Durbin: I'm Calling On FDA To Immediately Halt Its Enforcement Discretion And Remove All Unauthorized E-Cigarettes From The Market

FDA is eight months delinquent on a court deadline to complete review of e-cigarette applications & recently disclosed it will continue delays for an additional 13 months, allowing companies like JUUL to continue addicting kids

WASHINGTON  In a speech on the Senate floor, U.S. Senate Majority Whip Dick Durbin (D-IL) today blasted the Food and Drug Administration (FDA) for failing to meet a court deadline to 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—leaving dangerous, kid-friendly e-cigarettes available on store shelves to hook children.

On Friday, FDA submitted an update on the agency’s long-overdue review of e-cigarette applications. In it, FDA admitted it will not finish reviewing e-cigarettes until July 2023—nearly two years past the court’s deadline. JUUL and other e-cigarettes that get kids hooked on nicotine—and which have not received an authorization from  FDA—may continue being sold for more than a year. 

Durbin said, “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. 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.

Durbin continued, “But what’s most incredible to me is that this outcome is not inevitable. In fact, if it wanted to, the Food and Drug Administration, before the end of business today, could remove these products from the shelves of America. That’s right, addictive e-cigarettes like JUUL are only on the store shelves because the FDA has given the tobacco companies a free pass to sell their vaping products. This is just wrong. This is exactly the opposite of the intent of the law. The FDA is complicit in endangering the health of America’s kids.”

Durbin concluded his speech with an immediate call to action for FDA to rid the market of addictive, harmful e-cigarette products before more children get hooked.

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

The FDA’s and Centers for Disease Control (CDC) and Prevention’s National Youth Tobacco Survey found that more than two million youth used e-cigarettes in 2021.  The National Institute on Drug Abuse’s Monitoring the Future survey found that 19.6 percent of high school seniors used e-cigarettes last year. Approximately 85 percent of youth e-cigarette users report using flavored products.

Video of Durbin’s remarks on the Senate floor is available here.

Audio of Durbin’s remarks on the Senate floor is available here.

Footage of Durbin’s remarks on the Senate floor is available here for TV Stations.