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Mr. DURBIN. Mr. President, first, I will address the issue pending on the floor of the Senate, which is the issue of whether we are going to have the FDA regulate tobacco.
The FDA, historically, focuses on the obvious--food and drugs. Over the years, we have expected from them that they would do their job and make sure, as much as humanly possible, that American consumers would not be exposed to dangerous food products or dangerous drugs and medicine. Sometimes they have failed us, but most of the time they do the job pretty well.
The way they do their job, when it comes to food, is pretty obvious when you go to the grocery store. A consumer buying a pound of spaghetti can grab the box or bag and look at the label and find out the contents, including a nutrition square that talks about carbohydrates, fat, and calories, which people are concerned about before making choices.
When it comes to medicines and drugs, the Food and Drug Administration goes a step further. They require that products that are sold in the United States be both safe and effective. If you are going to sell a drug that is supposed to lower your cholesterol, the Food and Drug Administration wants it tested to make sure it does not hurt you, No. 1, and, No. 2, that it does what it is supposed to do.
So over the years, for almost 100 years, the Food and Drug Administration has created a safety net for American consumers so that the things we purchase, at least by that agency and a few other Federal agencies, have some review before the consumer purchases it.
Then along comes tobacco, and the tobacco industry has argued for as long as this issue has been going on that they should not be covered by the Food and Drug Administration. They say: We are not food. Nobody eats tobacco for nutrition or other purposes. And we are not a drug. We are just tobacco leaves that are ground up, put in a little paper cylinder that people enjoy smoking or maybe chewing. That is all it is about.
For the longest time, they were exempt from the Food and Drug Administration asking the most basic questions. For example: What is in your product? If you believe it is just tobacco leaf ground up and stuck in paper, you are wrong. It turns out that tobacco companies learned a long time ago that if they added chemicals to the cigarettes, they could get more consumer satisfaction, more consumer use, and people buying more of their product.
What did they add? They learned a long time ago that the tricky part of tobacco is nicotine. Nicotine is a drug naturally occurring in tobacco which, if you smoke it, your body starts to crave it, and with that craving and that demand of your body each day for more and more of the chemical, you smoke more and more. Nicotine, craving, leading to an addiction.
I don't use that word lightly. I have seen people who are addicted to tobacco products--virtually all of us have--folks who just cannot quit. They try everything--hypnosis, patches, lectures, you name it--and they cannot quit. They crave that nicotine chemical.
The tobacco companies learned a long time ago that if they added more nicotine to those tobacco leaves than naturally comes out of them, the people get more addicted. It makes it more difficult for them to quit. So they started piling more nicotine into the cigarette. But that was not the end of it.
They also said: The first time a kid or somebody picks up a cigarette and takes a big drag of it, often they cough because their body is saying: What are you doing to me? You are jamming that smoke into my lungs? That doesn't belong there. They found other chemicals that they could add to cigarettes which would reduce the body's rejection and would make it more pleasant to the taste, and so they pumped those chemicals in as well. Then came a whole soup of chemicals that they added for any number of reasons.
Obviously, when you buy a pack of cigarettes, if you want to know what is in the cigarette and take a look at the package, you will find there is no disclosure whatsoever. None. You don't know what is in there. All you know is this is paper and tobacco to start with, but you don't have a clue that there is more nicotine or other chemicals added. And you certainly don't have a warning on the package that some of the chemicals they stick in cigarettes literally cause cancer. It isn't bad enough that burning tobacco and inhaling the smoke can cause cancer, there are other chemicals that are carcinogenic added by tobacco companies because they think it makes a more pleasant product.
The obvious thing the American consumers would say is: Where is the Food and Drug Administration warning? Why won't they tell us the ingredients on that tobacco package? Why won't they tell us if they are dangerous? Because they do not have the legal authority to do it.
From the beginning of time, with the tobacco lobby being one of the most powerful in Washington, they made sure the Food and Drug Administration had no authority when it came to this product. None.
Who does regulate tobacco in the United States? The answer is not anyone; no agency does. The only real regulation has come out of court cases where people who were injured sued the tobacco companies because of things such as misrepresentations--light tobacco, low-tar tobacco, safer cigarettes. People take them to court and say that is misleading and deceptive. They have won cases, and they have had to disclose more information over the years.
Today we are trying to do something that the tobacco companies' lobby has been fighting for decades. We are trying to let the Food and Drug Administration take over the responsibility of making certain that American consumers are at least informed about tobacco products so they know what is in that little package, whether it is dangerous, and they can make a conscious choice about purchasing it.
The second thing we do is to make sure that we keep those tobacco products out of the hands of kids. Why? The math is very simple. Every day about 1,000 Americans die from tobacco-related disease--lung cancer, heart disease--1,000 die. If you were a company selling a product and 1,000 of your consumers are dying every day, you start wondering whether you are going to be in business in a few years. So you have to recruit more consumers of tobacco products.
But tobacco companies have a problem. If people wait until they are older--18, 19, 20 years old--to make a choice about smoking and using tobacco, they will probably say: Are you kidding? No way. It is dangerous and it is stupid and it is expensive. So if you cannot get adults to make up for the 1,000 tobacco users who die each day, where do you go? Kids. You go to children. You try to find ways to lure children into using tobacco products.
The advertising has a lot to do with it, but so does human nature. My wife and I raised three kids. We have seen a lot of kids being raised. I even have vague memories of my youth. The first thing you are attracted to is what your parents say you should not touch. Don't you dare touch that pack of tobacco. Don't you dare smoke a cigarette. Can't wait to try it, right? Get out behind the garage with your cousin, the way I did when I was 10 or 11 years old, to smoke my first cigarette. Man, that shows I am independent, I am grown up, I make up my own mind. Kids will do this. I wish they did not. I wish I had not. But they do it.
I told the story on the floor the other day about when I was a little kid growing up in East St. Louis. My cousin Mike and I went out behind a garage and smoked a cigarette. Lucky for me I didn't like it much. I didn't continue the habit. Unfortunately, my cousin Mike did. He passed away 2 weeks ago--younger than I am--passed away from tobacco-related lung disease. It was an addiction started behind that garage that he could never break the rest of his life. There he was, on oxygen, smoking the night before he died. He just could not quit. It is a terrible addiction.
The tobacco companies know to make up for the thousand who die each day. They need 1,000 new smokers a day. Where do they get them? They get them from our kids. Mr. President, 3,000 to 4,000 kids will try a cigarette in America for the first time today, and about 1,000 of them will decide: I am going to keep doing this. And so the ranks of those who die from tobacco-related disease are filled by children.
This bill says we know that and we have to stop it. So not only do we give the Food and Drug Administration the authority to tell us the ingredients in the package, we give them the authority to police how people sell tobacco products in America.
It is no coincidence that they start peddling these tobacco products with candy flavors, because they know kids enjoy candy and will enjoy candy cigarettes. I am not making this up. Chocolate cigarettes and vanilla and strawberry--all these things they come up with so that kids will be attracted to the product. We put an end to that stuff. And we say to retailers: Get serious. You better put those cigarettes away from kids. You better not sell to them or you are going to face a serious penalty. If we are sincere about protecting our kids, we have to do this.
I have been involved in this fight for a long time. I was attracted to it when I first got elected to Congress and probably because like virtually everyone following this debate, somebody in my family died from a tobacco-related disease. In my case, it was my dad. He was 53 years old, and he died of lung cancer. I was 14 years old. It was devastating to my family, to me. But my story is not unique. Sadly, it is a story that is repeated over and over every single day.
About 20 years ago, I decided as a Member of the House of Representatives that I was going to do something about it. The first thing I did was to tackle the tobacco lobby on one little tiny issue: banning smoking on airplanes. Hard as it may be for younger people to believe, there was a time when we had what we called smoking and nonsmoking sections on airplanes. Can you believe that? We are all sitting in the same metal tube flying across the world or around the country, and we are somehow of a mind that if I sit in row 1 through 18 in the nonsmoking section that I will not be bothered by secondhand smoke; it is only those folks in rows 19 to 36 who are going to be in the smoking section that are in trouble. Crazy idea. It never made sense and caused a lot of problems, health and otherwise.
So 20 years ago, we banned smoking in airplanes. I did it in the House. Senator Frank Lautenberg of New Jersey did it in the Senate. It became the law of the land and eventually all flights became smoke free.
I do not want to take more credit than is due, but I think finally people woke up and said: If secondhand smoke is dangerous on a plane, then it is dangerous on a train or a bus or an office or a school or a hospital. Things changed across America. Now, it is rare to walk into a public gathering place and see people smoking. Folks understand, and they do not do that. You do not expose some innocent person to secondhand smoke. If you want to smoke, if you made that terrible decision that you want to be a smoker, go outside and do it. Don't try to put yourself in a position where you endanger others.
What we are trying to do with this bill is to move this debate forward. It was not enough that we could put warning labels on at one time that now have become so small and irrelevant that people do not even see them. It wasn't enough that we banned it on airplanes. If we are serious about protecting our kids from tobacco and smoking, we have to do more.
This may be an easier issue for me coming from the State of Illinois than Senators from tobacco-producing States or tobacco-manufacturing States. I accept that. This is not easy. For them the issue may be different. It may be in terms of tobacco growers and farmers. It may be in terms of tobacco-related employees. For them the idea of reducing the number of people smoking cigarettes has an economic impact. So I am not going to begrudge them coming to the floor and their attempts to change this bill that is before us. It is perfectly understandable. I do not question their motives at all. But I come to it from a public health viewpoint. I think what they are offering as an alternative is not a good one. Let me tell you why.
We have 1,000 organizations, literally 1,000 organizations, health and consumer organizations across the United States that have endorsed this bill. I have literally in my time in Congress, 27 years, never seen a bill with this kind of endorsement. People understand this now. They understand we have to do this now. Senator Kennedy, who is our champion and inspiration, cannot be with us. He is battling a brain tumor and doing well, but he cannot make it to the floor. But I will tell you that he is in our hearts, thoughts, and prayers today. This bill is about his valiant effort to make sure we do this. So many organizations join him and us in saying this is long overdue.
Those on the other side have come up with a substitute, an alternative. There are a lot of problems with it. I have heard the Senators from North Carolina--Senator Burr was just on the floor--talk about their alternative. We took a look at it. It turns out there are some problems with their alternative.
They want to create a new Federal agency. They don't want the Food and Drug Administration to do this. Unfortunately, it will be an untested and underfunded agency. They do not understand the concept behind trying to keep tobacco products out of the hands of kids. They say maybe there are some alternative products these kids could use which would not be as dangerous, the so-called risk reduction idea. We started our bill on the premise that the tobacco industry's practices mislead people and result in terrible health consequences, and they have to be changed.
One of the ways they propose to reduce the risk of tobacco is to change the form of tobacco. Instead of cigarettes inhaled into the lungs, it turns out they believe that spit tobacco, chewing tobacco, is a safer way to use tobacco. The proposal that is being offered by the Senator from North Carolina virtually exempts smokeless tobacco products from regulation. You know what I am talking about, those little pouches you stick in your mouth that let tobacco juices flow, and so forth. We even have some Senators who chew tobacco, if you can believe that--it is a fact--and spit into cups. Not my idea of a good time. But some of them do it anyway.
This bill would not go after that form of tobacco. There is little, if any, evidence that smokeless tobacco products are a step in the way of quitting smoking or becoming healthy.
In fact, many of these new smokeless products are being marketed to smokers as a way to sustain their addictions in places where smoking is no longer allowed. Take a look at this product: Camel Snus, frost-flavored Camel Snus, 15 pouches. See these little pouches over here?
For those who aren't familiar with it, snus is a smoke-free, spit-free tobacco product that comes in little pouches which can be placed under the upper lip. And as one high school student described it: It is easy--says the high school kid--it is super discreet. None of the teachers will ever know what I am doing.
This is their idea and the alternative? This is the idea, the alternative of the Senator from North Carolina to kids smoking cigarettes. The Web site for Camel Snus boasts that ``snus can be enjoyed almost anywhere, regardless of growing smoking bans and restrictions.''
So do we really want a national policy--as the Senator from North Carolina is suggesting--that steers people toward this kind of a product? Let's look at the facts.
Smokeless tobacco is loaded with dangerous ingredients, just like cigarettes. The National Cancer Institute reports that chewing tobacco contains at least 28 known cancer-causing agents. Smokeless tobacco may be a reduced risk in some respects compared to cigarettes, but its use is still a serious health problem and a danger to children. If you need proof of that, look at this poor young man here.
Gruen Von Behrens is an oral cancer survivor. This young man has had more than 40 surgeries to save his life, including one radical surgery that removed half his neck muscles and the lymph nodes and half of his tongue. Like too many teenagers, Von Behrens first tried spit tobacco, which this bill says is a safer way of using tobacco than cigarettes, at age 13--13--in order to fit in. It only took 4 years for him to be diagnosed with squamous cell carcinoma. Look what this poor young man has been through because of a product which the North Carolina Senator tells us is something we should be moving toward in this country.
I think of all those kids who used to have the little can of snuff--baseball players--in the back of their jeans and how cool that was, and I just wonder how many of them face this kind of an outcome because of popular fads. Would we want to endorse that as part of our debate on the future of tobacco in America?
The Burr substitute is based in part on an unproven assumption that smokeless tobacco should be promoted as a way to help people quit smoking. But the 2008 U.S. Public Health Service Clinical Practice Guidelines concluded that the use of smokeless tobacco products is not a safe alternative to smoking, nor is there any evidence to suggest it is effective in helping smokers quit.
Smokers who are trying to quit already have access to safe, rigorously tested, and FDA approved forms of nicotine replacement, like including nicotine gum, the patch, lozenges and other medications.
Let's steer people who want to quit toward these FDA approved products, not toward smokeless tobacco, which is riddled with carcinogens.
Another weakness in my colleague's bill is in the limited authority it gives the new agency to oversee the contents of tobacco products.
The Kennedy bill gives the FDA strong authority to regulate the content of both existing and new tobacco products, including both cigarettes and smokeless tobacco products.
The Burr substitute gives the new agency virtually no authority over the content of existing smokeless tobacco products--no matter how much nicotine, and no matter how many cancer-causing agents they contain.
My colleague's substitute gives the agency far less authority to remove harmful constituents in cigarettes than the Kennedy bill does, and it makes it far more difficult for the agency to act.
The Kennedy bill allows the FDA to fully remove harmful constituents.
The Burr proposal allows only the reduction--but not the elimination--of known harmful substances.
The Kennedy bill allows the FDA to take into account the impact of product changes on potential users--including children--and the effects on former smokers who might be enticed to resume the nicotine addiction.
The Burr substitute allows the agency to consider only the narrow health impact on existing smokers.
The Kennedy bill allows the FDA to reduce or fully eliminate substances that ``may be harmful'' using the best available scientific evidence.
The Burr substitute requires the agency to demonstrate that a single product change is likely to result in ``measurable and substantial reductions in morbidity.'' This standard will be extraordinarily difficult to meet given the large number of harmful substances in cigarettes. It is language that will tie the agency in knots and prevent actions that are clearly in the interests of public health.
The Kennedy bill includes an outright ban on candy and fruit-flavored cigarettes.
The Burr alternative bans only the use of candy and fruit names on the products, while allowing the use of candy and fruit flavors to entice young people to begin using products laced with nicotine and carcinogens.
All these details are important--they mark the difference between an approach that gives the government real authority to regulate the contents of tobacco products, and an approach that bows down to the industry and leaves tobacco companies in charge of these decisions.
We shouldn't continue to give those companies that kind of power.
There is another serious problem with the substitute offered by the Senator from North Carolina. It does not adequately protect consumers from misleading health claims about tobacco products.
The Kennedy bill sets stringent but reasonable scientific standards before manufacturers of cigarettes and smokeless tobacco products are allowed to claim that their products are safer or reduce the risk of disease.
The Burr substitute completely exempts smokeless tobacco products from these standards even if those claims are likely to cause youth to take up tobacco for the first time.
When smokeless tobacco manufacturers aggressively marketed their products to young people in the 1970s, often with themes suggesting that they were less harmful than cigarettes, use of those products increased among adolescents.
The Burr substitute only allows the agency to look at the impact of health claims on individual users of tobacco products.
It does not allow the agency to consider whether the reduced risk claim would increase the harm to overall public health by increasing the number of youth who begin using tobacco products or reducing the number of current users who quit.
The Senator from North Carolina has criticized the Kennedy bill for limiting tobacco advertising to black-and-white text-only material in publications with significant youth readership.
His substitute, he says, goes further by banning tobacco advertising.
That is an attractive talking point. But like so much tobacco advertising, it is misleading. It has a barbed hook buried in it.
The fact is, a broad, indiscriminate ban on tobacco advertising would likely be struck down by the courts.
The courts would probably rule that it is an impermissibly broad limitation on speech.
They would say the ends are not sufficiently tailored to the means, and they would conclude that it violates the first amendment.
That is what constitutional scholars tell us.
The result of the Senator's amendment would be a continuation of current law--a continuation of the insidious advertising the industry currently uses to lure new customers. Under the guise of a total advertising ban, he would give us the status quo.
And the tobacco industry would thank him for it.
My colleague from North Carolina has improved the warning labels he would require on cigarettes. But they would not be strong enough.
The Burr substitute would allocate 25 percent of the bottom front of the package to a warning label.
In contrast, the Kennedy bill reflects the latest science on warning labels by requiring text and graphic warning labels that cover 50 percent of the front and back of the package.
Clearly, a health warning that takes up the top half of the front and back of a package will be more noticeable and easier to read than one that takes up only a quarter of the bottom of the package--an area that may be hidden by the sales rack.
Senator Kennedy's bill also gives the FDA the authority to change the warnings in light of emerging science. Under the Burr substitute, the agency would not have any authority to change the warning labels.
And the Burr amendment's required warning labels for smokeless tobacco products read more like endorsements than warnings.
For example, one of the required statements is a warning that the product has a significantly lower risk of disease than cigarettes. That is not a health warning--it is an unhealthy promotion.
We have an historic opportunity to finally put some real and meaningful regulations in place, and that will stop some of the tobacco industry's most egregious practices.
For decades, this industry has lied to us, and I don't know why we would trust them now to do the right thing.
We should not accept the underlying premise of the Burr substitute, that a lifetime of addiction and a high risk of premature death must be accepted, and that our strategy should be to steer people towards ``reduced harm'' products.
That is the smokeless tobacco approach, not the public health approach.
The Kennedy bill is a strong and carefully crafted solution that puts the public health first.
The Kennedy bill is the bill that should be enacted.