Dr. Kessler is the former commissioner of the Food and Drug Administration under both Presidents Bush and Clinton. He began looking into the regulation of nicotine as a drug and was instrumental in convincing Clinton to enact tough federal regulation of tobacco. The tobacco industry fought this in a North Carolina court and the FDA won. Kessler has been generally opposed to settlement with the tobacco industry and supports tough legislation against advertising to children.
In July 1997 Kessler became the Dean of the Yale University School of Medicine. Interview conducted in March 1998.
Q. How difficult an adversary was the tobacco industry, let’s say, in 1992?
Kessler: No matter who you asked, anybody you asked whether you can take on tobacco. You get the same answer. You can’t do that. It’ll be hard. It’s impossible. It’s a fool’s errand. No matter who you asked you got the same answer. You can’t do that. They’re just too powerful. You can’t take on the tobacco industry.
Q. Politically you can’t take them on? Legally? Anyway?
Kessler: In 1991 and 1992 people asked a very simple question. Why doesn’t the federal government regulate tobacco? Very simple question. Everyone you asked would give you the same answer. You can’t do that. You get your head handed to you. It would be political suicide. You would put not only yourself but an entire agency in jeopardy. It would be a fool’s errand.
Q. You were in the Bush administration during that period of time. You couldn’t do it then, why?
Kessler: We weren’t ready to do it. We didn’t, we had not thought through what it would take. We hadn’t done our homework. It took us 2 to 3 years to write a simple three page letter. We issued that letter in February, 1994. That letter turned out to be a critical turning point. It was the first time that the Federal government it would consider regulating tobacco products. First time in 30 years since the Surgeon General’s report in 1964 that linked smoking and cancer. The Federal government it would consider regulating tobacco products if there was evidence that the nicotine in cigarettes and smokeless tobacco were drugs under the federal law.
Q. How important was it that Bill Clinton was president of the United States when you did that. You got to step back.
Kessler: What happened here was we had to ask the right questions. Is nicotine a drug? You and I think we know the definition of drug and we know that a definition of a drug in common parlance, but the legal definition of a drug is different. It goes to what a company knows, what a company intends by an agent. And no one went to look before at what the companies knew about nicotine.
So, the first part was finding out whether nicotine was a drug under the Federal Food Drug and Cosmetic Act. It required us to figure out, to look for the first time and ask the question of what the companies knew. What the companies did.
Q. But if everyone in Washington, everyone you had gone to in the past said, if you go after tobacco it’s suicide, political suicide and you’re the head of the FDA in Bill Clinton’s administration, didn’t you have to check with them before you issued a letter?
Kessler: No, in fact we didn’t wait until the Clinton administration. We, in fact, started looking at that question in the Bush administration. We started thinking about how could we approach that question. When we issued that letter in February of 1994 no one asked the White House permission.
Q. You didn’t give them a heads up that you were about stir up the most powerful political lobby in Washington.
Kessler: About a year later a number of people in the White House said how did this start. But, in fact, I told the Assistant Secretary for Health, I told Phil Lee, my boss, but no one really focused on it. We issued… it was a very simple 3 page letter. It said that we would consider regulating nicotine if we could establish that the companies intended nicotine’s pharmacological effects.
Q. So, it was a year before the White House said anything to you about it.
Kessler: We asked a question and we went to look at the facts and we asked what the companies knew. What the companies were doing and no one had really gone to look before. We see 30 years worth of sophisticated research, highly sophisticated work on nicotine. We saw how they measured how fast nicotine gets to the brain. It identified specific receptors in the central nervous system. We were able to see what they knew, I mean for years, that, in fact, nicotine was an addictive drug. And it was that evidence, it was that evidence which was absolutely critical. Without that evidence we couldn’t have gone anywhere. Now that evidence… just having evidence is not necessarily going to get you where you want to get to. It’s one thing when a regulator goes out and says nicotine is a drug. It’s another thing when a regulator and a President of the United States makes that statement.
Q. So, how important was the backing, let’s say, of Vice President Gore or Clinton in what happened next?
Kessler: The Vice President was absolutely critical.
The Vice President, in the end, made this happen. We went to the Vice President. We told the Vice President what we knew, what we found, what our conclusions were. We told him what we were ready to do and he carried it to the president.
Q. And what were you ready to do?
Kessler: We made a decision that nicotine was a drug under the Federal Food Drug and Cosmetic Act. That was our decision. We didn’t ask for permission to make that decision, we didn’t ask for clearance on that decision. But we did as is normal policy, have to get a clearance on any regulation. So we brought the regulation through the normal channels, but in the end it was the Vice President going into the President.
Q. Did you have a face to face meeting with the Vice President?
Kessler: It was a face to face meeting with the Vice President. My… one of the people closest to me went in and saw the Vice President.
Q. And briefed him.
Kessler: Ten minutes.
Q. I guess what I’m trying to figure out now… we have an industry up until this point that is described as being politically bulletproof. Big tobacco, big tobacco. You sitting there in your agency come up with this policy. You do your study. You walk in… you send an emissary to the White House and the Vice President says sure we’ll do it. Something must have changed.
Kessler: The Vice President said that he would carry it into the President. What you saw was evidence that came out almost on a daily basis in floods of evidence. Thirty years worth of evidence that was always there, but no one had gone to look. And it was that evidence, evidence that they knew that nicotine was an addictive drug. Long before FDA knew that nicotine was an addictive drug and also the fact that they marketed it to young people. That they marketed to children and adolescents.
It’s one thing… you can talk about nicotine manipulation. You can talk about what they say about smoking and health. But when you read the documents of what they… how they marketed their products to children and adolescents that’s where, I think, the debate has changed.
Q. How important was Jeffrey Wigand to helping you figure out what was going on?
Kessler: I was sitting there in my conference room and I was talking to one of the most important people we would talk to during our investigation. I knew him only by his code name. I knew him as research. And I was sitting there one day and I’m looking at documents and I’m saying who’s this person, who’s that person. Then I go who’s Jeffrey Wigand? And he looks at me and he says I’m Jeffrey Wigand. Jeffrey Wigandd was among the most senior people to come out. Not… surprisingly there were not a lot of people. Maybe it’s not surprising.
Maybe when you think about it and you look at how… the costs of coming out for the people who came out. Certainly if you look at what Jeff Wigandd went through you understand why a lot of people haven’t come out and talked. But the one thing that was clear when we talked to people who knew what the industry knew, who had worked for the industry, there was one thing that united them all. They were very scared. They were very frightened. They knew what the industry’s modus operandi was. They knew the kind of force that unlimited resources could have on you. They understood the kind of legal proceedings that you could face. Not only today and tomorrow. But for years.
Imagine having unlimited resources to hire any lawyer, any number of lawyers you want and have them come after you. And that was generally understood to be how the industry operated. So it’s maybe not surprising that there weren’t a lot of people who came forward. But we didn’t know that the industry had spent millions of dollars researching genetically bred high nicotine plant. We didn’t know that the industry understood the effect of using certain chemicals that, in essence, were the same as free basing. We didn’t know that. We learned that through people who worked in the industry. We learned it from people like Jeff Wigandd.
Q. And if I remember correctly, back in May and June of 1994, when you first meet Jeffrey Wigand and some of your people go and talk to the various tobacco industry and gather information in North Carolina, in Richmond, Virginia and they go to Louisville and ask questions and it’s at that point, isn’t it, that you discover that they are lying?
Kessler: We received… Jeff Wigand told us. I knew him only by his code name, Research. Research told us to look at patents filed in foreign countries. Didn’t say here it is. But he led us down that path and we found the patent filed in Brazil, written in Portuguese, held by Brown and Williamson for a high nicotine, genetically bred tobacco plant that had twice the concentration of nicotine that normal tobacco has. We traced one of the individuals limit… we traced one of the individuals that was listed as one of the inventors to a small genetic engineering firm in New Jersey and began to piece together a rather remarkable story.
She told us that her company had been hired by Brown and Williamson to produce a special version of this high nicotine plant. A version of the plant that was sterile, so it couldn’t be stolen by other competitors and she told us that she had actually been to Souza Cruz and seen Y-1 growing in the fields.
Q. Souza Cruz is the Brazilian subsidiary?
Kessler: She told us that she had been Souza Cruz of Brazil and had seen Y-1 growing in the fields. But that didn’t mean that it came back into the United States. It certainly didn’t mean that it was used in American cigarettes. We sent an FDA inspector… I remember it was literally he had just come over to the agency. It was his first day on the job and he had come over from customs and I called him up and I said come up to the Commissioner’s office.
I need you to go see if there’s evidence that Y1 had been brought into the United States. And he literally went up and down the ports of call on the Southeast coast. Do you have any idea how many millions of entries, each day, come into this country? And I remember the phone call when he found that one invoice on page 25 of one of the manifests. There it was in small type. From Souza Cruz to Brown and Williamson. It said your order, Project Y1. It was illegal at the time to ship seeds outside of this country unless there was an export permit. We weren’t interested in the tobacco seed export laws. We were interested in understanding whether nicotine was a drug. And under the law, an article is a drug if a company intends its pharmacological properties, if it intends its effect on the body. So what we were interested in is whether a company manipulated or controlled nicotine levels. That’s what we were interested in, because the issue of control and manipulation went to the question of a company’s intent.
Here was research being conducted. Millions of dollars being invested in a high nicotine, genetically bred plant to boost the level of nicotine. It was the most blatant example of control and manipulation that we had seen. But they say they only use nicotine as a blend for taste. They don’t use it to manipulate for addiction. The… if you look, look at patents, you will see patents held by the tobacco companies that call for the use of certain chemicals to mask the harsh flavor of nicotine. Nicotine is a very bitter, harsh chemical. Look it up in the Merck index. See what it says. See what it’s taste is. And it’s very harsh. It’s very acrid.
Q. Over and over again they say we do not independently manipulate nicotine, right? They say it under oath. They say it in submissions to your agency.
Kessler: That’s correct.
Q. They say it publicly.
Kessler: That’s correct.
Q. You’re saying they’re lying.
Kessler: I am saying there is evidence that the tobacco companies manipulate nicotine. What they did. Understand what they did. If you put a filter in front of a cigarette what’s going to get taken out? It’s going to filter out the tar. It’s also going to filter out the nicotine. Why do people smoke? They smoke for the nicotine. If you take out the tar and you take out the nicotine and you take out too much nicotine people are not going to smoke. So what do you have to do? You have to up the nicotine levels and that, in fact, is what we saw. We saw an industry that was manipulating the level of nicotine in the low delivery cigarettes. And the vast majority of cigarettes sold in this country are low delivery. Light cigarettes are light in what? They’re light in tar. They’re light in nicotine. We sent light cigarettes to our laboratory and found the light cigarettes have a higher concentration of nicotine than the regular cigarettes. How does that happen? That can’t happen without manipulation and control of nicotine. At least I don’t know how that can happen without some form of manipulation and control.
Look at three brands of Merits. Look at three brands of Merit. Merit regular. Merit Light. Merit Ultra Light. Merit Ultra Lights has the highest concentration of nicotine in that cigarette. I don’t know how that can happen without some form of manipulation and control.
Q. The Council on Tobacco Research announced in the 1950’s that they would do independent research to determine the health effects and pharmacology of tobacco. What is their role?
Kessler: The Council… It’s interesting, CTR was set up by Hill and Knowlton, one of the largest PR firms. In fact, what CTR ended up funding, they funded a lot of stuff, that was on the periphery. They funded what caused cancer but it stayed away from what people really would like to know. What are the effects of tobacco? It didn’t fund critical research on pharmacology and cancer. Now that research was done and it was done by the tobacco companies and when you look you see all three companies have highly sophisticated research programs on nicotine but that wasn’t done by CTR. CTR was simply a PR operation.
Q. Run by lawyers apparently.
Kessler: Well there was a part of CTR that was run by scientists that gave out grants and those grants investigated a lot of things. But they didn’t investigate central questions about tobacco. They looked at a lot of things but they stayed away from questions about tobacco. And then there was another arm of CTR that really was designed to defend against cases. And that’s where the lawyers took over and that’s what the lawyers controlled.
Q. Don’t they have an obligation under the law to tell the FDA the truth? To be open about what they know?
Kessler: You can’t submit a document… you can’t make a statement to a federal agency that’s false or misleading. That would be a violation of federal law.
Q. Of the things that they submitted to you, that they said to you, were they truthful or were they misleading?
Kessler: They said they don’t manipulate nicotine. Everything I’ve seen suggests that they manipulate nicotine. Those two statements just don’t jive.
Q. To someone listening to what you just said, it sounds like they were lying.
Kessler: The ultimate question… It’s not up to me to determine whether they were lying. That’s a question for the department of justice.
Q. I want to take you back to April or May of 1994 when you issued this letter and the tobacco industry has just sued ABC News…
Kessler: And they sued ABC maybe, in part, as a signal to us. It was a shot across the bow. It was the day before I was going to testify in front of the house committee. Tell me it wasn’t just coincidental.
Q. And then the seven CEO’s get up at the same time and say we don’t believe nicotine is addictive. You didn’t feel threatened politically? You didn’t see your career going down the tubes?
Kessler: What would you have done? This wasn’t about careers or risks to individuals. We asked a question and we started looking at the evidence and once we started down that path it was evidence that we saw that just was overwhelming. And that’s what persuaded us.
Q. Did the White House ask questions and try to find out what the political cost of these regulations would be?
Kessler: The White House did conduct polls to see what the public thought of controlling tobacco use. In some ways, for years taking on tobacco was thought of impossible. For years if you went near it it would be highly controversial. People thought we had lost our minds. Speaker of the House, in fact said it, and said it in those exact words. But what people didn’t realize was this wasn’t controversial at all. Nobody wants vending machines out there that kids 11, 12, and 13 buy cigarettes from. Nobody wants kids exposed to these cartoon characters when they walk to and from school. Some people needed polls to see that. But it was there all the time. In fact, there was very strong support for what we did.
Q. Was it a surprise to you that the industry wanted to negotiate in the end? That they wanted to come to the bargaining table?
Kessler: Confronted with the choice of bankruptcy, it wasn’t surprising at all.
Q. Did you know negotiations were in the works?
Kessler: There were many different attempts at negotiations. There were numerous attempts of negotiations here and negotiations there.
Q. Let me take you back to something else. The Medicaid suits by the states.
Kessler: Right. Mike Moore, Dick Scruggs came to my house one day in April, May of 1994 after we sent out this letter and they told me what they were thinking of doing.
Q. And what was your reaction?
Kessler: What was important, in some ways, was we kept our eye on the ball ahead of us. We were asking very different questions. And we went down to roads. We, looking at the question of whether nicotine was a drug. They, looking at the question of whether they could win in court against the tobacco companies for all the health, Medicare, Medicaid expenses that the states incur.
Q. But when they first came to you with this idea no one had ever tried that before. What was your… You’re an attorney as well as a medical doctor. What was your reaction?
Kessler: They were basing their theories in some ways on similar, but not exactly, what we were looking at. We were focusing on nicotine manipulation. They were focusing on what the industry knew but never said. So, in some ways, we were on similar paths, looking at similar questions. But the approach was very different. We were focusing on federal regulation. They were focusing on state suits. I still believe that without a settlement we’ve only begun to scratch the surface of potential liability suits. The notion that you, the tobacco companies, fooled me, a 65 or 70 year old person with lung cancer into smoking in front of a jury, especially in this country where we believe in personal responsibility. I’m not sure you’re going to win that case. Sure there may be documents that would make that jury angry. And in some ways, it’s the same with the state’s Attorney General cases. You fooled me into smoking and therefore you’re responsible for paying all my Medicaid expenses. The jury can go either way. That’s not where the industry is most vulnerable. The case where the industry is the most vulnerable is a case that says you targeted my 11 year old. You knew that that was illegal and yet you went ahead and did that. I would take that case any day.
Q. That’s essentially the criminal case.
Kessler: No, the criminal case, as I understand it, is you lied. You lied to federal authorities. You lied to the FDA. You lied to the Congress. You committed conspiracy.
Q. To defraud the United States Government?
Kessler: To defraud the United States Government.
Q. And you think they did?
Kessler: I cannot reconcile their statements with the evidence. I’m not going to sit here and say they perjured themselves. I am not going to sit here and say that they lied. I’m going to tell you what the evidence looks like to me. And I see evidence of actions that just do not square with their conduct. I’m not sorry I didn’t do that right.
I’m not going to sit here and tell you that they committed perjury. It’s not for me to do. That’s for a US. attorney to do. But I can sit here and tell you that I saw things that they did, that they manipulated nicotine when they said, and they said it to federal authorities, that they did not.
Q. When the negotiations began in earnest in March of last year, actually April 3 when they actually sat down at the table, you were invited to the table weren’t you.
Kessler: I was invited to join the settlement talks.
Q. You chose not to?
Kessler: I decided not to go to the negotiating table.
Kessler: I didn’t want to be captured. I wanted to be able to evaluate it for what it was. I wanted to have some distance to be able to look at it and see whether I thought it would be in the public interest.
Q. What about advertising? The courts have held, as I understand it, that the industry has a right to advertise. It’s a legal product.
Kessler: You don’t have a legal right to promote an illegal use. You don’t have the right to deceptive advertising and in fact, if the government has significant public health interest and you take actions that are narrowly tailored. If you focused on kids, what could be more of a significant governmental interest and you focus on kids, that certainly permissible under the First Amendment. The Securities and Exchange Commission requires tombstone advertising. Three thousand kids starting everyday and a thousand going on to die is not as legitimate substantial government interest as the Securities and Exchange Act, I just don’t know what is?
Q. Let me ask another question about FDA jurisdiction of it as a drug. So you get jurisdiction? What do you do with it?
Kessler: What the agency did was to look and say that this product was an unsafe product. It’s a product that 50 million Americans use. Prohibition won’t work. So how do you reduce the use of an unsafe product? The focus on children and adolescents wasn’t because there was apple pie and motherhood. It wasn’t because who could object focusing on children and adolescents. The reason we focused on children and adolescents is if you really can get children not to start, 20 years from now very few people are going to be smoking. Because very few people begin to smoke after the age of 18. That’s what the industry knew.
Q. But my understanding is that in the June 20th settlement the industry agrees to fund $500 million a year in advertising and tobacco control activities to reduce that.
Kessler: The real question here is whether, for the first time, this country is going to break the hold that the tobacco industry on our elected representative. Whether for the first time in half century the real power of the industry over the Congress is going change. Whether for the first time Congress can enact a law without asking the industry for permission. That, in and of itself, may be more important than any single provision. Breaking that whole…
Q. What does that FDA control really mean? Control over the level of nicotine that’s in cigarettes? Control over advertising?
Kessler: What FDA said in it’s regulations was that it would assert control over the way cigarettes were sold, whether the way they are advertised, whether over the way they are promoted. That’s what FDA focused on in it’s ruling.
Q. But as of today, in that federal court decision in North Carolina, you have control over nicotine, but you don’t have control over advertising and promotion?
Kessler: The federal district court judge upheld FDA’s classification of nicotine as a drug. Upheld the restrictions on limiting access, making it harder for young people to buy. He said that the Food and Drug Act did not give FDA the ability, under the section that we use to control advertising.
Q. Now the June 20th settlement gives FDA, and the proposal in general, limits advertising. The industry gives up that control. What they won…
Kessler: The June 20th settlement is, in fact, that. The June 20th settlement is, in fact, just that. It’s a settlement. It’s a deal. It’s a deal between state attorney generals and the tobacco industry. That’s not the same thing as passing a law. The Congress of the United States doesn’t pass laws by doing settlements. The Congress of the United States can pass a law that’s in the public interest without asking the industry, without asking the industry whether it has it’s permission.
Q. The Congress of the United States, as I understand the law, or as been expressed to me, does not have the power to stop the industry from advertising a legal product.
Kessler: That’s absolutely false. The Congress of the United States can pass a law that restricts the ability to advertise. It does it in the Securities and Exchange Commission. It certainly… There are certain rules, there are certain ways you can do it. Perhaps you can’t ban all advertising, but you certainly can ban advertising that causes an increase in young people to smoke. Of course you can do that under the First Amendment. You can’t go yell fire in a theater. Not all commercial speech is protected. You go down your street and see ads for controlled substances. Of course there are rules and regulations that govern the form of some advertising.
Q. So you foresee that the FDA, having regulations that have now been upheld, do everything that’s in the settlement without the settlement?
Kessler: There’s no reason why… the Congress doesn’t have to make a deal. It can accomplish everything in that settlement without giving the industry special legal protections. It can accomplish everything in that settlement without any quid pro quo, without giving the industry… The industry would love you to think that, gee, you have to give us immunity. We’re not going to give that up. One of the lawyers for the tobacco industry said… It was one of the most remarkable statements that I’ve seen reported. He said if you don’t give us immunity, if you don’t give us limited liability, we just may bring back the cartoons. I thought I had heard and seen just about everything.
Q. Do you see the June 20th settlement, though, as, in a sense, a watershed? That something was actually accomplished?
Kessler: I give the state AG’s a lot of credit. If I were in their position I certainly would have considered settling also. But that’s a settlement. Their in a preceding where the tobacco industry is on the other side of the table. We’re not, in this country, in a position where the tobacco industry is on the other side of this table. That’s not the way we enact the laws. I didn’t, in 1994, when we went out a three page letter say, gee, what does the tobacco industry think.
Q. But you said it yourself, earlier. You said the industry was facing bankruptcy. The industry, in the face of everything we know today, facing bankruptcy primarily from the state attorney generals and their lawsuits…
Kessler: And all the lawsuits that are potential down the road.
Q. Possibly, but the reality that we’re facing where the state attorneys general, three of them became 20. Twenty became 40.
Kessler: When Mike Moore sat in my living room, it was Mike Moore. And then it was Mike Moore and Florida and then it was three of them and then it was 5 of them and then it was virtually all of them. It was very powerful force and in some ways that’s what it took. It took all the state law enforcement officials to send a very clear signal to the industry that the world in which they’ve been operating has begun to change.
Q. But it’s these same people who pushed the industry to the wall who are now saying O.K., let’s have some constructive settlement of this.
Kessler: Why a settlement? Why not enact legislation? Why not enact comprehensive legislation that’s aimed at reducing the number of young people who smoke? Why do you need a settlement? Why do you need to give the industry immunity? Why do you need to give the industry limited liability?
Q. Well they’re saying they’re not giving the industry immunity across the board.
Kessler: They’re certainly giving the industry forms of limited liability. That’s certainly forms of immunity.
Q. Their argument is no one has been able to certify a class action that’s gotten a judgment anywhere, from their perspective. So they’re giving them the ability to get out of the class actions.
Kessler: Why? Why do you have to give them that. Why does this industry deserve special protections that no other industry has?
Q. The alternative is to go back into the trenches and fight it out state by state. Go on for years and years. They’ll continue to spend their $600 million a year on lawyers and more kids will keep smoking every day, more kids will die and you’ll just have a bigger and bigger war and the original problem will never be addressed?
Kessler: Maybe there are people that don’t believe that you really can pass legislation without permission of the industry. Many people really do think that the industry still has controls and powers. Maybe it still is big tobacco, maybe not quite as big, but I think in the end… I think if you ask the average person out there whether they want their elected representatives giving special protection, special legal protections to this industry, especially in light of everything that’s come out… I certainly wouldn’t want to go home as a member of Congress and say that I voted to give this industry some form of special legal protection.