Romney, Durbin Lead Colleagues in Urging FDA to Regulate E-Cigarettes after Six Month Delay

WASHINGTON—U.S. Senator Mitt Romney (R-UT) led a bipartisan letter with Senator Dick Durbin (D-IL) and 13 other senators to Food and Drug Administration (FDA) Commissioner Robert Califf urging the FDA to end its delays in reviewing premarket tobacco product applications (PMTAs) for the e-cigarette products that have fueled the youth vaping epidemic. In the letter, the senators reiterated that the deadline for FDA’s review was six months ago as mandated by a U.S. District Court Judge for the District of Maryland.

The senators also urged FDA Commissioner Califf to promptly complete review of all pending e-cigarette applications; continue to rigorously apply the statutory standard for authorizing any e-cigarette and issue denial orders for all flavored products, including menthol-flavored e-cigarettes; cease FDA’s illogical discretion and immediately prioritize enforcement against the flavored e-cigarettes with the largest market share and those most popular with youth that continue to be sold without authorization, including those with pending applications; and ensure that all e-cigarettes receiving denial orders are quickly removed from the market. Full text of the letter is available here.

“Contrary to its initial plan, FDA has not prioritized review of e-cigarettes with the largest market share and therefore greatest public health implication. Instead, it has deferred its decisions on the most critical applications—including for those products that are most popular with youth—to the end. As a result, six months after FDA was supposed to have completed its reviews, e-cigarettes that hold the greatest potential harm to public health remain unreviewed and on the market,” the senators wrote.

“Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act’s statutory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users. FDA has the authority and responsibility to halt this grace period today and restore the statutory burden of proof on manufacturers to demonstrate their product is “appropriate for the protection of public health” prior to market entrance,” the senators continued.

“We hope FDA continues to apply this standard as it completes its review of other flavored e-cigarettes, including menthol-flavored e-cigarettes. We are concerned that if FDA were to authorize one or more flavored e-cigarettes, youth would simply switch to those products. This is not a theoretical concern. When FDA removed certain flavored e-cigarettes from the market in 2020, youth migrated to those flavored products that remained on the market. FDA’s game of whack-a-mole does not work,” the senators continued.

“It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine,” the senators concluded.

BACKGROUND:

FDA is still evaluating applications for JUUL and several other flavored e-cigarettes most responsible for hooking children, despite a September 9, 2021, court deadline to complete the review. The FDA has not issued a marketing order or denial for any product since October 2021. FDA’s long-overdue decisions on the PMTA applications will determine the course of the youth vaping epidemic, as e-cigarette manufacturers are required to demonstrate to FDA their products are appropriate for the protection of public health.

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.

Along with Romney and Durbin, the letter was also signed by Senators Tammy Duckworth (D-IL), Sherrod Brown (D-OH), Tammy Baldwin (D-WI), Ron Wyden (D-OR), Elizabeth Warren (D-MA), Tina Smith (D-MN), Ed Markey (D-MA), Richard Blumenthal (D-CT), Jack Reed (D-RI), Jeanne Shaheen (D-NH), Jeff Merkley (D-OR), Maggie Hassan (D-NH), and Sheldon Whitehouse (D-RI).