Senators Call On FDA To End Enforcement Discretion

May 24, 2022 Leave a message

In a Senate speech, U.S. Senator Dick Durbin slammed the FOOD and Drug Administration for delays in completing a public health review of the premarket Tobacco Product Application (PMTA) for e-cigarettes. The DEADLINE for the FDA to complete its review of e-cigarette applications was Sept. 9, 2021, more than eight months ago.

On June 13, the regulator submitted an update on the agency's review of e-cigarette applications, saying it would not complete its review of e-cigarettes until July 2023 and that the products under review could continue to be sold.

"These companies flood the market with addictive devices. Companies like Juul, which is partly owned by tobacco companies, understand that they have marketed their products to children, "Durbin said in a press release issued by his office. "These products have not been legally licensed for many years. Who should be the beat cop? The FOOD and Drug Administration, but they're nowhere to be found."

In March, Durbin and 14 of his colleagues led a bipartisan letter calling for the FDA to immediately complete its review of e-cigarettes; Rejecting e-cigarette applications, especially for children's tastes, without proving they are beneficial to public health; And eliminate all unapproved e-cigarette markets.

"I call on the FDA to immediately cease its enforcement discretion and remove all unauthorized e-cigarettes from the market," Durbin said. "Don't let Juul and other tobacco companies endanger our children one more day. Don't cower in front of big Tobacco's well-paid lawyers."