Steve Buyer

Mr. BUYER

Mr. BUYER. 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.

Mr. BUYER. 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.

Mr. BUYER. 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.

Mr. BUYER. 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?

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

Mr. BUYER. I yield to the gentleman from California.

Mr. BUYER. 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.

Mr. BUYER. 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.

Mr. BUYER. Will the gentleman yield?

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

Mr. BUYER. Will the gentleman yield?

Mr. BUYER. 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. BUYER

Mr. BUYER. 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.

Mr. BUYER. 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.

Mr. BUYER. I reserve the balance of my time.

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

Mr. BUYER. I yield to the gentleman of Georgia an additional minute.

Mr. BUYER. I reserve my time.

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

Mr. BUYER. 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?

Mr. BUYER. 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.

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

Mr. BUYER. Thank you.

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

Mr. BUYER. I thank the gentleman. How much time do I have, Mr. Speaker?