Durbin Slams FDA on Failure to Regulate E-Cigarettes, Synthetic Nicotine, Calls on Administration to Finalize Public Health Measure to Ban Menthol Cigarettes

In a speech on the Senate floor, Durbin calls out delays in vaping oversight and implementation of promised ban on the manufacturing and retail sale of menthol cigarettes, as Black communities face disproportionate harm from Big Tobacco’s marketing tactics

WASHINGTON  In a speech on the Senate floor today, U.S. Senate Majority Whip Dick Durbin (D-IL) slammed the Food and Drug Administration (FDA) on its unacceptable failure to protect children from the dangers of vaping as the agency continues to miss and delay critical deadlines.  Durbin has repeatedly criticized FDA for its long-overdue review of pre-market tobacco product applications (PMTAs) from e-cigarette manufacturers, which had a federal court deadline of September 9, 2021.  FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market and addict America’s children.

During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.  In his remarks, Durbin emphasized that communities of color bear the brunt of the addiction, disease, and death from menthol cigarettes as Big Tobacco has intentionally targeted Black Americans in advertising and marketing.  If the rule is implemented, an estimated 650,000 lives, including 255,000 Black Americans could be saved, and eliminate the disparity in lung cancer deaths between Black and White Americans.

Durbin said, “I know this President cares deeply about the toll of cancer.  It has touched his family personally, as it has mine.  If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes.  Lives hang in the balance.”

After repeated delays, FDA had told the U.S. District Court for Maryland that it would finish reviewing all major e-cigarette applications by December 31, 2023.

Durbin said, “The FDA is now 28 months past the original court-ordered deadline to complete this review.  That is not only unacceptable, it’s embarrassing.  Here’s why that’s a problem.  The law is clear that no vaping or tobacco product can be on the market without first proving to the FDA that it is, ‘appropriate for the protection of public health.’  Yet, thousands of products continue to flood store shelves and addict America’s children, without having met that bar of proof.  The FDA has the power and responsibility to protect public health by enforcing this pre-market review requirement, but it appears to be giving Big Tobacco a free pass.”

During his speech, Durbin cited other ways FDA had missed crucial deadlines, including failing to meet a statutory deadline for the regulation of synthetic nicotine products—an authority that FDA itself asked for.  Durbin and Senator Susan Collins (R-ME) successfully secured a bipartisan provision in the Fiscal Year 2022 Omnibus Appropriations bill that clarified FDA’s ability to regulate products containing synthetic nicotine as tobacco products. This legislative fix was necessary to close legal loopholes that manufacturers of kid-friendly, flavored e-cigarettes sought to sidestep FDA regulation, which had the potential to erase recent progress made toward curbing the nationwide youth vaping epidemic.  The new law required FDA to clear the market of all unauthorized synthetic nicotine products by July 13, 2022—18 months ago.

“Since then, FDA has failed to issue a single marketing denial for a synthetic nicotine vape application.  And worse, e-cigarettes using synthetic nicotine are now the most popular tobacco products used by children,” Durbin said.  “The consequences for our children are devastating.  According to the Surgeon General, e-cigarettes can damage the lungs, heart, mental health, and parts of the brain that control attention and learning.”

During his speech, Durbin cited two instances where he has heard from Illinoisans about the dangers of  youth vaping.  Durbin received a letter from the Chicago Teachers Union and a letter from the Regional Superintendent of Schools for five of the southern-most counties in Illinois: Alexander, Jackson, Perry, Pulaski, and Union Counties.

Durbin concluded his speech by calling on FDA Administrator Dr. Robert Califf to finally use the regulatory and enforcement tools within the agency’s jurisdiction to address vaping, as he approaches the two-year anniversary of his Senate confirmation on February 14.

Durbin has been a vocal leader in the fight against Big Tobacco, particularly since he lost his father to lung cancer at the age of 14.  He went after Big Tobacco when he served in the House of Representatives and led the charge to ban smoking on airplanes, which eventually lead to restaurants, office buildings, trains, and much more.  Durbin has also led efforts to grant FDA jurisdiction over tobacco, raise tobacco taxes to prevent youth initiation, and enhance support for tobacco cessation tools. 

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.