[Congressional Record (Bound Edition), Volume 155 (2009), Part 10]
[Senate]
[Pages 13927-13929]
[From the U.S. Government Publishing Office, www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  Mr. DODD. Madam President, I listened carefully to the conversation 
between the majority leader and our colleague from Arizona. As the 
manager of this bill on smoking, I for one have been a strong advocate 
for the reimportation proposal. Others have also expressed an interest 
in this. Most of my colleagues have expressed views, and a majority 
have expressed support for the idea. This is not about denying a vote 
on reimportation. We would all like that opportunity.
  However, this bill on smoking and children is about as fragile a 
proposal as I have seen here in a long time. There are strong voices 
that wish to kill this legislation, and they effectively have. The FDA 
has jurisdiction over almost every product--except tobacco--including 
pet food. We waited 10 years trying to get to this bill. If you lose 
one or two votes on this--if we lose this again, we are back to the 
last decade.
  There will be any number of attractive ideas proposed to this 
legislation, many of which I have either supported or would like to, 
but we will run the risk of breaking up the necessary 60 votes to deal 
with children and smoking. So no matter how appealing some amendments 
may be, understand what you may be doing, and that is destroying the 
ability to deal with the 3,000 to 4,000 kids who start smoking every 
day and the 400,000 people who die every year from tobacco. I want to 
vote on reimportation as well and a lot of other issues. If every time 
we bring up a bill of this significance and somebody offers a very 
appealing proposal--understand that the danger is that you fracture 
that relationship. That has denied us the opportunity to pass this for 
a decade, despite the fact that both bodies have voted overwhelmingly 
but not in the same Congress.
  We are on the brink of getting this done. What better thing could we 
accomplish on the eve of the health care debate than to start saving 
lives of children? I have 76,000 kids in Connecticut who will die 
because they are smokers if we do nothing. There are 6 million children 
today who are going to die prematurely because of smoking if we do 
nothing. As much as I want to deal with reimportation of drugs, if we 
do that and it is adopted and we lose the coalition on smoking, what 
have we achieved? The bill dies. You lose both reimportation as well as 
the smoking proposal.
  I appreciate the majority leader taking the position he did. I know 
where he stands on the issue. Senator Reid has been a strong advocate 
of reimportation. That is not the issue here. It is whether at long 
last, a decade later, our colleague from Massachusetts, Senator 
Kennedy, and Senator DeWine, a former colleague from Ohio, Henry Waxman 
from California, Tom Davis of Virginia, who on a bipartisan basis have 
tried year in and year out to get this done--we can finally achieve it. 
So I know the game. But this is not a game, this is life and death for 
people. For 10 long years, we have not been able to pass legislation 
involving kids and smoking. We can get it done in the next few days. If 
people insist upon nongermane amendments based on a short-term appeal 
that denies us that opportunity, we will have done great damage to our 
country.
  I appreciate the position the majority leader has taken. My 
colleagues know, because I went through the process last week in 
committee, there were any number of appealing amendments. I thank the 
members of the committee who wanted to vote for some of those 
amendments. I see Senator Merkley here, a member of our committee. He 
and I would have liked to have supported additional amendments, fines 
and such, for kids. We knew that if we did that, we might break that 
fragile coalition that would get to us the goal line of passing the 
bill.
  I thank the majority leader for standing up on an issue he cares 
deeply about, the reimportation of drugs. He understands, as does the 
Presiding Officer, as do all of us here who have loved ones who have 
been smokers and have been affected by tobacco and the damage it does 
to our citizenry. It is the only disease I know that is self-inflicted. 
There are more deaths each year as a result of smoking and tobacco 
products than alcohol, drugs, suicide, automobile accidents, and AIDS 
combined. It is the greatest killer in America. We have a chance to 
make a difference. The day will come for reimportation. We ought to get 
to that. If you do it on this bill, you lose both reimportation and the 
smoking bill.
  I thank the majority leader and yield the floor.
  Mrs. BOXER. Madam President, I urge my colleagues to join me in 
support of the Family Smoking Prevention and Tobacco Control Act, a 
comprehensive effort to address the threat of tobacco products to 
public health.
  This bill will finally give the Food and Drug Administration the 
legal authority it needs to prevent the sale of tobacco products to 
minors, make tobacco products less toxic and addictive for those who 
continue to use them, and prevent the tobacco industry from misleading 
the public about the dangers of smoking.
  As the leading preventable cause of death in the United States, 
tobacco use kills over 400,000 Americans a year. More deaths in the 
U.S. are caused by tobacco use than from illegal drug use, alcohol use, 
motor vehicle accidents, suicides, and murders combined. This 
legislation takes crucial steps to save the lives of as many as 80,000 
Americans every year.

[[Page 13928]]

  Sadly, our failure to address this issue is having the greatest 
effect on our Nation's children. Ninety percent of all new smokers are 
children. In just 1 day, about 3,500 children will try their first 
cigarette and 1,000 more will become daily smokers. In just 1 year, 
kids in my home State of California will purchase 78.3 million packs of 
cigarettes.
  Even though studies have shown children are twice as sensitive to 
tobacco advertising as adults and that one-third of children experiment 
with smoking due to advertising, marketing for tobacco products is 
virtually unregulated. Each year, the tobacco industry spends $13.4 
billion nationwide on advertising. Granting the FDA the authority to 
regulate tobacco advertising will reduce targeting of kids and crack 
down on false claims.
  Additionally, this bill will grant the FDA the authority to regulate 
smokeless tobacco--particularly those products that have been designed 
to appeal to children, such as tobacco candy. Claims by the tobacco 
industry that these products are safe alternatives to smoking are 
dangerous and wrong. In fact, the Surgeon General has determined the 
use of smokeless tobacco can lead to oral cancer, gum disease, heart 
attacks, heart disease, cancer of the esophagus, and cancer of the 
stomach.
  This legislation will ensure that tobacco companies can no longer 
market addictive carcinogenic candies targeted at children without 
review by the Food and Drug Administration and careful regulation to 
safeguard the public health.
  Cigarettes contain 69 known carcinogens and hundreds of other 
ingredients that contribute to the risk of heart disease, lung disease, 
and other serious illnesses. Yet tobacco products are currently exempt 
from basic consumer protections like ingredient disclosure, product 
testing and marketing restrictions to children. Tobacco products are 
the only products on the market that kill a third of their customers if 
they are used as directed. In spite of the risks, in spite of the 
costs, tobacco products are the most unregulated consumer products 
available today.
  This bill will ensure that the tobacco industry is finally required 
to tell us what is in the products they sell.
  This legislation will also give the Food and Drug Administration the 
authority to require stronger warning labels, prevent industry 
misrepresentations, and regulate ``reduced harm'' claims about tobacco 
products. According to a 2006 Harvard School of Public Health study, 
the average amount of nicotine in cigarettes rose 11.8 percent from 
1997 to 2005. More important, this bill will give the FDA the authority 
to ban the most harmful chemicals used in these products, or even 
reduce the amount of nicotine. The Family Smoking Prevention and 
Tobacco Control Act is not about unfairly punishing tobacco companies 
or consumers of tobacco products; it merely gives the Food and Drug 
Administration the right to regulate tobacco products as it regulates 
other products to safeguard the public health.
  This Congress and the President have committed to reducing health 
care costs through comprehensive reform. This legislation is precisely 
the kind of investment in prevention and wellness that will enable us 
to increase access to quality health care while reducing costs. Tobacco 
use results in $96 billion in annual health care costs and California 
alone will spend $9.1 billion on smoking related health care costs--
imagine if we spent those funds on preventative medicine or wellness 
measures.
  The passage of this bipartisan bill would be one of the single, 
greatest public health protections that affirms our commitment to 
prevention and wellness as the foundation of responsible health care in 
our country. I urge my colleagues to make an investment in the health 
of the American people and support this legislation.
  Mr. HATCH. Madam President, I rise today to share my views on H.R. 
1256, the Family Smoking Prevention and Tobacco Control Act of 2009.
  First and foremost, I want to make it perfectly clear that I am 
deeply concerned about the dangers of smoking, particularly when it 
comes to children and teenagers. We must do everything we can to 
discourage our youth from using tobacco products; because once they 
start, it is very difficult to stop. Long term use of tobacco causes 
serious health conditions such as lung cancer, emphysema, or COPD--
Chronic Obstructive Pulmonary Disease. There is no question that 
tobacco is a killer.
  And not only does tobacco kill, it also results in a tremendous 
amount of unnecessary health care costs. Experts believe tobacco costs 
society billions of dollars each year. Even second-hand tobacco smoke 
harms those who do not smoke themselves but are merely around those who 
do.
  Do I believe that tobacco should be regulated? Of course I do. But do 
I believe that the Food and Drug Administration is the appropriate 
agency to regulate tobacco? Absolutely not. Let me take a few minutes 
to explain why I feel so strongly about this issue.
  The FDA's core mission is to promote and protect public health. As a 
member and former chairman of the Senate Health, Education, Labor and 
Pensions Committee, the committee with jurisdiction over the Food, Drug 
and Cosmetic Act, I feel very strongly that the FDA should have 
sufficient resources to do its current job before taking on new 
responsibilities. Over the years, I have worked hard to get the FDA the 
funding it needs to protect consumer health; approve new drugs, 
biologics and medical devices; and protect our Nation's food supply.
  For years, FDA scientists have pleaded with Congress to give the 
agency more resources. In fact, according to the Alliance for a 
Stronger FDA, the FDA's budget is small--$2.04 billion was appropriated 
for the agency and it collects nearly $600 million in user fees. 
Eighty-three percent of the FDA's costs are staff-related. The 
Alliance, whose membership includes three former Secretaries of Health 
and Human Services and six former FDA Commissioners, believes that the 
FDA's appropriation must increase by about $100 million per year just 
in order to stay even with increased costs--anything lower will result 
in decreased staff and programming. In addition, the Alliance believes 
that the FDA's base has eroded even while it was given new 
responsibility and ``operates in a world of increased globalization and 
scientific complexity.'' To put it in perspective, the FDA receives 
less funding than its local school district. Montgomery County, MD, 
public schools received $2.07 billion in fiscal year 2009; the FDA 
received $2.04 billion in appropriated funds that same year.
  Recently, we heard about peanut products tainted with salmonella. 
Hundreds of people became sick and nine people lost their lives. In 
2008, consumers were sickened by salmonella in peppers and possibly 
tomatoes. Before that, it was spinach tainted with E. coli that was 
sold all across the United States.
  Overall, the FDA has done good work on food safety, but it also needs 
more inspectors and more resources to conduct inspections. In fact, on 
March 14, President Obama stated that about 95 percent of the Nation's 
150,000 food processing plants and warehouses go uninspected each year.
  Unfortunately, the FDA struggles with more than just food. On the 
pharmaceutical side, the FDA has had to deal with safety issue after 
safety issue. From the withdrawal of Vioxx, to new data about suicide 
and SSRI antidepressants, FDA has been working to match its performance 
to its mission. We all know that it still has a way to go.
  If the FDA is given the responsibility of regulating tobacco 
products, it will require the agency to expand considerably. A 
completely new center, the Center for Tobacco Products, will be 
established within the FDA and new scientific experts will have to be 
hired for that new Center. These individuals--epidemiologists, 
toxicologists and medical reviewers--could be working on evaluating 
cancer drugs, or new vaccines, or tracing outbreaks of food borne 
illness--areas where, quite frankly, they are desperately needed. 
Instead, they will be wasting time, effort,

[[Page 13929]]

and money in attempt to make a deadly product slightly less deadly.
  The former FDA commissioner, Dr. Andrew von Eschenbach, expressed 
serious concerns in 2007 that this bill does not provide enough funding 
for an expansion of the FDA and does not authorize appropriations for 
start-up costs. He also expressed concerns that regulating tobacco 
would jeopardize FDA's public health mission. Dr. von Eschenbach was 
right--it makes no sense to expand this agency and divert its attention 
to tobacco products. I simply cannot understand why Congress is giving 
this agency any additional duties without a clear idea, in my opinion, 
about how much money it will cost to carry them out. Although this 
legislation is funded by tobacco company user fees, how do we know that 
enough money will be collected? And, while it is my understanding that 
the substitute big being considered by the Senate will require 
performance reports on these user fees every 3 years, I feel that these 
reports should be filed on an annual basis so that we in Congress may 
make necessary adjustments if the program is running out of money.
  Another concern I have is the impact that these user fees could have 
on public health programs like the State Children's Health Insurance 
Program--CHIP--which relies on tobacco taxes for its financing. For 
that reason, I filed an amendment calling for the Comptroller General 
of the Government Accountability Office to study whether this bill will 
have an impact on public health programs. It is my hope that this 
amendment will be accepted by my colleagues.
  Finally, I want to talk in more detail about the mission of the FDA, 
which is to protect public health. I feel that by requiring the FDA to 
regulate tobacco, we are putting the agency in direct conflict of this 
important mission. Here are two undeniable truths about tobacco: (1) 
tobacco is known to cause serious illnesses and death, and (2) tobacco 
does not have any health benefits whatsoever. So, I ask you, what sense 
does it make to have the FDA regulate tobacco? How does an agency in 
charge of protecting public health regulate tobacco, a product that is 
inherently unsafe?
  In fact, when the bill was being considered by the Senate HELP 
Committee a few weeks ago, I cosponsored and strongly supported Senator 
Enzi's amendment to have the Centers for Disease Control and Prevention 
regulate tobacco products. Unlike the FDA, the CDC has the 
infrastructure, personnel and mission to take on tobacco. The CDC 
operates programs that reduce the health and economic consequences of 
the leading causes of death and disability, thereby ensuring a long, 
productive, healthy life for all people. For those reasons, I felt that 
the CDC's mission was far more suited to the regulation of tobacco. 
Unfortunately, that amendment was not approved by HELP Committee 
members and, as a result, the Senate is now considering a bill that 
would designate the FDA as the regulator of tobacco products.
  In conclusion, I am probably one of the FDA's strongest supporters in 
Congress. Back in the 1990s, I introduced legislation that created the 
White Oak campus; the unified FDA campus which I envisioned would bring 
prestige back to the agency. This campus is on track to be completed in 
2012. I wanted FDA to be able to attract the brightest minds so we 
could get the best researchers in the country working together in order 
to ensure the safety of our drugs, medical devices and food supply. Dr. 
Margaret Hamburg, the newly confirmed FDA Commissioner has impressed me 
with her strong vision for the future of the FDA. It is my hope that by 
adding the regulation of tobacco to the FDA's portfolio, that vision 
does not go off course.
  I want to make one thing perfectly clear--I support the intent of 
this bill which is to stop our young people from picking up that first 
cigarette and to protect public health by regulating tobacco. That 
being said, it is my hope that some of the concerns that I have raised 
will be carefully considered and addressed before this legislation is 
signed into law.
  Mr. REID. I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. KAUFMAN. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Delaware.

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