Madam President, I ask unanimous consent that the order for the quorum call be rescinded. Madam President, I needed to come to the floor and apologize for a misstatement I made yesterday on the current bill, the Kennedy tobacco bill. In…
Madam President, I ask unanimous consent that the order for the quorum call be rescinded.
Madam President, I needed to come to the floor and apologize for a misstatement I made yesterday on the current bill, the Kennedy tobacco bill. In yesterday's debate, I stated that the CBO, the Congressional Budget Office, report on the bill revealed that if enacted, smoking rates would decline 2 percent annually. In fact, I was wrong.
I prepared a chart yesterday that showed, based upon what CBO said, that we would reduce by 2016 the smoking rate in the country to 17.8 percent, and also the CDC's projection, which if we did nothing, we would reduce it to 15.9 percent, clearly showing the CBO estimate under the current bill we are considering would not bring the smoking rate down as much as doing nothing.
The mistake I made yesterday was I assumed the way I read it that the CBO estimate is it would reduce smoking 2 percent per year. In fact, what the CBO report actually said was it would reduce by 2 percent over 10 years. So, in fact, I have been way too generous to the current bill that it would reduce smoking to a point of 17.8 percent, which was figured based on a 2-percent-per-year reduction. In fact, the gap between doing nothing and passing this bill clearly is much bigger than I had anticipated; that by doing nothing, we get much more value, if the objective through passage of this legislation is to reduce the smoking rate in the United States.
The bill that is being considered does not change existing products. Let me restate that. We grandfather in all the tobacco products that are currently being marketed. What CBO has concluded is that then you have to permanently figure that about the same rate of Americans will continue to smoke because they do not have new options to turn to.
Let me make this pledge to my colleagues. If the CBO report that smoking will decrease by a scant 2 percent under the bill is because of new warning labels and graphic warning labels that are mandated in the bill, then let me say the substitute Senator Hagan and I will offer provides for the same warning labels and the same graphic warning labels. If that is what gets the 2 percent reduction over 10 years, which clearly it has to be, then I am willing to cosponsor that bill right now and substitute it for the entire Kennedy bill, so we get the full 2 percent we get in the Kennedy bill over 10 years of reductions.
A simple warning label would be a tremendous improvement over this legislation--$787 million, a new mandate to the men and women in our military to pay for it, and it has been portrayed as an effort to reduce the usage of tobacco products with our youth.
I covered for all our colleagues yesterday the fact that when you go down and look at the CDC proposals to States on part of the $280 billion of MSA payments that the industry made to States, that the States had spent a pittance of what CDC projected on cessation programs to get people to stop smoking. But more alarming than the fact that States use the tobacco money to fill their budget gaps and build sidewalks rather than to fund programs to get people to stop smoking is the fact that in practically every case of 50 States, the marijuana prevalence use among youth was higher than the tobacco prevalence.
Let me say that again. Marijuana usage by our youth is projected by CDC to be higher in practically every State than what they have projected youth prevalence of tobacco use. It is actually smoking. That does not necessarily include smokeless.
For my colleagues, including myself, I have spoken on the fact that we must keep tobacco out of the hands of our children. It has an age limit. I would agree it has some problems on enforcement. But marijuana is illegal. It is supposed to be enforced in every community. It is supposed to be enforced in every State. Yet more kids use it than they do tobacco products.
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 have started to come down and leveled off around 30 percent, all the way up to 1993.
For some unknown reason at the time, youth smoking rates started to increase around 1993, peaking at close to a new alltime high in 1997.
In 1998, 12th graders who said they tried cigarettes in the last 30 days was approximately 36 percent, according to the University of Michigan.
Congress did not 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 campaigns.
I heard a Member on the floor last night of the Senate basically blaming everything on these very creative marketing techniques. Trust me, if they
were that effective, every company would be figuring out how to adopt those techniques.
The tobacco industry has a checkered past, at best, when it comes to marketing and advertising. But what I am suggesting is, it may not have been all due to tobacco. There was another trend occurring in the 1993 to 1998 period that virtually mirrored that of youth smoking, and it was the increased use of illicit drugs by teenagers. Something much broader was happening among youths in our society during that time period. The Senate's answer to smoking rate increases was to pass a massive FDA tobacco regulation bill, the exact bill we are debating today. Congress said nothing else would work to save our kids and bring down youth smoking rates.
Senator Kennedy made the following remarks during the 1998 Senate floor debate to emphasize the need to protect our children. I quote:
FDA Commissioner David Kessler has called smoking a
``pediatric disease with its onset in adolescence.'' 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 for 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 smoking as rapidly as possible.
Senator Kennedy, on the Senate floor, May 19, 1998.
Of course, the Senate told the American public that passage of the massive FDA tobacco regulation bill back in 1998 contained the ``strongest legislative tools available'' to address youth smoking issue.
Congress did not pass the FDA bill we are debating today. What happened with youth smoking rates? They decreased since 1998 to current alltime lows. I am talking about record lows over a 34-year period. In 1998, we were told by some in the Senate that youth smoking rates would not come down absent a major bureaucratic expansion over tobacco at FDA. Those Senators were wrong, dead wrong.
Today, we continue the same debate over basically the same bill, and we are debating this as if nothing else has happened or changed. Obviously, something we are doing across this country is working, and it has nothing to do with what Congress is talking about doing. It has to do with the passage of the Master Settlement Agreement, advertising restrictions, awareness campaigns, and education.
None of these things are enhanced in H.R. 1256, the Kennedy bill. It is about design, not about keeping kids from smoking. CBO recently stated that if it was enacted, youth smoking would reduce, over the 10- year period, 2 percent--excuse me, 11 percent for youth, 2 percent overall. But according to the University of Michigan, youth smoking rates have declined by 5 percent over the last 5 years and 16 percent over the last 10 years.
If this is an indication of how youth smoking rates will go over the next 10 years, we will actually slow the decline by passing this bill.
Let me say that again. My colleagues do not understand. We slow the decline of youth usage by actually passing this bill. It is the University of Michigan, it is the Congressional Budget Office, all very reputable agencies.
I know I have a colleague on the floor who wants to speak. I am going to yield the floor to him. But let me remind my colleagues, we are talking about a massive expansion of regulation for the FDA, not a massive expansion of regulation over tobacco. There are a host of agencies currently that regulate tobacco. It is the most regulated product in the United States of America. Now we want to centralize that regulation into the FDA.
Let me read the FDA's mission statement:
The FDA is responsible for protecting the public health by
assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our
Nation's food supply, cosmetics and products that emit
radiation.
Just in the first phrase, ``protecting the public health,'' you are not protecting public health when you allow cigarettes to be sold. So the fact that we have constructed a bill that grandfathers every existing product but makes it practically impossible to bring to market reduced-risk products that allow Americans to give up the cigarettes and to move to something else, the CBO was right, it will slow the reduction in smoking rates. We do nothing for disease and death. We do more for disease and death by not passing legislation than we do by passing legislation. If the authors of this bill are, in fact, honest and the effort is to reduce youth access and youth usage, then the Members of the Senate should do nothing.
Hopefully, tonight Senator Hagan and I will offer a substitute that brings as much regulatory authority to an entity outside the Food and Drug Administration but one under the Secretary of Health and Human Services. Why? Because I spent 15 years in Washington trying to protect the integrity and the gold standard of the FDA, so that when every American goes to bed at night and they take that prescription they got from a pharmacist prescribed by a doctor, they don't have any question as to whether, one, it is safe, or, two, it is going to work; that when they go to the hospital and all of a sudden a doctor shows them a procedure they are going to have and a medical device is involved, they are not sitting wondering: Is this going to work? Is it going to hurt me? Because the FDA has already said it is safe and effective; as we bring on this new line of biological products that are going to cure terminal illnesses that are very expensive, we are not going to do it in a way that hurts our health because the FDA's gold standard is in place; that when we go to the store and we buy food, we are going to be assured it is safe, something we haven't been able to do for the last few years--spinach contamination, salmonella in peanut butter. The list goes on and on.
Why, with an agency that is struggling to meet their core mission, would we ask them to take on a product that in legislation we say we know you cannot prove it is protecting public health or it meets safety and efficacy, but on that we want you to turn your head, we want you to ignore the core mission for this new jurisdiction we are going to give you, but for everything else, we want you to apply that gold standard, we want to ensure drug safety, device safety, food safety but not with tobacco.
To my colleagues, it is very simple. Read the bill. You won't vote for this bill. You want to reduce youth consumption of tobacco? It is real simple. We reduce it faster by doing nothing.
Again, I think there will be a substitute that all Members can vote for tonight. It accomplishes further reductions of youth usage, because we don't constrict less harmful products in the future from coming to the market. We don't lock an adult population in to only being smokers because they are addicted to nicotine. We give them options, such as Sweden gave their citizens, where they have reduced adult tobacco smoking at incredible rates because of innovative new products that deliver nicotine in a way that reduces the risk of disease and reduces the rate of death.
If the objective here is to reduce disease, to reduce death, to reduce youth usage, then I would encourage my colleagues tonight, when Senator Hagan and I introduce the substitute, to listen very carefully and support the substitute. But at the end of the day, if your objective is to reduce youth consumption of cigarettes, in the absence of passing that substitute, it is very clear--the CBO and the University of Michigan says: Pass nothing.
Madam President, I yield the floor.
Madam President, let me say to my colleague, who had his constituent send him a letter and who served in an incredibly effective fashion as State attorney general and who was involved in the MSA, the MSA was very clear. States extorted--that is what I call it--money from the tobacco companies to pay for health care costs. That money that was part of the Master Settlement Agreement was laid out on behalf of the tobacco industry to address the health care costs in those States but also to provide the resources so those States could, in fact, do cessation programs for adults to stop smoking.
What is our experience in the country relative to the recommendations given by the Centers for Disease Control to those States in terms of what they ought to spend on programs to get individuals to stop smoking? Well, in the State of New Mexico, they have done very well. They have actually spent 44 percent of what the CDC suggested they spend.
But I think you would also find it shocking to know that the prevalence of marijuana usage in that State is 1 percent higher than the prevalence of smoking by youth. The prevalence of youth marijuana usage is 1 percent higher than the prevalence of smoking cigarettes by youth. In addition to that, I might add that the prevalence of alcohol among the youth there is almost double what the usage is of smoking or the prevalence of marijuana usage.
There are two objectives to regulating differently an industry that is currently the most regulated industry in America, and the sponsors of this bill have stated it numerous times: No. 1, to reduce youth usage; No. 2, to reduce disease and death. That is the public health component, and I agree totally with it. But I think what we have to look at is the experience of what is happening today and what the assessments are of the bill that is being considered that would grant FDA jurisdiction of this product.
Today, the Centers for Disease Control says smoking is being reduced annually by 2 to 4 percent. The Congressional Budget Office has looked at the Kennedy bill and assessed that over the next 10 years the bill would reduce consumption by smokers at 2 percent. Let me say that again. Currently, doing nothing--not spending billions of dollars, not giving new authorities to the FDA--we reduce smoking by 2 to 4 percent per year. But if we put this bill into effect--at $787 million annually--and we give the FDA authority and jeopardize the gold standard of the agency which approves drugs and biologics, medical devices and food safety, we are actually not going to reduce smoking usage as much as if we did nothing.
Why is that? This is very important because you will hear me talk over the next several days about reduced-risk products. Reduced-risk products are products that deliver the nicotine needed for the addiction but reduce the risk of disease and death because it may be moved from smoking products to smokeless products. The truth is, under the Kennedy bill, we basically eliminate any product that wasn't marketed in February of 2007--over 2 years. We have put a marker in the bill that says if there is a product in the marketplace that was not sold in February of 2007, it can't be sold any more. But if it is a product that was sold before February 2007, the FDA can't change it one bit. It is grandfathered in.
So what is the CBO's assessment? What the Kennedy bill does is it grandfathers every cigarette that was on the market 2\1/2\ years ago and it doesn't allow the FDA to change it in any way. The only thing it does is to increase the warning label. I stated on the floor earlier today that if putting a warning label on it reduces the usage of cigarettes, I am willing to do it today. I will cosponsor it with anybody. The truth is, what this bill does is it locks in these products; therefore, it eliminates the choices adults have to try to get off of cigarettes and move to a reduced-risk product.
My colleague pointed to the Supreme Court ruling on the tobacco industry, and he was partially correct. He just didn't tell the whole story. The whole story was the Court said, in 1998, when the FDA Modernization Act was written and passed and signed into law, Congress opened the entirety of the FDA Act and had the opportunity to give the FDA tobacco jurisdiction and chose at the time not to do it. That was 11 years ago; 11 years ago, the FDA Modernization Act was passed. I was the lead sponsor of that bill, writing that bill in the House of Representatives. It took 2\1/2\ years to construct it. Every Member believed that the gold standard of the FDA was so important that we never lost focus on the fact that we had to maintain the integrity of the mission statement of the FDA. But no Member of Congress ever attempted to extend jurisdiction over tobacco to the FDA because they were concerned at the time that to do that would lessen that gold standard at the FDA.
How can you tell an agency that has a regulatory responsibility to protect the safety and effectiveness of those products they regulate that we want you to do it on drugs and biologics and medical devices, but we don't want you to do it on this new product of tobacco? The risk and concerns and fears at the time were that this might diminish the effectiveness of the FDA.
What has happened in 11 years? For 11 years, we have had a steady decrease in smokers. Now we are going to adopt a bill that potentially locks us into just the products in 2007. Why have we had a reduction? Because new reduced-risk products have come to the marketplace. We ought to continue to bring new reduced-risk products to the marketplace. Unfortunately, this bill does not do that. As a matter of fact, in section 910 of this bill, a so-called new tobacco product would not be marketed unless these three things were met: No. 1, it can show the marketing is appropriate for the protection of public health; No. 2, the increased likelihood that existing users of tobacco products will stop using such products; and No. 3, the likelihood that those not using such products will not start.
Let's take the first requirement and put it into English. Before a company could market a new tobacco product, it would have to show that its use is appropriate for the protection of public health. Who in the world can show that the use of a tobacco product is appropriate for public health? It is impossible. In other words, this new tobacco product--be it a cigarette, raw tobacco, perhaps an alternative tobacco product--the companies would have to show that this new product is appropriate for the protection of public health. Somebody is going to have to explain to me how a cigarette can be appropriate for the protection of public health. It cannot be done. Therein lies why I grandfathered products before 2007.
Even if by some miracle the inventer could show a product was appropriate for the protection of public health, this would only meet a third of the qualifications for a new product to come to
market. It would also have to show that the product will make smokers or those using chewing tobacco less likely to smoke or chew and will prevent new people from starting. Again, somebody will have to show me how you can provide an example of a tobacco product currently for sale that would satisfy these standards: it discourages people from smoking, and it deters young people from starting. The bill's manager, the author of the bill, could not share with us exactly how you accomplish that.
How does one go about assembling the data that is needed for new products when, in fact, you cannot actually ask consumers about a product that has yet to have an application approved. It is a catch-22. It sounds good.
Let me highlight another problem with the bill as it relates to harm reduction. You heard me discuss harm-reduction products or products that are less harmful. These are not found in H.R. 1256.
I am sure my colleagues are aware that the legislation would ban several products not sold in 2007. One of the products is a product called snus. We have seen the can. It is a Swedish smokeless tobacco, it is pasteurized, and it doesn't require one to spit. It is a tool that in Sweden has been used to get people off of cigarettes. Yes, it is still the use of tobacco products, but it meets the threshold of diminishing the risk of death and disease. Some suggest because there is a wintergreen and there is a spice, that this is attractive to kids. That is not the case. If that were the case, we would see wintergreen marijuana, because the usage or preference among youth is higher. The truth is, that has nothing to do with it. As I understand it, the product does not require the burning of tobacco. It does not require the actual smoking of tobacco. It generates no secondhand smoke. It will not affect the children near a user. According to the research done by a host of reputable scientists and public health organizations, use of this product instead of cigarettes can actually reduce death and disease associated with smoking. Why would you ban this product if the pretext of passing this bill is to reduce the risk of death and disease? You would not. But we eliminate the ability for this product to come to market in the future, and that which is at market today we ban from the market. In other words, it is clear that snus is far less dangerous than cigarettes, and it would be appropriate for the protection of public health because it eliminates secondhand smoke, it moves people away from smoking cigarettes. It would meet much of the standard of the bill, but the legislation still mandates that the manufacturer of snus demonstrate that snus will not encourage nonusers to start.
Again, I am not sure how you communicate with the general public-- which is strictly prohibited in the bill until you have an approved application. If you need to communicate with the public in order to understand whether the product would cause nonusers to start for a reduced product approval application but you cannot communicate with consumers until you have an approved application, how would you ever get approval under section 911? The devil is in the details. In fact, you cannot communicate, but you have to communicate to be able to pass the third threshold of allowing the product to come to the marketplace.
So it is disingenuous to suggest that this bill is for the purposes of reducing death and disease when, in fact, those things that are proven to reduce death and disease have strictly been forbidden. And in the case of those that are at market today, they would be pulled from the marketplace.
It would be fair to say that what we are doing is freezing the marketplace for cigarettes and chewing tobacco. In 2007, I raised the issue with the HELP Committee because this same bill was brought up. The answer I was told then was that it may be difficult to bring a reduced-risk product to market. Bringing a reduced-exposure product to market is much simpler. So I said: Let's take a look at it. Maybe a cigarette with less benzene or nitrosamines can work, so I read the reduced-exposure portion of section 911.
The first part of the reduced-exposure language reads that in the absence of conducting a 20- to 25-year study on tobacco products, if you can show a reduction in a harmful constituent in the product, you can classify it as reduced exposure. That seems reasonable.
Then, in addition, those little pesky words pop up: ``additional findings.'' The reduced-exposure language states that you must show how the product would actually be used by consumers. Once again, catch-22-- you can't talk to consumers until you have an approved application. You can't show how the product is going to be used by consumers unless you can talk to consumers. Therefore, there is no such thing as reduced exposure.
The bottom line? The bill that is being considered to give FDA jurisdiction brings no new harm reduction to tobacco users in America. It does to smokers exactly what the bill states, it locks in place all the cigarettes that were sold prior to February 1, 2007. Any of the reduced-risk product that has been introduced in over 2\1/2\ years automatically goes off the market, and the pathway through FDA for any new technology that might not burn tobacco or that might use tobacco in a different way that enables somebody to quit smoking and reduces death and disease--there is no pathway for it to happen because there is no way to communicate with the public until you have an application, and a part of the application process means you have to communicate with the public to meet the test that has been designed.
You know what this is typical of what the American people think about Congress, that we say one thing and we do something else. That is exactly what we are doing here.
I will offer a substitute with Senator Hagan tonight, I believe. That substitute will bring full regulatory authority to an entity to regulate this industry. I am not up here saying we cannot regulate it better than we do today. It is the most regulated product in America. It is regulated by more agencies than any product that is sold today. Can we do it more extensively? Sure. Can we have better warning labels? Absolutely. Can we be graphic in our description of what these products cost? Certainly. But the question is, Where is it more appropriate to do the regulation?
I suggest that creating a new entity under the Secretary of Health and Human Services, where they have full authority to regulate this product, to limit its advertising, to eliminate its advertising, is a more appropriate place than to give it to the FDA, where their mission statement is to prove the safety and efficacy of all products they regulate, but they can never do it on tobacco products; to put it under the same guidance of the Secretary of Health and Human Services, who also oversees the FDA.
What is so magical about putting this at the FDA? I will tell you, because they have attempted to do it for 10 years. It is because when you put it there, over time you will be able to outlaw this product--or you think.
I go back to this chart from the CDC, the Centers for Disease Control, where in 48 out of 50 States the prevalence of youth marijuana usage is higher than the prevalence of youth smoking. Don't think just because you outlaw it you are going to reduce this country's youth usage. As a matter of fact, you may find out you have increased youth access.
The way to do it is to take the money the manufacturers gave to the States and use the money to provide the education, to provide the cessation programs, to provide the reduced-use products that will allow individuals to get off cigarettes and go to something that really does reduce death and disease. But if you pass the Kennedy bill, that is not what we are doing. What we are doing is we are locking in forever the 21 or 22 percent of the American people who are going to smoke. In fact, the Centers for Disease Control said that if we do nothing, by 2016 we will reduce, from 21 or 22 percent, the smoking rate in America to 15.9 percent. We will actually reduce it over 6 percentage points by doing nothing.
Yet we are getting ready, if we don't support the substitute, to lock in a measure that assures us indefinitely into the future that 21 or 22 percent of the country will choose cigarettes as their means of tobacco usage. It means we will continue the rate of death and disease. We may look back and say: But we picked the strongest regulatory agency that we could to be in charge of
the regulation of this product. Tell that to a patient waiting for a lifesaving drug and the reviewer who was reviewing the application was moved over to the tobacco section, because this new responsibility they had made them take senior reviewers and get them over because they had to regulate this product from day one. Tell the individual in America who is harmed because of a medical device that should have never been approved but got through the system because the gold standard of safety and efficacy was not adhered to at FDA because they were asked to turn to tobacco and not prove that public health was important on this product and, therefore, new reviewers looked at it and said: We don't have to be 100 percent accurate on devices. Or the biologic companies, when they see a delay in the approval of an application, that actually invest billions of dollars to bring a lifesaving biologic to the marketplace that ends a terminal or chronic illness, what if this product doesn't come because of what we do?
These are questions we should be asking ourselves. The American people deserve us to fully vet this. But in 2 days of markup on this bill, when questions were asked, the answers were ignored. They were more interested in the speed with which we pass this than the accuracy of the policies that we put in place. I have tried to keep the debate since yesterday on facts. I have tried, when I made a claim, to produce the numbers. The CDC is typically a credible source. The Congressional Budget Office is usually a credible source. The University of Michigan, many have come on the floor and used it as a credible source. This is not industry hype. These are institutions that we come to the floor and use to make our claims every day. What all of them say is: Don't pass this bill. But they don't say not to do something.
Tonight Members will have an opportunity to vote for a substitute, a substitute that gives the same level of authority, that does away with advertising in total, that puts the same descriptive labels on so that people cannot only read it in plain English but see it in detail. It just doesn't put it at the FDA. Why? Because I spent 2\1/2\ years of my life trying to modernize the Food and Drug Administration through a piece of legislation we passed in 1998. Why did it take so long? Because the FDA regulates 25 cents of every dollar of our economy. When the American people go to bed at night, they know if they take a drug that was prescribed by a doctor and filled by a pharmacist, it will not hurt them. More importantly, it is probably going to help them. It will make them better. Or when they go to the hospital or the doctor's office and they use a device, they know it has been reviewed and it is safe. They know that when they go to the grocery store, there is an agency called the Food and Drug Administration that is responsible for food safety. What they buy and what they eat is actually not going to kill them.
Yet we have seen instances over the last 3 years where spinach is sneaked through and peanut butter is sneaked through. And as we become a more global economy, our concerns about where it is made and what they put on it mean that our review of food safety has to be as stringent as everything else. The FDA is struggling today. The biggest mistake we could make is to give them another product and say, regulate this, and don't regulate it based upon the same standards you do everything else. But that is what we are doing.
If you want to reduce youth access, youth usage, if you want to reduce death and disease, vote for the substitute tonight. Reject the base bill. If we do that, we will have successfully done our job. If, in fact, we fall prey to jeopardizing the gold standard of the FDA, mark my words, this body will be back at some point fixing a mistake they made.
My only hope today is that there won't be an American who loses their life by the actions we have taken. I am willing to concede that if the FDA gets the jurisdiction, the authority to regulate this industry, we will miss the opportunity to take a lot of Americans off of cigarettes and move them to other products, other products that are better for their health and not as likely to kill them. The statistics say that that will happen. Ask yourself, knowing that, is it worth risking that you might change the gold standard at the FDA, that you might lower the bar for drug or device approval, that we might actually slip on food safety. I am not sure the risk is worth it.
This is about our kids. Vote for the substitute. This is about the status quo. This is about letting an outside group have a win that has fought this for 10 years because they are in some battle with an industry.
Is it worth it for us to give them a win versus the American people? I don't think so. I encourage my colleagues to support the substitute tonight. Reject the base bill.
I yield the floor and suggest the absence of a quorum.
Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.
Mr. President, while the Senate is in consideration of a bill to regulate tobacco, I think it is extremely important that Members of
the body understand that tobacco is not an unregulated industry today. Let me preface this by saying that I am not proposing that we do not do something additionally in the Senate. I think we can regulate more effectively. But what I have put up--I know it is hard for the Presiding Officer to see--is the current regulatory structure of the tobacco industry in America. It shows every Federal agency that currently has a regulatory jurisdiction over tobacco: Department of Transportation, Department of Treasury, Department of Commerce, Department of Justice, the Executive Office of the President, Department of Health and Human Services, Department of Education, Department of Labor, General Services Administration--the GSA--the Department of Veterans Affairs, Federal Trade Commission, Department of Agriculture, the Environmental Protection Agency, the U.S. Postal Service, and the Department of Defense. These are all Federal agencies that currently, today, regulate the product of tobacco. For any person to come to the floor of the Senate and claim that there is not sufficient regulation of this industry right now is ludicrous. As a matter of fact, this is the most regulated product sold in the United States of America currently.
The proposal Senator Kennedy has introduced is a proposal that concentrates all the regulation of tobacco in the Food and Drug Administration, an agency that was created for the sole purpose, by its mission statement, of approving the safety and efficacy of drugs, biologics, medical devices, cosmetics, products that emit radiation, and responsibility for food safety.
We are going to shift from all these Federal agencies and all the flowcharts underneath them of different aspects of regulation currently for the tobacco industry, and we will concentrate this in the Food and Drug Administration. It probably makes a lot of sense from the standpoint of consolidation, but what I want my colleagues to understand is that this truly today is the most regulated product sold in America, when we look at the expanse of the regulatory framework that exists today.
The authors of the bill have suggested we have to allow the FDA to have jurisdiction because there should be two objectives. One is to reduce death and disease, and the other is to reduce youth usage of tobacco products. These are two goals I embrace wholeheartedly.
Let me share this chart. It starts with a product I consider to be the base: 100 percent of these products presents a health risk. What is the product? Nonfiltered cigarettes. I know the President of the Senate probably remembers when all his friends smoked nonfiltered cigarettes. The truth is, we probably still have some friends who do it today. The continuum of risk goes down in the next category, filtered cigarettes. The industry introduced filtered cigarettes at some point, probably before I was born. The risk is only reduced by 10 percent. It meant it was 10 percent less likely to have a risk involved in it. But still, clearly, 90 percent of users having the risk is pretty unacceptable.
Then we go to a category that never hit the market, except for experimentally through market testing. That was tobacco-heated cigarettes, a product that didn't actually burn tobacco, but it had a ceramic disk in the front that glowed and got hot. As that hot air was pulled through the tobacco, the nicotine was extracted and delivered, but the product never burned. It never created secondhand smoke. In fact, it never had any smoke that actually was emitted afterward. Whatever was emitted was a vapor, and it dissipated.
Then we have a new category called electronic cigarettes, a fascinating product, rather expensive. It actually runs off a battery. It extracts the nicotine and delivers it into the system in a totally different way than the tobacco-heated cigarette. But, clearly, we see that in two new iterations, we have gone from 100 percent risk to 90 percent risk to 45 percent risk and now, with this new electronic cigarette, to a risk of less than 20 percent. One would say, moving from here to here from the standpoint of risk is an advantageous opportunity for people who use nonfiltered cigarettes. If we could get them over here, we have reduced the risk of death, and we have reduced the risk of disease.
Let me move out to the next category, which is smokeless tobacco, U.S. smokeless tobacco. I need to draw the distinction because globally there are new types of smokeless tobacco. But U.S. smokeless tobacco all of a sudden reduces the risk to 10 percent. We have gone from 100 percent to 10 percent. We have reduced by 90 percent the risk presented by the use of tobacco products. Now we move to the next category, which is probably hard to see. I would equate this to about 2 or 3 percent risk. This is Swedish smokeless snus, a pasteurized product. It is actually spitless. It can be swallowed because of the pasteurization. But, again, products that deliver the nicotine need to allow somebody to go from a nonfiltered product all the way over here to a U.S. smokeless or to a Swedish smokeless. We have now gone from 100 percent risk to 2 or 3 percent risk.
Now a new category, not even on the market, a category already targeted as a product that should not be: dissolvable tobacco, a product that dissolves in the mouth. That delivers what this person needs over here from the standpoint of being addicted to nicotine but puts the category of risk somewhere down in the 1 percent category. As innovation has taken place, we have allowed the opportunity for people to come off products that had 100 percent risk down to products that reduce the risk by 99 percent. Then we have therapeutics, such as gum and patches and lozenges, that have minimal risk and pharmaceutical products that allow people to actually either reduce or quit the habit of tobacco usage.
When we look at the goal of a tobacco bill--and the authors have said the goal is to reduce disease, death, and youth usage--I ask the Presiding Officer, if you reduce from 100 percent the risk to 10 percent for U.S. smokeless or 2 percent for Swedish smokeless, does that embrace the spirit or intent of what the author of the bill is trying to do? I say yes. But what I have to share with my colleagues is this category that is at 2 percent, under the current bill being considered, would be banned. Why? Because of an arbitrary date that they have chosen to say if the product wasn't sold in the United States before February of 2002, then this product is not allowed to stay on the marketplace.
My point is, if the authors say the objective of the legislation is to reduce the risk, as you reduce the risk, you reduce the likelihood of disease, the severity of death, isn't this the category we would like more smokers to move to? I think the answer is obviously yes. We would like to move people away. We would like to reduce the health cost. We would like to reduce death. If we can do that by bringing this new age of products to the marketplace, this is beneficial to everybody. It makes a lot of sense.
That is not what the legislation does. I have spent this day coming to the floor trying to emphasize with my colleagues that what the legislation does is grandfathers two categories, nonfiltered cigarettes and filtered cigarettes. It says these are the only products that will be allowed to stay on the market. It means the 20 percent of Americans who currently have chosen to smoke, hopefully adults, are not locked into these categories from the standpoint of choice. Yet in Sweden, they created this new product, and they have had a massive movement of people from these two categories to this category. This is not something I have made up. The data is there to show.
The authors of the bill would suggest we allow this product to be created, but there are three thresholds they have to meet. The three thresholds they have set are absurd. Let me focus on the third threshold. They suggest that the manufacturer would have to prove this product wouldn't be used by a nontobacco user. For you to accumulate data to know whether a nontobacco user would be interested in using this product, you would have to go out and present the product to them and explain it before they could comment on whether they would be inclined to want to try it. But the bill forbids any communication about a product that hasn't been approved. So I ask, how do we get a product approved if the threshold is to tell them what the likelihood is of people who haven't used tobacco products using it, if you can't talk to people who haven't used
tobacco products about using the product because the product hasn't been approved?
In Washington we call this a quite crafty way of making a claim but reversing in the bill the ability to use it. In essence, the bill that is under consideration creates these two categories indefinitely and says: It is OK if we have 20 percent of the American people who choose to use those products. Hopefully, over time, more adults won't choose to use them. We are willing to accept that 20 percent are using them, and they are going to die or have severe disease.
If that is the case, then how can you come out and claim that this is a public health bill, that we are going to pass this bill because of the responsibilities we have to public health?
Since 1998, smoking rates in America have dropped from approximately 23.5 percent to 19.5 percent. The Centers for Disease Control and Prevention, the agency that many come to the floor and quote with great frequency because of their expertise, says if the Senate does nothing, if we don't pass a piece of legislation, by 2016, the rate of smokers in America will drop to 15.7 percent. But if we look at the Congressional Budget Office that has had an opportunity to see the Kennedy bill, they estimate the Kennedy bill will reduce smoking 2 percent over the next 10 years. Meaning in 2019, the rate will fall from 19.5 percent to 17.5 percent. You get where I am going? By giving the FDA regulatory authority, we are going to increase by over 2.5 percent the number of smokers in the country than if we did nothing. That doesn't make much sense, does it?
Let me explain. When we lock in these two categories and we eliminate the ability for somebody who is a smoker to find one of these products to move to, we have now locked in the category of smokers. When we explain it to somebody, it makes tremendous sense. The question is, Why would we do this? I expect Sweden to be up here arguing that this is the right strategy. Yet Sweden is the one that is the most progressive. Why? Because they are truly focused on the health of Swedes. The fact that we claim that we are doing this because of death and disease isn't true. We are doing this because 10 years ago somebody wanted to do something punitive to an industry. As a matter of fact, the date that is set in the Kennedy bill is February 2007, meaning if the product wasn't sold before 2007, it is banned from the marketplace. Why did they use February 2007? Because they wouldn't even change the bill they passed out of committee in 2007 to reflect 2009, which is the current date. There was so little attention paid to this piece of legislation that they didn't even go through to purge the date and change it. They printed the same page of the bill they had last time.
I have said several times throughout, the only thing I ask Members to do before they vote on this bill is to read it. I don't think that is too much to ask. If they read the bill, they will never vote for it. If they read the bill, they will understand that, one, this makes a lot of sense. But, two, remember, when I went over the current regulatory structure, I didn't mention the Food and Drug Administration. I did mention the Department of Health and Human Services. As we go down this flowchart of things under the HHS, there is no FDA. We are choosing an agency of the Federal Government that has never regulated tobacco. How can that possibly make sense? Maybe if you claimed you were going to put it at the Centers for Disease Control, they actually have some responsibility within the framework currently of regulating tobacco. But not the FDA. We may have taken the only piece of the Federal Government that doesn't currently have any jurisdictional responsibilities to regulate tobacco, and we are giving them 100 percent of the requirement to regulate tobacco.
The truth is, we don't need the FDA to do it. We can do it by creating a new entity under the Secretary of HHS, the same person who is over the FDA today, and we would suggest doing that by creating a new center. That new center would be responsible to regulate in total tobacco products throughout the industry.
It is a Harm Reduction Center. Think about that: Harm Reduction Center. Let me go back to this chart: The continuum of risk. If the objective is to reduce death and disease, then you have to drive the risk down. To drive the risk down, you have to bring less harmful products to the marketplace. So you have two choices. You have a bill that will do that through creating a Harm Reduction Center that regulates with all the authority the FDA has or you can choose the Kennedy bill, which basically isolates these two categories of 100 percent risk and 90 percent risk; and you put that into statute that the FDA cannot touch products that are over here, as shown on the chart, but, more importantly, you structure it in a way that the FDA could never approve any new products that are less harmful.
The Harm Reduction Center actually has two responsibilities. One, it is to regulate the entire tobacco industry and, two, to facilitate smokers moving over to lower risk options because we want to reduce the harm that potentially can be caused.
I am going to speak later tonight, as I offer this substitute, which I hope every Member will take the opportunity to read on behalf of Senator Hagan and myself. I am sure we will both speak tonight and throughout the day tomorrow as we get ready to have a vote. It is my hope Members will take the opportunity to review the substitute.
Let me put Members on notice right now, some will come to the floor and claim: Well, this is a substitute that the HELP Committee considered and they rejected it 12 to 8, 13 to 8--I cannot remember exactly what it was. Let me put Members on notice before they come down here and make claims on it, it is not the same bill. It is not the same substitute. I am sure staff now is going to scramble to figure out what is in this new bill.
We listened to criticism. Where we thought we could better the bill, we did that. The fact is, there are still going to be Members who come and make claims tonight, tomorrow--before this is all settled--that are not accurate. I put them on notice now: I will come to the floor and expose exactly what you say.
This is not a debate where we are going to use the charts we had 10 years ago and say they are relevant today. This is not a debate where we are going to have information that was produced in 1990 for an issue we are discussing and debating in 2009. It is not right to do that to the American people.
In concluding--because I see my colleague is here wanting to speak--I pointed out earlier that in 1998 the industry made a massive payment to the 50 States of this country. It was called the Master Settlement Agreement, MSA. Mr. President, $280 billion that the industry, over a fixed period of time, was paying out to States. It was for two purposes: No. 1, to subsidize health care costs--the Medicaid costs in States--that might have been from the direct cause of tobacco usage; and, No. 2, so States would have the resources they needed to create cessation programs so people would move from this category, as shown on the chart, to this category or quit tobacco use all together.
I came to the floor yesterday--and I will say for the purposes of the Presiding Officer in the Senate, who is from Illinois--CDC made recommendations to every State to do this every year: How much of the money they got that year should be used for cessation programs.
Well, in Illinois, Illinois devoted 6.1 percent of what the CDC recommended for cessation programs to cessation programs--6.1 percent. Mr. President, 19.9 percent of the youth in Illinois have a prevalence to smoking--way too high. In Illinois, though, 43.7 percent have a prevalence to alcohol use. In Illinois, 20.3 percent have a prevalence of marijuana use. I am not picking on the Presiding Officer of the Senate, and I am certainly not picking on Illinois. I will have used all 50 States before this is over with.
As I said, one of the shocking things to me, as I explored this chart, was that I found that, I believe it was, 48 out of the 50 States have higher youth prevalence in marijuana use than of smoking.
Well, some are going to claim the reason you have to give FDA jurisdiction over this is because the age limitation of 18 is not working, that youth are getting products. Well, you know
what. There is no age where it is legal to buy marijuana, especially for youth. Yet in 48 out of 50 States, the prevalence of marijuana usage is higher than the prevalence of smoking.
Do not believe for a minute you are going to construct a regulatory regimen here that is going to take a product that is legal to people over 18 and it is going to allow a framework where people under 18 are not going to get it, when a higher percentage of them can get a product that is illegal for everybody in America.
I might also say to the Presiding Officer, his State is not the lowest from the standpoint of the percentage they chose of the CDC recommendation to devote to cessation programs. As a matter of fact, one State had a commitment of 3.7 percent.
Now, $280 billion--paid for by the tobacco industry to cover health care costs and cessation programs--I would suggest to you, if the States had all spent 100 percent of what the CDC told them they needed to spend, we would not be here talking about the regulation of the tobacco industry because cessation programs would have worked and the rate of 19.6 percent today of smokers would have reduced drastically.
I would remind you that the CDC says, if we do nothing, by 2016, we reduce the rate to 15.7 percent of the American people. But when CBO looked at the Kennedy bill, they said, in 10 years, in 2019, the Kennedy bill would reduce smoking to 17.5 percent. If we do nothing, we get to 15.7 percent. If we pass this bill, we get to 17.5 percent. If the objective is to have less smokers, the answer is: Do nothing.
But tonight, sometime around 6 o'clock, Senator Hagan and I will come to the floor not to suggest to our colleagues that we do nothing but to suggest to our colleagues we do the right thing, that we find the appropriate place to put regulation, that we give it the same teeth the FDA has, that we give them the ability not just to have black-and-white print advertising--such as the Kennedy bill does--I suggest in my substitute we eliminate print advertising, we do away with it in total.
We do not worry about whether Vogue magazine, which is typically bought by an adult woman, might be looked at by a teenage girl. If we just eliminate print advertising, we do not have that problem. The Kennedy Bill limits it to black and white. We ban it in total.
If Members will take the opportunity to read both bills--to read the substitute, to read the base bill--they will find out we are actually more expansive from the standpoint of regulation. We actually accomplish the task of reducing disease and death. I believe, by some of the things we do, we actually reduce the amount of youth usage, such as by eliminating print ads.
But there is a big difference. I do not turn it over to the FDA. I do not do that for a selfish reason--purely selfish. I spent 2\1/2\ years, 15 years ago, when I got to the U.S. House of Representatives, where I was tasked by the chairman of the Energy and Commerce Committee to write a bill that modernized the Food and Drug Administration. It took 2\1/2\ years to do. It was signed into law in 1998.
We opened the entirety of the Food and Drug Administration and revamped all the ways it worked to make sure we could reach new efficiencies in the approval of lifesaving drugs, biologics, which were new, devices. We spent a meticulous amount of time going through this with one goal in mind: Do not lower the gold standard the American people have come to expect through the FDA; do not lower the standard an applicant has to reach so we can assure the safety and efficacy of the products we regulate.
Well, I thought that was important, and in 1998 it became law. And you know what. When we had the entirety of the FDA bill open to every Member of the House and the Senate, no Member of Congress offered an amendment to give the FDA authority over tobacco because they knew, at the time, the integrity of the FDA was more important than who controlled it from a regulatory standpoint. They did not want to jeopardize the integrity of what the FDA core mission was.
But here now, 11 years later--I might also say, the Supreme Court ruled in a court case that the FDA did not have jurisdiction over tobacco. The reason they chose was, in 1998, the Congress opened the FDA Act and did not give FDA authority. Therefore, it was not the intent of Congress for FDA to have authority.
So those who claim this is part of the FDA--should have been, always would be--it is not the case. Because Members of Congress had the opportunity and did not do it. Why? Because of the integrity of the Food and Drug Administration. Why in the world would we have changed, in 11 years, to where we would risk the gold standard of drug approval, of biologic approval, of medical devices approval? Why would we risk at a time where, every year for the past 3 years, we have had an issue on food safety--we have had salmonella in peanut butter; we have had tainted spinach; we have had imported products that have killed Americans; and the FDA is the agency responsible for the regulation of food safety--why would we dump on an agency today that is struggling to meet their core mission of food safety a new product such as tobacco?
Why would we take an agency, such as the FDA, that regulates 25 cents of every $1 of the U.S. economy, and say: You know what. You have never regulated tobacco before, but we would like you to do it now. We would like you to take senior reviewers who are approving lifesaving applications for drugs, and we would like you to move them over to the tobacco area.
What else can they do? You cannot go out in the world and find people automatically at the FDA who have ever regulated tobacco. So they are going to take their most senior folks. What does that mean? The likelihood is, we are going to wait longer for that lifesaving drug. We are not going to reduce health care costs because chronic disease is not going to have new therapies because the applications will not be acted on. Heaven forbid we do this and all of a sudden somebody dies as a result of an FDA reviewer who looked at it and said: Well, you know, I know our core mission is to prove the safety and efficacy of all the products we regulate--with the exception of tobacco because you cannot prove it is safe and effective--so if I am going to turn my head on tobacco, maybe I will turn my head on this medical device because it does not look too bad, and all of a sudden somebody dies from it.
This is a huge mistake for the Senate to do. I urge my colleagues: Read the bill. You will not vote for it. Read the substitute, it will supply the sufficient amount of regulation to an industry that can be better regulated, should be better regulated--more importantly, a substitute that goes much further from the standpoint of reducing youth usage of tobacco, which gets at the heart of death and disease.
In fact, the substitute is the only bill that accomplishes what the authors of the current base bill suggest is the reason we are debating this issue. This chart I have in the Chamber proves it. It does it in the most visual of ways. If we do not allow these products to come, you have now locked it into this. That is not what the authors suggest is the objective.
I urge my colleagues, tonight, when given the opportunity, listen intently, read the bills. Tomorrow, when you are given an opportunity to vote, vote for the substitute. Do not support the base bill.
Mr. President, I yield the floor.