Durbin To Acting FDA Commissioner: Agency Is Three Months Past Court-Ordered Deadline To Regulate E-Cigarettes
In a letter to Acting FDA Commissioner Woodcock, Durbin cites regulatory delays fueling youth vaping epidemic
WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) today sent a letter to Food and Drug Administration (FDA) Acting Commissioner Dr. Janet Woodcock urging the FDA to complete its review of premarket tobacco product applications (PMTAs) for the millions of e-cigarette products that have fueled the youth vaping epidemic. In the letter, Durbin reiterated that the deadline for FDA’s review was three months ago as mandated by a U.S. District Court Judge for Maryland.
E-cigarette manufacturers were required to submit PMTAs to FDA by September 9, 2020, in order to legally stay on the market. Today, FDA is still evaluating applications for JUUL and several other flavored e-cigarettes most responsible for hooking children, despite a September 9, 2021 deadline to complete the review. 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.
“Today marks THREE MONTHS past a deadline set by a U.S. District Court Judge for Maryland for the Food and Drug Administration (FDA) to complete its review and action on premarket tobacco product applications (PMTAs) for the millions of e-cigarette products that collectively have fueled the youth vaping epidemic. The overwhelming majority of these products had illegally entered the market without FDA review. Worse yet, these kid-friendly vaping products have remained on the market due to the agency’s years-long failure to begin applying its regulatory oversight,” Durbin wrote.
While the letter applauded FDA’s recent efforts to better police the market of addictive, dangerous e-cigarettes by rejecting the applications of millions of products for failing to meet public health requirements, Durbin urged FDA to act quickly to regulate companies most responsible for driving youth e-cigarette use.
“However, FDA has failed to act on the vaping products with the largest market share and greatest appeal to children – a troubling and entirely perplexing delay given assurances by Center for Tobacco Products Director, Mitch Zeller, that these very PMTAs would be prioritized for review. Each day these flavored, kid-friendly e-cigarettes remain on the market, more children are at risk of picking up a dangerous nicotine addiction,” Durbin continued.
“How many more deadlines does the FDA need to blow past to finally wake up to its public health duty and do the right thing?” Durbin concluded.
Full text of the letter is available here and below:
December 9, 2021
Dear Acting Commissioner Woodcock:
Today marks THREE MONTHS past a deadline set by a U.S. District Court Judge for Maryland for the Food and Drug Administration (FDA) to complete its review and action on premarket tobacco product applications (PMTAs) for the millions of e-cigarette products that collectively have fueled the youth vaping epidemic. The overwhelming majority of these products had illegally entered the market without FDA review. Worse yet, these kid-friendly vaping products have remained on the market due to the agency’s years-long failure to begin applying its regulatory oversight.
Over the past few months, I have been pleased to see the agency finally right its wrongs by beginning to use its authorities under the Tobacco Control Act to police the market of dangerous, addictive, and flagrantly kid-friendly e-cigarettes. Notably, FDA has rejected the applications of millions of products for failing to meet the public health requirements set out in the law and FDA’s regulations.
However, FDA has failed to act on the vaping products with the largest market share and greatest appeal to children—a troubling and entirely perplexing delay given assurances by Center for Tobacco Products Director, Mitch Zeller, that these very PMTAs would be prioritized for review. Each day these flavored, kid-friendly e-cigarettes remain on the market, more children are at risk of picking up a dangerous nicotine addiction.
FDA finalized the deeming rule in 2016 to assert its authority over e-cigarettes, a time of promise for public health. Since then, tobacco and vaping companies have preyed upon and hooked millions of children. The Surgeon General and Centers for Disease Control and Prevention have found that these products, especially flavored e-cigarettes, are undeniably and overwhelmingly used by children, not adults. How many more deadlines does FDA need to blow past to finally wake up to its public health duty and do the right thing?
Sincerely,
CC: Mitch Zeller, Director, Center for Tobacco Products, FDA
CC: Dr. Robert Califf, nominee to serve as FDA Commissioner
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