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Floor Speech

Date: Sept. 15, 2022
Location: Washington, DC

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Mr. DURBIN. Mr. President, September 9, 2021, over a year ago, was supposed to be a historic day in America's efforts to stop the purveyors of candy- and fruit-flavored e-cigarettes from preying on America's kids. September 9, 2021, was the deadline, and it was set by a Federal judge for the U.S. Food and Drug Administration to finally-- finally--clear its enormous backlog of applications from e-cigarette companies seeking to sell their products in America.

Companies that can prove that their vaping products are, in fact, ``appropriate for the protection of public health,'' they can go ahead and sell their products legally, but e-cigarette products can't meet that standard. They can't demonstrate a benefit to public health. Vaping, as we know, is dangerous and addictive, and these companies, like the tobacco companies of years gone by, are preying on our children.

FDA had a legal mandate to ban these products from U.S. markets on September 9, 2021, but the Food and Drug Administration failed to meet the deadline--not by 1 day, not by 1 week, not even by 1 month. Last Friday marked the 1-year anniversary of the FDA's failure to meet this Federal court order.

As of today, the FDA has completed reviews of about half of these e- cigarette products that represent a large share of the market. As a result of FDA's inaction, dangerous, kid-friendly e-cigarettes remain available on store shelves without FDA review or authorization. The cops are not on the beat.

There are consequences to this action. The Truth Initiative is a nonprofit consortium of health groups that aims to protect young people from using tobacco. It estimates that, in the year since the FDA missed the court-ordered deadline to approve or reject e-cigarette applications, nearly 2\1/2\ million kids in America started using vaping products. Many of these young people will go on to develop nicotine addictions, with serious harm to their health. That is the human cost of this FDA failure.

Now the FDA says: Well, we might be able to finish this by 2023, 2 years after the Federal court-ordered date. And that is not the only deadline the FDA has blown when it comes to protecting kids from nicotine. After parents and public health groups demanded the FDA take action against candy-flavored, nicotine-spiked e-cigarettes, the vaping industry came out with a brandnew miracle product designed to evade FDA jurisdiction: synthetic nicotine. Products like Puff Bar are incredibly popular with middle and high school students. These new synthetic nicotine products include all the health dangers of traditional e- cigarettes, none of the regulation. When Congress learned about this loophole, we changed the law to say that the FDA had jurisdiction over synthetic nicotine products.

To make matters worse, even when the FDA does review a product and issues a denial, many e-cigarette companies just ignore them. It has reached a point that they are not viewed seriously. The No. 1 regulator of food and drugs in America, when it comes to protecting our kids from these deadly, addictive products, isn't viewed seriously.

The FDA has the legal right and the legal authority to do so. They can pull these products off the shelves tomorrow. Yet, with respect to illegal e-cigarettes, they do nothing--nothing.

Look, I understand they are understaffed. I understand they are underresourced. FDA is not currently authorized to collect user fees for e-cigarettes, as it does for so many other products. And Congress fails to appropriate the funds many times that they need.

These are real problems, but they do not absolve the FDA of its repeated failure to effectively regulate e-cigarettes. I am at my wits' end when FDA continues to miss these court-ordered deadlines, fails to enforce orders, and shows a lack of urgency when it comes to vaping products.

Last week, I asked Health and Human Services Secretary Becerra to step in. If FDA cannot or will not do its job, then it is time for the lead Agency, Health and Human Services, to take a more active role. The FDA cannot continue to let unscrupulous e-cigarette companies flout the law and put their own profits ahead of the health of our kids. This has to stop.

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