[Congressional Record (Bound Edition), Volume 155 (2009), Part 10]
[Senate]
[Pages 13673-13676]
[From the U.S. Government Publishing Office, www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  The PRESIDING OFFICER. The Senator from Connecticut is recognized.
  Mr. DODD. Mr. President, I ask unanimous consent the only amendments 
in order today after the amendment is offered by myself, Senator Dodd, 
the HELP Committee substitute amendment, be the Lieberman amendment re: 
TSP, and the substitute amendment of Senators Burr and Hagan.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.


                            Order For Recess

  Mr. DODD. Mr. President, I now ask unanimous consent the Senate stand 
in recess from 6 p.m. to 6:30 p.m. My intention would be to address for 
a few minutes some comments and then would defer to others who may want 
to speak until we recess at 6 p.m.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the bill.
  The assistant legislative clerk read as follows:

       A bill (H.R. 1256) to protect the public health by 
     providing the Food and Drug Administration with certain 
     authority to regulate tobacco products, to amend title 5, 
     United States Code, to make certain modifications in the 
     Thrift Savings Plan, the Civil Service Retirement System, and 
     the Federal Employees' Retirement System, and for other 
     purposes.

  Mr. DODD. Mr. President, I rise to offer an amendment in the nature 
of a substitute to H.R. 1256.
  As I understand it from the leadership, while there will be some 
comments I will make this evening, briefly, about the substitute, and 
others may have some comments to make before the evening concludes, 
there will be no votes this evening. The leadership has notified us of 
that, so colleagues ought to be aware there will be no votes at all 
this evening.
  If I could, I wish to take a few minutes to describe the substitute 
amendment, and I will yield the floor to others who want to talk before 
the 6 p.m. hour arrives and others who may come back around 6:30 to 
make some additional comments.


                           Amendment No. 1247

  The PRESIDING OFFICER. The clerk will report the amendment.

[[Page 13674]]

  The assistant legislative clerk read as follows.

       The Senator from Connecticut [Mr. DODD] proposes an 
     amendment numbered 1247.

  Mr. DODD. I ask unanimous consent the reading of the amendment be 
dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  Mr. DODD. Mr. President, this substitute amendment represents the 
work of the Committee on Health, Education, Labor and Pensions, which 
was reported out of our committee by a vote of 15 to 8 prior to the 
Memorial Day recess. In this substitute we have included some very 
important changes as a result of good work by my friend and colleague 
from Wyoming, Senator Enzi. I thank him and thank his staff, as well as 
the majority staff, for their work in reaching agreement on this 
amendment. It was important to my colleague from Wyoming that we 
improve the language on civil monetary penalties on companies that 
violate the law, and I agree with those suggestions. Senator Enzi also 
made clear, and I agree with him, that we need to make sure that over 
time, Congress and the public need to understand how this bill is being 
implemented, so we have enhanced the reporting requirements on the Food 
and Drug Administration and called on the General Accountability Office 
to make a study of the bill's implementation.
  These are strong provisions and I appreciate very much the diligence 
of my colleague from Wyoming, his work, and the work of his staff as 
well.
  Otherwise, the substitute would still give the Food and Drug 
Administration the authority to regulate the tobacco industry and put 
in place very tough provisions for families that, for far too long, 
have been absent when it comes to how cigarettes are marketed to 
America's children.
  We cannot afford to wait any longer. Every day we delay, as I have 
said over and over, another 3,000 to 4,000 children across our 
country--as they did today and will again tomorrow, will again every 
single day--3,000 to 4,000 of our young people are ensnared by the 
tobacco companies that target them with impunity as they try smoking 
for the very first time. Those numbers are incredible; 3,000 to 4,000 
every single day take that first cigarette, begin that process. Almost 
a third to a quarter of them will actually become addicted. Roughly a 
third of that number will die, in many cases prematurely, because of 
that process that starts today with 3,000 to 4,000 children.
  A thousand of these children become addicted. Of these addicted, a 
third, as I said, will die eventually of smoking-related diseases. 
Absent any action by this Congress, more than 6 million children alive 
today will die from smoking, including more than 76,000 people in my 
own State of Connecticut.
  The purpose of this historic public health legislation is very 
simple. It is to protect America's children and to give them the 
longer, healthier future they deserve. This is a cry from parents as 
well, including parents who smoke. As I said earlier, parents who 
smoke, if all of them could be here in this Chamber today and have the 
privilege that I have to have a microphone attached to my pocket here 
to talk about this, as smokers, would plead that their children never 
ever begin this habit. If they could wish anything, they would wish 
their children would avoid this deadly habit. So it is not just those 
who do not smoke or those who are offended by it or those who are 
worried about the health implications. I don't know of anybody who 
wants to see a young child begin the habit of smoking.
  Yet for almost 10 years we have been unable to get this bill passed--
almost 10 years of effort, led by our colleague from Massachusetts, 
Senator Kennedy, who has tried over and over to get this legislation up 
and to get it adopted by both Chambers.
  For the benefit of our colleagues, they should know this Chamber has 
adopted legislation, but at the time we did, the other body didn't. 
Candidly, the other body has acted as well, but when they did, we did 
not. So we have had this kind of circus going on over the last 8 or 10 
years, where when the Senate acted, the House didn't; then the House 
acted but the Senate didn't. We are on the cusp of both Chambers acting 
and a President who will sign this bill into law to make a difference 
for the millions of people who have been adversely affected by this 
subject matter.
  I also want to address some of the points our opponents of the bill 
have been saying about the legislation. Let me be clear. The Food and 
Drug Administration is absolutely the right agency for this job. It is 
the one Federal agency with the necessary scientific expertise, 
regulatory experience, and public health mission to do the job. No 
other agency of government is able to do all three of these.
  Many others can do good work, but they can't do all three. They don't 
have the scientific expertise, they don't have the regulatory 
experience, and they don't have the public health mission that the Food 
and Drug Administration does.
  The FDA regulates food, drugs, cosmetics, even pet food, but they do 
not regulate tobacco. They can regulate what your cat has and what your 
dog has but not what your child starts today, the 3,000 to 4,000 who 
do. We have been able to get that done so your pets are OK, but your 
child may not be because of our failure over the years to make sure 
tobacco will be regulated by the FDA. Tobacco, we know, is the most 
dangerous consumer product sold in the United States, or anywhere in 
the world for that matter. Yet it is currently exempted from oversight 
by the agency that regulates virtually every other product that 
Americans consume.
  Some have said this bill will drain precious resources away from the 
FDA. In fact, what we have done with this bill ensures that the Food 
and Drug Administration is given adequate resources to perform its new 
tobacco product responsibilities without taking any resources from its 
other important activities. We do this by setting up a special division 
within the FDA to do just this job and we allocate specific resources, 
collected as user fees, to fund the very efforts we are seeking to 
accomplish. So all of the other functions the FDA does are not going to 
be adversely affected because of what we have written into this bill. 
The legislation does this, as I said, by assessing user fees on the 
companies and the cost of regulating tobacco is paid entirely by these 
user fees.
  Some have also suggested that we should not act because States have 
squandered the funding provided in the Master Settlement Agreement on 
smoking and tobacco products. Some States have, and we do not defend 
their actions. But this is not a reason for inaction now, when we can 
protect as many children as we will with the adoption of this 
legislation.
  Furthermore, while the 1998 Master Settlement Agreement on tobacco 
between the States and the tobacco industry was a very positive step, 
it simply did not go far enough. In order to protect the public and to 
prevent and reduce smoking, especially among children and kids, tobacco 
products must be regulated by the Food and Drug Administration. Since 
the Master Settlement Agreement was signed, marketing expenditures by 
the tobacco industry have reached record levels. The industry spends 
$13 billion a year--$13 billion a year--to market their products to 
America's children.
  This bill would restrict the tobacco industry's ability to market to 
children. Mr. President, 400,000 people die every year from tobacco-
related illnesses. That is more than die from alcohol abuse, automobile 
accidents, violent crime, illegal drugs, and suicide. All of them 
combined do not equal the number of deaths caused by tobacco products 
and by cigarettes. In order to make up those loss numbers, the industry 
targets the youngest of our citizens, our children. They do it with a 
$13 billion appropriation to go out and actually solicit the children 
to become addicted to these products.
  Let me be clear that despite what some have claimed, this bill does 
not

[[Page 13675]]

grandfather any existing tobacco products. In fact, this legislation 
will finally allow the Food and Drug Administration to take action on 
these products that have had special protection for decades. For the 
very first time, the FDA will have the broad authority to require 
changes in existing tobacco products and make them less risky or less 
addictive.
  Some opponents have sought to downplay the significant impact of this 
bill. The Congressional Budget Office has estimated that the bill will 
reduce adult smoking by 2 percent over 10 years. This is true. But what 
opponents do not tell us is that a 2-percent decline in adult smoking 
is about 900,000 fewer adult smokers. That is not insignificant, almost 
a million people. That 2 percent sounds small, but when you translate 
it into actual numbers, it is somewhere in the neighborhood of 900,000 
to a million people. More importantly, opponents leave out the fact 
that, according to the Congressional Budget Office, this bill would 
reduce youth smoking by 11 percent. Such a decline would save the lives 
of some 700,000 children from premature smoking-related deaths.
  For adults to quit smoking is hard. I could be a personal witness to 
this, having been a smoker. I can tell my colleagues how hard it is to 
quit. People I know try every day and fail. It is hard. It is a very 
addictive product. So as a former smoker, I know what this is like and 
how hard it can be for people to break this habit. But 90 percent of 
the adults who smoke started as kids. They started as children. If we 
can break that link with children so that they don't begin this deadly 
habit, then we can start saving lives. And if lives don't impress you, 
how about money? It is billions of dollars we spend every year as part 
of our health care costs. A lot of those don't die but end up being 
sick or ill for years in a very debilitated fashion as a result of 
smoking-related products, particularly cigarettes.
  In a few days, we are going to be dealing with health care. There is 
a lot of division here about what we ought to do on health care. One 
subject matter we are not divided on is prevention. To avoid chronic 
illnesses, the best way is to prevent them from happening in the first 
place. If we thought we could make a dent of even 100,000 lives, what 
about 200,000 lives because we made a difference in the number of 
children who started this deadly habit each year? What better way to 
begin the debate about prevention than going after the one cause, the 
self-inflicted wound that we impose on ourselves because of smoking 
habits? That is self-infliction that we do. We know it kills. We know 
what damage it does. Here we have the ability in a few days, maybe, or 
less, to actually do something in a meaningful way that has never, ever 
happened before. Cat food, pet food, dog food get regulated by the FDA, 
and finally tobacco will, tobacco and cigarettes.
  Passing this bill will be a historic victory for our Nation's health, 
helping parents protect their children, as every parent across the 
country tonight would pray and hope their child would never begin this 
deadly habit. Their Federal Government is now going to be of some 
assistance. We are going to provide for these products the same kinds 
of protections we do for animals in terms of what they eat every night 
in your homes. We will now say the same kind of protection ought to be 
afforded to your children. Parents deserve peace of mind when it comes 
to how dangerous tobacco products are marketed. With this legislation, 
that is precisely what we will give them.
  I commend my colleagues in this Chamber who over the years have 
voted, when they have had the opportunity, to implement this 
legislation. I thank immensely our colleague from Massachusetts, 
Senator Kennedy. I thank Mike DeWine of Ohio, who is no longer with us 
as a Member. He was Senator Kennedy's partner on this issue, as were 
Henry Waxman and Tom Davis on the House side. This has had bipartisan 
support. Tonight, our friend from Massachusetts is at home recovering 
from his own struggle with illness. But he may be watching at this 
hour. We want him to know how grateful we are to him for his undying 
efforts to make this bill a reality.
  I thank Mike Enzi. Mike cares deeply about this issue. He gets 
passionate about a lot of subject matters, but this is one where I have 
seen the most passion by my colleague from Wyoming. He can tell his own 
personal stories of what he has witnessed over the years. While he may 
have some problems with this particular proposal, he has no problem 
with the idea that we ought to be cutting back and making significant 
inroads in children beginning this deadly habit.
  Our substitute is a bipartisan effort to bring together these ideas 
and once and for all to do something in a way that will make a 
difference in the lives of millions of people in this country and 
hopefully one day around the world as well. This habit is not confined 
to our own Nation. We can't legislate for the world, but we can 
legislate for ourselves, to say to America's parents that tonight and 
over the next day or so we will make a huge difference, I believe, in 
their children's lives by limiting the ability of this industry to 
appeal and market directly to their children. That is what this bill 
does.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from North Carolina.


                Amendment No. 1246 to Amendment No. 1247

  Mr. BURR. Mr. President, I ask unanimous consent to call up an 
amendment in the nature of a substitute, No. 1246, and ask for its 
immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from North Carolina [Mr. Burr], for himself and 
     Mrs. Hagan, proposes an amendment numbered 1246 to amendment 
     No. 1247.

  Mr. BURR. I ask unanimous consent that reading of the amendment be 
dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  Mr. BURR. Mr. President, let me say it is shocking that the argument 
as to why we should do this is because the Food and Drug Administration 
regulates cat and dog food, what we have just heard. The truth is, the 
FDA regulates every pharmaceutical product, every medical device, every 
biological product, lifesaving drugs, chronic disease, treatments, 
therapies. It is in charge of food safety, of products that emit 
radiation. It is the gold standard of the world from the standpoint of 
the approval and assurance of safety and efficacy of things Americans 
take that are prescribed by doctors and filled by pharmacists. They 
know when they go home, they can take it because it is safe and 
effective. Now we are talking about giving that same agency a product 
for which they can't prove safety and efficacy--their core mission 
statement for every product they regulate. They will have to turn their 
head on tobacco because it kills. It causes disease. It isn't safe. 
This makes no sense.
  What the substitute does is create a tobacco harm reduction center. 
It locates it at the Department of Health and Human Services, under the 
Secretary--the same Secretary who oversees the Food and Drug 
Administration.
  Within that tobacco harm reduction center, it gives the authority to 
the center to regulate all cigarettes, cigarette tobacco, roll-your-own 
tobacco, smokeless tobacco, and other tobacco products that are deemed 
by the Secretary to be necessary for regulation. We don't lessen the 
regulation of this industry. As a matter of fact, as Members have an 
opportunity to hear tomorrow about this substitute amendment, we 
increase the regulatory authority. We do it under the same guidance of 
the Secretary of Health and Human Services. We define what adulterated 
and misbranded tobacco products are. We give the tobacco harm reduction 
center the ability to pull products directly from the market and to 
prevent those products from going to market. Misbranded product would 
be a label that is false or misleading, labels that don't contain all 
the information, are not in compliance with section 109,

[[Page 13676]]

and tobacco or ingredients are not disclosed. It requires tobacco 
manufacturers to submit extensive lists of ingredients, substances, 
compounds, and additives by brand style to the tobacco harm reduction 
center. It requires the center to determine and make public a list of 
harmful constituents, including smoke constituents and by brand styles. 
It requires annual registration and submission of additional 
information by the manufacturers to the center. It requires 
establishment of tobacco product design standards and establishes tar 
and nicotine ceilings for cigarettes. It eliminates candy and fruit 
descriptors on cigarette advertising and marketing. It gives the center 
the authority to remove tobacco products from interstate commerce if 
such products pose an unreasonable risk of substantial harm to public 
health.
  This is about public health. The objective of any bill should be to 
reduce youth usage, to reduce disease, to reduce death. If we put it in 
the FDA, we grandfather a tremendous amount of smoking products, but we 
don't allow a pathway for new, less harmful products to reach the 
marketplace. In our case, we allow reduced-risk products to come but 
under the supervision, the direction of the harm reduction center.
  It requires all tobacco manufacturers of imported tobacco products to 
establish and maintain records, make reports, provide information as 
the Secretary requests, not as we prescribe. It requires premarket 
approval of new combustible tobacco products before entering interstate 
commerce. It bans the use of such descriptions as ``light,'' ``ultra-
light,'' and ``low tar'' on packaging, advertising, and marketing of 
cigarettes. It requires testing and reporting of all tobacco product 
constituents, ingredients, additives, including smoke constituents and 
by brand styles. It creates a scientific advisory committee of 19 
people. It establishes a new warning label that communicates the health 
risk of cigarettes, with placement for cigarettes on the front of the 
packaging. It requires ingredient disclosures and other information on 
all tobacco packaging. It has the graphic warning labels required. It 
establishes new warning labels that communicate the health risks of 
smokeless tobacco. It requires ingredient disclosure and information on 
tobacco products. The list goes on and on.
  The authors of the base bill and the substitute that has been offered 
in its place suggest that they do a better job of making sure that 
youth don't access tobacco products. That is just wrong. Every State 
sets an age limit. One bill does not police the process more than the 
other.
  The one thing this substitute does, this amendment in the nature of a 
substitute, is we ban print advertising except in a publication that is 
an industry publication. So every general print ad, every general print 
publication, a publication that a mom might buy but a teenager might 
look at, we eliminate advertising. What does the base bill do? It 
limits it to black-and-white advertising.
  Don't come to the floor and suggest one does a better job than this 
substitute. When you ban advertising, you have banned the ability to 
market to the youth. When you ban descriptors and other items such as 
candy and fruit descriptors, we do that as effectively, we just do it 
through a harm reduction center. Why? Because it is under the same 
leadership of the Secretary of HHS.
  I don't want to jeopardize the gold standard of the FDA. I don't want 
to compromise the gold standard that it has to meet the test of safety 
and efficacy so the American people have trust in products. We 
jeopardize that when we give the FDA this mission.
  Some will claim the FDA is the only one that can do it. As I showed 
before, there is the regulatory chart for tobacco today in the United 
States. Every Federal agency is listed up here, including HHS. FDA has 
no current jurisdiction. They have no expertise to regulate tobacco.
  It is the most regulated product sold in America today. But I am not 
on the floor arguing that this is enough. We can do better. We can 
consolidate that regulation. We can build on the strengths of all of 
these underneath the heads. But to add FDA is a huge mistake.
  We just got faxed to us the endorsement of this substitute amendment, 
No. 1246, by the American Association of Public Health Physicians. The 
Association of Public Health Physicians endorses the Burr-Hagan 
amendment. All of a sudden, health care entities are looking at these 
two bills, and they are saying: The amendment in the nature of a 
substitute, No. 1246, actually does accomplish what is best for public 
health. And public health physicians are willing to put their name on 
it.
  We are going to have an opportunity tomorrow to talk at length about 
what is in the substitute. My colleague, Senator Hagan, cosponsor of 
this bill, will have an opportunity to address it either tonight or 
tomorrow. I look forward to the opportunity to do that.
  I yield the floor.

                          ____________________