Durbin Again Urges FDA to Use its Authority to Protect Children, Stop Unlawfully Marketed Vaping Products in 2024
In the letter, Durbin calls out repeated delays in vaping oversight and enforcement for e-cigarettes, including synthetic nicotine vapes targeted at kids
WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) again urged the Food and Drug Administration (FDA) to use its authority to protect children from the dangers of vaping as the agency continues to miss and delay critical deadlines in a letter to FDA Commissioner Dr. Robert Califf. 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.
“This repeated failure to meet FDA’s own stated projections tells us FDA is not meeting its obligations under the court order. Given these delays, and with no end in sight, there is absolutely no reason why FDA continues to permit unauthorized e-cigarettes to remain on store shelves. FDA has the tools and the authority to clear the market of unauthorized products today, yet the agency instead is granting a free pass to scores of vaping products that are harming the health of children in our country,” the letter stated.
In the letter, 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.
The letter continued, “I have sought to assist FDA in its mission through legislative, regulatory, funding, and public awareness efforts. But the simple truth is that FDA does not appear to want to meet court orders or statutory requirements. Your unwillingness to utilize FDA’s arsenal of enforcement tools and the repeated apparent deference to industry is at the expense of our children. What could be more important than the health of our children?”
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 led 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.
Full text of the letter can be found here and below:
January 16, 2024
Dear Commissioner Califf:
Another Durbin vaping letter for you to ignore.
As we begin a new year, it appears very little has changed in the Food and Drug Administration’s (FDA) shamefully inadequate enforcement of the Tobacco Control Act against e-cigarettes that are addicting America’s children. Despite modest and long-overdue actions to forge interagency collaboration and conduct enforcement in the most flagrant of cases, the FDA’s delays in completing its reviews of premarket tobacco product applications and failure to remove all unauthorized e-cigarettes pose a threat to public health.
On January 1, 2024, FDA missed yet another deadline before a federal district court to complete reviews of e-cigarettes with the largest market share and youth appeal. FDA is now 28 months past the court-ordered deadline.
This repeated failure to meet FDA’s own stated projections tells us FDA is not meeting its obligations under the court order. Given these delays, and with no end in sight, there is absolutely no reason why FDA continues to permit unauthorized e-cigarettes to remain on store shelves. FDA has the tools and the authority to clear the market of unauthorized products today, yet the agency instead is granting a free pass to scores of vaping products that are harming the health of children in our country.
At the same time, FDA is now also 18 months past a statutory deadline related to all unauthorized synthetic nicotine products. After you testified to the Senate that, “we’ve got to close this loophole,” Congress acted swiftly to do so, and all unauthorized synthetic nicotine products were prohibited from being marketed after July 13, 2022. While FDA rejected a number of applications that lacked basic required information, the agency’s regulatory delays and timid enforcement has meant in practice that the statutory deadline has come and gone as if the new law never even took effect. It is outrageous that FDA sounded the alarm on this emerging public health threat, but has failed to issue a marketing denial order for a single product, at a time when the most popular e-cigarettes used by children contain synthetic nicotine.
I have sought to assist FDA in its mission through legislative, regulatory, funding, and public awareness efforts. But the simple truth is that FDA does not appear to want to meet court orders or statutory requirements. Your unwillingness to utilize FDA’s arsenal of enforcement tools and the repeated apparent deference to industry is at the expense of our children.
What could be more important than the health of our children?
Sincerely,
-30-