[Congressional Record Volume 169, Number 146 (Monday, September 11, 2023)]
[Senate]
[Pages S4340-S4341]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                         FDA and Appropriations

  Now, Mr. President, on another subject, this weekend marked 2 years, 
the second anniversary, since the Food and Drug Administration missed a 
Federal court-ordered date to finish its review of vaping applications, 
e-cigarette applications that have illegally flooded the market in the 
United States.
  We estimate that during that 2-year period of time when the FDA 
refused to respond to the Federal court order, approximately 2 million 
American children may have started vaping; and despite missing this 
deadline by 2 years, the Food and Drug Administration remains nowhere 
close to meeting the legal mandate to regulate these addictive e-
cigarettes.
  You see, under the law, a vaping product is required to apply first 
to the FDA before entering the market and prove to the Food and Drug 
Administration that the e-cigarette is, in the law--this is from the 
law--``appropriate for the protection of public health.''
  They can't prove that. This has not happened. Instead, tens of 
thousands of dangerous, highly addictive e-cigarettes have illegally 
shown up on store shelves without FDA review or approval, and they have 
hooked a generation of kids. In fact, studies have shown that there are 
more vaping devices on the market today than 2 years ago when the FDA 
was ordered by a Federal court to do so. That is unacceptable.
  My office recently investigated the FDA's effectiveness in following 
through even after it issues a denial for a vaping application. So a 
company comes to the FDA, submits their product. It is supposed to show 
how it is consistent with public health. It fails to do so. They are 
told not to sell the product in America.
  And what do they do? We found that many FDA-denied e-cigarettes which 
subsequently received warning letters for continuing to sell in 
violation of the law still remain available. I just don't understand 
it. The Food and Drug Administration is cowardly, refusing to use its 
full arsenal of enforcement tools--fines, injunctions--for even the 
most flagrant cases. We also found that the FDA has only issued 
``closeout letters'' to 10 percent of the tobacco products that it had 
warned were violating the law.

  The Administration, the Food and Drug Administration, has the 
authority to decide whether a vaping device or cigarette can be sold. 
If they decide it cannot be, they tell them: You have got to stop at 
this point.
  How many actually followed the warning and refused to violate the 
law: 1 out of 10, meaning the Agency has one of the worst records in 
history of

[[Page S4341]]

following through and ensuring compliance with enforcement.
  I have referred all this information to the Department of Justice. 
Maybe they will take action.
  Let me be clear. None of the most popular e-cigarettes used by kids 
have been granted the authority to be sold in the United States by the 
Food and Drug Administration, yet they remain on the market in 
violation of the law, putting our children and teenagers in harm's way.
  This isn't the only instance where the FDA's delays are dangerous. 
Last month, the FDA blew through a deadline to finalize rules to 
prohibit menthol-flavored cigarettes and flavored cigars. This 
regulation is also long overdue and has the potential to save thousands 
of lives. The FDA must end its delays.
  This week, we are going to embark on a task that is really rare. The 
full U.S. Senate, this week, is going to consider three government 
spending bills. You say to yourself: Well, I am sure that has happened 
before. Yes, about 5 years ago; and since then, what we have done is 
wait until the very last minute when all hell is about to break loose 
and create omnibus spending bills. But this year we are actually going 
to bring an appropriation bill to the floor in the Senate. It is a 
cause for celebration.
  This package includes appropriation bills for agriculture, which 
funds the Food and Drug Administration. In light of the FDA's 
embarrassing delay in reviewing these products and keeping them away 
from kids, I am preparing amendments to the bill to improve regulatory 
and enforcement efforts. I hope my colleagues will join me in this 
effort to protect children from Big Tobacco. It cannot be business as 
usual for the Food and Drug Administration and its commissioner. We 
have to do something.
  I am glad to say that the bills we are considering this week include 
bills that have had strong, overwhelming bipartisan support. In 
addition to agriculture, it will be the military construction and 
veterans affairs bill and the transportation, housing, and urban 
development spending bill. Each bill makes significant investments in 
America.
  These bills would provide veterans with the mental health services 
they deserve; strengthen and improve our Nation's infrastructure; and 
ensure women, infants, and children can get the nutrition that they 
need.
  My colleagues on the Senate Appropriations Committee, led by Chair 
Patty Murray, my fellow Senator from the State of Washington, and 
Ranking Member Susan Collins, my friend and Senator from Maine, worked 
across the aisle to pass all 12 bills out of committee.
  I know that the Presiding Officer is new to the Senate, but I want to 
tell you, this is also new to the Senate. It has been so seldom that we 
have ever had two working together so well on a bipartisan basis, and I 
commend them both.
  The leaders of each subcommittee drafted bills to the levels agreed 
upon in the debt ceiling deal made between the Republican-controlled 
House of Representatives and President Biden. Remember when we were 
facing that debt ceiling debate and afraid that our government--maybe 
our economy--would shut down and Joe Biden stepped in and negotiated 
with the Speaker of the House, Republican Kevin McCarthy, and they came 
up with a spending plan on a bipartisan basis so that they could pass 
the bill for the debt ceiling? That was just a few months ago.
  Now, a handful of Republicans in the House say: Throw out the deal; 
let's start over--with the risk of shutting down the government as a 
very real possibility for them. It would be the height of 
irresponsibility and a painful decision that would hurt veterans, 
people receiving Social Security, and innocent people across America. I 
hope that Kevin McCarthy will stick by his agreement with President 
Biden, and I hope that he will tell the extremists in his caucus this 
is no way to run a country.
  The Senate is making good on its promise on this side of the Rotunda 
to the American people by working to fund the government through 
regular order through our appropriation bills.
  I wish our Republicans in the House could say the same. They have 
drafted bills to levels wildly less than those that were agreed on. 
Here is where they think we should make cuts: education, medical 
research, public safety, public health programs, and more. And so far, 
they have been unable to pass all of these partisan drafts out of 
committee.
  Here in the Senate, we are following regular order and working to 
avoid a shutdown and fund the government without interruption because 
we have seen the ramifications of putting politics above our duty to 
the American people. Shutdowns severely reduce our gross domestic 
product, force families to go without paychecks, and signal to our 
adversaries that we hesitate to make the critical investments necessary 
to remain competitive and keep our country secure.
  Last week, I was pleased to hear Senate minority leader Senator 
McConnell, who just left the floor, say we need to ``keep the lights 
on'' by funding the government through regular order. I couldn't agree 
with him more. I hope our House Republican colleagues will heed this 
message and meet with us to meet this moment in history.
  Today is a day of history. Let's make our own in the future in a much 
more positive way, and I am confident we can.
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Murphy). The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. TUBERVILLE. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.