Press release | Press releases | Writing

0


09.12.21

In 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 Acting Food and Drug Administration (FDA) Commissioner Dr Janet Woodcock urging the FDA to complete its Pre-Market Tobacco Product Application Review (PMTA) for the millions of e-cigarette products that have fueled the youth vaping epidemic. In the letter, Durbin reiterated that the deadline for the FDA’s review was three months ago, as mandated by a judge in the U.S. District Court in Maryland.

Manufacturers of electronic cigarettes were required to submit PMTAs to the FDA by September 9, 2020, in order to remain in the market legally. Today, the FDA is still evaluating applications for JUUL and several other flavored e-cigarettes most responsible for hooking children, despite the September 9, 2021 deadline to complete the review. The long-awaited decisions by the FDA on PMTA applications will determine the course of the youth vaping epidemic, as e-cigarette manufacturers are required to demonstrate to the FDA that their products are suitable for the protection of the human body. public health.

Today marks THREE MONTHS after the deadline set by a judge in the U.S. District Court of Maryland for the Food and Drug Administration (FDA) to complete his review and action on pre-market tobacco product applications (PMTA) for the millions of e-cigarette products that collectively fueled the youth vaping epidemic. The overwhelming majority of these products had entered the market illegally without FDA review. Worse, these adapted vaping products to children have remained in the market due to the agency’s failure to start enforcing its regulatory oversight for years, ” Durbin wrote.

As the letter applauded the FDA’s recent efforts to better control the dangerous and addictive e-cigarette market by rejecting claims for millions of products for failing to meet public health requirements, Durbin urged the FDA to act quickly to regulate. the companies most responsible for the conduct of young people. -the use of cigarettes.

“However, the FDA has failed to act on the vaping products with the largest market share and the greatest appeal to children – a troubling and utterly puzzling delay given assurances from the director of the Center for Tobacco Products. , Mitch Zeller, that these same PMTAs would be given priority for consideration. Every day these flavored and child-friendly e-cigarettes remain on the market, more and more children are at risk of developing a dangerous nicotine addiction, “ Durbin continued.

“How many deadlines does the FDA still have to exceed to finally wake up to its public health duty and do the right thing?” ” Durbin concluded.

The full text of the letter is available here and below:

December 9, 2021

Dear Acting Commissioner Woodcock:

Today marks THREE MONTHS after the deadline set by a judge in the U.S. District Court of Maryland for the Food and Drug Administration (FDA) to complete its review and action on pre-market tobacco product (PMTA) claims for the millions of e-cigarette products that have collectively fueled the youth vaping epidemic. The overwhelming majority of these products had entered the market illegally without FDA review. Worse yet, these kid-friendly vaping products have remained in the market due to the agency’s failure to begin enforcing its regulatory oversight for years.

Over the past several months, I have been pleased to see the agency finally right its wrongs by starting to use its powers under the Tobacco Control Act to control the market for dangerous, addictive, and obviously suitable electronic cigarettes. children. Notably, the FDA has rejected claims for millions of products for failing to meet public health requirements set out in law and FDA regulations.

However, the FDA has failed to act on the vaping products with the largest market share and the greatest appeal to children – a troubling delay and quite puzzling given assurances from the director of the Center for Tobacco Products, Mitch Zeller, that these same PMTAs would be given priority consideration. Every day these flavored child friendly electronic cigarettes remain on the market, more and more children are at risk of developing dangerous nicotine addiction.

The FDA finalized the presumption rule in 2016 to assert its authority over e-cigarettes, a promising period for public health. Since then, tobacco and vaping companies have attacked and hooked millions of children. The Surgeon General and the Centers for Disease Control and Prevention have found that these products, especially flavored e-cigarettes, are undeniably and heavily used by children, not adults. How much more time does the FDA have to exceed to finally wake up to its public health duty and do the right thing?

Truly,

CC: Mitch Zeller, Director, Tobacco Products Center, FDA

CC: Dr Robert Califf, candidate for the post of commissioner of the FDA

-30-



Previous post Next post


Share.

Comments are closed.