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Jun 11 2021

The youth e-cigarette epidemic could have been prevented if the Food and Drug Administration had done its job of regulating e-cigarettes, instead of allowing them to stay on the market for years without undergoing a review of their public health impact. 

While Congress expressly gave FDA the responsibility to regulate tobacco products in 2009, repeated regulatory delays gave e-cigarette manufacturers 11 years to operate with minimal federal oversight. After finally facing a September 2020 deadline for e-cigarette manufacturers to submit premarket applications (known as PMTAs), FDA has begun reviewing the millions of product applications to determine whether these new tobacco products are “appropriate for the protection of public health.”

While the agency is supposed to conduct its review of those products in one year, FDA’s Center for Tobacco Products director has admitted “the likelihood of FDA reviewing all of these applications during the one-year review period is low,” foreshadowing yet more delays in necessary and urgent regulatory action.

Read the entire article here.