FDA’s tobacco arm “struggled to function as a regulator”: report

The arm of the FDA that oversees tobacco products has “struggled to function as a regulator” and has been “forced to operate primarily in a reactive mode” a report released Monday by the Reagan-Udall Foundation found.

Why it matters: It is the second independent report that FDA commissioner Robert Califf asked for last summer and comes on the heels of a scathing assessment, also from Reagan-Udall., which found deep cultural and systemic problems at FDA were contributing to vulnerabilities in the U.S. food system.

Zoom in: The tobacco report came from a panel chaired by former FDA chief of staff Lauren Silvis and had a more limited scope and was more measured in its criticisms. But its findings similarly highlight a number of shortcomings within the agency that were self-inflicted.

What they’re saying: The work by the FDA’s Center for Tobacco Products [CTP] has been made more difficult by the sheer volume of product applications it receives, the amount of agency leadership turnover it’s encountered and “near constant litigation” it faces,” the report read.

• It “has also struggled to function as a regulator in part due to some of its own policy choices,” the report read, saying the breadth and timelines related to product review regulations “have been difficult for both stakeholders and CTP to apply in practice.”

Between the lines: Among the problems experienced by the industry in working with the agency is that there is a lack of transparency around what’s guiding its harm-reduction strategies — which then creates a litigation burden for the FDA, said Guy Bentley, the director of consumer freedom at the libertarian think tank Reason Foundation.

• He pointed to an example of a lawsuit filed in April 2022 by Logic Technology after the agency approved the marketing of its tobacco-flavored e-cigarettes, but rejected applications for menthol-flavored versions.
• “It’s a big wakeup call to the Center for Tobacco Products,” he said. “Hopefully, FDA will take on board the recommendations to streamline the process, to ensure clarity and public transparency and that decisions around nicotine products are made on the basis of science, not politics,” he said.