Family Smoking Prevention And Tobacco Control Act
Madam Speaker, I yield myself such time as I may consume. I would like to congratulate Henry Waxman and Senator Kennedy and others with regard to their tenacity and persistence over the years. What is unfortunate is that we were not able…
Madam Speaker, I yield myself such time as I may consume.
I would like to congratulate Henry Waxman and Senator Kennedy and others with regard to their tenacity and persistence over the years. What is unfortunate is that we were not able to incorporate harm reduction strategies. It is also unfortunate that we are continuing to place more burdens and responsibilities upon FDA.
What I had sought to do is to regulate tobacco. I do not smoke, I do not encourage anyone to smoke. The health risks associated with smoking, I believe people recognize them and are cognizant.
Tobacco is an adult product. It's legal. And we are faced with this question of moralism versus pragmatism. And you have to be careful when you go down this path in weighing the balance of moralism versus pragmatism. So what I had sought to do was choose the pragmatic side of the equation and to incorporate a harm reduction strategy with the abstinence approach in the Kennedy-Waxman legislation.
While the authors of the bill, Madam Speaker, would say, Well, Steve, we have harm reduction in the bill. Well, it is mentioned in the bill, but there is a 2-tier standard in the bill that has been cleverly written in a manner to be an entry barrier to new innovative tobacco products. And that 2-tier standard is one that first must be achieved at the individual level, and then you must achieve this standard at the public at large. And the purpose is truly an entry barrier.
Now, if we wanted to work together and truly have a new scientific, pragmatic approach to improve the public health of our country, we would be doing both; we would be doing abstinence along with harm reduction. You see, that's exactly what Henry Waxman and others in this body do when it comes to teenage sex. They say, okay, by this body, Democrats and Republicans enjoin, we have both; we promote abstinence while also we have policies that promote harm reduction in our efforts to lower sexually transmitted diseases.
With regard to HIV, there are needle-exchange programs while we also try to promote abstinence. But all of a sudden now, when it comes to tobacco, approaches that we take in other forms of public health, whether it's in sanitary issues or whether it's in teenage sex issues or in HIV issues, all of a sudden we don't want to apply it to tobacco. It is a curious thing for me that we don't want to apply harm reduction strategies to tobacco.
So I would say to my good friend, Mr. Waxman, I think where we are is that you can have your day in the light, you have earned it, but we are going to have to come back to the table because what we have done is we have locked down the marketplace. You have given a big checkmark to Phillip Morris and said that your market share is okay. And when you lock down the marketplace, and we then stifle innovation and we do not have competition in that marketplace, we truly don't have the ability, then, for these companies to track at-risk capital to make investments in a harm reduction strategy whereby we can migrate people down the continuum of risk.
So if this bill becomes law, we've got some real challenges in front of us. One of them is how do we stand up this new mission within FDA, an agency that is already very stressed and underresourced, and we're already going to be addressing issues in the committee regarding food safety and drug safety while we pile on more missions.
So I would say to my good friend that as soon as this bill is signed into law, a couple of things are going to happen. Number one, the lawyers will make a run to the Federal courts, and the Supreme Court will be back sitting in judgment over the provisions on advertising restrictions, not only potential unconstitutional provisions on the First Amendment with regard to the regulation of commercial speech, but also in the Fifth Amendment with regard to whether it's a constitutional taking or not.
So while that is going on, I will introduce legislation, I'll work with Ms. Harman, I'll work with others, I'll work with the chairman, on how we can best incorporate these harm-reduction strategies to truly improve public health.
Madam Speaker, I embrace the sincerity of Mr. Waxman and Mr. Kennedy that they truly want to improve public health in the country, but this legislation, when we lock ourselves down to only what is presently available and that these nicotine replacement therapies only have a 7 percent success rate, I don't believe anyone here would endorse a 7 percent success rate as a good thing. It's failure. So we are going to have to go back to the drawing board here and figure out how we do a harm-reduction strategy to improve public health.
Madam Speaker, I reserve the balance of my time.
Madam Speaker, I yield myself 30 seconds to respond to my good friend Mr. Waxman.
To say that harm-reduction strategies are best left to the FDA gives me great concern. If you truly believe that, then you should have never set a 2-tiered standard and built a paradigm in which they are to make judgments, if you truly believe that they're the ones who should have designed the strategies to improve public health. So I would be more than happy to work with the gentleman to repeal the 2-tiered standard if we're going to let them set the standard based on sound science to improve public health.
Madam Speaker, I now yield 2 minutes to the gentleman from Pennsylvania (Mr. Platts).
Madam Speaker, I yield myself such time as I may consume.
It is nicotine that causes the consumption of tobacco. So I understand how truly, in my words, outraged then Chairman Waxman was and still is with regard to testimony that occurred years ago when he was the chairman of the Subcommittee on Health.
Now, if it is the nicotine from which adult users receive their satisfaction, the real issue is how do they gain access to nicotine in a manner that reduces their health risk? That's the issue. That's my passion.
I am not a smoker. I don't advocate for people to smoke. My charge and challenge is how do we improve public health in our country? And I don't want this abstinence-only approach. So if it's nicotine for which people want to gain access to and it's an adult product, then shouldn't we be trying to figure out methods or products where people can gain access to nicotine that is less harmful?
During the debate on the rule, Madam Speaker, I would share to my colleague, Chairman Waxman, an individual brought up a head of lettuce and said that there is more regulation on a head of lettuce than tobacco. And I guess it was an effort to be cute, but the real point here is what I shared, Madam Speaker, and to my friend Mr. Waxman, you could have smoked that lettuce and you would still end up with the same problems. You could cut the grass in your yard, dry it and roll it up in a cigarette and smoke it, and you're still going to have a lot of problems. It is the smoke that kills, not the nicotine. It's the smoke.
So when you look and you say, well, if the smoke is the killer because of the inhalation of the tobacco smoke, that's responsible for the pandemic of cancers, heart disease, respiratory disease, and these deadly results.
So I'm going back to this harm reduction. So despite decades of intense efforts to eradicate smoking, more than 40 million adults continue to smoke cigarettes, and they're likely to continue because we don't have this ability to migrate them to other products. It's extremely important, when we talk about a harm-reduction strategy, that not only is it the access to a particular product, it is the education of the people at large as to what type of products that they can avail themselves to that have less harmful health results. That should be our goal and that has been embraced.
The American Association of Public Health Physicians noted last year, Enhancement of current policies based on the premise that all tobacco products are equally risky will yield only small and barely measurable reductions in tobacco-related illness and death.
So in the public debate, there is sort of this presumption that all tobacco products are harmful. Well, all tobacco products have a degree of health hazards, but some are more harmful than others. So cigar and pipe are not subject to this legislation; yet they are the most harmful to the human body of all of the carcinogens that can be inhaled.
So how do we migrate people? And I think that's what is extremely important. And let's stop this premise that all tobacco products are equally risky; that Swedish snus, even though it's 98 percent less harmful than an unfiltered cigarette, should not be treated as though they're both just as harmful. They're not. If you're able to pasteurize and take away the nitrosamines, yet people can gain access to their nicotine, you know what? That ought to be something we should talk about. That ought to be something we should promote.
And the reason, Madam Speaker, that if we just turn this over to the FDA, like Chairman Waxman has just suggested, and let them come up with these strategies, it's not going to be able to get into the hands of the American people because of the 2-tiered standard that has been set in this legislation.
Madam Speaker, I reserve the balance of my time.
Madam Speaker, I yield myself as much time as I may consume.
It is with great disappointment that I hear the words of the Speaker because she is truly endorsing a 7 percent success rate as an acceptable level of success for those who are trying to quit smoking. Also, if we really wanted to try to help children, then she should have endorsed what I sought to do; that is, put tobacco on an equal plain as alcohol to make it illegal to possess. But we're not doing that today.
I also said that the States, with regard to the MSA, the Master Settlement Agreement, the States are not spending the money like they should. In the last 10 years, States have spent just 3.2 percent of their tobacco-generated revenue on prevention and cessation programs. In the current fiscal year, no State is funding tobacco prevention programs at levels recommended by the CDC. So I had offered an opportunity here to the body to strengthen and truly protect children, yet it was not adopted by this body. So be very careful about coming to the floor and saying we're doing it for the children when, in fact, the opportunity was there and you did not.
I now yield 3 minutes to the gentleman from Texas (Mr. Paul).
(Mr. PAUL asked and was given permission to revise and extend his remarks.)
I yield myself 30 seconds.
I would say that the gentleman and I are not always in total agreement. The substitute that I brought to the floor actually sought to regulate tobacco, and I know you did not agree with my substitute. I believe in the regulation of tobacco. I sought to do that. I just don't believe it should be done in FDA. We tried to create a harm reduction center to do that. But I respect the gentleman's views.
I reserve the balance of my time.
Madam Speaker, I now yield 2 minutes to the gentleman from California (Mr. McClintock).
Madam Speaker, there are a couple of issues that I would like to address that I mentioned in my opening. The last two issues that I will address are, one, on the constitutionality, and, secondly, is the FDA the right agency.
While we all agree that steps need to be taken to help lessen the use of tobacco products by underage youth, we must not do so in ways that clearly violate the First Amendment. Unfortunately, the bill in front of us I believe fails to meet that test.
The speech restrictions in this bill are clearly the most sweeping in the history of the United States for any legal product. Numerous top legal experts from every point of the political spectrum have looked at these provisions and declared that they will not meet First Amendment scrutiny.
During the debate on the rule, I questioned the responsibility of this body. I believe it is irresponsible for us to pass legislation that is prima facie unconstitutional.
What we are doing in this body is two things: we are taking the regs from the 1996 rule that the Supreme Court found unconstitutional and we are making them statutory, which means, attention to lawyers in America: you have an access and avenue right back to Federal Court immediately upon the President's signature of this legislation.
Also under the Constitution, private speech, private speech and the regulation of private speech among individuals, that is, companies, if individuals seek to restrict their speech between themselves or how they seek to communicate, they can do that in the private marketplace between themselves. Where the First Amendment comes in is when governments, States, municipalities or the Federal Government then step in and begin to regulate speech.
In this case, it is commercial speech, and that is what we are doing. When we take the MSA, the master settlement agreement, and also place these restrictions and then make them statutory, bang, we are right back to the Supreme Court. And I just find that very bothersome.
Larry Tribe, the noted constitutional expert and Harvard University law professor, commenting on the types of provisions in this legislation, stated, ``Given the extensive regulation of tobacco manufacturing (for example, the creation of manufacturing standards, the regulation of cigarette ingredients, and so on) elsewhere in the proposed legislation, and the mandates for new and improved warnings, it would be difficult to defend the sweeping restrictions on advertising as being narrowly tailored to an important governmental interest. The paternalistic view that tobacco advertising must be restricted because consumers might find it pervasive is antithetical to the assumption on which the First Amendment is based.''
Wow. Now you are going to find me quoting the American Civil Liberties Union. You may want to listen to this, because it is probably the first time I have ever cited the ACLU.
They also said in their testimony on identical language contained in this legislation, they stated if this type of legislation were to be passed, it would be ``wholly unprecedented'' and ``will most likely fail to withstand constitutional challenge.''
On the other side of the spectrum, the Washington Legal Foundation and Judge Bork also have called these proposals ``patently unconstitutional.'' Numerous other legal scholars have taken similar positions.
Now, in our zeal here to restrict tobacco products, there have been these comments by some, Madam Speaker, to say we are doing it for the children. It is wonderful. We can say we are doing it for the children. What does the Court say about that?
The Supreme Court has already examined one of the provisions in the FDA proposal, and that is the 1,000 foot ban on outdoor adds, and has suggested it violates the First Amendment because it is not narrowly tailored.
The Supreme Court rejected the efforts of the Massachusetts Attorney General to ``childproof'' the flow of information in our society. Children deserve to be protected from inappropriate or harmful material, but the government may not use the guise of protecting children to impose sweeping restrictions on information intended for adults.
So we come to the floor and we say we are doing it for the children. Yet we are taking provisions which the Supreme Court has already found to be unconstitutional, i.e., commercial speech that is not merely tailored to a legitimate government interest.
In Bolger v. Youngs Drug Products Corporation, the court stated that efforts to restrict advertising cannot lower disclosure in society ``to the level of the sandbox,'' and cited in the case Butler v. Michigan that ``government may not reduce the adult population to reading only that which is fit for children.''
So the type of drastic speech censorship that is contained in this legislation is almost certain to lead to challenges in the Federal courts, and I find that troubling and counterproductive.
Let me move to the FDA. This bill establishes a general standard that actions by FDA are in the best interest of public health, that they're the ones, that they can reasonably be likely to have measured scientific results.
What do we mean by results?
Substantial reductions in morbidity and mortality rates among smokers. That's what we seek to achieve.
So the great challenge that I have here is that, in the committee, we are now looking at legislation with regard to food safety and drug safety. The FDA is charged with approving medical products based on scientific evidence that benefits of the products outweigh the risks. Tobacco products are inherently risk products that cause disease when used as directed.
Now, we're going to turn to the FDA and say, we want you to regulate the tobacco product. So we take the gold standard of the FDA now, and apply it to tobacco, and now there is this inference that somehow the FDA has said that tobacco's a safe product. That is something we should not be doing. It's why I sought to create a separate agency, rather than the FDA, creating a mission that is counter to their present mission.
You see, if you use a cigarette and follow the instructions, and you do
that every day, it will kill you. Now, think about that. It will kill you. We don't want the FDA to create some type of inference into society that somehow it's okay.
President Obama stated on March 14 of this year that 95 percent of America's 150,000 food processing plants and warehouses go uninspected each year. Wow. Each year, 74 million people in the United States are sickened by tainted food, and about 5,000 die, according to the CDC. That's on food alone.
Then, with regard to drugs, I look forward to working with Chairman Waxman, Madam Speaker, and with Mr. Dingell, with regard to drug safety because right now we have 11 international mail facilities by the United States Government. You count the three private carriers that also have international mail facilities, and they are taking up to around 30,000 drug packages that are coming into our country by people who are going on to the Internet. Every time we do an inspection of those mail packages, we find that 80 percent of them are either counterfeit knockoffs or adulterated drugs. When, in fact, you do the math and you say, okay, wow, take that 14 times 30,000 times 365, then times 80 percent, we are looking at 96 million. Think about that. 96 million drug packages coming in. So what we're doing now is we're lumping this onto FDA, and FDA is a challenged, a very challenged agency.
I urge individuals to vote ``no'' on this legislation. There is a better way to regulate tobacco.
Madam Speaker, on that I demand the yeas and nays.