THE WHITE HOUSE
Office of the Press Secretary
PRESS BRIEFING BY SECRETARY OF HHS DONNA SHALALA AND FDA ADMINISTRATOR DR. DAVID KESSLER
The Briefing Room
3:00 P.M. EDT
MR. MCCURRY: Good afternoon, everybody. Several news organizations have had various opportunities today to talk to Secretary Shalala and to Dr. Kessler, but I thought it would be useful for a broader audience, to make them available for some questions and some answers on the President's announcement today. I assume by now everyone has had an opportunity to read the exhaustive materials that are now available. But without further ado, it's a great pleasure to have on a momentous day the Secretary of Health and Human Services, Dr. Donna Shalala; and Dr. David Kessler, the Administrator of the Food and Drug Administration.
SECRETARY SHALALA: Thanks very much, Mike. Thank you. We'll be happy to answer your questions. Yes.
Q Can you tell us how the jurisdiction of FDA and FTC will be affected by --
SECRETARY SHALALA: David, do you want to do the jurisdictional questions?
DR. KESSLER: We have, today, proposed a regulation. The basis of that regulation you will find in a document that goes through the legal and factual underpinnings. The evidence for the FDA supports the finding that nicotine in cigarettes and smokeless products is a drug and that these products are drug delivery systems. But we will take comment and further evidence, and we will give that comment and further evidence full and serious consideration.
SECRETARY SHALALA: I personally briefed the Chair of the FTC last night -- he was not in town -- and he will also be reviewing this because, of course, they also have some interest in the subject.
Q As part of the public comment period, Dr. Kessler, will you have public hearings around the country in the next 90 days? And the second question -- when the 90-day period is over, how long will you estimate from that point to a final decision?
DR. KESSLER: We've already had one scientific advisory committee last year that looked at the specific question of whether nicotine is addictive. So we've gone to our scientific advisory committees. There's no plan for additional advisory committees at this time. After the 90 days, we need to give full and serious consideration to the comments, but I don't have a specific time table.
Q After this 90-day period, is it possible that you could decide that some of these proposed regulations won't happen?
SECRETARY SHALALA: Well, the purpose of the comment period is to get everybody's best ideas. What we've done is brought to bear our best ideas for curbing smoking among young people. There have been extensive studies and recommendations on the subject -- the Institute of Medicine, the American Medical Association, the American Cancer Society, and years of research on the subject of kids and smoking.
So we've brought that to bear. And one of the things that you'll see in the reg is it's almost like an academic article because it's got all the citations on the research that backs up the recommendations. This is our best effort. Is it possible that there will be changes as part of that? The answer is, yes, but all very focused on kids, to reduce the percentage of kids that smoke.
Q But basically, I mean, you already know this is what you want to do.
SECRETARY SHALALA: We know this is what the research in the field and those that are the most knowledgeable, the direction they would point us in. Whether this is properly balanced and whether there are some other ideas out there from the advertising industry itself, for example -- there is part of the advertising industry that has been particularly committed to reducing smoking. And they may bring a different kind of research and ideas to some of those proposals.
Q Dr. Kessler, some experts are questioning whether -- the word drug for nicotine. Could you discuss in layman's terms why you believe that nicotine is a drug?
DR. KESSLER: I would refer you to -- if I can just have the documents -- I would ask that you look at the documents that are available on display today, the Federal Register. They're available over at Federal Office Building 8. They go through the analysis, the legal analysis and the factual findings.
When you look at the definition of drug under the act, it is an article -- open parenthesis -- except for food -- closed parenthesis -- intended to affect the structure and function of the body. And the evidence before the agency supports the finding that nicotine in cigarettes and smokeless tobacco products is a drug, and that these products are drug delivery systems and meet that definition under the Federal Food, Drug, and Cosmetic Act. But we are taking comments and further evidence.
Q Can you give us some of the specifics why? I mean, obviously, I haven't read those yet. I mean, I had the opportunity for you to be here. Why do you think that?
DR. KESSLER: Because of the definition. The elements of the definition are that it be an agent that affects the structure and function of the body, and that it be intended to affect the structure and the function of the body.
Q How will the administration judge whether Congress is making a good-faith effort to take action in this area to avert the kind of regulations that you're outlining today?
SECRETARY SHALALA: Well, we've outlined a very detailed, comprehensive, balanced proposal, and we will measure any alternative against that proposal and against existing information and research on whether it will do what the President's goal is; and that is to reduce smoking by young people by 50 percent over the next seven years.
Q But you don't perceive Congress acting shortly after this 90-day period to meet your objectives?
SECRETARY SHALALA: I can't predict it. My understanding is that Senator Ford has already gone to the floor and said that he's going to try to do that to meet the President's goals. And we welcome congressional involvement and congressional review of the proposals. But the President has set the bar very high with this proposal.
Q Dr. Kessler, is nicotine a safe and effective drug for adults?
DR. KESSLER: Nicotine is a dangerous product to which people, and especially kids -- kids start at 11, 12 and 13, and they become addicted at 16, 17 and 18. It is an addictive product. And what we have proposed today is a strategy to deal with that problem. It is a dangerous product.
Q But, sir, is it scientifically inconsistent, since nicotine poses as big a health threat to adults as to children, just to apply your jurisdiction to children?
DR. KESSLER: No, I don't believe so. You have 50 million smokers, adult smokers. It is estimated that 40 million of them are addicted. What is the right public policy approach, what is the right legal approach under our statute to deal with the substance which you already have 40 million addicted smokers? There is one fact that I think is very critical. If you don't start smoking by 18 or 19, you don't start smoking. So from a public policy approach, the best thing we can do is to prevent future generations from becoming addicted.
SECRETARY SHALALA: Eighty-percent of the current smokers, of the adult smokers in this country started as children. And therefore, the place to intervene is to slow down the number of children who begin smoking.
Q Dr. Shalala, how do you enforce things like the placement of vending machines, the sale of T-shirts with a Marlboro logo on it? I mean, who's going to do this? Who's going to enforce this?
SECRETARY SHALALA: The enforcement mechanism, which is described as part of the rule, number one, it's not the location of vending machines, it's the elimination of vending machines, and it's the elimination of products that advertise smoking for children -- the T-shirts, the gym bags, the whole range of products. So that will be -- and our partners in this have always been the state governments which have enforced laws related to cigarettes, related to alcohol, related to a whole range of illegal activities for a particular group or legal activities to restrain participation
Q So, in effect, it would be local police who would enforce if there are --
SECRETARY SHALALA: And the oversight of the Food and Drug Administration.
Q If Congress were to pass legislation doing essentially what the President has proposed, who would enforce that? Would the Food and Drug Administration be involved?
SECRETARY SHALALA: Well, that would depend on the legislation. And remember, Congress regularly passes laws that pass on to states and to local governments responsibility. So it's not unusual for them to, at the same time they're passing the law, identify that government. In fact, half our debate now with Congress is who is going to do the public purpose. So it would not be unusual, and one would expect them, in any kind of legislation, to identify what the enforcement mechanism is.
But remember, we've got the best enforcement mechanism. The best one is our measurement of whether kids are stopping smoking in this country, whether they're actually slowing down. And for that, what we will have is a survey. We have a baseline survey now; we'll be able to report back to the American public every year how many kids are smoking, whether the numbers are increasing or decreasing.
Q Why go this far all at once? In other words, there have been studies that suggest that anti-smoking advertising were to go back on TV, and there's not much of it right now -- have an effect on reducing smoking. The FDC said last year said the Joe Camel campaign doesn't -- there was no proof that it affects teen, young smoking. Why not just go with something where you're increasing the amount of advertising, anti-smoking advertising? Why go to this level?
SECRETARY SHALALA: We have tried all of the narrow kinds of approaches in this country. We've tried just the advertising and just other pieces. What we've learned is that we need a comprehensive program. We've learned that in other countries. The research now tells us that what we need is a comprehensive balanced approach for the United States.
We've tried the voluntary approach. We've tried the narrower approaches. We've begged and pleaded with the industry itself in terms of advertising to focus, to stop focusing on children. And during these periods, cigarette smoking has started to go up in this country. It steadied off for a while among children, and it's started to go up. And it's time for a much more comprehensive approach.
Q I don't know of any national action right now requiring anti-smoking ads on TV. It seemed to me the last time that happened, which was in 1969 or '71, there was a fairly drastic decrease in smoking.
DR. KESSLER: What we've learned from tobacco-control experts worldwide is that if you want to be effective in reducing kids who start smoking, it's absolutely critical that you have a comprehensive series of steps. There is no one step that is the magic bullet. It's the comprehensive nature. And the most effective programs are those programs that are the most comprehensive.
SECRETARY SHALALA: If I can remind you that during the late '60s and '70s, when there were campaigns on television, that we also at the same time didn't have the other campaigns for the gym bags and the T-shirts and all the other promotional kinds of activities. Now we need something far more concentrated, focused on both access -- if you heard the kids today, they said they had no trouble getting access to buy cigarettes -- as well as the promotional kinds of activities. So a balanced, comprehensive approach we believe is the only thing that will bring down these numbers significantly.
Q What would you say to a teenager who says, if cigarettes were really that bad and they risked my life, why isn't the government regulating them for everyone, restricting them, making them illegal, doing something for everyone?
DR. KESSLER: Because when you're dealing with people who are already addicted, the problem becomes much harder. And when a person starts, when someone starts at 11 or 12, they don't say, I'm going to smoke this one cigarette and 400,000 more. What happens is that an 11, 12, 13, 14-year-old starts smoking, and they think they can quit. But by the time they become 16 or 17, they soon learn that they're addicted, and quitting is much harder. So the right public policy is to make sure that we do everything possible to stop kids from ever starting.
Q So the government isn't taking additional steps because of concern about people who are already addicted? Is that what you're saying?
DR. KESSLER: What we're saying is, the right public policy is to prevent future generations from becoming addicted. Because it's very hard and not good public policy to deprive people who are addicted to cigarettes. The ban would simply not work.
Q Madam Secretary, how big a fight are you braced for, and do you think it will go nuclear, metaphorically speaking?
SECRETARY SHALALA: No, I don't think so. I actually don't think so. I just don't know of anyone in this country that believes that we shouldn't do everything we can to reduce the number of kids that start smoking. This is a very clear, focused campaign. And the industry itself has indicated that it did not intend to entice children. I want to take them at their word and offer them the opportunity to support this effort to significantly reduce the number of kids that start smoking.
I also think that we'll find partners in Congress from all over the country. The people that grow tobacco do not want their children to start smoking. And this is something that can have bipartisan support. The President hopes for it, and we do, too.
Q According to law, do you have to find tobacco products safe and effective as a method of delivery of nicotine in order to have jurisdiction over them?
DR. KESSLER: The way we've done the legal analysis, you need to understand, is that nicotine is a drug in cigarettes and smokeless tobacco, but the cigarettes and smokeless tobacco are drug delivery systems. So under the device laws, we have more flexibility. We're dealing with a dangerous product; kids are becoming addicted. So we have to put in place a strategy to prevent that from happening.
Q Would you take a question on another one of your advisory councils? We're coming up on the 60th anniversary of Social Security. Your advisory council on Social Security has been meeting for more than a year now and has been unable as yet to reach a consensus on any long-range solution to the financial imbalance -- How important is it, in your mind, that that council produce either a majority or consensus report on how to solve those problems?
SECRETARY SHALALA: Let me say two quick things, and then I would like to get back just to questions on cigarettes. Number one, the Social Security trust fund is in pretty good shape. We've got 30 years on it. So the fact that they haven't reported this month, but will report before the end of the year I think should reassure people that we will have a recommendation from that advisory committee.
Q Madam Secretary, what is the timetable for vending machines that, say, is in a public place, accessible mostly to adults, but also to children? When does that vending machine stop selling?
SECRETARY SHALALA: Well, remember, we've talked about the 90 days and the rule and whenever the rule went into place. But let me say a couple of things about vending machines. There have been no new vending machines brought to this country since 1990. It is an increasingly smaller part of the vending machine business in this country. And they don't make a lot of money off the cigarette vending machines.
The vending machine industry has been very robust, as you well know, in a variety of things including gourmet coffee as well as a much more sophisticated group of things that -- foods and things that they're selling. So it is a less and less important --
Q Not here. (Laughter)
SECRETARY SHALALA: -- less and less important part of the industry. And it will depend on when the rule goes into effect. And we've already indicated 90 days. And major rules usually take time after that, because we have to read every comment and respond to it under the procedures. And my assumption is we'll get thousands of them.
Q What is the earliest?
SECRETARY SHALALA: It could go much faster. Well, if Congress decides to take this whole thing and pass it as legislation, by this fall we could be very much in place.
Q What if Congress doesn't --
SECRETARY SHALALA: We're not estimating times. We know what the rulemaking period is, but we're not estimating times at all.
Q Couldn't you eliminate a lot of these regulations right now under the Synar regs, which have been sitting around 18 months and already have been commented upon?
SECRETARY SHALALA: Do you want to comment on the Synar regs? We will have some comment on the Synar regs next week, I think. We don't want to mix the two here.
Q What about the argument that critics have raised that this is a slippery slope; that you're starting down the road to totally regulating tobacco and eliminating it as a drug or eliminating it from the market. Can you speak to that criticism? Would you like to see it ultimately --
SECRETARY SHALALA: This is the camel's nose under the tent concern. Let me say that from the beginning -- Dr. Kessler, from the moment, the first meeting I had with him, which was January 21st or 22nd, he said what he was interested in and what he thought was the best public policy was kids; and that if we really wanted to have an impact on public health that what we had to do was to reduce the number of kids who started smoking in the first place because of the link of that activity and what happened to people, so that our focus and our interest and the interest of this administration has always been on children.
Q But by taking this step, by regulating this -- and you've got pages upon pages upon pages of proposed regulation -- don't you then take the very significant step toward actually regulating tobacco down the road for adults, too?
SECRETARY SHALALA: From our point of view, the answer is, no. Our interest is in children and in reducing the number of children that start smoking.
Q If that's true can you explain some of the specific regulations that you've come up with? Specifically, you said Philip Morris and RJR and tobacco companies can't mail items to adults that feature the Joe Camel and the Marlboro Man. Why is that aiming at children? How is that aimed at children?
DR. KESSLER: The theory behind the access provisions -- and this really comes down to two main categories, restricting access of tobacco products to teenagers and reducing the appeal of tobacco products. If you're serious about restricting access, photo identification and face-to-face sales are really necessary.
SECRETARY SHALALA: Let me say finally about the advertising. Our recommendations come from the huge Institute of Medicine study. We didn't sit down and just start thinking up a bunch of new ideas. There was an extensive study by the Institute of Medicine of the National Academy of Sciences and our advertising regulations are recommendations there focus on that which reflects a body of research.
Let me say one thing, finally, Mike, this is the chart that ought to have an impact on everyone in this country. AIDS, alcohol, motor vehicle deaths, deaths from fires, homicide, deaths from illicit drugs, suicide -- all of these in combination don't equal deaths from smoking in this country. More women die from lung cancer than from breast cancer. And this is why this new effort by the President is so significant.
Q Ms. Secretary, about the advertising, if the appeal is there, and the appeal by young people still is smoking, what is the lack of advertising going to do to get them to stop smoking? If they still see the adults want to smoke and things like that, what are you hoping the lack of advertising -- it's not going to cut off the appeal, is it?
SECRETARY SHALALA: It's the attachment. If you look at the impact on kids, it's advertising that determines their smoking habits. And the most advertised brands are the ones that young people smoke in this country. Access and advertising are inextricably linked. Adults don't follow advertising in their choices. It's kids that do. And that's the justification for some of our effort in relationship with advertising.
Q When the 90-day period is up, do you expect the rules to go into effect completely then, or would it be phased in over an extended period?
DR. KESSLER: Notice and comment, rulemaking.
END 3:25 P.M. EDT