Durbin, bipartisan senators slam FDA's 'repeated failures' at vaping regulation

A bipartisan group of senators on Wednesday slammed the "repeated failures" at the Food and Drug Administration (FDA) to regulate e-cigarettes and take action against companies illegally marketing products to minors.

Led by Sen. Dick Durbin (D-Ill.), the lawmakers sent a letter to Health and Human Services Secretary Xavier Becerra urging him to "do everything in your power to right the ship and take meaningful action to fix FDA’s persistent leadership failures and prevent youth from a lifetime of nicotine addiction."

The FDA is currently 16 months past a court-ordered deadline to finish reviewing e-cigarette applications, and the lawmakers criticized the agency for saying it needs another six months to complete its work for the e-cigarettes with the largest market share. An estimated 1 million children may now be at risk of picking up vaping before the FDA finishes its review, Durbin said. 

Durbin has been a leading Senate advocate against youth vaping and has repeatedly called for federal regulators to do a better job protecting children by immediately removing e-cigarettes and vaping products from store shelves.  

"For nearly a decade, the agency has neglected its duty under the law to regulate e-cigarettes, jeopardizing the health of millions of children. Now, after yet another delay in FDA’s efforts to regulate the e-cigarette marketplace, it is now clear to us that FDA is adrift and lives are at risk," the lawmakers wrote.

The U.S. District Court for the District of Maryland ordered the FDA to finish reviewing e-cigarette applications by Sept. 9, 2021. But the agency has only completed reviews of about half of those e-cigarettes, the lawmakers said.

"Some of the most popular e-cigarettes used by children today do not have market authorization but are on store shelves only because the FDA has granted a free pass and decided to exercise enforcement discretion," they wrote.

The FDA was given the authority to regulate the marketing, manufacturing and distribution of tobacco products in 2009 when Congress passed the Tobacco Control Act. 

But an independent report from the Reagan-Udall Foundation released in December found the FDA’s “failure to take timely enforcement action jeopardizes public health and undermines credibility and effectiveness in tobacco product regulation.”

The report faulted the FDA's inconsistent approach to regulation for being at least partially to blame for the popularity of vaping among young people.

Instead of proactively creating regulations, the report found the agency's tobacco center has been “forced to operate primarily in a reactive mode, moving from one challenge to the next."

Brian King, the head of the FDA's tobacco division, published an update on Tuesday saying the center would respond to the Reagan-Udall report later this month.