Durbin Calls On FDA Commissioner To Do His Job To Protect Our Children From E-Cigarettes Or Step Aside

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today released the following statement calling on Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to immediately clear the market of unauthorized, kid-friendly e-cigarettes or step aside. The court-ordered deadline for FDA to finish reviewing e-cigarette applications was September 9, 2021, exactly nine months ago, and yet the FDA has still not finished its review of these products—leaving dangerous, kid-friendly e-cigarettes, like JUUL, still available on store shelves to hook children.

Millions of children across America are hooked on e-cigarettes because the Food and Drug Administration continues to fail to do its job. I had hoped and expected that Commissioner Califf would bring a new, urgent commitment to protecting kids and the public health – but it’s now clear I was wrong. 

“Today marks nine months past a court-ordered deadline for FDA to finish reviewing e-cigarette products. And yet, the e-cigarettes most popular with children, like JUUL, have been given a free pass to remain on the market, targeting kids, while the FDA continues to wring its hands over their applications.

“If Commissioner Califf feels no urgency to follow the law and a court order to protect our children from the dangers of nicotine addiction, then he should step aside and let someone else lead.

“Dr. Califf apparently fears the wrath of Big Tobacco more than the verdict of history.”

After years of delay and inaction out of FDA, the U.S. District Court for the District of Maryland ordered the agency to finally begin enforcing its own deeming rule to regulate these addictive, kid-friendly vaping products—specifying that FDA had until September 9, 2021 to finalize review of e-cigarette applications. And yet, nine months later, FDA is still not finished.

Durbin previously sent a letter with ten Senators to Commissioner Califf urging FDA to immediately remove all unreviewed e-cigarettes from store shelves until the agency completes its public health review of these vaping products.  Currently, addictive, kid-friendly e-cigarettes like JUUL are on the market illegally but are being granted a free pass to be sold due to FDA’s decision to grant enforcement discretion. FDA recently 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.

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. The letters build upon an important bipartisan provision that Durbin and many of the letter’s co-signers led in the fiscal year 2022 Omnibus appropriations bill to clarify FDA’s authority over e-cigarettes’ synthetic nicotine. 

The National Youth Tobacco Survey—conducted by FDA and the Centers for Disease Control and Prevention (CDC)—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.