Senate Majority Whip Dick Durbin (D-IL) is pressuring the Food and Drug Administration to complete its review of e-cigarette products, arguing that prolonging the process leaves products appealing to underage teenagers on store shelves.
Durbin said that the agency failed to meet the one-year court-ordered deadline to review a range of e-cigarette products and ensure they meet the agency’s requirements, allowing unauthorized products to remain on the market that could be targeting underage people through a manufacturer’s marketing practices.
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“I am deeply concerned that FDA has not taken the steps necessary to complete these premarket reviews and to remove unauthorized products from the market. Youth e-cigarette use remains a serious public health problem, and FDA’s inadequate response is leaving our kids at risk,” Durbin said in a letter to FDA Commissioner Robert Califf and Health and Human Services Secretary Xavier Becerra.
In 2019, a U.S. District Court in Maryland ruled that the FDA had failed to adhere to premarket review requirements under the Family Smoking Prevention and Tobacco Control Act, giving the agency a deadline of Sept. 9, 2021, to review premarket applications for e-cigarette products. The ruling stated that manufacturers could keep their products on the market for an additional year if they filed their applications timely while waiting on the FDA to review them.
The FDA has said it does not anticipate completing its review of the most popular e-cigarette products on the market until 2023.
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Durbin argued that the Department of Health and Human Services should step in to address the issue if the FDA did not review applications in a timely manner.
“The FDA continues to fail our children with its missed deadlines, failure to enforce orders, and general lack of urgency with respect to e-cigarettes and synthetic nicotine products,” Durbin said.
