[Congressional Record Volume 170, Number 5 (Wednesday, January 10, 2024)]
[Senate]
[Pages S52-S54]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                      Food and Drug Administration

  Mr. DURBIN. Mr. President, having experienced legislative efforts of 
both the House of Representatives and the Senate, it would be a 
surprise to many people to learn that many Members come to the floor to 
address issues of personal importance to them, something that happened 
in their lives that motivates them to take up an issue, introduce a 
bill, try to create a new law.
  That happened to me in the House of Representatives many, many years 
ago when I first confronted the tobacco issue. I lost my father to lung 
cancer when I was 14 years old, and it was a profound experience, as 
you might guess, in my life.
  And I remembered what he went through in the last 100 days of his 
life, fighting lung cancer and, eventually, succumbing to it.
  And so I took on the tobacco issue in the House of Representatives on 
a personal basis as well as a public basis, trying to reduce the power 
which the Big Tobacco lobby had in the House of Representatives. And 
when I arrived there in 1982, they were the most powerful lobby in 
Washington.
  We were warned as new Members of Congress on both sides--Democratic 
and Republican--don't touch the tobacco issue. It is an issue that is 
very important for us to maintain our majority, and you shouldn't bring 
it up.
  Well, I ignored that advice and introduced several ideas on reducing 
the power of the tobacco lobby on Capitol Hill. The one issue that I 
pursued with success had a profound impact on this country--much more 
than I ever imagined. I introduced the first bill, successful bill, in 
the House of Representatives to ban smoking on airplanes.
  It seems so obvious today that it would be a fiction to suggest that 
there is a smoking and nonsmoking section

[[Page S53]]

on an airplane. We know that those people who were smoking were 
generating secondhand smoke, which was dangerous as well.
  Well, with an amazing bipartisan majority, we passed my bill to ban 
smoking on airplanes. It was taken up by Senator Frank Lautenberg here 
in the U.S. Senate successfully, signed into law, and the rest is 
history, as they say.
  What we did not anticipate was that this law, in and of itself, was 
going to be a tipping point. People thought and said: Wait a minute, if 
secondhand smoke is dangerous in an airplane, why wouldn't it be 
dangerous in a bus? on a train? in an office? in a hospital? in a place 
of work? in a restaurant? And the next thing you know, we saw a 
dramatic change over the years in the attitude towards smoking.
  New Members of Congress historically, before that was passed, would 
head to the stationery shop as soon as they were elected to buy an 
ashtray to put on the coffee table in their office for those visitors 
who wanted to smoke while they were meeting with the Senators and 
Congressmen. That is unthinkable today. I am not even sure they sell 
the ashtrays anymore. They used to be embossed with a big Congressional 
seal.
  Things started changing across America, and one of the things that 
led to that change was the discussion of the impact of tobacco on 
children.
  We knew that tobacco, with its chemical nicotine, was addictive. And 
we knew that kids, naturally, being told not to touch a tobacco 
product, started using them as soon as they could; and many of them 
developed an addiction even before they graduated from high school. So 
we started requiring warning labels and restricting retail sales to try 
to protect kids from this addiction.
  It was an ongoing battle because the tobacco companies were powerful 
and profitable and had many friends in high places, particularly here 
in Washington. I continued that battle over the years in the House and 
in the Senate with some success, dramatically reducing the percentage 
of children who were using tobacco.
  The tobacco companies knew that they were in trouble. That was their 
source of addicted people who, when they became adults, bought their 
products for the rest of their lives until they died from that 
addiction.
  And so these tobacco companies started a new campaign. It wasn't 
based on tobacco but on the chemical nicotine and the addictive nature 
of it. And they created something called vaping and e-cigarettes. And 
who did they go after? Kids, of course.
  They had fruit-flavored vaping devices that looked like they belong 
in a computer or in a school bag going off to grade school and high 
school. And these kids started buying them and using them; and so I 
switched my campaign not exclusively from tobacco but to vaping as 
their latest Big Tobacco product that was addicting children.
  I have asked the Food and Drug Administration, through many 
administrations, to basically police this product as they would a 
tobacco product, and they have promised that they would. I come here 
today to make a report, one very good piece of news and one very bad 
piece of news about that effort.
  First, I want to thank the Supreme Court which, on Monday, left in 
place a California law banning the sale of flavored cigarettes. That is 
great news for kids and communities of color who have been preyed upon 
by Big Tobacco's aggressive marketing with flavored products.
  We know that flavors play a unique role in hooking new smokers 
because they mask the harsh taste of tobacco and turbocharge the 
addictiveness of nicotine.
  In particular, we know that menthol cigarettes have been purposely 
targeted at Black communities for decades with heavy advertising, 
sponsorship of events, and free samples. It has contributed to the fact 
that Black adults in America are 30 percent more likely to die from 
heart disease and 50 percent more likely to die from a stroke compared 
to Whites.
  There is a Federal proposal on the table now to prohibit the 
manufacturing and retail sale of menthol cigarettes. That rule would 
save an estimated 650,000 lives, including 255,000 Black Americans. It 
would eliminate the racial disparity in lung cancer deaths between 
Black and White Americans.
  I know this President cares deeply about the toll of cancer. It has 
touched his family personally, as it has mine. If we want to make a 
difference in the health of Americans and set a legacy for future 
generations, then the administration must finalize this public health 
measure to end Big Tobacco's predatory promotion of menthol cigarettes. 
Lives hang in the balance. That is the good news out of California and 
the Supreme Court.
  Here is the bad news. Robert Califf is the head of the Food and Drug 
Administration. Two years ago, he was approved by the Senate in a very 
close vote; it was 50 to 46. If two Senators had gone the other way, he 
would not be the Commissioner of the Food and Drug Administration.
  He came to my office and made a plea that I vote for him. I was 
planning on voting against him. He ended up getting five Democrats 
voting against him and six Republicans who voted for him, and that made 
the difference in the final rollcall.
  On the final rollcall, because he looked me in the eye in my office 
in this building and promised that he would take on the vaping 
interests, I voted for him. It has been a miserable disappointment to 
see what he has done with that office when it comes to this issue.
  As the calendar turns to 2024 and the new year, I am afraid that it 
has not brought any change in the Food and Drug Administration's 
shameful, abysmal job of preventing tobacco companies from addicting 
our children.
  On January 1, the Food and Drug Administration missed yet another 
court-imposed deadline to finish reviewing 
e-cigarette applications. Even after repeated delays, the FDA had told 
the U.S. district court for Maryland that it would finish reviewing e-
cigarette applications by December 31, 2023. It failed. That deadline 
came and went.
  The FDA is now 28 months past the original court-ordered deadline to 
complete this review. That is not only unacceptable, it is 
embarrassing.
  Here is why that is a problem: The law is clear that no vaping or 
tobacco product can be put on the market without first proving--
proving--to the FDA that it is--listen--``appropriate for the 
protection of public health.''
  In other words, the industry, the vaping industry, has the legal 
burden of proof to prove that their product will protect the public 
health. Vaping companies cannot do that. We know they can't. Yet 
thousands of products continue to flood store shelves and addict 
America's children without having met that bar of proof.
  The FDA has the power and the responsibility to protect public health 
by enforcing this premarket review requirement, but it appears to be 
giving Big Tobacco a free pass day after day, week after week, month 
after month, despite court orders to the contrary.
  While the FDA has missed a court-ordered deadline, it also failed to 
meet a statutory deadline for the regulation of synthetic nicotine 
products, an authority that the FDA asked us in Congress to provide. 
You see, vaping companies thought they found a loophole in the law by 
using nicotine that was synthesized in a lab, rather than derived from 
a tobacco leaf. They thought they could skirt FDA regulation by 
exploiting this ambiguity in the law.

  The same FDA Commissioner I referenced earlier, Dr. Robert Califf, 
testified to the Senate: We have to close this loophole. He pleaded 
with us to close it, and we did.
  Senators Collins, Murkowski, and several others joined me to lead a 
bipartisan effort to clarify FDA's jurisdiction over synthetic 
nicotine. The new law required the FDA to clear the market of all 
unauthorized synthetic nicotine products by July 13, 2022--18 months 
ago--and they have failed. After asking us for this authority, after 
our passing the law and having it signed by the President, they have 
ignored the law and the requirement to clear the shelves since 2022. 
Since then, FDA has failed to issue a single marketing denial for a 
synthetic nicotine vaping application.
  Worse yet, e-cigarettes using synthetic nicotine are now the most 
popular tobacco products used by children. There are many examples of 
that.

[[Page S54]]

Think about that for a moment. The FDA Commissioner comes here and 
says: My hands are tied. I cannot regulate e-vaping to protect kids 
because they are using synthetic nicotine and we are not sure the law 
covers it.
  We change the law and tell them: Now you can proceed. Enforce this 
law that you have asked for, and do it 2 years ago to make sure these 
products are not on the shelves.
  They ignore it. After calling for our passage of the bill, they 
ignore the reality, and the shelves are stocked with these e-cigarette 
synthetic nicotine products that kids are using across America.
  The consequences for our children are devastating. According to the 
Surgeon General, e-cigarettes can damage lungs, heart, mental health, 
and parts of the brain that control attention and learning. Don't just 
take it from me. I recently received a letter from the Chicago Teachers 
Union. Here is what it said:

       Teachers have noticed a growing frequency of disposable 
     vapes in our schools. These products come in colorful 
     packages and fruity, kid-friendly flavors that are pushed on 
     social media. . . . Some even look like school supplies.

  And it is not just the big cities like Chicago. Last month, I also 
received a letter from the regional superintendent of schools for five 
of the rural areas, southernmost parts of Illinois: Alexander, Jackson, 
Perry, Pulaski, and Union Counties. They said:

       While most young people view smoking as no longer cool, 
     they look at vaping differently . . . as being a ``healthy'' 
     and cool alternative.

  The FDA was given the tools to protect our kids and consistently 
failed to do it under Dr. Robert Califf, head of the FDA.
  Here is what I want to make clear today: February 14 is the second 
anniversary of Robert Califf's approval by the U.S. Senate. By that 
date, by February 14, I expect his compliance and the compliance of the 
FDA with all of these court-ordered mandates which they have ignored 
for months and years. What is at stake? The health of our kids and 
their addiction. If Dr. Califf cannot exercise the authority of the 
FDA, it is time that we put somebody in who will.
  I yield the floor.