[Congressional Record Volume 168, Number 115 (Wednesday, July 13, 2022)]
[Senate]
[Pages S3252-S3253]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                      Food and Drug Administration

  Madam President, the Food and Drug Administration of the United 
States is one of the most important Agencies. It is not one of the 
largest, but it has the responsibility to determine the safety and 
effectiveness of more products than most Americans can imagine.
  I have been a big fan of the Food and Drug Administration in the 
years that I have served in Congress. I have seen some wonderful things 
happen there. They are the ones who decide whether drugs are safe and 
effective before they can be sold in America, and they have regulatory 
authority over so many different issues.
  But it is sad to say the Food and Drug Administration of the United 
States of America today is at a crossroads. In fact, it may be in free 
fall. The Agency's missteps, its close connection with the industries 
it regulates, its delayed response to formula safety and decisions that 
fuel the opioid epidemic have shaken public confidence and endangered 
public health. But the FDA's ongoing incompetence and failure to 
regulate tobacco products stands in its own distinctive, grim category.
  Last month, the Food and Drug Administration announced a long-awaited 
decision to remove all e-cigarettes produced by the JUUL company from 
the market after 2 years of scientific review of data that had been 
submitted by the company JUUL to the Food and Drug Administration. 
Numerous health studies have determined that JUUL is one of the most 
popular e-cigarettes used by children.
  Let's get down to the bottom line. When the tobacco companies found 
their cigarettes falling into disfavor, they needed a replacement 
product. Their marketing proposal and strategy has always been: addict 
children. They did it with cigarettes. They did it with tobacco 
products, whether they were spit tobacco or smoking products, and, 
unfortunately, millions of Americans--particularly children--became 
addicted to their products.
  When those tobacco products fell out of favor, the industry needed a 
new replacement. They found one in vaping and e-cigarettes. Today, at 
least 2 million American kids are hooked on e-cigarettes and vaping. If 
you don't believe me, ask a student in high school or middle school 
what is going on with vaping, and you are going to be told the grim 
reality.
  Numerous Federal health studies have determined that JUUL is among 
the most popular e-cigarettes used by kids in America. More than 2 
million children in America are using them, including 750,000 kids who 
picked up these addictive products in the 9 months since the Food and 
Drug Administration missed a court-ordered

[[Page S3253]]

deadline to regulate their products. That is right. The court ordered 
the Food and Drug Administration to regulate these products, and, 
unfortunately, for 9 months the FDA refused to do it.
  To put a new tobacco product on the market, an e-cigarette company 
has the burden to prove to the Food and Drug Administration that it is 
``appropriate for the protection of public health'' before they could 
put the product on the market. That is the law. It makes sense. You 
can't sell a tobacco product in America at this point without FDA 
authorization. And that is what the authorization requires. It has to 
be appropriate for the protection of public health. Tobacco products 
can't prove that, neither can e-cigarettes. But FDA and JUUL ignored 
this law for years as JUUL sold its products without FDA authorization.
  I was relieved when FDA finally announced it was going to ban JUUL's 
addictive, kid-friendly products after determining that the company 
could not prove they presented a public health benefit.
  For anyone who has spoken to a teenager, parent, or teacher in the 
last 5 years and seen the powerful addiction to nicotine that JUUL 
causes, FDA's finding makes sense. So imagine my surprise when after 
FDA Commissioner Califf called to tell me the good news, the Agency a 
few days later suddenly reversed course. Not 2 weeks after ordering 
JUUL off the market, the FDA backtracked and halted its own decision.
  JUUL sued the FDA. Well, you expect that. These tobacco companies 
have more lawyers than sense. Big Tobacco loves nothing more than 
lawsuits to preserve its ability to addict children to their products. 
Now, FDA and JUUL have jointly asked the DC Circuit Court to suspend 
the litigation now pending on their products while the FDA resumes its 
regulatory review.

  But here is what baffled me. Health experts and parents across 
America wonder, Why is FDA in a legal free fall at this moment? One day 
they are banning the product. A week later they are putting them back 
on the market. When we need the Agency the most, it is proven to be 
adrift. And lives are at stake.
  JUUL is now free to continue selling its deadly products again, and 
FDA has not stated how long they are going to suspend this litigation 
while they review information.
  FDA has a choice: rely on science and public health to protect 
America's kids or cower to Big Tobacco's lawyers. Adding to the chaos 
on Friday--listen to this--we learned that the FDA is neglecting to 
enforce still another part of the law, which I passed this spring, that 
clarified the authority to cover synthetic nicotine.
  The tobacco companies thought they had found an escape hatch. They 
wouldn't have to justify their products if the nicotine wasn't derived 
from tobacco but was derived from a synthetic source. We changed the 
law and made it clear that was not going to be a loophole.
  FDA sounded the alarm over this emerging public health challenge of 
e-cigarette companies trying to evade oversight, including the No. 1 e-
cigarette used by children today. It is called Puff Bar. FDA has 
another deadline today to clear the market of unauthorized synthetic 
nicotine e-cigarettes, and I hope the Agency doesn't repeat its history 
of failed enforcement.
  The FDA is a cop on a beat. They are supposed to protect all 
Americans and our children, in particular. They know there is a product 
on the market that is addictive to kids and leads them into a tobacco 
addiction. That product is e-cigarettes and vaping. The law says you 
can't sell the product until you prove it is effective for public 
health. The tobacco companies could never prove that, but yet the FDA 
allows them to continue to sell the product, to ignore the law, to 
ignore the court order and does nothing.
  I don't know what it takes. I am calling on the FDA to finally come 
to its senses. If you are going to err, err on the side of public 
health and public safety, err on the side of kids, not tobacco 
companies.
  This free fall in the legal department at the FDA is unimaginable. It 
is not safe for America, and it is not safe for our future.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Vermont.