Following The Two year Anniversary Of FDA Failing To Regulate Unlawfully Marketed Vaping Products, Durbin Again Urges FDA, DOJ To Act
Press Release
"Since FDA missed the court's deadline two years ago, I have sent eight letters raising key questions about FDA's regulatory review process and enforcement actions. You and I have met and spoken by phone several times. And a July 26, 2023, letter from public health leaders representing 24 of the nation's largest cities pleaded with FDA to shut down domestic distribution of unauthorized e-cigarettes that are filling store shelves across the country. Despite these efforts, FDA has failed to meaningfully act. It is unclear what--if anything--will finally prompt FDA to get its act together and take more seriously the risk of the tobacco industry addicting a new generation of kids."
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"In the nearly six months since my correspondence, it is unclear what interagency coordination has taken place between the Food and Drug Administration (FDA) and DOJ to address the public health harm from thousands of unauthorized e-cigarettes that are marketed to youth online and in stores. Because FDA lacks independent litigation authority, DOJ plays an important role in taking enforcement action in response to these violations of the TCA."
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"In response to my March 16, 2023, inquiry, DOJ stated that, "FDA is not required to give notice to or receive approval from the Department before issuing such warning letters or civil monetary penalties.' It is not clear why in these instances FDA has not used its authority to issue CMPs [civil monetary penalties]. In the continued absence of FDA action, my office has referred these cases to DOJ for review and potential enforcement action.
For years, you and FDA leadership have sought to distract from or justify your failures to protect children from being preyed upon by Big Tobacco by touting something around the corner: needing to close the synthetic loophole; a Reagan-Udall review; a summit with DOJ; time for a new Center for Tobacco Products Director to get acclimated. Meanwhile, FDA has missed a federal court deadline by two years, and the problem has only grown worse: the CDC found a 46 percent increase in the number of e-cigarette brands on the market between 2020 and 2022. If you are unwilling to meet this moment, perhaps FDA requires new leadership."
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