The strategy will also include cleaning up a vast market of largely unauthorized e-cigarettes, as well as provide more transparency to companies regarding its decisions. 

The announcement follows the FDA having rejected more than a million applications from e-cigarette makers seeking to market their products to adults. 

Amid flak from a wide range of critics that include tobacco companies, lawmakers and anti-smoking activists, FDA chief Robert Califf commissioned an external review of the agency’s tobacco program last summer, along with a separate review of its food program.

The report on the FDA’s tobacco program was issued in December. It found the FDA’s workforce to be “reactive and overwhelmed,” struggling to oversee the burgeoning e-cigarette market on top of traditional tobacco products. 

Critics, meanwhile, have hit on all sides. Public health groups accuse the FDA of not being aggressive enough in policing regular and e-cigarettes that appeal to teenagers. Tobacco companies charge that the FDA is unwilling to approve new alternative products— including vape products—that might help adults quit smoking.

The FDA’s tobacco chief, Brian King, said in an interview Friday that regulators are exploring ways to “better communicate” with companies about how the FDA makes decisions. The agency is also working to streamline the review process where possible.

“Some things will take longer than others, but we’re committed to getting everything done that we’ve outlined as expeditiously as possible,” King said.

The tobacco chief added that in response to a recommendation in December’s report, the FDA would meet with DOJ officials to review its efforts to crack down on unauthorized e-cigarettes, particularly the flavored ones that are appealing to kids.

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