THE WHITE HOUSE
Office of the Press Secretary
PRESS BRIEFING BY SECRETARY OF HHS DONNA SHALALA FDA COMMISSIONER OF FOOD AND DRUGS, DR. DAVID KESSLER, AND ASSISTANT SECRETARY OF HHS, DR. PHIL LEE
The Briefing Room
2:30 P.M. EDT
MR. MCCURRY: Good afternoon, everyone. You've witnessed the President's historic announcement a short while ago, and to brief you further about our strategy to curb tobacco use by young people in America, I'm delighted to have Secretary Donna Shalala here from the Department of Health and Human Services; Dr. David Kessler, Commissioner of Food and Drugs from the Food and Drug Administration; and Assistant Secretary for Health Policy, Phil Lee. They're all here.
Donna, why don't you start? And mostly we'll be taking questions if you have any about the materials we've now given you.
SECRETARY SHALALA: Thanks, Mike.
Just quickly, this is -- the President used the word, "historic" -- this is the most important public health initiative in a generation. It ranks with everything from polio to penicillin. I mean, this is huge in terms of its impact.
Our goal is very straightforward; to reduce the amount of teenage smoking in the United States by half over the next seven years. We are doing it through the FDA regulatory process and through some other initiatives within the department. This is a comprehensive approach, and let me ask David and Phil to come up to help answer questions.
Q Dr. Kessler, can I just ask you, does this rule allow the FDA now to regulate changes in packaging of cigarettes, filters, control the content of cigarettes at all?
DR. KESSLER: This rule focuses on kids and kids only.
Q But, I mean, the focus aside, technically by declaring the cigarette a delivery device for a drug, could you theoretically do that?
DR. KESSLER: Just so you know what we've put out -- this is the regulation. This is the new regulation we're putting out today. This is the evidence. If you read this regulation, which gives us the authority, it focuses only on children.
Q But the question is, could you, would you like to at some point in the future --
SECRETARY SHALALA: The answer is no, we have no plans to regulate tobacco for adults. It is a legal activity. Our total focus is on children. It is illegal for children to buy cigarettes in the United States; the total public health focus is on reducing the number of children -- this is all about 3,000 young people who start smoking each day and the fact that 1,000 of them will die prematurely because they start smoking each day.
Q -- of polio to tobacco smoking?
Q How much litigation do you expect and --
Q There's a question on the floor.
Q How do you relate polio to tobacco smoking?
SECRETARY SHALALA: Phil, why don't you talk a little about the public health?
DR. LEE: The magnitude of polio compared to the number who die every year from tobacco -- 400,000 people a year die prematurely. At the height of the polio epidemic in the '50s, there were maybe 50,000 people who got polio and a maximum of maybe 10,000 people who died as a result of polio. We're talking magnitude differences.
And that's why this is such an important public health initiative, is because it begins in childhood. It begins before kids reach the age of 20; they become addicted. The number who die, it's over 400,000 people a year die prematurely. Lung cancer, heart disease, various other cancers, devastating not only in terms of death rates, premature, but illness
SECRETARY SHALALA: At a huge cost, of course, to our health care system.
Q How much of a relationship is there between the rise in drug abuse among our young people, teenagers and so forth, and smoking?
SECRETARY SHALALA: Well, I think we don't talk about the relationship as much as a set of risky behaviors that are going on in adolescent and our deep concern about a literal culture of adolescence that seems to provide a haven for risky behaviors. So it's not simply tobacco and drug use, but it's also, as you know, abusing alcohol, risky sexual behavior. And tobacco is one manifestation of it, but not necessarily linked to the others.
Q Why is that? I mean, what is the cause of the risky behavior? Is it more so than two decades ago?
SECRETARY SHALALA: Well, it is -- in some of these activities it is not more so. As you know, when I reported the drug behavior, that drug usage now compared to the 1970s, late 1960s-1970s, is down. What we seem to have among adolescents is a concentration of risky behaviors among some adolescents -- not the vast majority. And we're deeply concerned, but we are not drawing a causality or a direct linkage, but simply saying that we need to concentrate on this with comprehensive efforts.
Q Dr. Kessler, the advertising industry says this is a freedom of speech issue and that you can be prepared to fight this at the Supreme Court level. What's your strongest card if it gets that far?
DR. KESSLER: Encouraging advertising and promotion that encourages illegal behavior is simply not the right thing to do, nor is it protected under the First Amendment. The government can protect children.
Q How can you prove that that advertising is targeted at children?
SECRETARY SHALALA: Look, does that grab you? It does adolescents. It offers tickets to rock shows.
Q Don't you anticipate, though, that you're going to be tied up in the courts with this? Don't you anticipate that they'll go in and seek some kind of legislation to --
SECRETARY SHALALA: Well, we already, as you know, on the preliminary proposal there is a court act. But we think we're doing the right thing. We know that we're on the strongest possible legal grounds. The Justice Department has worked very closely with the Department in working through this issue. And we believe we will be able to put the comprehensive strategy in place and that it will begin to have an impact on this country's public health, particularly on its kids.
Q -- with regard to advertising in specific, Dr. Kessler. Where's your statutory authority to regulate advertising?
DR. KESSLER: Under the Food and Drug Act.
Q To regulate advertising?
DR. KESSLER: We regulate the advertising of drugs all the time.
SECRETARY SHALALA: Yes.
DR. KESSLER: We regulate whether it's valium or prozac. We regulate that advertising.
Q But is there an age-based precedent, where the advertising is okay if it's to a legal destination for an otherwise legal product?
DR. KESSLER: There certainly is law on that -- on being able to protect children.
DR. SHALALA: There's a whole history of laws, including constitutional decisions, in loco parentis, for example -- on the right of government on finding that children are at risk to protecting children.
Q If tobacco-related disease is, in your words, an epidemic and the health risk problem facing our society is as grave as you say -- 10 times worse than polio at its height -- why aren't you as health officials calling for immediate illegalization of tobacco today?
SECRETARY SHALALA: Because that would not be effective. We also know the history of prohibition and attempts to ban alcohol in this country, which led to black markets. And so the aim here is to reduce the number of people that start smoking in the first place, and that is the public health strategy.
Q Madame Secretary, as you know, though, there's a lot of legislation on the Hill that would basically incorporate almost everything the President proposed today. Why not just sign on to that legislation, avoid all these costly and lengthy court fights and just get this program off the ground immediately instead of two or three years from now?
SECRETARY SHALALA: We have said before that we would be happy to support legislation that's as comprehensive and as effective as these sets of regulations that we've laid out. We have not yet seen a piece of legislation that is as comprehensive and as effective. But we have never said that we thought regulation was the best approach; we have always said that we were prepared to take legislation and to work with the Congress to produce legislation.
Q Dr. Kessler, when it comes to declaring these a delivery system for nicotine, can we expect the FDA to have some sort of testing of these as devices, as medical devices?
DR. KESSLER: You're right. I mean, these are drug delivery systems. I mean, nicotine is an addictive drug; that's why people smoke. Tobacco companies know this. But our regulation focuses on restricting access and reducing the appeal to children. That's what the regulation focuses on. Because as the Secretary said, that's the right public health strategy. That's where we're focused.
Q For example, prescription bottles have child-proof caps. Could we see some sort of regulation that would make cigarettes inoperable for children?
DR. KESSLER: This is the regulation. This focuses on kids. I really do commend it to you. I mean, it's one page. It's eminently reasonable, it makes sense.
SECRETARY SHALALA: And readable.
DR. KESSLER: I mean, it's compellingly common sense.
Q When will we see these steps implemented, actual vending machines out, advertising gone?
SECRETARY SHALALA: The regs, once they go into effect, take between six months and a year for all the parts of the regulation to take effect. It now goes -- there's a 60-day period in which Congress has an opportunity to comment and review the regulations and then they will go into effect. They will be published on Wednesday in the Federal Register. Dr. Kessler and I signed them yesterday.
Q Doesn't taking color out of billboards affect everyone, and how is that particular spot reached in the agreement?
DR. KESSLER: What we focused on was reducing the appeal, reducing the imagery. For so long we send children mixed messages. You go out, you drive on the highway and you see billboards that focus -- that play on themes of fun, independence, glamor. And, yet, we as parents and we as physicians, we tell our kids not to smoke. We've been sending very mixed messages. We need, as the President said today -- as the President stood up and said, those images are not the kind of images that we should be sending our children.
Q My follow-up just would be how does color on a billboard do that?
DR. KESSLER: Secretary, if you'd like, we can hold it up again. I think that probably --
SECRETARY SHALALA: It attracts your eye in a way that black and -- I'm supposed to look mean with this -- (laughter.)
Q Is the administration confident, since you're going to be in court for a while, that you're going to win these lawsuits?
SECRETARY SHALALA: No, we're not -- we're confident that we will win. I don't know whether we're going to be in court for a while. We took our time to develop this program. We went through a long process. We had 700,000 comments and we went through each one. We actually strengthened and retargeted the proposal between the time we handed out the proposed regulations and now, and it's more focused on children. It's on the firmest possible ground that the best advisors could give us. But this is a country of litigation and of litigators. We'll see. But we do intend to move forward.
Q Madame Secretary, the 1,000 who you predict would die prematurely, what is the public health cost to the American public?
SECRETARY SHALALA: It's $50 billion a year -- $50 billion a year is the public health cost.
Q Given the court battle and a possible injunction, how long could this be delayed by the industry?
DR. KESSLER: That's up to them.
Q Well, I mean, how long do you think a case that would go to Supreme Court could drag out?
SECRETARY SHALALA: You're asking three public health officials a question that you could -- I think it could be anyone's guess in terms of how long it would take. But we will be as efficient as we possibly can in getting into court if we're sued again. But we're now in court, as you know, in federal court in North Carolina. But it's our intention to push forward and to do that. It's the strength of our arguments that we think will prevail, and the righteousness of our cause.
DR. KESSLER: The evidence, the case is very, very strong.
SECRETARY SHALALA: It's overwhelming.
Q Can you talk a little bit about enforcement. There are a couple things at issue here. The magazine industry says it's not easy for them to pin down numbers on youth readership. And what happens if somebody, in your opinion, breaks the law?
SECRETARY SHALALA: Boy, they pin down numbers on readership when they're pitching advertisers. I don't think they're going to have a significant problem identifying who their readers are and the age distribution. That's precisely what they do when they go to make a pitch to an advertiser. And I think that the way in which this is going to be handled will be pretty straightforward for them and they will not have as much trouble as they expect.
Do you want to explain how they'll define their market?
DR. KESSLER: These are very -- the regulations are very clear-cut. They're not hard to enforce, and we will work in partnership with the states. But on this question of surveys, there's some very credible surveys out there, and as we stated in the rule, we will accept those surveys.
SECRETARY SHALALA: These are surveys the advertising industry uses itself and it's credible information that will be available to us and that they have been contributing to.
Q What about the penalty?
Q What happens to violators?
DR. KESSLER: The violations are the same violations under the act available for any other product, includes civil money penalties and other remedies under the act.
Q How long do you think you'll need before you're able to implement the current --
SECRETARY SHALALA: Well, it can all be done within a year, and there's a phase-in of the implementation, assuming that we're not held up by any kind of litigation.
Q When cigarette advertising was banned on radio and TV, we found by name sports sponsorships go up dramatically. You're now banning those by name.
SECRETARY SHALALA: No, we're banning sports advertising -- I'm very sensitive about this point -- we're banning sports advertising by cigarette brand name, not by company name. A number of these companies --
Q -- Meyers Slim or its equivalent?
SECRETARY SHALALA: Absolutely. Yes, absolutely. They can continue to sponsor sports, but they must use their corporate name, not the brand name.
DR. KESSLER: The point is to break that link between the sports event, the sports hero and the brand. That's what's important when you're focusing on kids.
Q Can you tell us if there were any discussions with the tobacco industry to try and reach agreement on a voluntary plan and, if so, what happened?
DR. KESSLER: We've been engaged in rule making over the last year. So comments were submitted and we followed the rule-making process.
SECRETARY SHALALA: Which means that we take comments in writing, as opposed to having individual conversations.
Q President Clinton touched on help for tobacco farmers. Obviously, you're public health officials; do you know anything that might come down as far as specifics?
SECRETARY SHALALA: I think the President is willing and has always been willing to work with Congress to make sure that this transition -- and, obviously, the way that we're going at this slowly brings down the number of young people who start smoking in the first place, so it does have an economic effect. But the President has indicated his willingness to work with Congress to focus specifically on those parts of the tobacco business that will have some economic effects.
And since we have time, this is a gradual impact -- and I think we've passed out information that points that out. We have always said that we're prepared to work with Congress to work through those issues.
Q How is the FDA going to enforce this? Already there's this feeling that the FDA doesn't have enough resources to do its current job, so how do you enforce this?
DR. KESSLER: These are very simple requirements. They're clear cut. There's a vending machine where it shouldn't be, or it's not. Either the billboard is black and white, or it's not. They're very simple to enforce.
Q Just to follow up on that, in regard to the vending machines and the billboards, how will you identify areas in which children congregate? Will there be a set --
SECRETARY SHALALA: Fairly straightforward in terms of where children are. There are, obviously, businesses like bars in this country that card at the door, where they don't allow children in. They can continue to have their vending machines. That's pretty straightforward. What you don't want them to have is any kind of a sign that shows to the outside of the building. But they can continue to have advertising that's stuck firmly -- and as well as continue their vending machines.
So, in adults-only places, they can continue to have vending machines and advertising. But wherever children will see it, it will be banned.
Q There was a widely-publicized picture last week of the President smoking a cigar while he was playing golf on vacation. What kind of signal does that send to young people, and are you going to ban that?
SECRETARY SHALALA: Well, we have advised the President as the senior public health officials of the government that we think it's a bad idea for him to be chewing on a cigar. But I understand that both his wife and his daughter have made it even clearer to him. So I think we'll leave it at that.
Q -- the educational campaign that the FDA would like to require, that would be a separate rule-making? Where is that? How does that --
DR. KESSLER: That would be done under 518 of the act. It's not rule-making, per se, it's a process that would lead -- that could lead to an order.
Q When would you initiate that?
DR. KESSLER: We will begin the process -- we're going to begin to work on it, but it is a process under 518 of steps that we have to follow.
Q And you would like to see it in effect maybe within a year or --
DR. KESSLER: We will actually begin the process after the 60-day congressional review process.
SECRETARY SHALALA: There's a new congressional law that requires that all regulations go through a 60-day process. So we have to honor that and then we'll start the implementation process.
Q Dr. Kessler, the Secretary said that prohibition against banning of tobacco outright would be ineffective and she cited the prohibition on alcohol. Do you agree with that?
DR. KESSLER: Absolutely. The most important thing is to stop kids from ever starting, before they get addicted. It's much harder when you're dealing with people who already are addicted. This is the right public health approach.
Q So you don't support a ban on tobacco.
DR. KESSLER: Absolutely not. It won't work. It's not the right public health approach.
SECRETARY SHALALA: Could I repeat again -- I know everybody throws around the word, "historic" -- how significant this is for public health in the United States, and how significant it is that a government takes this action in terms of protecting the public health. We have done nothing in the history of this country anywhere near this in terms of the number of people that it will impact in the United States or the financial implications. I mentioned the $50 billion a year which is our expenditures for this.
Thank you very much.
Q Are you saying this is the most important public health initiative in the nation's history?
SECRETARY SHALALA: Only Phil Lee can answer that. Phil Lee was Assistant Secretary -- the first Assistant Secretary of the Johnson administration and is Assistant Secretary of Health --
Q I just want a yes or a no --
DR. LEE: I would say it's one of the most important. In the top five.
DR. KESSLER: It's up there. It's up there.
THE PRESS: Thank you.
END 2:53 P.M. EDT