Senator Calls on U.S. FDA to End Enforcement Discretion

In a speech on the Senate floor, U.S. Senator Dick Durbin blasted the U.S. Food and Drug Administration for its delays in complete its public health review of e-cigarette premarket tobacco product applications (PMTAs). The deadline for FDA to finish reviewing e-cigarette applications was September 9, 2021, more than eight months ago.

On June 13, the regulatory agency submitted an update on the agency’s review of e-cigarette applications and stated it will not finish reviewing e-cigarettes until July 2023 and products under review may continue being sold.

“These companies have flooded the market with addictive devices. Companies like JUUL, partially owned by the tobacco companies, understand that they’ve promoted their products to children,” Durbin said, according to a release from his office. “For years none of these products were legally authorized. Who was supposed to be the cop on the beat? The Food and Drug Administration, but they were nowhere to be found.”

In March, Durbin led a bipartisan letter with 14 of his colleagues calling on FDA to finish its review of e-cigarettes immediately; reject applications for e-cigarettes, especially kid-friendly flavors, that do not prove they will benefit the public health; and clear the market of all unapproved e-cigarettes.

“I am calling on the FDA to immediately halt its enforcement discretion and remove all unauthorized e-cigarettes from the market,” Durbin stated. “Don’t allow JUUL and other tobacco companies one more day of endangering our children. Stop cowering before Big Tobacco’s highly paid lawyers.”