[Congressional Record Volume 168, Number 149 (Thursday, September 15, 2022)]
[Senate]
[Page S4630]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                              E-Cigarettes

  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.