Non-Foreign AREA Act of 2009

I yield myself such time as I may consume.

I would note that the gentleman read a list of individuals that supports his bill. But what he left off the list and the prior speaker under the rule, the gentleman from Colorado, was very critical of the tobacco companies. But Altria supports the Waxman bill. Now what is interesting about this is I would ask the gentleman from Colorado, he was so critical of tobacco, but obviously he didn't know that a tobacco company was supporting the Waxman bill.

I truly believe in my heart, since I had written Altria, and they have sent me a letter here in response to the substitute, H.R. 1261, I truly believe that had they not endorsed the Waxman bill 8 years ago that they would be endorsing this bill. And the reason I say that, I just find it in my heart, they let me know in their bill dated to me by the chairman and chief executive of Altria, he says, ``We specifically support H.R. 1266 and supported its predecessor bills for more than 8 years.'' That is the Waxman bill. But he goes on further in his letter, and he says, ``Your letter seeks our input on several aspects of tobacco regulation. You recently introduced H.R. 1261, including harm reduction, product design standards and the appropriate public health standard for tobacco regulation. Before addressing these topics more specifically,'' and they do that in the letter, he said, ``I want to commend your thoughtful leadership on the topic of comprehensive tobacco regulation. Your focus on H.R. 1261 on harm reduction strategies will, we believe, encourage further meaningful conversation about how Federal regulators should exercise authority over tobacco products. We especially appreciate the focus you are bringing in the public policy debate in an important principle that regulation should ensure and certainly not discourage adult consumers access to accurate, objective and non-misleading information about the relative risks of all tobacco products. We have consistently expressed our view that it would be wrong for the Federal regulatory framework to deny adult tobacco consumers access to information about potential benefits to products that could ultimately reduce the harm caused by smoking.''

Now that is the harm-reduction strategy that we have incorporated in this bipartisan bill. And so I wanted to bring that to everyone's attention that this harm-reduction strategy is extremely important. We should not have this abstinence approach that is in the Waxman bill. Now this was an approach that was drafted many, many years ago, and a lot of things have taken place since Mr. Waxman drafted this bill. And he is not taking these things into account. I respect the gentleman. I respect his efforts. I respect his tenacity and his persistence. And hopefully we will have a meeting of the minds one day, and we can incorporate both of our dual-tracked efforts here to move people to stop smoking.

The supporters of the Waxman bill, as I noted from some of the speakers, they claim that it is designed to protect children from the dangers of smoking. But H.R. 1256 does not include any provision that actually protects minors from tobacco use. The American Association of Public Health Physicians wrote on March 3, 2009, ``The current bill, the bill which is before us and being debated, referred to as the Waxman bill, H.R. 1256, in its current form would ensure current levels of tobacco-related deaths while doing nothing of significance to reduce the number of teens who would initiate tobacco use with no bill at all.''

You see, those of whom are supporting the substitute, we support steps to require the States to use more of their Master Settlement Agreement funds to combat underage smoking and promote smoking cessation while also strengthening the Synar amendment which prevents the underage purchasing of cigarettes. Unfortunately, H.R. 1256 does not contain these important public health provisions.

With that, I reserve the balance of my time.

I yield myself such time as I may consume.

The gentleman just spoke about his concern with regard to product standards. It is one of the chief concerns in the Waxman bill. The provisions on product standards allow the FDA to impose any requirements or prohibitions it sees fit, except that it may not ban the product or reduce nicotine delivery to zero. FDA need not consider the cost or feasibility of imposing a standard. FDA does have to consider

the possibility of a black market, but can impose a standard even if it will lead to the creation or expansion of a black market. That should concern everyone with regard to illicit trade.

The Waxman bill also prevents communication about significant differences among levels of risk presented by different types of tobacco products, and it clamps down on any effects to develop and market modified-risk tobacco products. Modified-risk tobacco products are defined as any existing or new product that bears a claim or where the manufacturer conveys to consumers through media or otherwise that: It presents a lower risk or is less harmful than other tobacco products; has a reduced level of substance or reduced exposure to a substance; is free of or does not contain a substance; or uses the descriptor ``light,'' ``mild'' or ``low'' or a similar descriptor.

Approval of a modified-risk product requires under the Waxman bill that the product will significantly reduce harm and the risk of disease to the individual users and that approval benefits the health of the population as a whole. You see, this is a two-tier standard and is almost impossible or nearly impossible to satisfy. So I completely understand why the gentleman came to the floor concerned about product standards. So if you want to embrace a harm-reduction strategy to migrate people from smoking down the continuum of risk to eventually quitting, the Waxman bill does not permit that. We don't permit the innovation of science to drive people to lower-risk products. And that is what the substitute tries to do.

With that, I will yield to the gentleman, the ranking Republican, Lamar Smith of Texas, such time as he may consume.

I would yield now 3 minutes to Dr. Gingrey, the gentleman from Georgia.

I yield to the gentleman of Georgia an additional minute.

I reserve my time.

We have two speakers that I'm aware of that are on their way.

To the gentleman's question, you wanted to know how many more speakers do I have. I was not prepared that you would not have speakers in support of your bill, so I thought that we'd be going back and forth, so I have Members coming from their offices to the floor. But I would be more than happy to take some of my time.

May I ask, Mr. Speaker--actually, we're on your time, I guess, at the moment. I guess, on your time. May I ask how much time both of us may have remaining?

I yield myself such time as I may consume.

We've had a discussion here on the floor, Mr. Speaker, with regard to other concerns over the Food and Drug Administration and its ability to regulate tobacco products, products that will never qualify as safe and effective, and could have significant negative impacts on all Americans.

Congress has spent a great deal of time investigating the ways in which the FDA has been unable to fulfill its core mission. Burdening the FDA with additional responsibilities outside the agency's expertise and core missions at this time will have dire consequences for the American people and the FDA's ability to ensure the safety and efficacy of our Nation's food, drugs and medical devices.

H.R. 1256 allows the FDA to divert resources from its core mission, including funds from food safety inspections and drugs and devices approvals to fund the startup costs of a newer tobacco center. At a time when FDA is struggling to perform many of its core functions, diversion of its limited resources will negatively impact the safety of the American public.

Now, in a bipartisan manner, we share the concerns of many in the public health community that effectively giving FDA's stamp of approval on cigarettes will improperly lead people to believe that these products are safe, and they really aren't. So there actually could be this perception, when people see that the FDA has approved it, there could be this public perception that there's an FDA approval of a particular nicotine delivery device.

Now, what we seek to do is to turn this over to a different agency, whereby we can learn about the different relative risks among that continuum of risk, so that people can make, then, informed decisions and choices relative to the use of tobacco products.

Now, I agree with the American Association of Public Health Physicians, which wrote on March 3, 2009, in regard to H.R. 1256, ``The current bill, in its current form, would assure current levels of tobacco-related deaths, while doing nothing of significance to reduce the number of teens who would initiate tobacco use with no bill at all.''

Now, I read that earlier, but it's so important I had to read it again. Now, Congressman McIntyre and I have authored this bipartisan alternative to establish the Tobacco Harm Reduction Center under the Department of Health and Human Services. The alternative is based on public health policies that acknowledge a continuum of risk among all tobacco products, and referenced scientific literature which shows that smokeless tobacco products are 90 to even 99 percent less hazardous than cigarettes in their risks of causing tobacco-related illnesses and death.

Now, why wouldn't we embrace that as a form of public policy?

Unlike H.R. 1256, the alternative substitute would have insured adult tobacco users are given complete, accurate and truthful information about the risks and relative risks of all tobacco products so that they can make informed health decisions, while providing incentives to develop reduced-risk tobacco products.

See, that's really one of the chief concerns I have about Mr. Waxman's legislation is that when he creates a two-tier product standard with the implementation of new products, how can we ever migrate people to a lesser-harm nicotine delivery device in our efforts to get them to quit? That's why we have this position by Mr. Waxman, either you smoke or you die. And that's not what we should be embracing.

The alternative substitute, which Members will have a chance to vote on, strengthens prevention against minors' tobacco use, ensures that States properly fund anti-tobacco education and smoking-cessation programs, and protects American jobs.

Now, this alternative legislation will significantly improve the public health, while also protecting the already overburdened FDA from new responsibilities that take away from its ability to protect, once again, our Nation's food and drug supply.

In 2001 the Institute of Medicine noted, ``The potential for reduction in morbidity and mortality that could result from the use of less toxic products by those who do not stop using tobacco, justifies the inclusion of harm reduction as a component in a broad program of tobacco control.'' That was my appeal to Chairman Waxman as to why the harm reduction strategy should be endorsed.

You see, if enacted, H.R. 1256, Mr. Waxman's bill, significantly curtails, if not entirely eliminates, incentives for manufacturers to develop and market products that reduce exposure to tobacco toxic substances. In order to obtain approval of a modified risk product, an applicant must demonstrate that the marketing and the labeling of the product will not mislead consumers into believing that the product is or

has been demonstrated to be less harmful than current products.

Further, it has to be demonstrated that the product reduces risk for both the individual and for the population as a whole. This is the two- tiered standard I keep referring to. It is unlikely that such a standard could ever be proven. You see, that is what is so clever about Mr. Waxman's legislation. He puts in a standard that can never be achieved. And if you want to move people down a continuum of risk and improve public health, it cannot be done under Mr. Waxman's approach.

Now, those of us that support the substitute are concerned that such disincentives will effectively freeze the current tobacco market and prevent innovation that could lead to significantly less harmful tobacco products and improve the Nation's health. That is the exact position that Altria took in their letter to me.

Mr. Speaker, H.R. 1256 directs the Secretary of HHS to promulgate an interim final rule that is identical to the FDA's 1996 rule, which legal experts from across the political spectrum have stated would violate the First Amendment. While these experts' views should carry great weight, even more dispositive is the fact that the U.S. Supreme Court has also weighed in on various provisions of the rule, finding them unconstitutional.

In Lorillard Tobacco Co. v. Reilly, the U.S. Supreme Court struck down a Massachusetts statute that was similar in many ways to the FDA's proposed rule. The statute banned outdoor ads within 1,000 feet of schools, parks and playgrounds and also restricted point-of-sale advertising for tobacco products. The Court held that this regulation ran afoul of the test established in the Central Hudson case, which defines the protection afforded commercial speech under the First Amendment, as it was not sufficiently narrowly tailored, and would have disparate impacts from community to community.

The Court then noted that since the Massachusetts statute was based on the FDA's rule, the FDA rule would have similar unconstitutional effects on a nationwide basis. As Justice Sandra Day O'Connor wrote for the Court, ``the uniformly broad sweep of the geographical limitation demonstrates a lack of tailoring.''

Additionally, the proposed rule in H.R. 1256 would require ads to use only black text on a white background. Again, the U.S. Supreme Court found a similar provision unconstitutional in Zauderer v. Office of Disciplinary Counsel. In that case, dealing with advertising for legal services, the Court held that the use of colors and illustrations in ads are entitled to the same First Amendment protections given verbal commercial speech. Justice Byron White, in his opinion for the Court, wrote that pictures and illustrations in ads cannot be banned ``simply on the strength of the general argument that the visual content of advertisements may, under some circumstances, be deceptive or manipulative.''

There are numerous other speech restrictions in this legislation that raise serious First Amendment issues and will create a swarm of lawsuits that will only divert us from trying to develop more effective approaches to tobacco use in the United States. To put forward speech restrictions that a broad range of experts have stated are almost certain to be struck down would be highly counterproductive, and the only winners in this effort will be the litigants' constitutional lawyers rather than the American public.

I reserve the balance of my time.

You would not rob me of the opportunity to put my chart on display, would you, Mr. Chairman?

Thank you.

I am prepared to show a chart on my debate time.

I thank the gentleman.

How much time do I have, Mr. Speaker?

I yield 3 minutes to the gentleman from Texas, Dr. Burgess.

I want to thank both gentlemen--Mr. Platts and the chairman--for his bill. As I've said, I complimented you earlier about your persistence and about your tenacity, about your drive and your sincerity. I don't question it at all. I have a different approach on how we can improve public policy, and this has been a good debate. I want to thank the chairman for allowing this debate to occur. It was a healthy debate at the committee during the markup. I think it's a healthy debate for us to have.

Over 100 countries around the world are struggling with how they answer these public health questions on how to deal with individuals who become addicted to nicotine. When you look at this approach of, ``Well, let's just quit. Stop smoking and just quit,'' I just take a simple look at this. I say there are 45 million smokers, and then there are 2 million who are trying to stop smoking. Yet there's only a 7 percent success rate. Something is not working. To me, that's a rate of failure.

So that's why Mr. McIntyre and I came up with a different approach. We came up with a harm-reduction approach, and what we seek to do is to put our arms around everything. Not only are we trying to accomplish some of the similar goals of Mr. Waxman and Mr. Platts and of others who support Mr. Waxman's approach, but we wanted to include everything. We could include abstinence. We could include cessation programs and prevention and education. We seek to do that because we have a harm- reduction strategy to do that, and we want to move people down a continuum of risk.

When you look at the 45 million smokers, 85 percent of them are smoking light or ultralight cigarettes. Now, the reason they do that is they make a subconscious decision that somehow it's a healthier or a safer cigarette. The reality is it's not. It's not.

So Mr. Platts is absolutely correct, but what we seek to do in the substitute is we want to regulate tobacco. That's what Mr. McIntyre and I seek to do. We want to regulate tobacco. We don't want to do it under the FDA. We want to do it in a harm-reduction center, and we want the tobacco companies to come forward. We'll regulate that tobacco, but we want to migrate smokers into other forms of products. I'm going to talk about that in greater detail on the substitute.

At this point, Mr. Waxman, I don't have any other speakers, so we can proceed to the substitute.

I yield back the balance of my time.

Mr. Speaker, I have an amendment at the desk.

Thank you.

Mr. Speaker, I have a parliamentary inquiry: Because this is my substitute, do I speak last on the substitute?

Thank you.

With that, I will yield to the cosponsor of this bipartisan substitute, Mr. McIntyre of North Carolina.

I would say to the gentlelady who just spoke in the well that Mr. Waxman's bill was drafted years ago, and it was drafted prior to the Master Settlement Agreement. And it is the Master Settlement Agreement itself that has great restrictions upon advertisers. So there is a reason that I don't have it--I say to the gentlelady, there is a reason I don't have that part in the bill because the Master Settlement Agreement that is now administered by the attorneys general in 46 States, including the District of Columbia, who work in concert not only with the FDA but also with the Federal Trade Commission. These tobacco companies are not even advertising today in these types of magazines.

But one of the reasons I didn't go further in advertising is that when we work in concert with the Harm Reduction Center under Health and Human Services, what we seek to do is to inform the public with regard to the relative risks among different types of tobacco product, and that's what we seek to do. We seek to migrate people from the smoking to other types of products.

If I could, I would like to show exactly what I am about to share.

What I would like to share here with you is a chart, and what is important about this chart is about the continuum of risk and about all of the different types of products that are available in the marketplace today.

So when you think about this and you think about the continuum of risk, what I did is I sought to say, All right. Let's think about the products that are presently available out there.

So when you think about that, we have non-filtered cigarettes. That's the worse. I mean, you get those toxins. You get them right into your body and substance, and that's really bad. Non-filtered cigarettes.

Then you've got filtered cigarettes. We know that's a little bit better--all of these tobacco products are harmful. So we go from non- filtered cigarettes to a filtered cigarette.

Then I have a vented filtered cigarette, but those are really bad, too, because people try to gain access to that nicotine so they suck a little harder on that cigarette and they draw it deeper into their lungs. That's not a good thing.

Then we have tobacco-heated cigarettes like the Accord. Now, we know that that reduces a lot of the toxic substances, but we're really not sure where on the continuum of risk does it lie along with the electronic cigarette because there isn't sufficient science yet to back that up.

And these are products that--innovation that is coming out in the marketplace because people every day are making conscious decisions about what we eat, what we drink on a risk assessment, and that's what we are trying to do here in the statute.

So after electronic cigarettes, we have smokeless tobacco products. Now, when I think about this, we can go from a non-filtered cigarette and go all the way down 90 percent down the health risk chart, 90 percent, to get to a U.S. smokeless product.

Let's talk about the difference between a U.S. smokeless product and a Swedish Snus. The U.S. smokeless tobacco product is fermented. So through that fermentation and the natural processing of tobacco and the nitrosamines, you still have some serious carcinogens and some toxic substances. But it is still scientifically shown to be a much better and safer tobacco product than that of smoking.

You see, it is not the nicotine that is killing people. It's the smoke. It's the

smoke. It's the smoke. That's killing people.

So to get away from that--I heard somebody coughing. It was the smoke, I am telling you.

If we can pull them away from the smoke and move them down the continuum of risk chart--actually if we could get them into a Swedish snus, get them into a pasteurized product, we take away 98 percent of the health risk. And then if we can get them to--actually they are now called dissolvable tobacco products. These are orbs or strips that you can lay on your tongue or a stick that's a little like an oversized toothpick that you can stick in your mouth. These are tobacco products that contain no nitrosamines, and you can eliminate 99 percent of the health risk, but an individual can still gain their access to nicotine if they like.

And what we're trying to do, though, is move then down the continuum of risk, make informed decisions in order for them to be healthier but still gain access to their nicotine.

Then you have therapeutic nicotine devices, which are your gum, your patches, your lozenges.

And then we have pharmaceuticals. We want people to quit smoking. But in order to do this, what we've done--not only Mr. McIntyre but Mr. Shuler and others here in a bipartisan effort--is to create a harm- reduction strategy. And we embrace--so not only the goals of Mr. Waxman on abstinence, but we also embrace the goals of education, prevention and cessation activities as we try to move people and make informed choices along this continuum of risk.

Now, what is so, to me, unconscionable is that if, in fact, Mr. Waxman's bills were to pass, is that these new innovative types of nicotine delivery devices could not make their access to the market. Now as I said--I will say it for the umpteenth time--I respect Mr. Waxman and his desire to try to get people to eliminate smoking. We just recognized that today only 7 percent success rate with regard to these type of nicotine replacement therapies, and that's a failure rate, and we shouldn't do that.

I reserve the balance of my time.

Mr. Speaker, I would yield to one of the cosponsors of this substitute, Mr. Shuler of North Carolina, for as much time as he might consume.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Tennessee (Mrs. Blackburn).

I yield myself such time as I may consume.

According to the Journal of Health Care Law and Policy, dated 2008, ``There is a very strong basis in science for believing that the harm caused by current cigarettes can be massively reduced by alternative nicotine delivery systems. Anti-tobacco campaigners who refuse to discuss harm reduction will merely be ensuring that they are not part of the ongoing dialogue that will shape this key area of policy.''

I also would like to cite Britton and Edwards in The Lancet, 2007. ``The risk of adverse effects associated with Snus use is lower than that associated with smoking, overall by an estimated 90 percent. Whatever the true overall hazard, use of low nitrosamine smokeless products is clearly substantially less harmful than tobacco smoking.''

Also citing the Scientific Committee on Emerging and Newly Identified

Health Risks, dated 2007, ``The magnitude of the overall reduction in hazard,'' meaning switching from cigarettes to smokeless, ``is difficult to estimate.'' But as outlined in their paper, for cardiovascular disease, it is at least a 50 percent reduction; for pancreatic cancer, it is at least 30 percent; for oral and other GI cancer, it is at least 50 percent reduction and probably more; and for lung cancer and chronic obstructive pulmonary disease, it's possibly even 100 percent.

Now, what I'm hopeful is that at some point, I'm going to make this quest that Mr. Waxman and I can somehow come together, because according to CBO the reduction in the rates of smoking in the Waxman bill is two-tenths of 1 percent per year. So we're going to take over $6 billion to reduce smoking rates under Mr. Waxman's approach by two- tenths of 1 percent per year. Which means over a 10-year time frame, the total that we're going to reduce for smoking in the entire country is 2 percent. We are going to reduce smoking rates in the country under Mr. Waxman by 2 percent.

We can do much better than that, and that's why we have this substitute is that we want to move people from smoking down the continuum of risk to eventually quitting, and I think that's exactly what the chairman embraces.

Please support the substitute.

Mr. Speaker, pursuant to House Resolution 307, I call up the bill (H.R. 1256) to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, and ask for its immediate consideration.

Mr. Speaker, I yield myself such time as I may consume in debating this legislation.

Mr. Speaker, and my colleagues, we have come to what I hope will be an historic occasion, and that is finally doing something about the harm that tobacco does to thousands and thousands of Americans who die each year, and to stop the attempt to get our children to smoke. But it has taken us far too long to get to this point.

In 1994, the tobacco executives stood up before my subcommittee, they raised their hand, and they said they were going to tell the truth. They swore under oath, though, that nicotine was not addictive. They also said cigarettes were not harmful. They also said they didn't manipulate nicotine. They also said that they would never target kids. And, it turned out, they were not telling us the truth.

In 1996, the Food and Drug Administration tried to regulate tobacco products, but the Supreme Court told them that they needed Congress to give them specific legal authority. Now, 13 years later, here we are finally giving FDA that authority to regulate the leading preventable cause of death in America.

Every one of us has seen the devastating effects of tobacco through losing someone we love, watching others grow sick, or even feeling the grip of addiction firsthand. Worst of all is watching our children and grandchildren be targeted as the next wave of casualties.

Regulating tobacco is the single most important thing we can do right now to curb this deadly toll, and FDA is the only agency with the right combination of scientific expertise, regulatory experience, and public health mission to oversee these products effectively.

This legislation will direct the Food and Drug Administration to end the marketing and sales of tobacco to kids; to prevent manufacturers from calling cigarettes ``light'' or ``less dangerous'' when in fact they are not; and to require changes to what is in cigarettes, like toxic ingredients such as formaldehyde, benzene, radioactive elements, and other deadly chemicals.

Some have objected that this bill is too big a challenge for an already overburdened FDA. But it is clear to me that FDA's recent struggles are primarily a result of years of chronic underfunding. This does not mean that FDA, with strong and committed leadership, cannot take on the critical role of protecting the country against the harms of tobacco. It simply means that when we give the agency this new responsibility, we also must give it the

resources necessary to do the job and to do it well.

We have ensured that this will happen. The tobacco program will be fully funded through a new user fee paid for by the industry. That money will go exclusively to the new tobacco center and will be enough for FDA to handle this task well. Furthermore, by doing so, we will ensure that the new tobacco program will have no impact on other missions at the Food And Drug Administration.

In short, we have everything we need to take this historic step: A comprehensive and flexible set of new authorities and full, certain funding. All we need now is the political will to do the right thing.

The breadth of support for this bill, from the AARP to the American Academy of Pediatrics, from the Southern Baptist Convention to the Islamic Society of North America, shows just how critical this issue is to all Americans. It is also supported by the American Lung Association, the American Heart Association and the American Cancer Society, the groups that are best situated to understand the damage caused by tobacco.

I also want to note that we have worked hard to accommodate specific concerns that we have heard about this bill. In committee consideration of the bill last year, we made changes to ensure fairness and flexibility for convenience stores, tobacco growers and small manufacturers, and we worked with the minority to incorporate their suggestions. We also worked with members of the Congressional Black Caucus to ensure that menthol cigarettes will be an early focus of the agency's attention and the agency has the authority to deal with these and other products.

I want to thank my colleague, Todd Platts, for his strong leadership and dedication to working on this legislation, as well as John Dingell and Frank Pallone for their diligent work in moving this bill forward over the years. I also want to thank Ed Towns, Stephen Lynch and Ike Skelton, all of whom were critical in getting us to this point. Each of these individuals has made this possible and produced a great victory for all Americans, especially our children.

I urge the passage of this legislation.

I reserve the balance of my time.

Mr. Speaker, I yield to the gentleman from North Carolina (Mr. Etheridge).

I thank you for the question, Mr. Etheridge. This is an important question, especially for those who represent tobacco-growing districts. There has been some confusion about this point, so let me be clear. It is not the intent of this bill to allow FDA on the farm. The bill gives FDA the authority to regulate tobacco products but not tobacco leaf.

The gentleman is correct.

I am including in the Record an exchange of letters on H.R. 1256 between the chairman of the Committee on the Judiciary and myself.

Committee on the Judiciary,

Washington, DC, March 24, 2009.

Hon. Henry A. Waxman,

Chairman, Committee on Energy and Commerce,

House of Representatives, Washington, DC.

Dear Chairman Waxman: This is to advise you that, as a

result of your having worked with us to appropriately craft

provisions in H.R. 1256, the ``Family Smoking Prevention and

Tobacco Control Act,'' that fall within the rule X

jurisdiction of the Committee on the Judiciary, we are able

to agree to discharging our committee from further

consideration of the bill in order that it may proceed

without delay to the House floor for consideration.

The Judiciary Committee takes this action with the

understanding that by foregoing further consideration of H.R.

1256 at this time, we do not waive any jurisdiction over

subject matter contained in this or similar legislation. We

also reserve the right to seek appointment of an appropriate

number of conferees to any House-Senate conference involving

this important legislation, and request your support if such

a request is made.

I would appreciate your including this letter in the

Congressional Record during consideration of the bill on the

House floor. Thank you for your attention to this request,

and for the cooperative relationship between our two

committees.

Sincerely,

John Conyers, Jr.,

Chairman.

Mr. Speaker, I have no further requests for time. Although some Members may join us shortly, I ask the gentleman how many other speakers he wishes to call on before we close the debate.

I'll reserve my time and let you go forward. I see there are some of your Members there if they're going to speak on the bill.

We're going to reserve the balance of our time.

Mr. Speaker, I am ready to move on to the Buyer substitute, and if the gentleman from Indiana is ready to yield back his time, I will yield back my time, and we can go to the substitute, itself.

I wouldn't deny you any opportunity to make any points or to show any charts.

Is the gentleman ready to offer his amendment?

Oh. Well then, I'll reserve the balance of my time.

Mr. Speaker, we have put in this bill that the FDA has the power to lower the levels of nicotine to a level that would be appropriate for the protection of the public health. We did not allow the FDA, under the legislation, to eliminate nicotine from cigarettes because we're all aware that, if cigarettes were not permitted to contain nicotine at all, that would be tantamount to an outright ban on cigarettes. I would not like to see people smoking cigarettes at all, but I'm not for prohibition, and therefore, we did not give the FDA that power to ban cigarettes in effect.

Now, it's odd to find that we're criticized for not doing enough and then are criticized for doing too much. You can't have it both ways. I think the FDA is in the position to regulate. We ought to give them that power, and that's why I would urge support for the legislation.

At this time, I would like to yield 5 minutes to the gentleman from Pennsylvania (Mr. Platts), and if he needs more time, I'll yield more to him.

Mr. Speaker, I also yield back my time.

Mr. Speaker, at this time, I rise to claim the time in opposition to the amendment.

Mr. Speaker, I am pleased at this time to yield 3 minutes to a very important member of the Energy and Commerce Committee and its Subcommittee on Health, the gentlelady from California (Mrs. Capps).

Mr. Speaker, may I inquire how much time each side has remaining?

Well, I plan to close the debate, and I know that Mr. Buyer has another speaker on his side, so I want to reserve the balance of my time.

Mr. Speaker, I am going to reserve my time to close the debate, so I will allow the gentleman from Indiana (Mr. Buyer) to continue.

Mr. Speaker, I strongly oppose this substitute amendment offered by Mr. Buyer.

The bill before us, the Waxman-Platts bill, has been carefully crafted over more than a decade, in close consultation with the public health community. It's been endorsed by over 1,000 different public health, scientific, medical, faith, and community organizations. It is also supported by a prestigious and bipartisan group of former public health officials, including former Secretaries of Health and Human Services, Tommy Thompson and Donna Shalala; former Surgeons General, David Satcher and Richard Carmona; former CDC Director, Julie Gerberding; and former FDA Commissioner, David Kessler. It reflects a strong, reasonable, and comprehensive approach to addressing the tobacco epidemic.

Now, this Buyer substitute is deeply flawed. It represents an inadequate response for the greatest preventable cause of death and disease in the United States.

One of the biggest problems in this substitute is that it places oversight of tobacco under a totally new, untested agency. They create a new government agency that lacks any experience in protecting the public health. FDA is our Nation's primary protector of the public health, and it has both the regulatory and scientific expertise to handle the complex task of regulating tobacco. The agency devoted 10 years to investigating tobacco in the 1990s. It has over 100 years of experience in setting science-based standards to protect and promote the public health.

Mr. Buyer's substitute would ignore all of this expertise, would ignore the whole record of all of the public health organizations, and set up a new agency. And the premise of his new agency would be tobacco harm reduction, and he showed us a chart. That chart in effect said that what we should do is try to encourage people to reduce the harm from tobacco by using other tobacco products.

There's no evidence to support his approach. He is basing his assumption that current smokers will use smokeless tobacco to quit, but there's no evidence to support this assumption. In fact, the U.S. Public Health Service's clinical practice guidelines finds no evidence to suggest that smokeless tobacco is effective in helping smokers quit. Rather than have smokers quit, it's just as likely that smokeless tobacco can be used to introduce youth to tobacco use and to discourage smokers from quitting. I would submit that what his proposal would do would be to do everything but get smokers to quit, and it does not focus on getting people not to start smoking in the first place. The only evidence one can cite for using smokeless tobacco to quit is inadequate. It's not based on science, and I'm sure it will be a tremendous boon to the smokeless tobacco industry.

A second major problem with the substitute is that it fails to provide any dedicated funding for tobacco regulation. Instead, it relies on a future appropriation that may or may not ever come along, and then this new agency is supposed to do something to reduce smoking in this country.

It fails to create effective Federal enforcement to prevent tobacco sales to minors. The Buyer amendment would not punish individual retail clerks. Instead, it would fine kids for possession rather than making sure that they don't have access to cigarettes in the first place. The Waxman-Platts bill would instead create a strong Federal enforcement system to ensure that retailers do not sell to minors, while providing adequate procedural protections for retailers.

Another flaw, it allows tobacco companies to keep targeting the kids. One of the most critical goals of our bill is to stop tobacco industry targeting of our children. This bill that's being offered as a substitute does nothing to address the problem. It leaves companies free to continue pushing their products on kids and teenagers, and I would submit that that is not a good substitute for the bill that is before us.

I'm also extremely concerned that it effectively exempts smokeless tobacco products such as chewing tobacco from any oversight. It assumes that those products are safe. Well, there's no evidence for that. It ignores the range of harm-reduction options that pose far less risk such as nicotine replacement therapies, which, by the way, are already being approved as safe by the FDA, and instead, he wants to substitute smokeless tobacco for smoking cigarettes.

The substitute fails to protect consumers from false and misleading claims about reduced harm. It would allow tobacco companies to market products as safer or posing less risk without providing scientific evidence that those claims are actually true. This means that consumers would still be vulnerable to false and misleading claims, and we know those claims: cigarettes are light, cigarettes are low tar. Those are the claims we've heard over the years, and they're wrong, they're dangerous, they're misleading, and nothing would be done to stop those kinds of claims under this substitute. Our bill would allow products to be marketed as less hazardous only when those claims are based on sound science and only when the health of the entire population is considered.

And finally, the substitute gives the tobacco industry a vote in advising the agency on scientific decisions. This flies in the face of everything we know about the industry. Big Tobacco has shown repeatedly that it will distort and discard scientific evidence in service of its business objectives without regard to the public health. We don't give drug or device manufacturers a vote in advising the FDA, and we shouldn't do that here. Giving the tobacco industry voting representation on a scientific advisory committee has no precedent.

I would submit you can choose between a substitute that's just been offered only in the last month or so or you can vote for a bill that has been reviewed by and approved by the Heart Association, the Lung Association, the Cancer Society, the Campaign for Tobacco-Free Kids, the American Public Health Association, the American Academy of Pediatrics, the New England Journal of Medicine, and the AARP, just to mention a few of the thousand groups that oppose the Buyer amendment and support the underlying bill.

This tobacco harm-reduction act proposal is no substitute. In fact, it seems to me that the only harm it reduces is harm to the tobacco industry.

I urge a ``no'' vote on the Buyer substitute.

I yield back the balance of my time.

Mr. Speaker, I rise in support of H.R. 1256, the Family Smoking Prevention and Tobacco Control Act. My good friend and former colleague, Congressman Tom Davis, helped to champion this effort with Chairman Waxman for many years. With Congressman Davis' retirement last year, I'm honored to have taken

his place as the lead Republican sponsor of this important legislation and to have the privilege of working with Chairman Waxman and his staff on this important effort.

Mr. Speaker, tobacco is one of the deadliest consumer products on the market today. It kills over 400,000 Americans every year. Yet it is one of the least regulated of all consumer products. In other words, while the FDA has the authority to regulate seemingly harmless products such as lipstick, hair spray and shaving cream, to name just three, the FDA does not have the authority it needs to regulate one of the deadliest, if not the deadliest, products available for sale to our citizens. It is long past time when tobacco products should be subject to serious regulation to protect the public's health. This bill would finally accomplish this important goal.

First, this legislation would ensure that tobacco products are not advertised to or sold to children. Addiction to tobacco begins almost universally in childhood and in adolescence. Every day, almost 4,000 children try their first cigarette, and over 1,000 become daily smokers. Tobacco companies have long taken advantage of this vulnerability by promoting their products through such tactics as cartoon advertisements, free tobacco-themed merchandise that appeals to kids and through sponsorships of sports and entertainment events.

With health care costs spiraling out of control every year, the cost of treating these smokers later in life is fast becoming prohibitively expensive. Prohibiting advertising to children would go a long way in preventing young people in America from starting to smoke, and it would save billions of dollars and countless lives in the years to come.

Second, this legislation would require that tobacco products marketed as safer than other tobacco products are, in fact, demonstrated to be safer. The history of low-tar cigarettes illustrates the grave danger to public health caused by fooling consumers into believing unsubstantiated claims that one kind of cigarette is safer than another. Millions of Americans switched to low-tar cigarettes, believing they were reducing their risk of lung cancer. Many were convinced to switch instead of to quit. It was not until decades later that we learned through the deaths of those smoking low-tar cigarettes that low-tar cigarettes were just as dangerous as full-tar cigarettes. Under this legislation, we will not have to wait for the deaths of millions of more Americans to learn whether a so-called ``safer'' cigarette is what it claims to be.

This bill does not ban tobacco products. H.R. 1256 would allow the FDA to scientifically evaluate the health benefits and risks posed by ingredients in cigarettes, and it would take steps to reduce the harm caused by tobacco products. This legislation preserves an adult's choice to smoke. Even though I don't believe we want anyone to, it preserves that choice, and we make sure that those tobacco products that are marketed as safe alternatives to cigarettes are, in fact, scientifically proven to be safer.

Finally, I understand that some individuals have concerns with placing such authority under the FDA. I think it's important to note that the FDA already regulates products that people use to help quit smoking, such as nicotine gums and patches. In addition, this legislation does provide an entirely separate funding stream for the FDA's regulation of tobacco products to ensure that other important efforts carried out by this agency are not diminished.

I hope my colleagues will join me in supporting the Family Smoking Prevention and Tobacco Control Act.

For the record, I believe there was reference that the reason we're not completely banning it is because of the influence of tobacco funds in campaigns. If I understand that correctly, I want to be on the record as one who doesn't accept any political action committee funds, including tobacco funds, and I've not received any such funds. Never have. Never will. This is about doing right for American citizens. It's about the health of our citizens. It's especially about the health of our children.

Vote ``yes'' and oppose this substitute. Support the underlying bill.

Mr. Speaker, I rise this evening in support of the Youth Prevention and Harm Reduction Act, which is embodied in the substitute that Mr. Buyer is describing and offering and on which he and I have worked together, which is a bipartisan bill.

I have worked with Mr. Buyer to craft a practical approach to government regulation of tobacco that protects health while preserving a vital economic engine for many communities, not only throughout my district in southeastern North Carolina and across the great Tar Heel State, but also across the country.

The underlying bill will grant the Food and Drug Administration wide authority to dictate to manufacturers and growers dramatic changes in product design and leaf cultivation, a concern that has been raised repeatedly by the tobacco growers in my district and tobacco growers throughout the States that are affected. The last thing we want, of course, is to have any government bureaucrat coming on the farm or dictating to farmers about how they grow their crops. This is the part that we want to be abundantly clear about.

The tobacco industry contributes over $36 billion to the U.S. economy each year employing over 19,000 individuals nationwide. In my home State of North Carolina, over 8,600 people are employed by the industry with a Statewide economic impact of nearly $24 billion. The manufacturing provisions and

the concern about the FDA and its involvement on the farm in the underlying bill would put many companies and growers out of business. And in this time of economic uncertainty, the last thing that any of us can afford is to lose more jobs. Our substitute specifically protects growers by preventing any government agency from requiring changes to traditional farming practices, including standard cultivization practices, curing processes, seed composition, tobacco-type fertilization, soil, record keeping or any other requirement affecting farming practices.

In addition, this bill is about public health and prevents minors from smoking. Our substitute considers cutting-edge scientific research, as Mr. Buyer has indicated a little while ago, which would promote a harm-reduction strategy to move smokers to less harmful tobacco products.

So we're talking about here about protecting public health, definitely protecting minors, and making sure that our growers and farmers are not put out of business.

According to applied economics, the use of these reduced tobacco products increases the average probability of smoking cessation by over 10 percent. The Buyer-McIntyre substitute specifically addresses youth tobacco by encouraging States to penalize minors for purchasing and possessing tobacco products. Under current law, retailers are prohibited from selling tobacco products to minors, but unlike with the purchase of alcohol, minors are not penalized for underage purchase and possession of tobacco products.

This also calls upon the States to increase their percentage of the Master Settlement Agreement dollars to fund tobacco cessation and public health programs. In the past 10 years, States have spent just 3.2 percent of their total tobacco-generated revenue on tobacco prevention and cessation programs.

We take this concern about our youth seriously. I had a son. Back when he was in high school he was part of the Tobacco Free Kids Program and we understand, appreciate, and respect that; and, in fact, our bill has even stronger provisions dealing with that.

The Buyer-McIntyre substitute is a commonsense way to help protect public health and protect our vital tobacco economy and the jobs that we cannot afford to lose, especially in this time of economic crisis in our country.

I urge my colleagues to vote ``yes'' on the Buyer-McIntyre substitute, a bipartisan support, which provides a reasonable and pragmatic way to deal with tobacco regulation and help protect our minors from the harms of tobacco.

I reserve my time.

Mr. Speaker, I thank the gentleman for yielding. And I certainly want to pay tribute to Chairman Waxman in regard to the work that he has done over these many years, 10, at least, in regard to trying to help our society rid themselves of, really, the scourge of smoking cigarettes and many health care problems that that leads to. I don't think that there's any question in anybody's mind about that. And certainly the Surgeon General's warning, very profound, clear warning on a package of cigarettes, should bring their attention to that every time they light up, whether we're talking about young adults or at any age group. And leading to lung cancer and chronic obstructive pulmonary disease, maybe better known as emphysema. So I commend Chairman Waxman very much. I think his heart is in the right place, and what he's trying to do is very credible.

But I do feel that Representative Buyer, from Indiana, and his substitute amendment, will be presented shortly. I really feel, Mr. Speaker, that this is very likely a better way. And so I do rise in strong support of the Buyer amendment in the nature of a substitute.

Despite decades of intense efforts to eradicate the practice, still more than 40 million American adults continue to smoke cigarettes, and that is likely to remain the case, unfortunately, for decades to come.

All tobacco products are harmful, but the health risks associated with cigarettes are significantly greater than those associated with the use of smoke-

free tobacco and nicotine-only products.

So, given these facts, an increasing number of public health experts advocate adopting a tobacco ``harm-reduction'' approach like that proposed in the Buyer amendment that will lower the health risks associated with using tobacco or nicotine.

A growing body of science shows that smokers who switch to smokeless tobacco products can significantly decrease their risk of tobacco- related illness and death.

A World Health Organization Study Group wrote last year that: ``Smokeless tobacco products do not cause the lung diseases causally associated with the use of combusted tobacco products such as cigarettes, pipes and cigars.''

Scientific studies show that even the risk for cancers of the mouth and the throat are higher for smokers than for those who use tobacco products that do not burn. Year after year, this body has considered tobacco regulation that fails to recognize the significant progress that can be achieved by adding this harm-reduction component to tobacco-control efforts.

An article last year, Mr. Speaker, in the Journal of Health Care Law and Policy correctly concluded that, and this is a quote, ``Ignoring harm reduction is simply not a viable option as there is no question that it is possible to provide massively less toxic alternative products.''

Mr. Speaker, a 2007 article in the International Journal of Drug Policy noted that ``A pragmatic, public health approach to tobacco control would recognize a continuum of risk and encourage nicotine users to move themselves down the risk spectrum by choosing safer alternatives to smoking, without demanding abstinence.''

The Buyer amendment presents us with the opportunity to institute that type of pragmatic approach. It offers a stringent regime under which harm-reduction strategies can augment and leverage continued efforts to prevent tobacco use, and to encourage current smokers to quit.

So, as a physician who deeply cares about the health and the welfare of our citizens, I urge you, my colleagues on both sides of the aisle, to adopt the amendment as our Nation's best option for fighting the disease and the death caused by tobacco in the 21st century.