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15.09.22

During his speech, Durbin also urged his colleagues to pass his bipartisan dietary supplement legislation.

WASHINGTON — In a speech to the Senate today, U.S. Senate Majority Whip Dick Durbin (D-IL) condemned the Food and Drug Administration’s (FDA) failure to meet e-cigarette and drug deadlines. synthetic nicotine, the reluctance to take action against companies that defy agency orders, and the general lack of urgency when it comes to protecting children from the harms of tobacco and nicotine. The court-ordered deadline for the FDA to complete the review of e-cigarette applications was over a year ago, September 9, 2021, and yet the agency only completed the review by about half of these e-cigarettes with submitted applications which account for a large share. out of the market – leaving unsafe, child-friendly e-cigarettes available on store shelves to snag children.

Durbin said, “Due to FDA inaction, unsafe and child-friendly e-cigarettes remain available in stores without FDA review or clearance. The Truth Initiative estimates that in the year since the FDA missed a federal court deadline to approve or deny e-cigarette claims, nearly two and a half million children and young adults have started using vaping products.Many of these young people may develop an addiction to vaping. nicotine, which seriously harms their health.This is the human cost of the FDA’s unwillingness to do its job.

Durbin also condemned the FDA for failing to meet synthetic nicotine application deadlines. Durbin and Sen. Susan Collins (ME-R) successfully secured a bipartisan provision in the FY2022 Omnibus Appropriations Bill that clarified the FDA’s ability to regulate synthetic nicotine products in as tobacco products. This legislative solution was necessary to close legal loopholes that makers of kid-friendly flavored e-cigarettes sought to circumvent FDA regulations, which had the potential to erase recent progress made in curbing the youth vaping epidemic. at national scale. Unfortunately, the FDA also didn’t complete its review of synthetic nicotine products until July 13.e delay, leaving these addictive products on the market without permission and in violation of the law. One of the most popular e-cigarettes among kids today, Puff Bar, uses synthetic nicotine.

“To make matters worse, even when the FDA reviews a product and issues a denial, many e-cigarette companies simply ignore it. It’s gotten to a point where they’re not taken seriously. America’s number one food and drug regulator when it comes to protecting our children from these deadly addictive products is not taken seriously. The FDA has the legal right and legal authority to do something. They can remove these products from the shelves tomorrow. And yet, when it comes to illegal e-cigarettes, they do nothing,” Durbin continued.

Given these continued FDA failures to meet deadlines or enforce prescriptions, Durbin last week sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra to intervene.

During his speech, Durbin also urged his colleagues to tie his bipartisan dietary supplement legislation to an upcoming reauthorization of the FDA’s “user fee” programs. These programs authorize the FDA to collect various user fees from the companies it oversees, including prescription drug and medical device companies.

“A lot of people were surprised to learn that today dietary supplement companies aren’t even required to register their products with the FDA. They aren’t required to tell the FDA what ingredients are in their products,” Durbin said.

Durbin and Senator Mike Braun Dietary Supplements List Act 2022 would require supplement manufacturers to list their products with the FDA, as well as provide basic, common-sense information on ingredients and labels. Durbin is currently pushing for the legislation to be included in any final “user fee” package that reaches the Senate floor.

Durbin concluded, “The FDA is one of the most important agencies of the federal government. He fell on hard times. It is there to protect the health of families across the country, especially our children. Whether it’s dietary supplements, tobacco, or e-cigarettes, we need to make sure the FDA not only has the tools for the job, but uses them.

Video of Durbin’s speech is available here.

Audio of Durbin’s speech is available here.

Footage of Durbin’s floor speech is available here for TV channels.

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