[Congressional Record (Bound Edition), Volume 155 (2009), Part 11]
[Senate]
[Pages 14288-14293]
[From the U.S. Government Publishing Office, www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  Mr. BURR. Mr. President, I came to the floor last week for north of 5 
hours and spoke about the bill that will be disposed of as this week 
goes on and, specifically, on an amendment that, though nongermane 
postcloture, the majority leader has agreed to hold a vote on. To me, 
this will be one of the most important votes Members in this body cast 
this year.
  Again, I believe this is one of the most important votes Members in 
the Senate will cast this year. Let me try to say why. This is a debate 
about the regulation of tobacco and, to start with, Members need to be 
reminded that today this is not an industry without regulation. This is 
the current charted Federal regulation of the tobacco industry before 
we do anything. I point out that included in that regulatory structure 
is the Department of Transportation, Department of Treasury, Department 
of Commerce, Department of Justice, Office of the President, Department 
of Health and Human Services, Department of Education, Department of 
Labor, General Services Administration, Department of Veterans Affairs, 
Federal Trade Commission, Department of Agriculture, Environmental 
Protection Agency, U.S. Postal Service, and Department of Defense.
  One, no Member can come to the floor and claim this is not a 
regulated product. It is the most regulated product sold in America 
today. I think there is consensus, and I agree, that we can do better 
than this maze of regulatory oversight in jurisdiction that is 
currently structured within the Federal Government, because it has been 
cobbled together as the Federal Government has grown, as new areas saw 
they had a piece of this pie, and they wanted some jurisdiction. We are 
throwing this regulatory structure away, and the proposal in the base 
bill, H.R. 1256, is to centralize this regulation of tobacco within the 
FDA.
  For those who aren't familiar with the FDA, let me say the Food and 
Drug Administration regulates 25 cents of every dollar of the U.S. 
economy--25 percent of all of the products sold in the United States 
are regulated by this one agency.
  FDA's core mission is this:

       Responsible for protecting the public health by assuring 
     the safety, efficacy, and security of human and veterinary 
     drugs, biologic products, medical devices, our Nation's food 
     supply, cosmetics, and products that emit radiation.

  Nowhere in there does it say tobacco, nor has it ever. A layperson 
would look at this and say if there is an agency whose responsibility 
it is to approve safety and effectiveness, for God's sake, you could 
not give them tobacco because they could never prove it was safe. It 
kills, and there is no dispute about that. We are trying to take a 
round peg and put it in a square hole. We are trying to find an agency 
that we think has punitive steps that they can take, but we are 
actually going much farther than that. You see, not only is there 
experience or expertise at the FDA to regulate tobacco, they are not. 
We are going to ask the FDA to surge, with their resources, their 
personnel, expertise, away from things such as lifesaving drugs, 
effective medical devices, and a responsibility to food safety at a 
time Americans have been killed because this agency couldn't 
effectively do their job. We are going to ask them to surge to handle a 
new product they have never, ever regulated.
  As a matter of fact, the last FDA Commissioner, von Eschenbach, said 
this:

       The provisions in this bill--

  I might say this was slightly over 2 years ago. As I have pointed out 
and talked about last week for over 5 hours on H.R. 1256, the authors 
of the bill didn't even change the dates in the bill from the bill 
written 2 years ago. As a matter of fact, the section by section is the 
same bill written 10 years ago. So I think it is appropriate, if they 
are going to use an effective date of February 2007, that I use the 
comments of the FDA Commissioner at the time, who said:

       The provisions in this bill would require substantial 
     resources, and FDA may not be in a position to meet all of 
     the activities within the proposed user levels. . . . as a 
     consequence of this, FDA may have to divert funds from other 
     programs, such as addressing the safety of drugs and food, to 
     begin implementing this program.

  This is not Richard Burr, this is the former Commissioner of the FDA 
saying we may have to divert funds from other programs, such as safety 
of drugs and food. If the American people are given this choice, they 
would say uphold the gold standard of the FDA. Let me go to bed at 
night as I take that medication my doctor prescribed and the pharmacist 
filled, and let me feel confident that the most qualified reviewer 
looked at that application, at the clinical trial date, and made a 
determination that this drug was safe

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and effective for me. Make sure when I go to the grocery store and buy 
food in a global marketplace, where the melons might have come from 
Chile or the spinach from Mexico, that they have the best and brightest 
addressing food safety.
  They have already flunked that several times in the last 3 years, and 
we have all dealt with the consequences of it. But think about what we 
are getting ready to do. We are getting ready to make it worse. We are 
getting ready to take an agency that has a seal of approval, a gold 
standard, and we are getting ready to say we want you to maintain that 
gold standard on drugs, and food, and biologics, and medical devices, 
but we understand you cannot hold tobacco to the same threshold. So we 
want you to ignore the fact that tobacco kills, and we want you to 
regulate it as we prescribe it in legislation. How does H.R. 1256 
prescribe this in regulation?
  We will turn to this, which is my continuum of risk chart. It 
basically starts to my right, and your left, Mr. President. It has 
unfiltered cigarettes. You remember those. They had a risk of 100 
percent. If you smoked them, there was a 100-percent likelihood that 
you were going to have a health problem from smoking.
  Then the industry came up with filtered cigarettes, and they reduced 
the risk by 10 percent, from 100 percent to 90 percent. But when one is 
looking for a way to play this, a 90-percent risk is not a good one.
  What H.R. 1256 says is: OK, we realize FDA is not the right agency, 
but we are going to place it there anyway, and we are going to tell the 
FDA: We want you to leave this alone; we don't want you to touch this 
100-percent risk or 90-percent risk. We want to grandfather all the 
products that were made before February 2007. And, oh, by the way, that 
would include U.S. smokeless tobacco.
  The most risky we are grandfathering in and we say to the FDA: You 
can't change it. You basically can't regulate it. You can't regulate 
the 100 percent, you can't regulate the 90 percent, and you can't 
regulate this small but growing U.S. smokeless market that has a risk 
of 10 percent.
  One might look at the chart and say there are other things on there. 
There are electronic cigarettes, tobacco-heating cigarettes, Swedish 
smokeless snus. There are dissolvable and other products that have less 
risk. All those products in February 2007 were not in the marketplace. 
They are banned. They are eliminated.
  What are we asking the FDA to do? We are asking them to grandfather 
three categories of products and let all adults who choose to use a 
tobacco product choose from the most risky categories.
  What are we saying to the 40 million Americans who smoke today? If 
you are in this category of using cigarettes, we are not going to give 
you any options as to what you turn to as you realize that is not the 
best thing for your health. We are going to lock you in and hope it 
kills you fast so our health care cost goes down.
  Any claim--any claim--that H.R. 1256 reduces the cost of health care 
is only because we have grandfathered in smokers who will die sooner, 
not that we have allowed them a pathway through this bill to ever 
experience not only products that are currently on the marketplace that 
reduce the risk from 100 percent to as little as 1 percent, but we have 
completely eliminated any additional innovation in product in the 
future that would allow somebody to get from 100 percent to 1 percent 
and actually be a healthier American.
  I am not on the floor today suggesting that regulation is not in 
order. It is in order. At 4:20 p.m. today, Members of the Senate will 
have an opportunity to vote on a substitute amendment that has several 
changes from this current bill. One, it does not centralize the 
jurisdiction in the FDA. It creates, under the Secretary of Health and 
Human Services, a new agency called the Harm Reduction Center. Its sole 
job is to regulate tobacco. It regulates tobacco more specifically than 
does the FDA under H.R. 1256. But what it does allow is the development 
of new products that might encourage individuals to give up smoking and 
to turn to products that are less harmful.
  Here is a list of the organizations that support tobacco harm 
reduction: The American Association of Public Health Physicians, 2008; 
the World Health Organization, 2008; the Institute of Medicine, 2001; 
the American Council on Science and Health, 2006; the New Zealand 
Health Technology Assessment, 2007; the Royal College of Physicians, 
2002, 2007; Life Sciences Research Office, 2008; Strategic Dialogue on 
Tobacco Harm Reduction Group, 2009--this year.
  People around the world are talking about reduced harm, except in the 
Senate. As a matter of fact, we don't need to look far across the pond 
before we find Sweden. During the past 25 years, Swedish men have shown 
notable reductions in smoking-related diseases: a decline in lung 
cancer incidence rate to the lowest of any developed country; no 
detectible increase in oral cancer rate; improvement in cardiovascular 
health. Tobacco-related mortality in Sweden is among the lowest in the 
developed world.
  Why? Every Member of this Congress should ask why. Because the 
sponsors of this bill have said this is what we are trying to do in the 
United States.
  How did Sweden do it? It is very simple. Sweden did it by allowing 
these products to come to market. As a matter of fact, Swedish 
smokeless snus is currently on the market in the United States. I am 
not going to tell you the market share is big, but I can tell you this. 
The risk of death or disease is less than 2 percent. But under H.R. 
1256, which the Senate may or may not adopt this afternoon, what we 
would do is we would eliminate Swedish snus, and we would lock smokers 
into the categories that are currently on the market, all because of an 
arbitrary February 2007 date because somebody was too lazy to change 
the bill.
  Think about that: that we would take something Sweden found over 25 
years had been an incentive to get people off cigarettes and move 
toward other products, to the degree that, in Sweden, they had a 
decline in lung cancer, they had no detectible increase in oral cancer, 
and they had an improvement in cardiovascular health; that tobacco-
related mortality in Sweden is among the lowest in the developed world. 
Why is that? Because the authors of H.R. 1256 suggest that new product 
innovation can happen, and I would tell you there are three thresholds 
one has to meet for new products to come on the market. I will not talk 
about the first two. I will focus on the third one.
  The third one is this: that to have a product approved to be placed 
on the market, a company has to prove that a nontobacco user is no more 
likely to use that new product if that product is available. Then it 
goes on to say, in great congressional form, that unless you have an 
application that has been approved, you cannot engage the public on a 
product that has not been improved.
  How does one do a clinical study that proves to the FDA that no 
American is more likely to use tobacco on a product that wasn't in the 
marketplace if, in fact, you can't talk to them about the product until 
it is approved? It is a Catch-22.
  The authors of this bill knew exactly what they were doing. Let me 
say it again. The authors of this bill knew exactly what they were 
doing.
  What has changed over the weekend since I was out here for 5 hours-
plus last week? Public health experts around the country are beginning 
to read the bill and they are beginning to go: Oh, my gosh. Do not pass 
this. This is a huge mistake. As a matter of fact, I will get into it 
in a little while. I have plenty of time that I am going to spend on 
it.
  Understand there are only three reasons we would consider new 
additional regulations: to reduce the rate of disease and death and to 
reduce the prevalence of youth access to tobacco products and 
specifically smoking.
  I know the Presiding Officer heard me say this last week. This is my 
chart of 50 States. In 1998, the tobacco industry came to a settlement 
with States called the Master Settlement Agreement, MSA. In that 
agreement, they

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committed $280 billion to defray the cost of health care for the 
States--specifically, their Medicaid costs--and also provided money to 
make sure they could have cessation programs to get people to quit 
smoking and to make sure youth access, youth prevalence went down.
  These are the CDC levels for last year, and I might say the CDC makes 
a recommendation to every State at the beginning of the year as to how 
much they should spend on programs that encourage youth not to smoke. I 
am just going to pull randomly a few States.
  Connecticut: Of the CDC recommendation, Connecticut spent 18.9 
percent of what the CDC recommended; 21 percent of the youth in 
Connecticut have a prevalence of smoking; 23.2 percent of the youth in 
Connecticut have a prevalence of marijuana usage.
  The Presiding Officer's own State, Illinois: Of the CDC 
recommendation of what Illinois should spend on youth prevention, 
Illinois spends 6.1 percent; 19.9 percent of the youth have a 
prevalence to smoke. They are at 23.3 percent who have a prevalence of 
marijuana use.
  In Missouri, of the CDC recommendation on how much should be spent on 
the prevalence of youth smoking, Missouri spent 3.7 percent; 23 percent 
of the youth have a prevalence of smoking; 19 percent a prevalence of 
marijuana use.
  I can see that the Presiding Officer gets where I am going. We have 
constantly, since 1998, with the money provided by the tobacco industry 
to the States, chosen to build sidewalks over promoting programs to 
reduce youth prevalence of smoking. Now the authors of this bill would 
have us suggest that by allowing the FDA to have regulation of tobacco, 
the prevalence of youth smoking is going to go down because now we have 
one Federal agency that will have total jurisdiction over this product.
  Let me say this: If that were the case, the prevalence of marijuana 
usage by youth would be zero because it is illegal. There is no age 
limit. As a matter of fact, there is no agency need for jurisdiction 
because nobody in America--adult or youth--is supposed to use it. It is 
a myth for us to believe the authors of this bill that by simply 
dumping this in the FDA, somehow youth prevalence of smoking goes down. 
It is a joke. It is a joke, and the public health community has now 
recognized this.
  In 1975, Congress commissioned the University of Michigan to track 
youth smoking rates. At that time, youth smoking was at an alltime 
high. However, those rates started coming down and leveled off around 
30 percent all the way up to 1993. For some unknown reason at that 
time, youth smoking started to rise and peaked at an alltime high in 
1997. In 1998, 12th graders who said they tried a cigarette in the last 
30 days was approximately 36 percent, according to the University of 
Michigan.
  Congress didn't have a good sense of why this was happening. 
Opponents of the tobacco industry started blaming all this on the 
alleged manipulation of young people by tobacco manufacturers through 
sophisticated marketing and advertising.
  The tobacco industry has a checkered past, I will be the first to 
admit that, when it comes to advertising in the market. But what I am 
suggesting is, it may not have been all due to tobacco marketing. There 
was another trend occurring during the 1993 to 1998 period that 
virtually mirrored that of youth smoking. It was the increase in 
illicit drugs in the United States.
  Let me say that again. What mirrored the trend from 1993 to 1998 of 
the increase in youth smoking was the increase of use of illicit drugs 
by teenagers. Something much broader was happening among our country's 
young people.
  The Senate's answer to the smoking rate increase was to pass this 
initiative, to give FDA jurisdiction.
  Senator Kennedy made the following remarks during the 1998 Senate 
floor debate to emphasize the need to protect kids. Let me quote him:

       FDA Commissioner David Kessler has called smoking a 
     ``pediatric disease with its onset in adolescents.'' In fact, 
     studies show that over 90 percent of the current adult 
     smokers began to smoke before they reached the age of 18. It 
     makes sense for Congress to do what we can to discourage 
     young Americans from starting to smoke during these critical 
     years. . . . Youth smoking in America has reached epidemic 
     proportions. According to a report issued last month by the 
     Centers from Disease Control and Prevention, smoking rates 
     among high school students soared by nearly a third between 
     1991 and 1997. Among African-Americans, the rates have soared 
     by 80 percent. More than 36 percent of high school students 
     smoke, a 1991 year high. . . . With youth smoking at crisis 
     levels and still increasing, we cannot rely on halfway 
     measures. Congress must use the strongest legislative tools 
     available to reduce youth smoking as rapidly as possible.

  Well, the Senate told the American public that the passage of a 
massive FDA tobacco regulation back in 1998 contained the strongest 
legislative tools available to address youth smoking issues.
  By the way, they have decreased since 1998--youth smoking has 
decreased. As a matter of fact, overall smoking has decreased. I don't 
want anybody to think there is no light at the end of the tunnel. As a 
matter of fact, what this shows is a comparison--a study done by the 
Centers for Disease Control and Prevention and then a Congressional 
Budget Office estimate after reviewing the Kennedy bill, or Waxman 
bill, H.R. 1256. What the CDC said was that if we do nothing, we reduce 
smoking to 15.97 percent by 2016, and the Congressional Budget Office, 
under H.R. 1256, said that if we pass the Kennedy bill, the rate would 
be 17.80 percent. As a matter of fact, I miscalculated when I put the 
chart together, and it is actually 2 percent higher, meaning we do 4 
percent better if we do nothing.
  You see, my point is this, and it is exactly what I said at the 
beginning: The authors of this bill said its purpose is to reduce the 
risk of death and disease and to reduce youth smoking. I would tell you 
that a caveat to that should be that we should reduce smoking. Clearly, 
the Centers for Disease Control and Prevention says that if you do 
nothing, it goes to this point, and the Congressional Budget Office, 
after looking at the bill, suggests it is 2 percent or 4 percent higher 
if, in fact, we pass the bill. Why is that? How could it possibly be 
higher if you pass legislation that is supposed to fix it? Well, it is 
for this reason: It is because of what H.R. 1256 does. It is not a 
public health bill. It is a bill that locks in the most risky products 
and grandfathers them to the Food and Drug Administration and allows no 
pathway for reduced-harm products to come to market. It actually takes 
some reduced-harm products that are currently on the market, that 
haven't been sold since February 2007, and says, therefore, they are 
gone. There is no ability for the FDA to look at this product and say: 
My gosh, in the name of public health, let's keep this product on the 
market, because the Senate is legislatively telling the FDA what to do.
  Why does it matter what agency we put this in? If Congress believes 
they can fix it, then why haven't they fixed it up until now? If 
writing a bill that legislates how to fix it would work, why haven't we 
done it? Well, I would contend that all I have to do is go to this 
chart of 50 States, and for the majority of the States the prevalence 
of marijuana usage is higher than the prevalence of youth smoking, 
which tells you there is no regulatory body that can eliminate the 
usage of an illegal product by those who choose to use it, unless--
unless--it is through education. There is no education in H.R. 1256. 
Let me say it again: There is no education in H.R. 1256.
  If the goal is to reduce the risk of death and disease and education 
is the only way to accomplish that, if the goal is to reduce youth 
prevalence of smoking and the only tool to accomplish that is 
education, then I ask the sponsors to come to the floor and show me 
where the education is in FDA regulations.
  I am on day 5 now--maybe day 6 if you count that I was here for a 
short period of time last Monday, but I didn't make it yesterday, 
Monday--day 6, and I have yet to have anybody come to the floor and ask 
a question, refute anything I have said or question the facts

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I have produced. Why? Because I am using the same agencies most Members 
come to the floor and reference: the Centers for Disease Control and 
Prevention and the Congressional Budget Office. It is hard to say that 
they are wrong, that they are not reputable entities within the Federal 
Government, and then turn around next week and bring your own 
statistics using the same entities we use as a gauge.
  One can question whether the Royal College of Physicians came to the 
right conclusion when they said:

       In Sweden, the available low-harm smokeless products have 
     been shown to be an acceptable substitute for cigarettes to 
     many smokers, while ``gateway'' progression from smokeless to 
     smoking is relatively uncommon.

  Let me say that again: ``. . . while gateway progression from 
smokeless to smoking is relatively uncommon.''
  Some authors of H.R. 1256 have come to the floor and said: Well, my 
gosh, if we let reduced-harm products come to the marketplace, this is 
going to create a gateway to youth usage of tobacco products that will 
eventually turn them into smokers.
  Read the substitute bill. The substitute bill requires the Reduced 
Harm Center to actually list for the American public the most risky 
tobacco products and the least risky. The bill that consolidates all 
this jurisdiction for tobacco within the Food and Drug Administration 
doesn't even require the Food and Drug Administration to rank the most 
risky products. Why? Because those are the ones we have grandfathered. 
We have said they can't touch them.
  Compassion would tell you that if you want people to switch from 
smoking and give it up, you have to give them a tool to get there. But 
what we have said is that the future will consist of no new tools 
except those manufacturers that were on the market before February 
2007--some magical date in history we will all look back on and 
probably find that to blame as to why this program doesn't work.
  In a little over an hour, we will have an opportunity to come to the 
floor and to vote on the substitute. Let me say to my colleagues, if 
you want a real public health bill, vote for the substitute. If you 
want to reduce the prevalence of youth smoking, vote for the 
substitute. If you want to reduce the rate of death and disease, vote 
for the substitute. Don't just listen to me, listen to public health 
experts and authors who now have written on this issue.
  This happens to be a book--and I am not sure how long ago it was 
published, although I am sure I can probably find that out--that I 
think I spent $50 today to get, either that or it is on loan. That 
seems like a lot of money, but the truth is, it is a book about how the 
Senate of the United States is getting shafted. It is a book about the 
collusion that happened behind closed doors between the authors of this 
bill and Philip Morris. It is written by an author named Patrick 
Basham. I want to read a few things he has printed in his book.

       Handing tobacco regulation over to the FDA, as Congress is 
     poised to do, is an epic public health mistake. It is 
     tantamount to giving the keys of the regulatory store to the 
     Nation's largest cigarette manufacturer.

  It goes on:

       There are significant and numerous problems with the FDA 
     regulating tobacco and virtually no benefits to public 
     health.

  Let me say that again.

       There are significant and numerous problems with FDA 
     regulating tobacco and virtually no benefits to public 
     health.

  Do you get it? I mean, if you are going to bill it as a public health 
bill, for God's sake, put something in there that is to the benefit of 
the public health of this country.
  Mr. Basham goes on to say:

       Kennedy, Waxman, and the public health establishment 
     present their legislation as a masterful regulatory stroke 
     that will end tobacco marketing, preventing kids from 
     starting to smoke, make cigarettes less enjoyable to smoke, 
     and reduce adult smoking. But FDA regulation of tobacco will 
     do none of these things.

  This is not a fan of the tobacco industry. This is an author, an 
individual, who has been covered in numerous publications. He is an 
adjunct scholar with the Cato Center for Responsible Government. He is 
a lecturer at Johns Hopkins University. He has written a variety of 
policy issues, and his articles have appeared in the New York Times, 
the Washington Post, USA Today, the New York Post, and the New York 
Daily News, just to name a few. His book is titled ``Butt Out! How 
Philip Morris Burned Ted Kennedy, the FDA & and the Anti-Tobacco 
Movement.'' This is no fan of tobacco. This is a guy who is calling 
balls and strikes. He is one person who is so concerned about the 
public health in this country and making sure what we do accomplishes 
good public health policy that he is willing to be outspoken.
  He goes on in his book and says this:

       The process of validating new reduced-risk products appears 
     to be designed to prevent such products from ever reaching 
     the marketplace, thus giving smokers the stark, and for many 
     the impossible, choice of ``quit smoking or die.''

  You might want to remember that part. We can now call the continuum 
of risk ``quit or die.''

       Rather than making smoking safer for those who continue to 
     smoke, it will deny smokers access to new products that might 
     literally save their lives. That is hardly a sterling 
     prescription for good public health.
       If the objective is public health, H.R. 1256 falls way 
     short. Even if the idea of FDA regulation were good in theory 
     and practice, several things, including the FDA's competence 
     in tobacco policy and science, its public image, its fit with 
     the tobacco file, its available resources, and its overall 
     current competence, argue strongly against giving it 
     regulatory responsibility for our Nation's tobacco policy.

  This is a scholar, Mr. President.

       FDA regulation of tobacco need not be a public health 
     tragedy, however. By bringing the crafting of tobacco policy 
     out into the light of day, by taking it out of the hands of 
     the special interests and, most importantly, by keeping it 
     away from the FDA, there is every opportunity to begin to 
     create a policy that not only serves the interest of 
     nonsmokers and smokers, but a policy that might really work.

  To Senators of the U.S. Senate: If you want a policy that really 
works, do not adopt H.R. 1256. Consider strongly the merits of the 
substitute amendment, which does focus on the public health of this 
country.
  Mr. Basham is a professor who studies and writes on a variety of 
topics, and when he took an objective view of the situation, he saw 
H.R. 1256 for what it was. He saw it as misguided legislation.
  Our amendment--mine and Senator Hagan's--accomplishes exactly what 
Mr. Basham raises. Our amendment sets up a new agency under the 
auspices of HHS and a Secretary who will examine all tobacco products 
and set up a regulatory framework that will save lives. That is in the 
public health interest of America. We don't preclude new reduced-risk 
products from entering the marketplace. We do not preclude reduced risk 
products from coming into the marketplace; H.R. 1256 does. We mandate 
the Tobacco Harm Center post the relative risk of each tobacco product 
currently on the market. Wouldn't that be incredible if we had a 
ranking between cigarettes and all the other things? We wouldn't need 
that if H.R. 1256 passed because we would only have nonfiltered 
cigarettes, filtered cigarettes, and smokeless tobacco. I can tell you 
the ranking would be unfiltered cigarettes the worst, filtered 
cigarettes next to the worst, and smokeless third. Those are the 
choices that adults would have in this country, and for somebody who is 
addicted to smoking, if smokeless wasn't something that enticed them to 
quit smoking, they would be left out because the legislation does not 
create a pathway for new products.
  We also give current users the information they need to decide 
whether they want to migrate from a more harmful product, such as 
cigarettes, to less harmful products.
  I have heard my colleagues and many other advocacy groups boast how 
the underlying bill will give the FDA authority to remove toxins in 
cigarettes, boast how granting the FDA the ability to regulate 
advertising will encourage people to not use, and current smokers to 
quit.
  I agree, better warning labels will act as a deterrent to nonsmokers. 
But what about current smokers? Dr.

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Basham sites a very interesting study conducted in Canada and the 
United States by an independent organization. The study consisted of 
showing smokers packages of their current cigarettes with an increased 
warning label and graphic pictorials of cancer and other diseases. The 
study concluded that no statistically significant change in smoking 
behavior could be expected to be followed from the redesigned packages.
  If you have noticed, over this 45 minutes, so far, I have sort of 
knocked all the things out that the sponsors of this bill said it 
accomplished. It does not do any of them. It does do one thing: it 
grandfathers the most risky products and consolidates their regulation 
at the FDA. It does not reduce risk of death, disease, or youth 
prevalence of smoking.
  Since H.R. 1256 bans any reduced risk smokeless products from 
entering the marketplace, it locks current smokers only into 
cigarettes. However, our amendment does not lock them into just 
cigarettes. We provide this consumer with the ultimate amount of 
choice. The purpose of my amendment, as I said, is to reduce the risk 
of death and disease and to reduce youth prevalence of smoking.
  The regulated products under my amendment? All tobacco and nicotine 
products. There are no holes in the substitute. It covers the entire 
scope of tobacco products. New smoking provisions in H.R. 1256, 
``change current tobacco advertising to black and white only and 
require graphic warning labels on packages of cigarettes.''
  We require graphic warning labels on the package of cigarettes, and 
we eliminate print advertising. Somehow the authors of this bill would 
have us believe if we go from color to black and white advertising that 
people under 18 actually will not read it or can't read it. Maybe 
today's youth can only read in color. But they suggest theirs is a 
stronger regulatory bill. But the substitute eliminates print 
advertising. No longer will the Vogue magazine that a mom finds in the 
grocery store attractive, that might not be one of those publications 
that is considered a publication that youth would purchase, but a 14-
year-old might go to her mother's Vogue magazine and flip open and see 
a tobacco ad by mistake--it can't happen under the substitute 
legislation. It will happen under H.R. 1256, but only in black and 
white.
  H.R. 1256 uses user fees to fund the FDA, about $700 million over 3 
years. We asked the Secretary of Health and Human Services: How much do 
you need to stand up a complete new agency that is only focused on 
tobacco legislation? One hundred million dollars a year because these 
fees that we charge the tobacco companies are passed on to the 
consumers, the people least likely to fund it, the ones who are already 
funding the Children's Health Insurance Program, funding the majority 
of the State Medicaid programs. Let's give these folks a break. Let's 
not put this entire burden on their backs, especially if it is not 
going to do any good.
  It is not just Mr. Bashan. As a matter of fact, Brad Rodu wrote, 
March 26--Brad Rodu, the Endowed Chair of Tobacco Harm Reduction 
Research, School of Medicine, University of Louisville--I will read a 
couple of excerpts of what he wrote.

       According to the American Association of Public Health 
     Physicians, the bill ``will do more harm than good in terms 
     of the future tobacco-related illnesses and death.'' While 
     the AAPHP favors ``effective regulation of the tobacco 
     industry. . . . This bill does not meet this standard.'' The 
     bill, introduced by Rep. Henry Waxman, is supported by 
     medical groups that are engaged in a crusade against the 
     tobacco industry. That's the problem: In a blind desire to 
     kill tobacco manufacturers, the Waxman bill may end up 
     hurting smokers.

  It goes on and on. Again, an endowed chair of a major academic 
institution says don't do this.
  How about Michael Siegel, Professor in the Social and Behavioral 
Sciences Department at--get this--Boston University School of Public 
Health, home of the authors of the bill. The Los Angeles Times, op-ed, 
June 3--not long ago. Let me read a couple of excerpts out of Mr. 
Siegel's op-ed.

       In the end, it ensures that federal regulation of tobacco 
     products will remain more about politics than about science.
       H.R. 1256 gives the FDA the ability to lower nicotine 
     levels in cigarettes. Since H.R. 1256 locks current users 
     into cigarettes only by banning reduced risk products, H.R. 
     1256 ensures that 40 million Americans who currently smoke 
     are doomed to death and disease associated with cigarette 
     smoking. H.R. 1256 will cost lives, not save lives.

  This is a professor in the Boston University School of Public Health, 
talking about his Senator's bill. He goes on to say:

       Even worse, by giving a federal agency the appearance of 
     regulatory authority over cigarettes without the real ability 
     to regulate, the legislation would seemingly create a FDA 
     seal of approval for cigarettes, giving the public a false 
     sense of security about the increased safety of the product.
       In fact, the bill's crafters are apparently so worried 
     about the harmful effects of such a public perception--

  Get this--

     that they have written a clause into the bill that prohibits 
     the cigarette companies from even informing the public that 
     cigarettes are regulated by the FDA or that the companies are 
     in compliance with FDA regulations.

  The legislation forbids a company from even referring to the 
regulator. He goes on to say:

       This is clearly an unconstitutional provision, as it 
     violates the free speech rights of the tobacco companies; 
     nevertheless, it suggests that even the supporters of the 
     legislation are aware that the bill creates a false 
     perception of the increased safety of cigarette smoking.

  There is a charge I have not made. The bill is actually 
unconstitutional. When we recognize things as unconstitutional, I know 
it is the inclination of some Members of the Senate to wait and have it 
passed and somebody refer it to the Supreme Court so the Supreme Court 
can tell us it is unconstitutional. When scholars tell us it is 
unconstitutional, I believe our responsibility is then: don't pass it, 
don't do it.
  Let me conclude with Michael Siegel, professor in the School of 
Public Health, Boston University.

       During the previous administration, the FDA was accused of 
     making decisions based on politics, not health. If the Senate 
     passes the FDA tobacco legislation, it will be 
     institutionalizing, rather than ending, the triumph of 
     politics over science in federal policymaking. This is not 
     the way to restore science to its rightful place.

  I am not saying it. It is a professor from the School of Public 
Health at Boston University.
  What is this bill about? Its author said reducing the rate of death 
and disease and prevalence of youth smoking. Michael Siegel's 
assessment: It is about politics.
  Patrick Bashan's conclusion in ``Butt Out,'' the book: It is about 
politics. As a matter of fact, it says on the back of the book:

       Philip Morris outwitted this coalition of useful idiots at 
     every turn.

  The decision in front of Members of the Senate is simple. Do you want 
to reduce the risk of death? Do you want to reduce the risk of disease? 
If you want to reduce the prevalence of youth smoking you only have one 
chance, and that is support the substitute amendment.
  If you want to do politics as usual, if you want to let politics 
trump science, if you want to lock in a category of products that have 
a high likelihood of risking the American people, if you want to ignore 
the research from around the world that suggests by allowing lower harm 
smokeless products on the marketplace it allows smokers to get off the 
tobacco products, support H.R. 1256.
  I believed 5 days ago when I came to the Senate floor that was all I 
needed to put up to win this debate. I actually believed that was all I 
needed to put up for the American people. I have learned over the past 
5 days just how stubborn Members of the Senate are. I hope that now, 
after 6\1/2\ hours of coming to the Senate floor on this one bill, 
staff members through every office--Republican, Democrat, and 
Independent--have taken the opportunity to check the facts that I have 
presented, and they have found I am right; they have found a study did 
exist in Sweden. I didn't make it up; they have found that CDC did do a 
study--if we did nothing we would reduce smoking more than if we pass 
this bill; they have found that in Sweden, people did become healthier

[[Page 14293]]

because of the decision to use smokeless products.
  I thought this was all it took for the American people to understand 
it; that you can't take an agency of the Federal Government that is 
``responsible for protecting the public health by assuring the safety, 
efficacy and security of human and veterinary drugs, biologic products, 
medical devices, our Nation's food supply, cosmetics and products that 
emit radiation''--it is impossible to take an agency where that is 
their core mission and give them a product where you ask them to ignore 
the gold standard on everything else they regulate. I think the 
American people would say it seems reasonable to create a new entity to 
regulate tobacco, if for no other reason than--if you didn't believe 
any other science that I have shown and the data that has been proven--
if for no other reason than why would we jeopardize this gold standard? 
Why would we make one American at home wonder whether that 
pharmaceutical product they were taking was actually safe or effective?
  Why would we have them question for a minute whether that medical 
device was approved and reviewed by the most seasoned reviewer versus 
maybe somebody who was fresh on the job because that seasoned person 
went over to regulate tobacco products?
  Why would we put the American people in a more difficult situation 
today on their question of food safety with the incidents we have had 
of death in the United States of America because the Agency could not 
quite meet their mission statement?
  Why would we dump on them now? Why would we do this to the American 
people? It is beyond me. But when you turn to some of the folks who 
have written on this issue--whether it is Brad Rodu, whether it is 
Patrick Basham, whether it is Michael Siegel, in the public health 
department at Boston University--I guess the only answer is, it is 
politics over science, that for 10 years people have said we have to 
put this in the FDA, that Matt Meyers, head of Campaign for Tobacco-
Free Kids, is the most powerful ``U.S. Senator'' because he is getting 
his wish, he is getting exactly what he has been trying to do for 
decades. He is not a science expert. If he was, he would be voting for 
the substitute, if he were here.
  He wrote the bill. I am surprised he did not catch the mistake of 
February 2007. Nobody caught that. But the truth is, the bill has not 
changed much in 10 years, though the world has changed a lot. The 
science has changed a lot. Health care has changed a lot.
  There is a real opportunity to do the right thing in the Senate. But 
Members will have to show a degree of independence and vote for the 
substitute and not wait for the base bill. I hope Members will heed the 
words of people who have no dog in this fight who have suggested, if we 
pass this bill--not the substitute, the base bill--we will have done a 
great disservice to the public health of America. More importantly, we 
will have done a disservice to those individuals to get locked into 
these categories, as shown on this chart, because their certain future 
is death and disease. They are counting on us. They are. They are 
counting on us to do the right thing.
  I can leave this debate tonight and say: I left nothing in the bag. I 
have tried everything to convince my colleagues not to make a huge 
mistake. I will sleep well tonight. If this substitute does not pass, 
if H.R. 1256 passes and becomes law, it is others who are going to have 
to live with the way they voted. When people die because of what they 
did, it is others who are going to have to live with it.
  There are going to be more articles. This is just the tip of the 
iceberg of health professionals, of public health individuals, people 
who detail in great quantity exactly what has been going on. As a 
matter of fact, as they say, the wool has been pulled over our eyes. 
Well, it has not. That is why we have a substitute amendment. That is 
why the majority leader allowed a nongermane amendment to come to the 
floor. Well, it might have had something to do with that he did not 
have the votes for cloture without allowing it to come to the floor, 
but I give him the benefit of the doubt that he understood this was an 
important debate to have, that this was worth extending the opportunity 
for people to vote up or down.
  I see my colleague is here to speak, and I am not going to prolong 
this debate. In less than an hour, Members will have an opportunity to 
come to the floor. Most Members will get probably 2 minutes equally 
divided; 60 seconds to hear what it has taken me 6 hours to say in this 
debate. Clearly, that is not much time. But now it is in their hands. 
It is a decision Members of the Senate will have to make about the 
future of the public health policy of this country.
  I urge my colleagues, on both sides of the aisle, to support the 
substitute amendment today at 4:20 and make sure the future of our 
country is one we will be proud of and not one we will find as an 
embarrassment.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Udall of Colorado). The Senator from 
Nebraska.
  Mr. JOHANNS. Mr. President, I ask unanimous consent to speak in 
morning business.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.

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