Providing for consideration of the bill (H.R. 1256) to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products.

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, by direction of the Committee on Rules, I call up House Resolution 307 and ask for its immediate consideration.

Mr. Speaker, for the purposes of debate only, I yield the customary 30 minutes to the gentlewoman from North Carolina, Dr. Foxx.

General Leave

I ask unanimous consent that all Members have 5 legislative days within which to revise and extend their remarks and to insert extraneous material into the Record.

I yield myself such time as I may consume.

Mr. Speaker, House Resolution 307 provides a structured rule for the consideration of H.R. 1256, the Family Smoking Prevention and Tobacco Control Act. The rule makes in order a substitute amendment, if offered, by Representative Buyer of Indiana or his designee.

I rise in support of House Resolution 307, the Family Smoking Prevention and Tobacco Control Act. I thank Chairman Waxman and my colleagues who serve on the Energy and Commerce Committee for their leadership in this bipartisan effort.

This legislation, which passed this House by a margin of more than 3- 1 last July, would at long last give the U.S. Food and Drug Administration, the FDA, the authority to regulate tobacco products and to take additional critical steps to protect the public health. The bill prevents the tobacco industry from designing products that entice young people. It develops programs that help adult smokers quit, and it funds the efforts through fees to tobacco manufacturers.

America's youth face intense pressure every day from friends, fancy advertisements and irresponsible adults to make bad decisions that will affect their long-term health. A 2006 study conducted by the Substance Abuse and Mental Health Services Administration found that 90 percent of all adult smokers began while they were in their teens or earlier and that two-thirds became regular daily smokers before

they reached the age of 19. A shocking number of American children are at least casual smokers before they can even drive a car.

As a cosponsor of the Family Smoking Prevention and Tobacco Control Act, I am strongly committed to seeing this figure drastically reduced. Congress must work to help make our children's lives safer and their choices easier.

This bill bans flavored cigarettes with names like Mocha Taboo, Midnight Berry and Warm Winter Toffee that clearly attract children as consumers. The history of low-tar cigarettes illustrates the grave danger to public health that's 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 substantially. Many were convinced to switch instead of to quit. It wasn't until decades later that we learned through many deaths that those low-tar cigarettes were just as dangerous as full-tar cigarettes.

Under this legislation, which simply empowers the FDA to regulate tobacco products, we will not have to wait until the deaths of millions of more Americans to learn whether a so-called ``safer'' cigarette is what it claims to be.

The bottom line is we have an interest in making sure our constituents know the facts, all of them, before making potentially deadly choices.

Americans must also be aware of the dramatic health risks associated with smokeless tobacco. Many believe that chewing tobacco and snuff are safe alternatives to smoking cigarettes. That's wrong. This bill would require warning labels that indicate that smokeless tobacco causes mouth and gum cancer, serious oral diseases, and tooth loss. A study by Brown University reveals that just a few weeks of chewing tobacco can develop leukoplakia of the cheek and gums, which is the formation of leather patches of diseased tissue on the mouth.

The American Dental Association strongly supports this legislation, and calls tobacco use the number one cause of preventable disease in the United States. It should be a no-brainer to responsibly regulate such a dangerous product. And the FDA, the only agency charged with food and drug safety, is a logical Federal agency to place with this great and important responsibility.

I reserve the balance of my time.

Mr. Speaker, I yield 2 minutes to the gentlewoman from California (Ms. Harman).

Mr. Speaker, the Buyer version is opposed by many credible health organizations, including the American Lung Association, the American Heart Association, the American Academy of Pediatrics, among many others who support the Waxman administration because it would protect children from tobacco marketing.

The Buyer bill falls short of banning brands that are potentially targeted to children like Mocha Taboo and Midnight Berry. It does not protect consumers from misleading health claims about so-called reduced-risk tobacco products, and it embraces smokeless tobacco as a means to reduce the harm caused by cigarettes. While certainly there should be sound, scientific investigation, and there is a process under the Waxman bill for doing that, we must not rush to prejudgment of what works and what doesn't.

Mr. Speaker, I yield 2 minutes to the gentlewoman from the Virgin Islands (Mrs. Christensen).

Mr. Speaker, the Waxman bill does allow something different to be tried. It sets up a scientific process for review to make sure that all technologies that might help wean smokers away are allowed into the marketplace in a manner that makes sure that they don't publish misleading claims regarding their health.

Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Lewis).

I would remind the gentleman that the FDA is the primary agency charged with food and drug safety and, as such, to ensure the safety of our Nation's food supply and safety of our Nation's drug supply is the logical place at which to reside the regulation of tobacco products.

Mr. Speaker, I yield 2 minutes to the gentleman from New York (Mr. Engel).

Mr. Speaker, the gentleman from Texas mentioned 2 percent decrease in smoking over 10 years. I will say that every cigarette not smoked, every person who never starts is a life saved.

One of my late constituents, Ms. Susan DeWitt of Lafayette, passed away of lung cancer this last year. Posthumously published on her Web site is a very powerful statement which I will submit in its entirety to the Record but would like to quote from as follows, in part.

``Just prior to being told I suffered from stage IV lung cancer, Dr. Karen Kelly, an oncologist at the University of Colorado Cancer Center, lifted her arms and emphatically exclaimed, `We have to raise the awareness of lung cancer.'

``With those words resonating in my head, I thought back to those high school moments and the few drags I took from my cigarettes. I thought of the precious few years that followed. Years that would include a marriage, a son, my youth and cigarettes. I remembered the day I said, `No more.' That was the day I was given another diagnosis by my doctor, I would again be a mother. That day was 14 years ago . . .

``The day I quit, I was 27 years old. Lung cancer was something I understood the elderly suffered from. It was nothing a young mother of two need bother herself with. I was 28 when my daughter was born. I was young, in love, and beginning to walk my path of life . . . At 37, I was given the gift of another daughter.

``Then, standing there listening to this oncologist tell me I have stage IV lung cancer. I was only 39.''

Ms. DeWitt dedicated the remainder of her life to educating people about the danger of cigarettes. I had the opportunity to speak to her husband just yesterday who shared with me the message that she shared with so many Americans. There is no free ride. There is no break. Don't start smoking.

This bill will help prevent children from ever starting to smoke and help prevent many, many cases of lung cancer and many, many deaths that disrupt families and cause a great risk to our public health as well.

[From the Dailycamera, Oct. 4, 2007]

Lung Cancer Educator Dies After Long Battle

(By Cindy Sutter)

Susan DeWitt, a Superior mom who made a widely distributed

DVD about her family's struggle with her lung cancer, died

Wednesday. She was 43.

``She died at home with her family members holding on to

her,'' said DeWitt's husband, Randy.

DeWitt, a Boulder County court reporter for eight years and

founder of the Susan L. DeWitt Foundation for Extended

Breath, was diagnosed with Stage IV lung cancer in 2004 at

the age of 39. Although DeWitt was a light smoker in her

teens and 20s, she quit in 1992. After her diagnosis, she

made it her mission to warn young people that even casual

smoking can cause cancer. The DVD--``Lung Cancer, Through My

Children's Eyes''--begins with this line from her son, Cody,

then 19: ``There are some things in life that people

shouldn't have to go through.''

Then this from his sister, Gabrielle, then 13: ``I was

afraid to go to sleep at night.''

The film, now on You Tube as well as available on DVD

through the foundation, has been distributed to school

districts in Colorado and around the country. The family has

subsequently made music videos about the subject.

Those who knew DeWitt say she touched people, not only with

her DVD, but with the grace and courage with which she faced

her illness and treatment--which included multiple rounds of

chemotherapy and brain surgeries.

Dan Hale, who retired as a Boulder County District judge

last fall, called DeWitt's spirit even as she became gravely

ill ``truly incredible.''

``Why this happened is one of those great mysteries of

life, but despite that, she wanted to see how she could

benefit others,'' Hale said.

Rob Harter--lead pastor at Larkridge Church in Erie, where

the DeWitts attend--remembers being at the hospital with the

DeWitts when Susan was being prepped for a second brain

surgery. She was giving Randy last-minute instructions on

gifts she had bought for them to open during her surgery.

``Right before they were to wheel her away for three- to

four-hour surgery, what she was thinking about was, `Make

sure you get the gifts for the kids in the car,' '' Harter

said. ``Her idea was to not have them focused on her pain.

It's a powerful example of how she was very other-centered in

her approach to life.''

Randy DeWitt said she touched many people.

``Her group of friends is very vast,'' he said. ``She had a

way of speaking to and treating people with respect. . . . If

you had a troubled look on your face, Susie would attend to

you.''

The DeWitts' story and clips of the DVD were featured on

``Good Morning America'' and ABC's ``World News Tonight'' in

2006. The DeWitts estimate that at that time about 15 million

people had heard of her documentary through those national

news sources, articles in local newspapers, features on local

TV news, speaking engagements and distribution of the DVD.

Susan, who was born in Wheat Ridge and graduated from

Arvada High School, got the idea for the film after seeing a

group of teenagers smoking outside the Westminster Promenade

shortly after her diagnosis.

With their suburban bedrooms as the simple backdrop, the

documentary shows Cody and Gabrielle talking about how their

mother's cancer has upended life as they once knew it.

``Now comes the hard part,'' Cody says in the film. ``What

if my mom dies?'' The DVD shows footage of him graduating

from high school with the sound of his family yelling, ``Woo-

hoo!''

``I want her to be there when I graduate from college,'' he

says.

The foundation will continue its work, distributing the DVD

and music videos. The family plans to expand its focus to

help people deal with a diagnosis of terminal cancer.

Randy DeWitt said the children are doing well. He and Susan

were frank about her illness from the beginning, even with

their youngest child, Gianina, now 6.

Cody is attending the University of Northern Colorado part-

time. He's in his fourth year. Gabrielle is a sophomore at

Monarch High School. Gianina is a first-grader at Superior

Elementary.

``The kids are pretty resilient,'' Randy said. ``My 6-year-

old is giving us a lesson on how to deal. She's talked to me

about this. She gets it. She knows what death is. She knows

that Mommy's not coming back, and she's OK.''

Will the gentleman yield?

What I stated--I believe in the affirmative--is the Waxman bill prevents false and misleading advertising.

The program is fully funded with user fees to set up within the FDA the ability to regulate tobacco products.

The gentleman, Mr. Buyer's proposal, rather than using an agency that exists, would create a new agency and then go on not to fund that new agency. It's fiscally irresponsible to create a new regulatory agency but fail to provide it with any new funding to do the job. The FDA is up to the task, given the funding which this bill provides with user fees.

Mr. Speaker, tobacco is the deadliest product on the market today. It kills over 400,000 Americans each year. Despite this grim statistic, tobacco companies have enjoyed a great deal of influence over public policy, avoiding the appropriate oversight of their dangerous business.

By giving the FDA the authority to exercise their proper oversight duties, we strip Big Tobacco of their special privileges and power. We owe consumers the same level of protection with regard to tobacco use as food and drink consumption, prescription and over-the-counter drugs, and even makeup and cosmetics. Why should tobacco, such an obviously harmful product, not be subject to the same scrutiny?

The FDA is more than capable of handling this new responsibility. We entrust the most sensitive regulation oversight to the Food and Drug Administration. We must give this agency the opportunity to succeed, providing the necessary resources, which the Waxman bill does, to get the job done. It's the most appropriate agency to regulate these deadly products.

Tobacco companies have long taken advantage of this vulnerability by promoting their products through cartoon advertisements, tobacco theme merchandise products, and flavored products that appeal to kids.

By barring the sale of fruit, chocolate, and clove-flavored tobacco products, this bill would protect the health of children who are lured to smoking by these candy-like flavors, with little if any impact on adults' enjoyment of tobacco.

I yield to the gentleman from Indiana.

Reclaiming my time, we can find that out from the gentleman.

I would read a number of groups that are backing the Waxman bill, including the American Lung Association, the American Association of Respiratory Care, the American College of Preventative Medicine, the Association of Schools of Public Health, the Lung Cancer Alliance, the Oncology Nursing Society, and Oral Health America, among many others.

No. Let me finish my statement. Opponents ask kids to make grave health-related choices with incomplete information and hold these kids responsible for childhood mistakes as they would a fully aware adult.

When 80 percent of kids smoke the most heavily advertised brands, we can't help but infer that the ads influence the children.

Big Tobacco claims they don't market to kids. Yet, they continue to do a pretty good job of getting kids to use their product. This has got to change.

This legislation will require that tobacco products marketed as safer than other tobacco products are in fact demonstrated to be safer with scientific proof. By providing the Health and Human Services Secretary with authority to regulate tobacco product standards and product testing based on scientific evidence, this legislation will promote and protect the Nation's public health.

Far too long we have not followed doctor's orders, so to speak, with regard to tobacco use. Science tells us a great deal about the causes of disease and the risk of certain behavior. This legislation puts those scientific findings at the forefront of policymaking by the Department of Health and Human Service.

The bill also promotes public health by requiring the Health and Human Services Secretary to consider placing tobacco replacement products on a fast track FDA approval process. If we want Americans to stop smoking, we must provide them the help they need to kick the habit.

By creating the special category of small tobacco manufacturers, the bill ensures that small businesses have the assistance they need for the FDA to comply with the new regulations.

Supported by over 1,000 health and faith groups from across the country, this bill preserves States rights by not preempting State tobacco laws. It's extremely important to respect that many States, including my home State of Colorado, already recognizes the danger of smoking and the role regulation can play in keeping cigarettes out of the hands of kids.

My home State of Colorado is recognized as a national leader in tobacco control, demonstrated by our leadership in enacting a comprehensive smoke-free law that includes casinos and increasing our State tobacco tax to fund health programs.

Even with this legislation in place, health care costs in Colorado caused by smoking every year is over $1.3 billion. Nearly 15 percent of Colorado high school students still smoke. Nearly 6,000 kids in Colorado start smoking every day.

I reserve the balance of my time.

Mr. Speaker, I would inquire of the gentlelady if she has any remaining speakers.

I am the last speaker for my side, so I will reserve my time until the gentlelady has closed for her side and yielded back her time.

Mr. Speaker, protecting the health of our Nation's children is of paramount importance to me, personally, to all of us, and to the strength and security of our Nation. We need to work to ensure that children have access to adequate health care, including vaccinations and attention from medical professionals.

Tobacco use is the single most preventable cause of death in the United States, and yet it continues to receive less regulation than a head of lettuce. Indeed, even pet food is regulated by the Food and Drug Administration.

When we pledge to safeguard our children's health, we are investing in where the return is, a generation of healthy, productive Americans. Congress not only has an obligation to provide adequate funding for programs that offer health care access and a healthy start for all children, but also a responsibility to step in and provide meaningful oversight and restore accountability. This bill embodies both of these commitments.

This is a personal issue for many of us. I had the opportunity to talk to another widow of a victim of tobacco

from Colorado last night. I spoke to Ms. Kathy Hughes of Loveland, who lost her husband. David succumbed to lung cancer. Again, the latter years of his life were dedicated to combating the dangers of secondhand smoke.

Just as my colleague from California, Ms. Harman, shared her own family experience with this, we too in my family have direct experience. My partner Marlin's late mother, Wendy Klein Reiss, passed away from lung cancer 2 years ago. It was a very painful thing to go through; and, of course, her wish and her dying breaths were that she never started smoking.

Americans across all political, demographic, and geographic lines have expressed overwhelming support for this legislation. The strong endorsement of hundreds of public health organizations for this bipartisan bill sends a powerful message.

The bill simply gives the FDA the long overdue authority to regulate tobacco products and reduce their devastating harm, just as they enjoy today for pet food and lettuce and cosmetics.

Today, we have an opportunity to protect millions of children across this Nation and to safeguard their future and prevent them from starting smoking. We have an opportunity to do the right thing, to save lives and to strengthen American families.

I urge a ``yes'' vote on the previous question and the rule.

Mr. Speaker, I yield back the balance of my time, and I move the previous question on the resolution.

The previous question was ordered.

Mr. Speaker, I applaud my friend from California, Congressman Waxman, for his persistence over the past decade and all Members who have supported his legislation in the past. However, Mr. Waxman's legislation was drafted over 12 years ago and has not taken into account the positive outcomes from the Master Settlement Agreement and the changing conditions of the tobacco market in our country. Additionally, the legislation has unconstitutional provisions, and according to CBO, will only reduce smoking rates by 2 percent over 10 years.

Over the past 2 years I have participated in three markups of Congressman Waxman's bill, and I, along with my colleagues, have offered numerous amendments to improve and update Mr. Waxman's bill. Unfortunately, no significant changes have been incorporated, and our concerns have not been addressed in totality.

That is why I introduced a new bipartisan bill this year which I offer today as an amendment in the nature of a substitute to H.R. 1256. This substitute mirrors the legislation that I introduced with Congressman Mike McIntyre of North Carolina which has strong bipartisan support, including the support of Chairman Collin Peterson of the House Ag Committee along with Chairman John Spratt of the Budget Committee and other ranking members.

This strong bipartisan substitute amendment seeks to regulate tobacco by creating a new science-based, pragmatic harm-reduction strategy to improve public health. The amendment combines education, prevention, and cessation goals while using public policy to migrate over 45 million smokers to nonsmoking tobacco products and nicotine therapies which are scientifically proven to be significantly less harmful to human health and greatly assist in our efforts to decrease tobacco- related deaths and disease rates in our country.

I strongly believe that no tobacco products are safe. However, Americans today are left in the dark about the relative risks of all tobacco products, and it is false to assume that all tobacco products have equal health risks. Adult smokers deserve to understand the relative health risks of all tobacco products so that they can make informed health decisions.

According to the Royal College of Physicians, ``The application of harm reduction principles, to nicotine and tobacco use, could deliver substantial reductions in the morbidity and mortality currently caused by tobacco consumption.'' Making such information available to adult tobacco users is one of the purposes behind this substitute amendment.

Tobacco harm reduction adds to current tobacco-control policies in order to drastically improve our Nation's health outcomes. It is important to note that harm reduction strategies do

not replace tobacco cessation programs but work along with them. That is why when I first put this bill together, I was very, very hopeful that Mr. Waxman and I could combine our efforts, but unfortunately, that did not prevail.

If we can move our smoking population away from smoking products, the most dangerous tobacco products on our market, and move them to less risky tobacco and nicotine products as we move in this effort to wean them off nicotine and tobacco, we have a chance to decrease the adverse effects of tobacco by up to 90 percent over 20 years, according to the American Council on Science and Health. For smokers who are unwilling or unable to quit smoking, we must provide them with the information they can use to decrease their health risks.

Additionally, this substitute protects the core missions of FDA by creating a new harm-reduction agency within Health and Human Services to ensure we have a safe, secure food supply, pharmaceuticals, biologicals and medical device supply. Given the numerous news reports over the years of counterfeit and adulterated drugs and our tainted food supply, the last thing we should be doing is forcing the FDA to regulate an inherently dangerous product in carrying out a mission that is counter to its culture.

This substitute also goes further than the Waxman bill in protecting children because we require States to spend a larger percentage of their master settlement agreement for tobacco education, prevention and cessation efforts. In the last 10 years, States have spent just 3.2 percent of their total tobacco-generated revenue on prevention and cessation programs, and in the current fiscal year, no State is funding tobacco prevention programs at the level recommended by CDC.

Additionally, we require States to make it illegal for minors to purchase and possess tobacco products, aligning our Nation's tobacco policies with our Nation's alcohol policies. Not only will it be illegal for retailers to sell tobacco to minors, but now minors will be strongly discouraged from purchasing or possessing tobacco.

We also ensure that the Feds stay off our Nation's farms. We ensure that our farmers are not hit with additional Federal regulations that affect their traditional farming practices, and we make sure that these regulations stay within the purview of the agriculture department.

Mr. Waxman's legislation will directly and indirectly affect farming practices, and I was quite surprised that the Parliamentarian ruled that the Agriculture Committee did not have jurisdiction on this bill. My amendment expressly prohibits the tobacco legislation from finding its way into today's farming practices.

Finally, this substitute calls for a blue ribbon study of tobacco advertising in our Nation. I am very concerned about the first amendment potential violations in the Waxman bill. It was discussed during the last two markups we have had before the Energy and Commerce Committee. You see, in 1996, 46 States, plus the District of Columbia, reached an agreement with the tobacco companies known as the Master Settlement Agreement. This agreement has proved extremely effective in regulating tobacco advertisements in our Nation.

It is important to note that the advertising restrictions reached in this agreement were voluntary. When we legislate such advertising restrictions, we violate the first amendment. So I'm very concerned, even if we take the rule that was done, the rule-making effort to place restrictions on advertising back in 1996 as then incorporated in this bill, in fact the Supreme Court has already ruled that unconstitutional. So to put that back in this legislation just throws this right back to the Supreme Court. To me as a lawyer, that's unconscionable. We shouldn't be doing that here on the House floor.

So when we legislate these advertising restrictions, we should never, never violate the first amendment. This is one of these really awkward positions where I find myself as a conservative Republican aligned with the ACLU. I also believe we must study ways in which we can better address tobacco advertising without violating the Constitution.

To conclude, we offer this substitute as a bipartisan effort, as an innovative and pragmatic health approach in addressing the harms of tobacco in this country. This substitute protects our children, jobs, farmers, retailers, and wholesalers while protecting our Constitution and protecting the health of our Nation.

To respond to the gentlelady's concern and her efforts promoting nicotine replacement therapies, there are over 45 million adult smokers in the United States. Each year approximately 2 million smokers use these nicotine replacement therapies in an attempt at quitting. The public success rate of nicotine replacement therapies is only 7 percent, meaning that only 7 percent of smokers who try to quit using nicotine replacement therapies are successful. To me, a 7 percent success rate is failure. It's failure. So we need to try something different, and that's why we have this substitute.

I wanted to touch on just a few things. I don't believe that the gentleman from Colorado meant to do this, so I wanted to make sure to correct any potential false misperception.

The Buyer amendment does not allow for false and misleading advertising. So when you look at the existing State and Federal law adequately today, it protects against false and misleading advertising in a range of consumer products, which also includes tobacco.

I yield to the gentleman from Colorado.

Reclaiming my time, the point is that there are existing State and Federal laws, including the Master Settlement Agreement, which protects against false and misleading advertising in a range of these tobacco products. With regard to the MSA--the Master Settlement Agreement--it's administered by the attorneys general of the 46 States, including the District of Columbia.

So I don't want the gentleman's affirmative statement to somehow mean that we don't. That was my point of clarifying the Record.

In addition, the consumer fraud statutes in each State are also applicable to tobacco products and, at the Federal level, the Federal Trade Commission has--and enforces--section 5 regarding false and misleading jurisdiction over tobacco products. The FDA currently has authority over tobacco advertising and makes therapeutic and health claims.

I would ask the gentleman from Colorado a question because he was talking about the FDA. My question to the gentleman from Colorado would be: Has the FDA ever regulated an inherently dangerous product, is the gentleman aware?

Today. My question is: Has the FDA today ever regulated an inherently dangerous product?

I yield to the gentleman from California.

Reclaiming my time, since two speakers chose not to answer my questions, I then therefore must assume that by silence they're not aware of the FDA ever in its past regulating an inherently dangerous product.

Therein lies the challenge that we have. The FDA is the gold standard with regard to the protection of our food supply, our medical devices, our biologics, and our pharmaceuticals. So right now the FDA--we all know the FDA is overworked and under-resourced.

So when we look at that agency, the last thing we should be doing is taking the FDA and overburdening them with a new mission that is counter to their culture. That's the issue here.

You see, the difference between the Waxman and the Buyer and the McIntyre approach is this: Both of us seek to regulate tobacco. Mr. Waxman chooses the FDA to do it. We say that the world even recognizes that the FDA is stressed in doing its job.

You see, 80 percent of our domestic drug supply is comprised of ingredients produced in foreign countries--increasingly produced in less developed nations. So the FDA has the capability to inspect only a small percentage of foreign drug manufacturing facilities.

So when you think about it, we have 3,000, there could be approaching 4,000, of these foreign manufacturing facilities, and we are only inspecting 200 to 300. If we do that at that rate, by the time we get through all of them, it will be 13 years.

So when you think about all the stress that we're presently placing on the FDA, the last thing we should be doing is giving it another mission counter to its core mission.

Also, when I think about trying to protect our drug supply, not only with regard to how they're manufactured, but let's talk about the products that are coming into the country.

When you look at the 11 international ports of entry run by the United States, coupled with the two by FedEx and UPS, that's 13 international ports of entry. On any given day, each of those ports of entry have between

30,000 and 35,000 drug packages that are coming in.

Now let's just do the math--and let's be conservative. Of the 13 international mail facilities, take 13 times 30,000 drug packages. That's 390,000.

So we continue to do this math. Thirteen international mail facilities times 30,000 drug packages. That's 390,000 times 365 days a year. That's 142,350,000 drug packages.

Now why am I taking time to do this? It's because if 80 percent of these drug packages--every time the FDA does a spot check, they find that these drug packages are counterfeited, adulterated. They're knockoffs. A very small percentage are actually even sent to labs. So the FDA is not being able to do its job to protect our Nation's drug supply.

With regard to food, Americans eat food imported from 150 countries and processed in 189,000 plants scattered all over the world. Here in the United States, FDA inspectors visit every food processor about once every 10 years. FDA examined less than 1 percent of the 7.6 million fresh produce lines imported into the United States from fiscal years 2002 to 2007.

So what we have here is we recognize that Congress, over the last 20 years, has continued to lump more and more jobs and missions on FDA. So when the gentleman from Colorado said it only makes sense that we give it to FDA, well, I disagree.

That's why we want to create a separate agency called the Harm Reduction Agency Under under FDA to--with a laser beam--recruit some of those great scientists and build that science base to regulate tobacco products along a harm-reduction strategy.

I don't support tobacco. I don't use tobacco products. But I don't want to leave 45 million smokers out there to an abstinence approach, whereby it's either smoke or die or go to a harm-reduction therapy, which only has a 7 percent success rate. That's what we're kind of faced with. I don't want to do that.

So I think if we combine our efforts here, at some point in time we're going to have to get together on this if we really want to promote public health for the country.

Will the gentleman yield?

You have been talking about tobacco companies. I don't have tobacco companies supporting my bill. Are there any supporting the Waxman bill?

Mr. Speaker, as you know, we have had some really tough decisions lately. We have had to act boldly on many fronts to address the current financial crisis. People today are suffering, and they are unsure of their future. But I have faith in the American people.

Throughout history we have shown courage in the face of adversity, and today I am asking Members of this Congress to show courage by supporting the Youth Prevention and Tobacco Harm Reduction Act.

It is the only bill before this body that directly addresses the issue of youth smoking in this country. It is the only piece of legislation that builds on the success that we have seen in youth smoking rates, which are down more than 50 percent in the last 10 years.

How did this happen? It happened because the American people, parents, teachers, and the retail community, came together and said that we are going to do something about kids smoking, and they have.

More than 10 years ago, Congress passed legislation that included the Synar amendment. This amendment requires the States to enforce laws prohibiting the sale of tobacco products to individuals under 18 years of age. Synar seeks to develop a strategy to help States achieve a retailer violation rate of 20 percent or less.

In 2006, for the first time, the Secretary of HHS found that no State was out of compliance, and the average rate of tobacco sales to minors was at its lowest in history. This is a great achievement, but we cannot be complacent. We must look to the future and build on the success of the last 10 years.

Our esteemed colleagues, in particular Mr. McIntyre, the chairman of the Ag Committee, the chairman of the Budget Committee, the ranking members, have given us an opportunity to do just that and vote on this substitute.

The Youth Prevention and Tobacco Harm Reduction Act is a tough measure that allows us to really address youth tobacco use in the 21st century. The substitute requires that the States spend a minimum of 20 percent of their tobacco settlement money on prevention, cessation, education, and harm-reduction programs.

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 thank the gentleman from Colorado for yielding time.

This is a terrible bill. And we should vote down this rule. The bill is a de facto prohibition of tobacco. It's going to legislate a Big Tobacco monopoly. This bill is going to increase taxes, expand government bureaucracy at the expense of public health. This bill will decimate the family farm. This bill fails to focus on protecting our kids and instead, targets adult tobacco users and retailers.

This bill will increase black market activity, potentially funding criminal enterprises and terrorists' activity. This bill precludes the development of reduced-risk products. The advertising and communication provisions of this bill are duplicative and unconstitutional. This bill eliminates Federal preemption of marketing and advertising, allowing each State to set its own standards.

This bill is bad for the U.S. economy. It is another power grab on the part of the majority here. This is not something that we need, and it is not something that we should do.

I am going to urge my colleagues to vote ``no'' on the rule and to vote ``no'' on the underlying bill.

On that, Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I now would like to yield 6 minutes to my distinguished colleague from Indiana (Mr. Buyer).

Mr. Speaker, I yield the gentleman 1 more minute.

Mr. Speaker, I yield 30 seconds to the gentleman from Indiana (Mr. Buyer).

Mr. Speaker, I now yield 3 minutes to the gentleman from North Carolina (Mr. Coble), the dean of the North Carolina delegation.

Mr. Speaker, I now yield 5 minutes to the distinguished gentleman from Texas (Mr. Poe).

I would like to enter testimony from Commissioner Steve

Troxler into the Record, and I would like to recognize Mr. Buyer from Indiana again for 5 minutes.

Testimony of North Carolina Agriculture Commissioner Steve Troxler, Subcommittee on Rural Development, Biotechnology, Specialty Crops and

Foreign Agriculture--March 26, 2009

Good morning, Mr. Chairman and members of the committee.

Thank you for inviting me here today to talk about a topic I

know very well.

I grew tobacco in Guilford County, North Carolina, for more

than 30 years. I dealt with dry weather, wet weather, the

steady decline of quotas, and the end of the federal price-

support system.

As North Carolina's Commissioner of Agriculture, I have

seen tobacco production bottom out following the end of

federal price supports. And I have seen it rebound.

North Carolina produced nearly 385 million pounds of flue-

cured tobacco on 171,000 acres last year. We are still the

nation's leading producer of flue-cured tobacco, despite the

fact that we now have less than 3,000 tobacco farmers. That

might seem like a lot, but in 2002, we had 8,000 tobacco

farmers.

When it comes to tobacco, I have seen a lot. But I have

never seen the situation facing North Carolina's tobacco

farmers today.

Tobacco farmers are under siege. First, Congress raised the

excise tax on cigarettes by 62 cents a pack. Now many states

are lining up to do the same. In North Carolina, Governor

Perdue has recommended raising the tax on cigarettes by $1

per pack.

The consequences for our farmers will be severe. The

increase in the federal excise tax hasn't even taken effect

yet, but it has already impacted North Carolina farmers.

Cigarette companies have reduced 2009 contracts with our

farmers by as much as 50 percent.

If the state excise tax goes up, too, our growers will be

hurt even more. And, this increase could also lead to job

losses in the manufacturing sector.

Tobacco manufacturing employs more than 10,000 North

Carolinians and pays average wages of more than $86,000 a

year. That's more than twice the state's private industry

average of $39,000. The last thing North Carolina--or any

state--needs right now is more lost jobs.

In addition to higher taxes, Congress is considering

regulating tobacco. Congressman Waxman's bill would put

tobacco under FDA oversight. This is ill-advised. FDA's focus

right now should be, and needs to be, on food safety.

Expanding FDA's mission would dilute its effectiveness in

protecting our nation's food supply.

Chairman McIntyre and Indiana Congressman Buyer have

introduced a bill that would create a new agency within the

Department of Health and Human Services to oversee tobacco

products. One of the things I like about this bill is that it

would not subject farmers to additional regulations on the

way they grow tobacco. That's good.

North Carolina growers increasingly rely on export markets.

In fact, tobacco is our most valuable agricultural export,

valued at more than $1 billion. Additional regulation would

put our growers at a competitive disadvantage in

international markets.

Agriculture is by far North Carolina's largest industry,

with a $70.8 billion economic impact. Tobacco manufacturing

represents almost $24 billion in added value for North

Carolina's economy.

On average, a single tobacco plant is worth 71 cents in

revenue for a U.S. farmer. That same plant will yield an

average of $15.74 in state and federal taxes on tobacco

products. This money supports a variety of economic and

health programs. A decrease in tobacco revenues will

ultimately hurt states' ability to carry out programs that

benefit many citizens.

In closing, I want to say that farmers must endure many

hardships. They have to deal with the weather and manage

their input costs amid fluctuating commodity prices. As I've

said many times though, the single greatest factor in a

farmer's ability to make a living isn't the weather, but

government policy.

I urge you to make wise policy decisions concerning the

future of our nation's tobacco farmers. Your decisions will

ripple throughout the states, in communities both large and

small. If you regulate and tax U.S. tobacco farmers out of

business, America will become reliant on foreign tobacco that

is not subject to the same high standards. The situation will

be no different from the many problems with imported foods

that our nation has experienced in recent years.

Please choose wisely. Thank you.

I yield the gentleman another 2 minutes.

Mr. Speaker, I now would like to yield 3 minutes to our distinguished colleague from Michigan (Mr. Rogers).

I yield the gentleman another 30 seconds.

Yes, we do.

Mr. Speaker, I yield 2 minutes to the gentleman from Indiana (Mr. Buyer).

Mr. Speaker, the Family Smoking Prevention and Tobacco Control Act will not serve to advance the cause of improving public health, and instead will serve only to act as an unnecessary and expensive regulatory scheme at the expense of our rural farming communities, our small businesses, and the American economy.

This bill includes more than $5 billion in new tax increases on tobacco companies and gives sweeping control of the tobacco market to the FDA. This bill imposes undue bureaucratic and logistic hardships on tobacco manufacturers by burying them under multiple layers of regulation.

FDA regulation will have a devastating economic impact on rural tobacco companies, their employees, associated businesses, and the largely rural communities which they support. As Department of Health and Human Services Secretary Leavitt noted, this legislation could also be viewed by foreign governments as a hostile trade action. Many of the clove and other flavored cigarettes that are banned under this bill are manufactured in foreign countries.

This also grants de facto power to ban existing conventional tobacco products. It will dramatically increase black market activity. It favors larger companies over smaller companies. It favors existing products over new products. It creates insurmountable barriers to development of reduced-risk products. It limits the ability to communicate with adult consumers. It eliminates existing Federal preemption of State limits on labeling, marketing, and advertising. And, it grants FDA indirect authority to mandate changes in farming practices.

In effect, this is a very, very bad bill. I urge my colleagues to vote against the rule and to vote against the bill. We do not need more examples of Big Brother as we are seeing in this Congress and in this administration.

I yield back the balance of my time.