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Failings at FDA’s Tobacco Center Highlighted by Independent Report

December 20, 2022 By Matthew Tabacco
FDA Updates

Cigar Rights of America applauds a new report from the Reagan-Udall Foundation (RUF) that suggests increasing transparency and predictability at the Food and Drug Administration’s Center for Tobacco Products (CTP). CRA participated in the Foundation’s review process, providing comments on the need for sound science, clearer guidance to industry, and prioritization of Agency focus on higher-risk products.

The Reagan-Udall Foundation is an independent entity, created by Congress and staffed by experts, and is tasked with providing operational advice to the Agency. FDA Commissioner Robert Califf requested the review.

The report highlights several operational failings at CTP that have prevented the Agency from achieving its public health mission. Specifically, the RUF found that CTP lacked clarity about its own priorities, resulting in “extraneous work” for industry and the Agency itself and “an inefficient review process.” Recommendations to the FDA included a clearer focus on science and communication with industry to fulfill itsduty to run [the Tobacco Program] efficiently, fairly, and transparently.”

These findings come in the wake of several missteps at FDA that have been pushed back on by the courts. In July 2022, a decision from US District Court Judge Amit Mehta found that FDA’s regulation of premium cigars was not based on sound science. In his ruling, Judge Mehta cited CRA’s comments and stated that the Agency had not adequately responded to them but had instead “resorted to a common refrain to obscure this issue” by saying that FDA lacked sufficient data. The remedy in that case is still pending.

Mike Copperman, Federal Regulatory and Legislative Director of CRA, said, “The RUF report highlights the need for more industry input, clearer science, and increased predictability from FDA. We further believe that the Agency should focus its efforts first on products that pose the highest risks to public health. We look forward to working with FDA to implement these recommendations.”

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