[Congressional Record (Bound Edition), Volume 155 (2009), Part 10]
[Senate]
[Pages 13916-13919]
[From the U.S. Government Publishing Office, www.gpo.gov]




           FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

  Mr. BURR. Mr. President, we are desperately working to try to make 
sure we can move to amendments on H.R. 1256, a bill that attempts to 
consolidate the regulatory responsibility for tobacco products under 
the FDA.
  This is being sold as a public health bill. I have been now to the 
floor for over 3.5 hours in the balance of this week suggesting it does 
not meet that threshold and that, at some point today, I would have the 
opportunity, along with Senator Hagan, my colleague, to give, in some 
detail, what is in the substitute amendment.
  I am going to attempt to do that now, even though we have not moved 
to the consideration of the other pending amendments. But let me start 
with a chart I had used earlier today. The reason I make the claim that 
this is not a public health bill is from this chart that shows the 
continuum of risk of tobacco products.
  It starts on my right, your left, with nonfiltered cigarettes. The 
baseline we use is that is 100 percent risky. The industry, at some 
point, probably before I was born, all of a sudden created a filter 
that went on the end of an unfiltered cigarette.
  Because of that filter, it eliminated, it removed some of the 
constituencies of the combustion of tobacco. That made it 10 percent 
less risky. The risk went from 100 to 90 percent. Then in the 1990s we 
had a new product that was never marketed except in test markets. It 
was a tobacco-heating cigarette, where it did not actually burn the 
tobacco, it heated the tobacco. It extracted the nicotine, delivered 
the nicotine in the system but never produced smoke.
  That product was considered to be about 45 percent risky but, 
clearly, a reduction at the time of 45 percent. All of a sudden, in the 
past 12 months, 18 months, we have seen a new product called an 
electronic cigarette. Again, no tobacco is burned. It is a fairly 
expensive product, it is popular outside the United States, not as 
popular or readily available in the United States. But that electronic 
product that has a cartridge you replace actually brought the risk 
level down to about 18 percent. Some might be catching on. As we have 
introduced new products, we have brought the risk down, the health 
risk, the risk of disease, of death.
  Now we are over here to U.S. smokeless tobacco, a product that most 
Americans understand. It is not the old snuff our parents and 
grandparents grew up with, it is ground tobacco. All of a sudden, we 
realize we reduced even further the health risk. It is now down at the 
10-percent risk level, 90 percent below where we started decades ago 
with an unfiltered cigarette.
  Now introduced in the marketplace in the past year is something I 
referred to as Swedish smokeless snus, it is now on the market. It is 
sold, it is pasteurized, it is spitless. It was not something the 
United States or U.S. tobacco companies created, it is something the 
Swedes created.
  Part of what I will get into is how the Swedes have used this product 
and other innovative products, other new products, in the marketplace 
to move smokers from very risky products to less risky products. In the 
case of Swedish snus, you see a risk level of about 2, maybe 3 percent.
  Then we get over to a product that has yet to hit the market except 
for test markets, the one I covered in great detail several hours ago 
on the floor, a dissolvable tobacco product, one that was covered by 
CNN as a candy, one that still meets the age requirements and proof of 
ID for somebody to purchase.
  But to magnify CNN's report, they actually took that product from 
behind the counter and put it in the candy section next to Reese's cups 
and gum and had an underage person come up and take one as CNN filmed 
to make it even more appealing from a standpoint of a story.
  But this is the product. This is the product some have come to the 
floor of the Senate and said looks like a cell phone. I am not sure. It 
does not look like my cell phone. Maybe it looks like someone's cell 
phone but not mine. It is not a product that is accessible for anybody 
who does not produce an ID and does not meet the minimum age 
requirements of that State.
  Risk? About 1 or 2 percent. We are actually getting better with every

[[Page 13917]]

product that is innovative: therapies, gums, patches, lozenges, 
pharmaceuticals, negligible, if any, risk.
  Let me explain why I started with this because the base bill that is 
being considered, 1256, takes these categories right here, nonfiltered 
cigarettes and filtered cigarettes, it locks them in forever. The 
legislation says to the FDA: You cannot change these categories unless 
you find some specific thing that would cause you to alter it. It 
forbids the FDA.
  Even though H.R. 1256 creates a pathway to less-harmful products, it 
is a pathway that cannot be met because one of the conditions of new 
products entering the market is, you have to prove that people who 
don't use tobacco products will not be enticed to use these products. 
It also says you can't communicate with anybody in the public unless 
you have a product that is approved.
  I ask: How do you meet the threshold of proving that somebody who 
doesn't use tobacco products is not going to use this product, if you 
can't communicate with them until you get the product approved by the 
FDA? I have come to the conclusion, since nobody who is a cosponsor or 
author of the bill has come up with an answer, it can't be done.
  To claim that this is a public health bill, one would have to make a 
reasonable claim that these products are going to be available and 
maybe potentially more products in the future. But what H.R. 1256 does 
is, it cuts off availability of product right here. It says, on this 
side of the line, we have constructed a pathway that nothing will pass. 
I don't believe you can make a genuine claim that this is a public 
health bill when you have locked every user into the 90- or 100-percent 
category of risk.
  Senator Hagan and I have offered a substitute amendment. That 
amendment will be voted on about 4:30 today, if things go according to 
schedule. It is absolutely essential that Senators listen to their 
staffs who have read the bill, read the substitute amendment, listened 
to the debate. I know there are a lot of things that go on during the 
day. It doesn't allow Members to sit down and listen to what Richard 
Burr is going to say. Hopefully, staff has looked at the statistics I 
have presented, the facts I have brought to the table, the claims I 
have made, and understands I am right. H.R. 1256 is not a public health 
bill.
  The substitute does allow this to happen. We allow it to happen 
because the substitute doesn't concentrate regulation in the Food and 
Drug Administration, an agency that, by their mission statement, is 
required to prove safety and efficacy of all products they regulate. 
Pharmaceuticals, biologics, medical devices, food safety, cosmetics, 
products that emit radiation--that is the world of the FDA. They 
regulate 25 cents of every dollar of the U.S. economy. They are the 
gold standard for every American. When they get a prescription and go 
home to take it, they never wonder whether it is safe or whether it 
will work because the gold standard in the world is the Food and Drug 
Administration. When they go to a doctor's office and they get ready to 
use a device, they don't question whether it was something the doctor 
made in the back room. They know that device was approved by the FDA. 
Up until recently, they had every assurance when they bought food that 
that food was not contaminated, that it wouldn't hurt them or kill 
them. But as we know over the past several years, we have had things 
that have slipped through, and Americans have died. The FDA is 
struggling today to make sure that, in fact, they meet the demands of 
the regulation they have in place.
  What I am saying is, don't concentrate this regulation at the FDA. 
Don't jeopardize the gold standard. Employees work there with a 
complete understanding that if it doesn't pass safety and efficacy, it 
does not receive approval of the FDA.
  Let me say it as I said it a couple hours ago. Tobacco products are 
not safe. Tobacco products cause disease and death. There is no way the 
Food and Drug Administration, on their current mission statement, can 
regulate a product they can't prove safe and effective. If you try to 
put a square peg in a round hole, you will have reviewers at the FDA 
who say: The gold standard is no longer important because Congress has 
legislated that it is important. If I turn my head on tobacco products, 
I can turn my head on this medical device because it doesn't look like 
it is going to be dangerous. All of a sudden, something is going to 
slip through, a pharmaceutical product that kills somebody, a device 
that does somebody damage, because we lowered our guard. We lowered the 
threshold that every product must meet to get FDA approval.
  I am not advocating for the Federal Government to sit back and do 
nothing with respect to tobacco. I am advocating that we craft a bill 
that will achieve the real goals of what Federal regulation should 
accomplish: To reduce death and disease associated with tobacco and to 
reduce youth usage of tobacco products. That is exactly what our 
substitute amendment does. It is designed to keep kids from smoking. 
But you can't keep kids from smoking if you are not willing to limit 
advertising.
  In the base bill, H.R. 1256, they limit print advertising to black 
and white. In the substitute amendment, we eliminate print advertising. 
Let me say that again. In the current base bill, they restrict print 
advertising to black and white only. In the substitute amendment, we 
eliminate the ability for print advertising. The substitute amendment 
is actually tougher on advertising than the base bill.
  Specifically, the Burr-Hagan amendment bans outdoor advertising, 
youth-organized sponsorships, usage of cartoon characters, sponsorship 
of events that youth attend, and many other provisions, all designed to 
limit children's exposure to tobacco advertising.
  Our amendment does not stop at print advertising. The amendment 
codifies the other youth marketing restrictions contained in the Master 
Settlement Agreement of 1998 and makes it a crime for underage youth to 
possess tobacco products. Let me say that again. In 1998, all the 
tobacco companies got together, responding to State concerns that 
health care costs were out of control and that tobacco contributed to 
it. They provided $280 billion to all 50 States for two things: Cost 
share of their health care and so they could create cessation programs 
to get people to quit.
  I covered in great detail over the last couple days that even with 
this money available, one State only spent 3.7 percent, not of their 
total money, of the amount of money CDC said was an adequate number to 
spend on cessation programs. No State hit 100 percent. There are some 
that deserve gold medals for the fact that they were higher than 
others.
  I pointed out one yesterday. I will point it out again. The State of 
Ohio is a large State. Of the amount CDC recommended Ohio should take 
of the tobacco money and devote to cessation programs, Ohio spent 4.9 
percent. When you hear these numbers, no wonder we are not doing better 
at moving people off cigarettes to other products or getting them to 
quit altogether. It is because the effort we have made through 
education has been pitiful. As a matter of fact, 21.6 percent of the 
youth in Ohio have a prevalence to smoke; 45 percent have a prevalence 
to alcohol; 17.7 percent have a prevalence to smoke marijuana. Yet some 
come to the floor and claim that if we give this to the FDA, youth 
smoking, youth usage will go away. If that claim were even partially 
correct, the marijuana usage would be zero because it is illegal. There 
is no age limit.
  Some will claim we don't address labeling. We address labeling on 
packages of cigarettes to discourage children from even looking at 
them. We require warning labels on the front and the back. We require 
graphic warning labels that show gruesome and tragic cases of mouth 
cancer, lung cancer, and other pictures designed to deter children from 
smoking. As my colleagues can see, keeping kids from tobacco 
advertising is a key component to the Burr-Hagan substitute amendment. 
Compare that with the underlying bill, and they will not see the

[[Page 13918]]

same commitment to limit advertising that children see. The underlying 
bill contains graphic warning labels but doesn't limit print 
advertising. Tobacco companies would still be able to advertise in 
magazines such as People, U.S. Weekly, and Glamour--clearly, purchased 
by their parents but accessed by their kids, and they can then see the 
black-and-white ads.
  Maybe in some weird way the authors of this bill thought children 
can't read black and white, that they can only read color. That is why 
they chose to limit it just to black-and-white advertising.
  The only stipulation is, the ads would be in black and white. We can 
do better. We can absolutely do better than this. Keeping children from 
using tobacco products must be the first accomplishment of Federal 
regulation. The Burr-Hagan amendment accomplishes that goal with a two-
pronged attack. First, our amendment encourages States to use more of 
their MSA payments on cessation, putting billions of dollars into the 
effort. In the last 10 years, States have used just 3.2 percent of 
their total tobacco-generated money for tobacco prevention and 
cessation. In 2009, no State is funding tobacco prevention programs at 
CDC-recommended levels. Our amendment would change this by requiring 
States to comply with the CDC-recommended spending levels on cessation 
programs. It would no longer be voluntary.
  In the case of Ohio, instead of spending 4.9 percent, Ohio would be 
obligated by law, if we pass the substitute amendment, to spend 100 
percent of what the CDC said needed to be spent for us to successfully 
make sure our Nation's children were given the message that the use of 
tobacco products is not an advantageous thing.
  Studies show that when States commit the money to cessation, youth 
smoking and smoking in general declines. Unfortunately, the underlying 
bill, H.R. 1256, contains no cessation program. Even though the bill 
requires the manufacturers to pay up to $700 million a year, it 
contains no cessation program. How can you call this a public health 
bill? How can we suggest this is going to reduce the risk of death or 
disease? How can we make the claim we are going to reduce youth usage, 
when there is no commitment, no requirement to cessation?
  Secondly, our amendment assists current smokers who are unable and 
unwilling to quit by acknowledging a continuum of risk of tobacco 
products, what I showed here. More specifically, our amendment does not 
preclude reduced exposure products from entering the marketplace. The 
piece over here, they lock this in. We try to pull all the 100 percent, 
90 percent over here to less harmful products because the objective in 
this bill should be to reduce death and disease.
  There is a great debate underway in the academic world on tobacco 
controls. Some advocate abolishment of tobacco. Straight abolishment is 
hard to achieve and can bring many unintended consequences such as 
elicit trade, and we all know that. Since abolishment is not an 
effective solution at this point, the question remains: How do we lower 
death and disease rates associated with smoking? Nicotine therapy has 
proven to be a failure. NIH states that patches and lozenges and other 
things have a 95-percent failure rate. They fail because smokers don't 
physically use these products as they do cigarettes. They are marketed 
poorly and are not designed to be a long-term solution. Under H.R. 
1256, the base bill, that trend continues.
  Also, H.R. 1256 does not give manufacturers of nicotine products the 
regulatory framework needed to market and enhance smoking replacement 
products appropriately. Since we have scratched current nicotine 
therapy products and abolishment as an effective means to stop smoking, 
that leaves us with very few options. The most promising option the 
Federal Government can help perpetuate to reduce death and disease 
associated with smoking is low-nitrosamine smokeless tobacco products.
  Until recently, the academic community resisted the fact that 
smokeless products could aid in tobacco harm reduction. Skeptics, many 
of whom helped write the underlying bill, stated that smokeless tobacco 
products are gateway products that will lead to more children smoking.
  Experience and data shows differently. Over the last 20 years, Sweden 
has allowed tobacco manufacturers to promote low-nitrosamine snus, a 
smokeless tobacco product, as an alternative to smoking.
  This quote is from the Royal College of Physicians dated 2007:

       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.

  You get where I am going. The data is out there. I never dreamed we 
would use Sweden as an example of where the United States would go. But 
when the focus is on how you reduce the risk of disease and death, they 
never lost focus of what that was. They were not clouded as to the 
introduction of new tobacco products in a blinded effort to lock in 
what existed. They experimented and found new products that would 
actually entice smokers to switch.
  The claim that in some way, shape, or form these products are gateway 
products, that they will take nonsmokers and turn them into smokers--
for the Royal College of Physicians, in 2007: ``relatively uncommon.''
  No statistic is perfect, and I am sure there are some who might have 
made a decision to use one of these products. But as you saw on the 
chart before, had they decided to use it, the risk of that Swedish snus 
was not 100 percent, it was 3 percent. There was no risk of heart 
disease, COPD, lung cancer, the things that one might get from these 
products, as shown on the chart over here, that the base bill H.R. 1256 
locks in.
  As a matter of fact, let me bring this other chart up: Harm 
Reduction: Smokers, Quitters, Switchers. The question we have to ask 
is, do we want people to be smokers? Do we want them to be quitters? Or 
do we want them to be switchers? Because this graph clearly shows you 
that there is a reduction--quite dramatic--in the relative risk for 
quitters and switchers in relation to smokers. What every Member will 
have to ask themselves, as they get ready to decide what they are going 
to do on this legislation, is: Do we want the American people to be 
smokers? Do we want them to be quitters? Or do we want them to be 
switchers?
  If the answer is, you want them to be quitters or switchers, then it 
is very easy. Support the Burr-Hagan substitute. Because the base bill, 
H.R. 1256, does not create any effort to have quitters or switchers. 
All it does is lock in smokers. And if the bill's intent is to reduce 
the risk of death and disease, common sense tells you, without creating 
quitters and switchers we are not going to do a very good job of 
reducing the risk of death and disease.
  Mr. President, how much time do I have left?
  The PRESIDING OFFICER. The Senator has 4 minutes remaining of the 30 
minutes granted.
  Mr. BURR. I thank the Presiding Officer.
  Mr. President, you see the chart behind me. The Lancet supports the 
goal of harm reduction. I will be honest with you, I do not know what 
the Lancet is. But I have been told it is a very reputable health 
publication. But let me quote it:

       We believe the absence of effective harm reduction 
     strategies for smokers is perverse, unjust, and acts against 
     the rights and best interests of smokers and the public 
     health.

  A reputable health publication that basically says: The absence of 
effective harm reduction strategies acts against the rights of smokers 
and public health. But the base bill, H.R. 1256, has no effective harm 
reduction strategy, no pathway to harm reduction products. But they 
claim it is a public health bill. A health care publication says that 
cannot happen. It is ``perverse.'' It is ``unjust.'' Well, they said 
it. I did not. But I think what they mean is, that to consider passing 
H.R. 1256, with the knowledge that has been given, would be perverse, 
unjust.

[[Page 13919]]

  I am not going to have an opportunity to talk fully at this time 
because I have a colleague who will take the floor. But let me say, I 
talked earlier about Camel Orbs and the way CNN portrayed this product 
as candy and staged a news event--well, ``news'' would be--let's say 
``entertainment'' event by taking this from behind the counter in a 
convenience store and putting it in the candy section and having a kid 
go up and pick the Orbs up out of the rack to say that it was candy.
  Orbs represents a 99-percent reduction in death and disease 
associated with tobacco use compared to cigarettes.
  I ask my colleagues, if the objective of Federal legislation is to 
reduce the risk of death and disease--with nonfiltered cigarettes, it 
is 100 percent; with filtered cigarettes, it is 90 percent; and with 
Orbs, it is 1 percent--isn't it perverse and unjust not to allow the 
American consumer to have this product to switch from cigarettes? I 
think the answer to the question has already been answered.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Udall of Colorado). The Senator from Ohio.
  Mr. BROWN. Thank you, Mr. President.
  I ask unanimous consent to address the Senate for up to 10 minutes.
  The PRESIDING OFFICER. Is this objection?
  Without objection, it is so ordered.
  Mr. BROWN. Thank you, Mr. President.

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