U.S. lawmakers are urging the Food and Drug Administration to end its review of pending premarket tobacco product applications for e-cigarettes, Law360 reported.
U.S. lawmakers are urging the Food and Drug Administration to end its review of pending premarket tobacco product applications for e-cigarettes, Law360 reported.
In a letter to FDA Commissioner Robert Califf, 50 members of Congress asked the agency to complete its review of pending applications for vaping products; reject all applications for non-tobacco-flavored vaping products, including menthol and to remove from the market all synthetic nicotine products, including those pending application, using the enforcement tools already provided to the agency.
The call from lawmakers came after the FDA failed to meet a court-imposed deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In a recent court filing, the FDA said it would not complete its review of the product with the largest market share until December 2023.
"The FDA's repeated delays in removing flavored e-cigarettes from the market are putting children's health at risk," Rep. Diana DeGette of Colorado said in a statement. The FDA needs to step up its enforcement against these harmful products and take them off the shelves immediately. Every day these products remain on the market, the more harmful they are to the health of young people.
While the FDA has completed reviews of many vaping products, it has not yet completed reviews of the thousands of pending applications — including those for popular products made by Juul Labs, Reynolds Vapor Co. and Smok.
Lawmakers urge agency to complete review of all pending applications no later than December 31, 2023
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