Talk:Y1 (tobacco)/Kessler testimony full

Congressional Hearing Transcripts

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June 21, 1994, Tuesday

REGULATION OF NICOTINE-CONTAINING TOBACCO PRODUCTS UNDER THE FEDERAL FOOD, DRUG AND COSMETIC ACT

COMMITTEE: House of Representatives, Committee on Energy and Commerce

SUBCOMMITTEE: Subcommittee on Health and the Environment, Washington, D. C.

LOCATION: Room 2123, Rayburn House Office Building

TIME: 9:45 a.m.

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NAME: Hon. Henry A. Waxman, (chairman of the subcommittee) presiding.

Present: Representatives Waxman, Synar, Wyden, Kreidler, Bliley, Bilirakis, McMillan, Hastert, Franks, Greenwood.

LENGTH: 25755 words

[This transcript was prepared from an audio + video recording of the proceeding.]

P R O C E E D I N G S

MR. WAXMAN: The subcommittee will come to order. It's hard to believe that it was less than two months ago that## David Kessler, Commissioner of the Food and Drug Administration, presented historic testimony to this subcommittee about the investigation into whether nicotine in tobacco is a drug, subject to regulation, under the Food, Drug and Cosmetic Act.

Since that time, this Subcommittee has engaged in a wide-ranging investigation, which has included the critical issue of whether cigarette companies intend that tobacco have drug-like effects.

This morning we will hear testimony from Dr. Kessler on the current status of his investigation; on Thursday, we will have Thomas Sandifer, the CEO of Brown & Williamson, back before the Subcommittee.

Before calling on Dr. Kessler, I want to see if any members have opening statements and to recognize Mr. Bliley first.

MR. BLILEY: Thank you, Mr. Chairman.

Good morning, Dr. Kessler.

I must say that, as I review this room, there seems to be a good bit of media interest in this subject. It brings to a mind a version of that old question concerning a tree falling in a forest. If the media was not here, would we be holding this hearing today?

Four months agency Dr. Kessler dropped a bombshell that made all of the papers. For decades, the Food and Drug Administration had declined to assert jurisdiction over cigarettes as drugs, as long as the manufacturers promoted their products on the basis of smoking enjoyment and not for some effects cigarettes might be thought to have on bodily structures or functions.

In his famous letter of February 25th, however, Dr. Kessler suggested that FDA would now consider cigarettes as drugs if the Agency found that the manufacturers intended that people buy their products to satisfy a, quote, "nicotine addiction."

With the stage properly set, Dr. Kessler then appeared before the Subcommittee and the television cameras to describe the mounting evidence that nicotine is addictive and that cigarette manufacturers deliberately manipulate the amount of nicotine in cigarettes, in order to, quote, "produce and sustain addiction," unquote.

With coverage of the Evening News guaranteed, Dr. Kessler exited the stage.

Since then, the Subcommittee has learned that nicotine is actually lost in the manufacturing process and that cigarettes as sold contain less nicotine than is found in the raw tobacco used in its manufacture.

We also learned that the nicotine yield in the average cigarette today is one-third what it was in the early 1950s, although the average nicotine yields fell by two-thirds over the last 40 years, Dr. Kessler was now accusing the cigarette manufacturers of adding nicotine to their cigarettes, in order to keep smokers, quote, "hooked," unquote.

No matter, onto the next hearing.

Today we will hear more from Dr. Kessler on the subject of tobacco. We will hear about Brazilian tobacco in chemical analogs and, based on the turnout today, it will make the Nightly News. But where does that leave us?

For those of us who insist on basing policy on facts and reasoning, this hearing will leave us cold. Much like the street sweepers after a parade, long after the cameras have gone, we will have to sift through the testimony to separate the facts from the spin.

Thank you, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Bliley.

Mr. Synar.

MR. SYNAR: Thank you, Mr. Chairman.

First of all, let me thank you for this very important and timely hearing and also welcome back Dr. Kessler.

The testimony we are about to hear today is beyond fascinating. It is going to add to my disbelief, as well as my colleagues, about the tobacco company's unwillingness to allow public access to the truth.

The CEOs of the 7 largest tobacco companies stood in this very room and swore that their companies did not manipulate nicotine levels in cigarettes.

Today, the FDA will tell us that, in fact, Brown & Williamson, whose CEO took that oath before this Subcommittee, developed a genetically-altered tobacco plant and used that tobacco in a blend to manipulate and maintain relatively high levels of nicotine in cigarettes.

The FDA also will tell us today that they found that Brown & Williamson uses some of the compounds on the list of the 599 chemicals added to domestic cigarettes, to increase their nicotine potency levels. Other tobacco companies have refused altogether to tell the FDA why they use chemical additives in their cigarettes.

America and the consumers of this country remain in the dark as to how the other nearly 600 chemicals in cigarettes interact with tobacco and with each other when they are lit.

I lament that it is the government, instead of the tobacco industry, that has to inform the public of the dangers of these cigarettes, but I laud the courage of Dr. Kessler and other health officials that have no cowered in the face of the tobacco industry's power and influence.

This is an important hearing, and I am glad to be here today.

MR. WAXMAN: Thank you, Mr. Synar.

Mr. Wyden.

MR. WYDEN: Thank you, Mr. Chairman. Let me join you and my colleague, Mike Synar, in commending Dr. Kessler for again an excellent job. We are going to hear another chapter of the tobacco industry's hidden history this morning.

In the prepared testimony I've read, it's clear from Dr. Kessler's standpoint that one major manufacturer, Brown & Williamson, bankrolled development of a high nicotine tobacco plant in Brazil. Later, that specialty tobacco, which was far more potent in nicotine content than normal cigarette tobaccos, was incorporated into a small number of Brown & Williamson cigarettes.

There appears to be no reason for the development of this tobacco plant, labeled Y-1, other than it artificially maintained the level of nicotine in Brown & Williamson products.

I think it's important to note at page three of Dr. Kessler's testimony that industry representatives have repeatedly stated for the public record, according to Dr. Kessler and also our transcripts, that they don't manipulate nicotine levels in cigarettes, and yet now there is a very clear, very obvious, direct attempt to manipulate nicotine.

It seems to me, Mr. Chairman, this raises serious questions about whether the tobacco executives, when they appeared before our Committee, deliberately and intentionally misled the Congress regarding the manipulation of nicotine in tobacco. Those executives were testifying under oath.

This Committee, in my view, has an obligation to make sure that that oath stands for something, and I think this is an issue that we are going to have to review further.

Finally, let me make a point with respect to ammonia. Like you and other colleagues, I pressed for years to try to get out the list of chemicals that are added to cigarettes. We heard from the tobacco industry, at the time, that these chemicals were in effect much like those that you eat in a cookie or drink with a soda, and that the American people should not be concerned or alarmed.

In effect, right before our hearing with the executives, they put out a list of the chemicals and said that the case was closed.

Now what we are learning, with the testimony that will be offered today, is that there are much more significant health effects in these chemicals. In effect, what cigarette consumers are getting amounts to a chemistry set in a tube, and I think it is important that the American public had a chance to know exactly what the health effects were of smoking these chemicals.

Those effects are not known. The tobacco industry has worked to say that when you simply eat a foodstuff in our country, that is like smoking a cigarette, but the fact is, the scientists are saying that that is not the case; that when you smoke a cigarette, you are sucking in these chemicals, and Dr. Kessler's testimony raises important, new issues with respect to the use of chemicals and additives in our cigarettes as well.

This is an important inquiry, Mr. Chairman, and I commend you and look forward to Dr. Kessler's testimony.

MR. WAXMAN: Thank you, Mr. Wyden.

Mr. Kreidler.

MR. KREIDLER: Thank you, Mr. Chairman. I appreciate your holding this hearing today on tobacco regulation. As we learn more about the contents of cigarettes, the addictive nature of nicotine and the extraordinary steps the tobacco industry has taken to conceal the truth, it becomes clear that the FDA regulation is needed.

We can't expect the industry to tell the truth. The attempt one company made to intimidate you through a subpoena shows how far they will go to keep the truth hidden.

Now another company is running full-page ads to mislead the American people. They claim that regulating tobacco will lead to bans on alcohol, caffeine, and fatty foods. The fact is that all of those products are regulated now, much more than tobacco. The fact is, tobacco is the only product that kills people when it is used as intended by the manufacturer.

Intent is the key issue in determining whether the FDA should regulate a product as a drug. In this case, the intent to use nicotine to addict people is too a deadly product.

I look forward to hearing from Dr. Kessler about his progress with this investigation.

Again, thank you, Mr. Chairman, for holding these hearings.

MR. WAXMAN: Thank you, Mr. Kreidler.

Mr. Greenwood.

MR. GREENWOOD: No opening statement.

MR. WAXMAN: Dr. Kessler, we want to welcome you back to our Subcommittee hearing today. I want to inform you that at the table are the applicable rules of the House and the rules of this Committee that apply. They indicate the limits and the power of this Subcommittee and the extent of your rights during your appearance today.

Do you desire to be represented by counsel or advised by counsel during your appearance today?

There's a switch on the base of the mike, if you would push it forward.

DR. KESSLER: Counsel from the Food and Drug Administration is with us.

MR. WAXMAN: Okay. Do you, or those who you have asked to accompany you, object to appearing before this Subcommittee under oath?

DR. KESSLER: No, we do not.

MR. WAXMAN: If you have no objection to appearing under oath, I would like you to rise, and then also have those that will be furnishing testimony as well rise as well to take the oath.

[Sworn en masse.]

MR. WAXMAN: Please consider yourself to be under oath. Identify yourself for the record, and include those who are accompanying you as a witness.

DR. KESSLER: Thank you very much, Mr. Chairman. My name is David Kessler. I am Commissioner of the Food and Drug Administration.

With me today will be Catherine Lorraine from the General Counsel's office; Margaret Porter, Chief Counsel; Mitch Zeller, Office of Policy, and Ann Witt, in the Office of Operations.

Mr. Chairman, in my last appearance before this subcommittee on March 25th, 1994, I raised the question of whether the Food and Drug Administration should regulate nicotine-containing cigarettes as drugs under the Federal Food, Drug, and Cosmetic Act.

According to this Act, a product is a drug if its manufacturer intends it to be used to affect the structure or function of the body.

Because of the enormous social consequences of such a decision, we have asked Congress for guidance as we try to answer this question.

The information that I presented about industry control and manipulation of nicotine at that hearing was suggestive. Today, as a result of an extensive investigation over the past several months, I am here to provide you with actual instances of nicotine control and manipulation in the tobacco industry.

My first example involves the deliberate genetic manipulation of nicotine even before tobacco seeds were planted in the fields. A major American tobacco company spent more than a decade quietly developing a tobacco plant with exceptionally high nicotine levels, growing it in Central and South America, and ultimately using it in American cigarettes.

My second example involves the addition of chemical compounds to tobacco. Based on our investigation, I will describe the use of chemical compounds to manipulate nicotine delivery.

Let me begin with the story of a high-nicotine tobacco plant that was code-named Y-1.

The story begins in Portuguese with our discovery of a Brazilian patent for a new variety of a flue-cured tobacco plant. One sentence of its English translation caught our eye:

"The nicotine content of the leaf of this variety is usually higher than approximately 6 percent by weight, which is significantly higher than any normal variety of tobacco grown commercially."

In fact, this Y-1 plant has almost double the nicotine that naturally occurs in flue-cured tobacco.

The holder of the Brazilian Y-1 patent is Brown & Williamson Tobacco Corporation. Let me tell you why this discovery interested us.

Industry representatives have repeatedly stated for the public record that they do not manipulate nicotine levels, that they do not design for nicotine.

Moreover, when we asked company officials whether plants were bred specifically for higher nicotine content, we were told that this was not feasible. We were told that tobacco growers and cigarette manufacturers have an agreement that the nicotine level of new varieties of tobacco grown in the United States can vary only slightly from the levels of standard varieties if they are to be sold commercially.

Nevertheless, we learned that interest in developing a high nicotine tobacco plant dates back to at least the mid-1970s. In 1977, Dr. James F. Chaplin, then of both the USDA and North Carolina State University, stated, and I quote:

"Manufacturers have means of reducing tars but most of the methods reduce nicotine and other constituents at the same time. Therefore it may be desirable to develop levels constant or to develop lines higher in nicotine so that when the tar and nicotine are reduced there will still be enough nicotine left to satisfy the smoker," end quote.

In fact, Dr. Chaplin had actually begun work on genetically breeding tobacco plants to increase nicotine levels.

Dr. Chaplin reported that tobacco could be bred to increase nicotine levels, specifically by cross breeding commercial varieties of tobacco with Nicotiana rustica, a wild, high nicotine variety, that is not used in cigarettes in the United States.

Over the next several years Dr. Chaplin continued these efforts, but he never succeeded in developing a plant that would grow properly.

During that time, an employee of a Brown & Williamson-affiliated company -- that employee told us -- that he requested and received tobacco seeds from Dr. Chaplin. From what we can gather, there was no formal release of this high-nicotine tobacco variety for commercial use.

In the early 1980s, Brown & Williamson grew a number of different high nicotine plant lines on its experimental farm in Wilson, North Carolina, selecting those that had the best agronomic characteristics.

In 1983, Brown & Williamson contracted with DNA Plant Technology to work on tobacco breeding, including Y-1. Much of the Y-l took place in the laboratories, greenhouses, and fields owned by DNA Plant Technology. A few years later Brown & Williamson also hired Dr. Chaplin as a consultant. The scientific work on Y-1 involved a combination of conventional and advanced genetic breeding techniques. These include traditional crosses and backcrosses between different plant varieties and more sophisticated state-of-the-art breeding techniques including anther culture, tissue culture, hybrid sorting, and protoplast fusion that resulted in cytoplasmic male sterility of the plant.

The genetic makeup of Y-l was verified by using genetic engineering techniques involving Restriction Fragment Length Polymorphism -- RFLPs.

The story of this high-nicotine plant continues in Rio Grande do Sul, Brazil.

DNA Plant Technology and Dr. Chaplin both told us that they saw Y-1 growing in Brazil on several farms in the 1980s.

These farms were under contract to Souza Cruz, a sister company of Brown & Williamson.

We do not yet have all the details of how Y-1 came to be growing in Brazil. We do know that until December 13, 1991, export of tobacco seeds or live tobacco plants was prohibited a Tobacco Seed Plant Export Permit from the U.S. Department of Agriculture. Such a permit could be granted only if the shipment was for experimental purposes, and then only in amounts of less than half a gram.

Brown & Williamson and DNA Plant Technology have each informed FDA that it believes that the other may be responsible for the shipment of Y-1 seeds outside the United States. We have asked both companies to furnish copies of any export permits for Y-l.

Ultimately, Brown & Williamson succeeded in developing a tobacco plant, with about double the nicotine content of the standard variety that grew well and could be used commercially.

To object commercial protection, Brown & Williamson filed a U.S. patent application and a plant Variety Protection Certificate application for Y-1 in 1991. The company also deposited samples of Y-1 seeds with the National Seed Storage Laboratory in Fort Collins, Colorado.

The plant certificate application was withdrawn about three months ago, on March 14th, 1994. Brown & Williamson also removed the Y-1 seeds it had deposited.

The patent application was rejected initially, but the company filed an appeal on February 28, 1994. However, two weeks later, on March 16, even before receiving a ruling on the appeal, Brown & Williamson abandoned the patent.

On Friday, June 10, 1994, DNA Plant Technology told us that it had been authorized by Brown & Williamson to tell FDA that Y-1 was never commercialized.

Mr. Chairman, I wish to submit for the record two invoices filed with the U.S. Customs Service in 1992.

MR. WAXMAN: Without objection, that will be received for the record.

DR. KESSLER: It was like looking for a needle in a haystack. The invoices are addressed to Brown & Williamson Tobacco Corporation, Louisville, Kentucky, from Souza Cruz Overseas. They refer to "Your Order Project Y-1" and reveal that more than a half a million pounds -- more than 500,000 pounds -- of Y-1 tobacco were shipped to Brown & Williamson on September 21, 1992.

Late last Friday, once it became clear that the Agency already knew about Y-1, Brown & Williamson told FDA that 3 1/2 to 4 million pounds of Y-1 are currently being stored in company warehouses in the United States.

More significantly, Brown & Williamson revealed that Y-l had, in fact, been commercialized.

Mr. Chairman, these brands of cigarettes -- Raleigh Lights, Richland Lights, Viceroy, Viceroy Lights, and Richland King Size -- were manufactured and distributed nationally in 1993 with a tobacco blend that contains approximately 10 percent of the nicotine tobacco called Y-1.

Company officials explained that one of the reasons they developed Y-1 was to be able to reduce tar while maintaining nicotine levels.

Let me now move on to the second area, chemical manipulation of nicotine.

In April of this year, the six major American cigarette companies released a list of 599 ingredients added to tobacco. Among those chemicals were several ammonia compounds.

Many people have wondered why the cigarette industry would add ammonia compounds to tobacco. In fact, there are many uses of ammonia in cigarettes.

One is denicotinizing;

Two: strengthening the adhesive matrix of reconstituted tobacco;

Three: It is used to react with sugars to produce certain flavor compounds.

Our investigation has revealed another important use: to affect the delivery of nicotine to the smoker.

Let me refer to one company's 1991 Handbook on Leaf Blending and Product Development, which describes this use. The handbook states, quote:

"Cigarette smoke ammonia is entirely different from the way ammonia reacts with sugars in tobacco. It can liberate free nicotine from the blends which is associated with increases in impact and satisfaction reported by smokers."

The handbook also describes ammonia as, quote, "an impact booster."

Quote: "Ammonia, when added to a tobacco blend, reacts with the indigenous nicotine salts and liberates free nicotine. As a result of such change, the ratio of extractable nicotine to bound nicotine in the smoke may be altered in favor of extractable nicotine."

Continuing with the quote:

"As we know, extractable nicotine contributes to impact in cigarette smoke and this is how ammonia can act as an impact booster," end quote.

Ammonia's role is further explained elsewhere in the handbook.

Quote: "This means that at the same blend alkaloid content, a cigarette incorporating this technology -- ammonia technology -- will deliver more flavor compounds, including nicotine into smoke than one without it," end quote.

Understand, Mr. Chairman, that only a fraction of the nicotine in the tobacco gets inhaled by the smoker. Ammonia technology enables more nicotine to be delivered to the smoker. How much more? It is our understanding, based on smoke analysis, described in that company handbook, that an experimental cigarette made of reconstituted tobacco, treated with ammonia, has almost double the nicotine transfer efficiency of tobacco.

How widespread is ammonia use in the industry? The company handbook states that many U.S. tobacco companies use ammonia technologies. Until we have access to similar documents from other companies, we will not know whether other companies intentionally use it to affect nicotine levels.

Mr. Chairman, the control and manipulation of nicotine I have described raises important questions. Why spend a decade developing through genetic breeding high nicotine tobacco and adding it to cigarettes if you are not interested in controlling and manipulating nicotine?

Why focus on the enhanced delivery of free nicotine to the smoker by chemical manipulation if you are not interested in controlling and manipulating nicotine?

These questions are even more important in the light of the industries' repeated assertions that it does not control or manipulate nicotine.

Let me discuss why the industry pays attention to nicotine.

We have learned that at least one company has identified target levels of nicotine necessary to satisfy smokers' desire for nicotine. Furthermore, we now know about industries' research into nicotine physiological and pharmacological effects.

Let me give you one example of how a company identified specific levels of nicotine necessary to satisfy smokers.

A company document describes consumer preference testing on, quote, "impact," which the company correlates with nicotine. The document states that impact is a high priority attribute of cigarettes and is, quote:

"controllable to relatively fine tolerances by product development and product intervention by manipulating nicotine in blend and in smoke."

This document goes on to describe an elaborate model, shown on the chart, for establishing the minimum and maximum nicotine levels tolerated by consumers. It states that the model provides, quote: "a median ideal point level for milligrams nicotine in smoke," end quote, and a range of tolerable nicotine levels around this ideal point.

The document notes what happened when the testing method was applied to a group of European smokers. Quote:

"It is clear that consumers are less tolerant of decreases than they are of increases in nicotine delivery. By the time nicotine level fall to approximately 0.35 milligrams, 50 percent of consumers will be saying that the level of impact is so low they would reject the product," end quote.

Mr. Chairman, this document makes clear that at least one company is aware of the need to target nicotine delivery to levels necessary to satisfy smokers.

In fact, as one tobacco flavor specialist has written: "one of the most important goals of cigarette design is to, quote, 'ensure high satisfaction from an adequate level of nicotine per puff,' end quote, and that even cigarettes with reduced levels of nicotine and tar must have this property.

Mr. Chairman, let me turn to the industry's knowledge of the drug-like effect of nicotine. I will first describe several studies commissioned by the tobacco companies.

As I go through them, ask yourselves: Are these the kinds of studies that would be conducted by an industry interested only in the flavor or taste of nicotine?

On May 16, 1994, Brown & Williamson released results of research conducted more than 30 years ago. A review of this research, known as the Project Hippo I studies, documents that the industry was interested in the physiologic and pharmacologic effects of nicotine as early as 1961. The first report, known as Project Hippo I, discussed the effects of nicotine in the body, including its effect on the central nervous system.

Let me quote from the final report on Project Hippo II, which focused on the newly-evolving field of tranquilizers.

"The aim of the whole research HIPPO was to understand some of the activities of nicotine, those activities that could explain why cigarette smokers are so fond of their habit," end quote.

The document goes on, quote:

"It was also our purpose to compare these effects with those of the new drugs called tranquilizers, which might supersede tobacco habits in the near future," end quote.

These studies represent a serious commitment by a tobacco company to a scientific examination of nicotine pharmacological properties. The comparison of the drug-like effects of nicotine and tranquilizers was not exactly a well-kept secret.

Even in the 1940s, Mr. Chairman, you could pick up a magazine and see an advertisement like this.

[Pause.]

If upset by a 5-year-old, why be irritated -- Life and Old Gold?

Another report released with Hippo, called The Fate of Nicotine in the Body presents the results of studies on nicotine metabolism in a group of smokers.

The report states, and I quote:

The numerous effects of nicotine in the body may at first be conveniently measured by various physiological and pharmacological experiment. Such research is inconsistent with the industry's representation that it is only interested in nicotine flavor and taste.

Mr. Chairman, we believe that the studies released by Brown & Williamson are relevant to the determination of whether nicotine-containing cigarettes are drug, for the purposes of the Federal Food, Drug, and Cosmetic Act.

Thanks to this Subcommittee's work, we now know that Philip Morris also studied the reinforcing effect of nicotine.

We are also aware of research utilizing electroencephalographic measurements to monitor the biological effects of nicotine on brain function at both R.J. Reynolds and Philip Morris.

Let me also quote some of the recently reported statements in the media of officials from one company that reveal a recognition of nicotine's drug-like effect.

Quote: "Nicotine is not only a very fine drug but the techniques of administration by smoking has considerable psychological advantages.

Quote: "Nicotine is a very remarkable, magnificent drug that both helps the body to resist external stress, and also can, as a result show a pronounced tranquilizing effect."

These statements were apparently made by Sir Charles Ellis, who served as Science Advisor to the Board of Brown & Williamson's sister company, British American Tobacco Company.

Dr. Ellis made another statement in 1962, quote:

"Smoking is a habit of addiction," end quote.

But perhaps the most striking statement attributed to him is one from a meeting of company scientists in 1967.

Quote: "Sir Charles Ellis states that this company is in the nicotine rather than the tobacco industry," end quote.

These statements are echoed by those made in an internal company document of another senior scientist at a British tobacco company:

Quote: "There is now no doubt that nicotine plays a large part in the action of smoking for many smokers. It may be useful, therefore, to look at the tobacco industry as if for a large part of its business is the administration of nicotine in the clinical sense."

Another scientists are quoted in a May 30, 1963 paper that is reported to have been produced by the British American Tobacco Company and labeled "Confidential A Tentative Hypothesis on Nicotine Addiction".

Quote: "Chronic intake of nicotine tends to restore the normal physiological functioning of the endocrine system, so that ever-increasing dose levels of nicotine are necessary to maintain the desired action. Unlike other dopings, such as morphine, the demand for increasing dose levels is relatively slow for nicotine," end quote.

Other statements reportedly made in this paper describe what happens when a chronic smoker is denied nicotine.

Quote: "A body left in this unbalanced state craves for renewed drug intake in order to restore the physiological equilibrium. This unconscious desire explains the addiction of the individual to nicotine." The information that we have presented today has been the result of painstaking investigation. We now know that a tobacco company commercially developed a tobacco plant with twice the nicotine of standard flue-cured tobacco, that several million pounds of this high-nicotine tobacco are currently stored in warehouses, and that this tobacco was put into cigarettes that have been sold nationwide. We now understand that several tobacco companies add ammonia compounds to cigarettes.

Further, one company's documents confirm that the intended purpose of this practice is to manipulate nicotine delivery to the smoker. We now know that some in the industry have identified target ranges of nicotine delivery. These findings lay to rest any notion that there is no manipulation and control of nicotine undertaken in the tobacco industry.

It is equally important to lay to rest, once and for all, the industry's assertion that nicotine is not addictive. Up until very recently, the tobacco industry was able to claim that it does not believe that nicotine was addictive.

The release of company documents, and the testimony of company scientists before this Subcommittee, has opened a window on what some senior tobacco officials knew about nicotine's physiological and addictive properties, as much as 30 years ago.

Mr. Chairman, members of this Committee, one important thing that every teenager in this country needs to know before deciding to smoke his or her first cigarette is how one cigarette industry official viewed the business of selling cigarettes:

And I quote: "We are, then, in the business of selling nicotine, an addictive drug."

Thank you, Mr. Chairman.

MR. WAXMAN: Thank you very much, Dr. Kessler.

I have to tell you that I thought your testimony was riveting, and I want to commend you on the investigation that you and the people at FDA have conducted, at least at this point.

We have heard over the years, and even very recently in this subcommittee, from the executives of the tobacco industry, that they don't think smoking cigarettes is addictive. Now they certainly know that nicotine is a property of cigarettes. You've said it in your testimony. You want to lay to rest, once and for all, the industry's assertion that nicotine is not addictive, and you go on to say that the release of company documents and testimony of company scientists has opened a window on what some senior tobacco officials knew about nicotine's physiological and addictive properties as long ago as 30 years.

Is that correct?

DR. KESSLER: That's a correct statement.

MR. WAXMAN: So, in other words, you're telling us the tobacco company executives, and those in the tobacco industry, have known for three decades that the nicotine in cigarettes is addictive and is causing a pharmacological reaction in people which causes them to smoke?

DR. KESSLER: I was reading their words, Mr. Chairman.

MR. WAXMAN: What is it in the tobacco or the nicotine that keeps people ### tape change ##

nicotine is solely a function of giving people a taste or a flavor in the cigarettes themselves. In your investigation, is this a conclusion that you have reached as well?

DR. KESSLER: Mr. Chairman, when you smoke a cigarette, within 8 to 10 cigarettes, that nicotine travels through the lungs, into the bloodstream and starts affecting the brain. It is that portion of the brain and those chemicals that nicotine affects that results in nicotine psychoactive effects, and that psychoactive effect makes it addictive.

MR. WAXMAN: If that nicotine were administered through an oral dose, a pill or a patch or an injection, would it be any different?

DR. KESSLER: No form of nicotine delivery is as potent, that I know of, as smoking. Inhalation results in very rapid transfer of nicotine from the delivery agents to the brain -- 8, 10 seconds.

MR. WAXMAN: Now, you've indicated that when you first looked at this issue of whether there can be a genetic manipulation of the tobacco plant to increase its nicotine level, you were told that it couldn't be done. Who told you that?

DR. KESSLER: Let me turn the microphone to Ms. Witt, who was at one of our trips.

MR. WAXMAN: There's a microphone she could use right there. Push the button and then face forward.

MS. WITT: Mr. Chairman, we visited Brown & Williamson's facilities on May 3rd of this year -- several representatives from FDA visited Brown & Williamson. And, at that time, company officials told us, first, that it wasn't feasible to increase nicotine levels in tobacco because of voluntary agreements that the industry had entered into that would preclude them from growing and selling that nicotine in the United States.

We also asked them, as part of our general investigation, as to whether they were manipulating nicotine levels, whether the company had engaged in any breeding of tobacco for high or low nicotine levels. At that time, they told us the answer was no, they had not.

Shortly thereafter, their in-house counsel offered the qualification that they might have provided some unrestricted grant money to universities that might have been engaged in breeding research.

MR. WAXMAN: In other words, you asked the company officials whether they could breed a plant for higher nicotine levels. When was that first question posed to them?

MS. WITT: On May the 3rd of this year.

MR. WAXMAN: Their response was that they could or could not?

MS. WITT: That they did not and that it would not be feasible to do so, in any case, because they couldn't grow it in the United States.

MR. WAXMAN: And that was this year they told you that?

MS. WITT: This year. Six weeks ago.

MR. WAXMAN: As of last Friday, after they learned all that you now know about the Brazilian operation and the commercial use of this genetically-altered tobacco plant Dr. Kessler, did they have any explanation for their inconsistency?

DR. KESSLER: Ms. Witt also met with them on this Friday. Let me let her comment.

MR. WAXMAN: Okay.

MS. WITT: The explanation that they offered was that they thought we were asking whether they had genetically-engineered tobacco, and that the answer to that was no.

Having been present at the original meeting, I can tell you that I had no idea that there was any genetic engineering going on, and the only question we asked was whether they were breeding tobacco for high or low nicotine levels.

MR. WAXMAN: Well, that sounds like a pretty deceptive way, or misleading way, of answering the question. Unless you knew, which you later found out, that they had gone through this whole elaborate system of genetically-altering the plant and using a ranch, a farm, in Brazil, to produce that plant, their answer would have stood.

DR. KESSLER: Mr. Chairman, I am not here to characterize any statement. We would be happy to provide the Committee and stay with the factual basis.

MR. WAXMAN: I appreciate that. I think we can draw our own conclusions as to whether they were being helpful to you, when you inquired of them, whether they were able to do this sort of thing.

They were not only, like one of the patents you discussed last time you were here, theoretically able to increase the nicotine levels through genetic change, it wasn't theoretical, they, in fact, did it, and it was added to cigarettes in this country in the last year or so. Is that correct?

DR. KESSLER: That's correct.

MR. WAXMAN: In this genetically-altered tobacco plant, how great was the increase in nicotine levels.

DR. KESSLER: Ann, there's a chart that compares the flue-cured with the Y-1.

We were told by the industry, actually, in a letter that we received -- it wasn't from this company, but it was a general statement about industry practices -- that flue-cured tobacco naturally contains about 2.5 to 3 percent nicotine.

In Patent Claims No. 6 of the Brazilian patent, it states: "Tobacco plants" -- and they were referring to the patent for Y-1 -- "in accordance with Claim 5, characterized by the fact that the nicotine content is approximately 6.2 percent."

MR. WAXMAN: So they're able to double the nicotine level in tobacco through this genetic alteration?

DR. KESSLER: They were able to double it compared to flue-cured tobacco, yes, which Y-1 is.

MR. WAXMAN: How did this transfer into the cigarette, being at a higher nicotine level, if it was, in fact, at a higher nicotine level?

DR. KESSLER: What the company has told us what their purpose was, to be able to lower tar and maintain nicotine. We are not here stating that the issue is putting enormous amounts of nicotine beyond traditional ranges, but what was important was to keep the nicotine, I believe, in that traditional range.

That traditional range, as we said, is more than enough to be able to create and sustain an addiction, in my opinion.

So what they wanted to do was maintain the nicotine while lowering the tar. That was their intent, as they told us.

MR. WAXMAN: But the nicotine is not just simply a byproduct of whatever the tobacco might be. It's a carefully-calculated level in every cigarette that's sold in this country?

DR. KESSLER: Mr. Chairman, the story of Y-1 is one example of nicotine being, as you've said, double compared to the standard of flue-cured variety.

We have spent a lot of time looking at the Y-1 story. The reason why the Y-1 story is important is not for the sake of Y-1. The reason why the Y-1 story is important is it goes to the heart of the assertion by some of the tobacco industry that they do not control or manipulate nicotine.

I don't know how you design a plant, you genetically alter a plant, and spend a decade doing that, and say you are not interested in controlling or manipulating nicotine.

MR. WAXMAN: Thank you very much, Dr. Kessler.

Mr. Bliley.

MR. BLILEY: Dr. Kessler, I listened to your discussion of the nicotine plant that Brown & Williamson apparently developed, which has a somewhat higher nicotine content and a somewhat lower tar content.

You appear to be suggesting that B&W did something secret and possibly detrimental to human health, but don't you know that this federal government, through its Cancer Institute, propose just such changes in tobacco?

Specifically, I want to ask you if you are aware that in 1980 Dr. G.B. Gorey, the Director of NCI's Smoking and Health Program, proposed just what you are now accusing B&W of doing surreptitiously?

I would like to introduce for the record and read a quote from Dr. Gorey's presentation. He stated that: "NCI, that is, the federal government, as late as 1980, was just considering just that relationship of nicotine to tar as follows: The end of this review one cannot avoid a special consideration for nicotine which, besides being a major contributor to the taste and smell of smoke, is the most important pharmacologic principle in the complex relationship of the smoker and the cigarette. Most commercial cigarettes in the U.S. have maintained a ratio of approximately 1:10 between nicotine and tar delivery in cigarette smoke, but in the past last few years, new generations of cigarettes have begun to appear on the market where the ratio of nicotine to tar has been pushed to as low as 1:5 or less. But it may be possible to reach levels of nicotine concentration in the smoke that are still pharmacologically satisfactory, but so low as not to pose significant concerns."

Dr. Gorey then went on to explain exactly how this change in the nicotine to tar ratio might be achieved.

"The progressive reduction of the nicotine to tar ratio in commercial cigarettes is a feasible but not a simple proposition. It may require changes in tobacco variety, and agricultural practices in the field of tobacco processing and blending, and fine-tuning of filtration and ventilation practices before the ratio could be favorably altered for the majority of cigarettes on the market."

Other words, Dr. Gorey was explaining that perhaps it would be useful to increase nicotine delivery relative to tar delivery, and that it might be useful to try to do that by changing tobacco varieties, which, as I understand it, is is exactly what B&W apparently did.

My question to you, Dr. Kessler, do you believe that it was wrong for the federal government, through the National Cancer Institute, to encourage the tobacco companies to try to change tobacco varieties in order to increase nicotine relative to tar delivery?

Do you believe it was wrong for NCI to work on these sorts of things with the tobacco companies in the 1970s before Secretary Califano pulled the plug on the government, Less Hazardous Cigarette Program?

And do you believe that it is now fair for you to accuse these companies of some type of insidious manipulation when all they were doing was precisely what the federal government suggested that they should do, to yield a cigarette that still had the taste and smell of smoke produced by nicotine but had somewhat lower tar and delivery?

DR. KESSLER: Mr. Bliley, I'm not here to say what's right or what's wrong. I am simply here to say that if what Dr. Gorey said, in fact, was going on, then I believe that that is evidence of manipulation and control of nicotine and, as Dr. Gorey cites, there are pharmacological effects, and that I believe the manipulation and control, if you are manipulating nicotine delivery, if you are doing what Dr. Gorey is suggesting and you understand the pharmacological effects of nicotine, then I believe that is relevant to the Food and Drug Administration's determine of whether nicotine is a drug.

It may well be that people addicted to nicotine need nicotine in some form, but if you are going to have a nicotine delivery system and you're going to have what Dr. Gorey is suggesting, then the question for this Agency is whether that system should be regulated as a drug.

MR. BLILEY: You apparently, Dr. Kessler, have not read your Surgeon General's report before claiming that the FDA has made a, quote, "startling discovery."

Let me read to you from page 50 of a 1981 Surgeon General's report, which clearly stated that: "Scientists were actively involved in the genetic manipulation of tobacco plants to yield a wide range of nicotine levels. A substantial collection of tobacco lines is available to plant geneticists. These include 63 species related to tobacco and about 1000 tobacco varieties. The wealth of this material permits genetic manipulation of the leaf which could be used selectively to enhance or reduce the content of specific constituents.

"Among flue-cured tobacco lines available at present, the nicotine concentration varies from .2 of 1 percent to 4.75 percent. Among various Burley lines the concentration varies between .3 of 1 percent to 4.58 percent. The ranges should be extended by agronomists should that be desired."

Did you not read this report, written 13 years ago, before making your statement here today, to suggest that B&W's variety with some # genetic plant?

DR. KESSLER: Mr. Bliley, not only have we gone through the 1981, I have read an enormous number of papers on genetic breeding. I cited papers that go back even earlier than the 1981 Surgeon General's report. I cited Dr. Chaplin's work in 1977.

This cross of 6.2 percent is higher than any commercially viable -- it was higher than even Dr. Chaplin initially thought he could get.

I asked, when I read this report -- I asked, in fact, Dr. Koop, was Surgeon General back in the early 1980s, what he thought about a high nicotine, medium nicotine, low tar cigarette. His answer to me was if, in fact, companies are developing a medium or high nicotine cigarette with low tar and they're doing it by manipulation, then that is, in his opinion, a nicotine delivery system.

Now that was not in the 1981 Surgeon General's report, but that's what Dr. Koop told me very recently.

MR. BLILEY: You mentioned Dr. Chaplin. When he started development of the strain of Y-1 tobacco, was he not an employee of the federal government?

DR. KESSLER: He was an employee of the Oxford Research Center of U.S.D.A., and he also had an appointment in North Carolina State University.

MR. BLILEY: Thank you.

Thank you, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Bliley.

Mr. Synar.

MR. SYNAR: Dr. Kessler, again, thank you for your very important testimony. With it, I think we may to a close of this debate with respect to whether or not tobacco companies do indeed manipulate.

Not to oversimplify but to summarize, what we've learned today is that manipulation really takes three forms:

(1) Plant breeding;

Secondly, chemical charging; and then,

Third, targeting levels of nicotine.

What I'm interested in is the motive behind that, and I think you may have given us that with Chart 21. If I could ask the staff to put that up.

I'm particularly interested in that last sentence: "It was also our propose to compare these effects with those of new drugs called, tranquilizers, which might supersede tobacco habits in the near future."

Does that sentence read to you as it does to me, which is:

(1) It is an admission that nicotine and tobacco are, indeed, drugs; and that,

Secondly: The entire manipulation may have been, because of the fact of their fear of the competition of future tranquilizers?

DR. KESSLER: It's a statement that certainly reflects their concern about their market share versus tranquilizers.

MR. SYNAR: That's all I have, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Synar.

Mr. Greenwood.

MR. GREENWOOD: Thank you, Mr. Chairman.

Dr. Kessler, your testimony has been fascinating and interesting in that it's helped us to better understand a fine point in the debate about the ability of tobacco companies to affect the amount of nicotine in their products and whether or not we need to consider that issue only if they can somehow inject it into the process, or was it actually manipulation of tobacco leaf itself.

But it doesn't really go at all to the central question, which you raise in the first sentence of your testimony, which is the question of whether the Food and Drug Administration should regulate nicotine-containing cigarettes as drugs under the Food, Drug, and Cosmetic Act. That's really the issue.

This is interesting, but the issue is whether we ought to change the law in some way to give you the responsibility to do that.

Let me make it very clear that I don't have any interest in defending the tobacco industry. I think the world would be a lot better if no one smoked another cigarette and the tobacco companies all went out of business. We'd all be healthier; that'd be fine.

But the question is what is the government's role, and does the government have a role in seeing that that happens, or what would the FDA's role be in controlling and regulating tobacco products if we gave it to you?

Would tobacco companies be in the business of advertising that our cigarette is guaranteed by the FDA to have the highest nicotine levels possible? Do we want to see that or do we want to see the tobacco companies saying that Dr. Kessler has certified that this cigarette is the safest cigarette on the market? Or that this has been approved by the FDA to contain no higher level of tar and nicotine?

To me, I don't see that that is forward progress on public policy with regard to smoking.

What would be the FDA's role? Would it be to limit nicotine in cigarettes? To set some level and say, all right, manufacturers, you can't have more than this percent of nicotine, or content of nicotine in your product, or tar, and so forth? And if that's the role that the FDA played, where on God's earth would you set that level? Who wants that assignment to decide what is the lethality or the habituating qualities of cigarettes?

I guess my question for you is, flat out: Do you want the responsibility to regulate tobacco products; and,

(B) If we gave it to you, what would you do with it?

DR. KESSLER: Congressman, I think those are all excellent questions.

Please understand that the current Food, Drug and Cosmetic Act has a definition of drug and, without any other congressional intervention, then we, as an Agency, are left with the question of deciding whether nicotine-containing cigarettes -- and it's a nuance here, but we're focusing on nicotine in the cigarettes -- nicotine-containing cigarettes -- rather than just the cigarettes, but the nicotine-containing cigarettes -- are drugs for the purposes of the Food, Drug and Cosmetic Act.

If Congress does nothing, if Congress is not in a position to be able to give us guidance, then we have a responsibility to answer that question under the law as it's presently written.

I think, let me go to the broader question, because under the law as presently written, it is fair to say that the tools available to the Agency are relatively crude. We can decide it's a drug, what's the different levels; but they are relatively crude tools, looking at nicotine in cigarettes.

I believe that if I were sitting where you were sitting, what I would focus on, and I would ask myself this question: How can I prevent the next generation of teenagers, at least some in the next generation of teenagers, who are going to decide, for whatever reason, to start their first cigarette, how can we reduce the numbers of them who are going to get addicted to cigarettes?

Prohibition does not work.

MR. GREENWOOD: Let me interrupt you. I think that is a good policy question, and I think that that question is probably largely answered by saying that programs in schools, that my little girls have been exposed to, are very clear about that. All sorts of public service, behavior, role models -- there's lot of things. The role of the parents certainly is first and foremost.

The question is, what is your Agency's role? If you were me, you would probably ask the head of the FDA what do you want? What responsibility do you want in this process? What do you think would be good public policy in terms of the FDA's role?

DR. KESSLER: I believe steps that would reduce the risk of a teenager from becoming addict --

MR. GREENWOOD: Let's be more specific. How do you do that?

DR. KESSLER: The current cigarette --

MR. GREENWOOD: If you get --

DR. KESSLER: -- the current cigarette --

MR. GREENWOOD: -- if you get the authority, then these tobacco companies have to bring their products to you, and you've got to say something about it.

DR. KESSLER: There are many things that could be considered.

One: You could consider restricting access even further;

Two: You could consider looking at nicotine levels. The current cigarette has multiple, as far as amounts of nicotine, that will create and sustain addiction. Wouldn't it be great if a teenager, who is going to smoke a couple of cigarettes, didn't get hooked on that nicotine, by the amount of nicotine in that cigarette?

It's a very difficult question because obviously we have 40, 50 million children --

MR. GREENWOOD: Yes. We could give you the authority and you could limit the amount of nicotine in cigarettes, and then the cigarette companies could go on television -- or I guess they can't go on television -- but they can go into Sports Illustrated and advertise that: Dr. Kessler says this cigarette won't get you addicted. Smoke it.

DR. KESSLER: Congressman, you could also restrict the advertising in the magazines. There are many things that could be done. What I would focus on is how do we reduce the demand for cigarettes? And the way to do that --

MR. GREENWOOD: I just have a hard time imagining --

DR. KESSLER: -- is to reduce the number of people who are going to become addicted.

MR. GREENWOOD: I agree with that, and I want to see that happen. I just can't figure out what the chemists at the FDA have to do there.

If a pharmacological product is FDA-approved, your job is to say, yep, this has the right dosage to cure what ails you, not too high; won't have these side effects, not too low, won't be ineffective. That's the role of the FDA in many regards.

I just can't figure out what in the heck role -- we can pass laws about advertising. We don't need the FDA to get involved there.

DR. KESSLER: Congressman, we will convene in early August one of our advisory committees -- the Drug Abuse Advisory Committee -- to look specifically at the question of what level -- what do we know about levels, what are addictive levels of nicotine in cigarettes? When we have those scientific answers, I will be happy to come back and share that information and continue this dialogue with you.

MR. GREENWOOD: My time is short, and I think it's running out, but let's get right to the question.

Do you want us to give you the authority to regulate the content of cigarettes?

DR. KESSLER: I think the Congress should give us guidance, under our current authority, of whether we should regulate cigarettes as drugs.

MR. GREENWOOD: And I would like you to give us guidance as to whether you want that authority.

DR. KESSLER: I think that when you look at caffeine and alcohol and other things that the cigarette industry is currently putting out there in the news, those products are regulated. I see cigarettes as much more hazardous by orders of magnitude, and I don't understand why all of those other substances are regulated and cigarettes are not regulated by the Food and Drug Administration.

MR. GREENWOOD: I think that you would like us to put your Agency in --

DR. KESSLER: I would like you, Congressmen, for us to figure out the right policy step, based on the right scientific answers, so that together we can reduce the demand, reduce the future generations from becoming addictive.

Yes, I think that is scientifically possible to do by focusing on the nicotine in cigarettes, as well as considering other policy options, such as you raised advertising, such as restricted access; but if prohibition won't work, we are going to have to do this by reducing demand.

MR. GREENWOOD: My guess is that kids that smoke cigarettes don't smoke them because they're addicted early on, they smoke them for a lot of ridiculous social notions about what's cool and what their peers are doing.

DR. KESSLER: Congressmen, exactly.

MR. GREENWOOD: The FDA ain't gonna fix that.

DR. KESSLER: But what we can talk about is if they're going to smoke cigarettes, about smoking a cigarette that's going to assure to deliver the kind of doses of nicotine that's sure to get them hooked. That's what we need to focus on: how can we prevent that teenager, who's going to smoke because of peer pressure or because someone in the family is going to smoke, how can we reduce the risk of that teenager getting hooked on cigarettes?

You're right. They don't smoke because they think they're going to get hooked. They smoke because they smoke one cigarette, they think they can stop. They don't know that once they start smoking regularly, it becomes very hard to do so.

MR. GREENWOOD: Thank you, Dr. Kessler.

Thank you, Mr. Chairman.

Mr. Wyden.

MR. WYDEN: Thank you, Mr. Chairman. And thank you very much for an important presentation, Dr. Kessler.

I think that the people of this country should not be mistaken at this point. It seems to me that the Food and Drug Administration is now building an administrative record that would require that tobacco be regulated as a drug in our country.

We look, for example, at what you've said, that tobacco companies have patented the technologies to manipulate a nicotine content;

The tobacco companies have bio-engineered tobacco plants, specifically for higher nicotine content;

Tobacco companies have added chemicals to enhance the nicotine hit of cigarettes.

It seems to me that you have already built what amounts to an undeniable proposition with respect to requiring that tobacco be regulated as a drug.

My first you to you is, do you all have evidence that the nicotine content of cigarettes that you tested in your laboratories meets the drug content uniformity specifications that are set out in the U.S. Pharmacopeia?

DR. KESSLER: Andrew, could we have the USP chart. My staff always jumps on me when I refer to this chart, because it is very complicated, and so just indulge me for a second, Congressman.

We tested -- our St. Louis Drug Laboratory tested -- over the years, over 11,000 drug samples and tested many different tablets within each of those drug samples, and we also tested 10 different brands and tested a lot of different cigarettes within those 10 brands.

The bottom line is that if you fall -- as you see all cigarettes fall -- within either the yellow or blue areas of that chart, you meet USP -- United States Pharmacopeia -- standards for drugs uniformity and drugs delivery.

You even see that some drugs don't meet, that have been tested, that standard, but all cigarettes meet.

This, again, shows very fine control, very precise uniformity. It is a measure of quality control. It may just be, hey, we just want every cigarette to be exactly the same, but when you get to this level of uniformity, it is striking to us that the uniformity does meet USP drug delivery standards.

MR. WYDEN: My next question is, I understand and have heard reports that there is evidence that European manufacturers are using other means of manipulating nicotine levels in cigarettes.

My question to you is: Have you all picked up this evidence and, if so, can you share with the subcommittee what information you may have about other approaches that are being used in Europe and manipulate nicotine levels and whether or not those approaches are being used in our country?

DR. KESSLER: I've seen certain other additives, certain humectants, for example -- I've seen the patent by one company, use of certain percentages of, again, chemicals -- other chemicals, that are called humectants, that are used in an attempt, according to the patent, to alter nicotine and tar ratios. We would be happy to submit that, Mr. Wyden, for the record.

MR. WYDEN: Have you all found Brown & --

DR. KESSLER: There is one other. Andrew, there is an LTR quote that I think is interesting.

This is from a quote in World Tobacco, and it talks about a European maker of reconstituted tobacco, essentially using the dust and stems to make a sheet. They talk about how various European cigarette houses cannot only reduce tar in the sheet it sends back to clients, it is able to work into clients, scrap and waste new tobacco, of the rustica type, which I mentioned earlier, which, in nicotine, in order to change the relationship of nicotine and tar, it is able to do the same by the alternate method. This is part of the quote:

It is able to do the same by the alternate method of adding salt, of pure nicotine, into the slurry that eventually becomes tobacco sheet.

The article goes on to say that this is an operation that adding of the pure nicotine in the slurry, into the sheet, is an operation parallel to, though more exact than that on which U.S. geneticists are engaged in seeking to develop types of tobacco that are low on tar but fairly rich in nicotine, and similar processes.

MR. WYDEN: And you are now further investigating these issues?

DR. KESSLER: Our investigation continues, sir.

MR. WYDEN: Has Brown & Williamson been forthcoming in your requests at the Agency for documents that would clear up these remaining questions you have?

DR. KESSLER: I'm not in a position, Mr. Chairman, to editorialize in any way on --

MR. WYDEN: Let me ask, specifically.

I understand that the Agency requested a number of documents about six weeks ago, early in May, and that the Agency felt that those documents were necessary for its inquiry. My reports are that they have not been forthcoming. Is that correct?

DR. KESSLER: I think it was early May, two senior counsel for the Agency requested, after reports in the press of documents that we believe are found relevant regarding the pharmacological and physiological effects of nicotine, we asked outside counsel for those documents on the physiological and pharmacological effects of nicotine. Those documents have not been produced to the Agency as of this, six weeks later.

MR. WYDEN: And they would be relevant to your inquiry with respect to knowledge and intent concerning manipulation of nicotine, would they not?

DR. KESSLER: Absolutely.

MR. WYDEN: All right.

DR. KESSLER: The last question that I had, Dr. Kessler, concerns the nicotine enhancement effects of ammonia. As I mentioned, you and I have discussed, I have long been concerned about these chemical additives, and now you've told us that this will increase the hit of this drug, which I think you all are moving to categorize as a drug, as I noted, Administratively.

Have you all looked at the adverse health effects that may be part and parcel of smoking these chemicals, such as ammonia?

Congressman, I think it is very important for the industry to release certainly all of its inhalation studies and all its pyrolysis studies. I think it is disingenuous to simply state that 599 chemicals that are on the list are used in foods, digested.

The issue is not what the effect of those compounds are when they're digested. The issue is what compounds will even be formed through combustion and pyrolysis. What other compounds will be formed.

We know that when you pyrolyze a compound, other compounds are formed. I think it is very important for the industry not only to make available the list of compounds but to make available any pyrolysis studies that have been undertaken, as well as any toxicity studies on the inhalation products, either of the direct additives or any newly-formed compounds by combustion or pyrolysis.

MR. WYDEN: My understanding is, at this point, there is very little research data along the lines that you're talking about, that the tobacco industry, after it put out its list of ingredients, said, look, folks, everything's fine; you can see these kind of chemicals in a cookie you eat, and that ought to close the debate.

But we got letters from federal agencies saying that they wanted the kind of information that you're talking about, the health effects of these chemicals being smoked or burned, and my understanding is there's very little research to date on that. Is that correct?

DR. KESSLER: It is very important, that you can't look at that list, and we are certainly restricted in our analysis by simply looking at that list. If you go to just the published literature, you don't get all of the answers on what are all the possible pyrolysis products of those additives. It's really those pyrolysis products and their toxicity that needs to be examined, Mr. Wyden.

MR. WYDEN: Dr. Kessler, this has been very helpful. It seems to me crystal clear where your Agency is headed and where your Agency is headed, whether or not Congress acts on this issue whatsoever. And I, for one, could fully go on about another hour.

I, for one, think it is very helpful that the Food and Drug Administration is calling this on the basis of the science and not the politics. I think there is a series question about whether the tobacco executives, when they came before this subcommittee, deliberately and intentionally mislead this subcommittee with respect to the industry's ability to control nicotine levels and, fortunately, you all at the Agency are setting aside these kind of considerations and letting the scientific facts fall where they ought to is part of an Administrative record, and I think the American people ought to be very clear on where that record is heading this country in terms of smoking policy.

I appreciate your testimony.

I yield back, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Wyden.

Mr. Franks.

MR. FRANKS: Thank you, Mr. Chairman.

Dr. Kessler, I, too, have found your testimony and charges very intriguing. However, I am always somewhat skeptical when I only hear one side of a story.

Dr. Kessler, though I have a concern for the entire tobacco industry for various reasons -- commerce, individual rights, and also having family members in North Carolina that once grew tobacco -- I have a particular concern about the smokeless tobacco industry, since I have a major manufacturer based in my state.

My question to you would be, how much of your comments will be applicable to the smokeless tobacco industry?

DR. KESSLER: Congressman, I talked a little, in my last testimony, some of the promotional activities and some of the evidence that had been released over the years that relate to nicotine. We have yet to visit any smokeless tobacco company and begin a face-to-face dialogue, but I would welcome that.

And I would certainly request the smokeless tobacco industry to produce for the Agency all documents relating to nicotine, nicotine's physiological and pharmacological effects, and any documents relating to control and manipulation of nicotine. I welcome that. I have not seen them, but we would ask them to do so.

MR. FRANKS: I'm sure they will be happy to provide that information.

Getting back to your earlier point, obviously, when you're talking about smoking tobacco, in most of your comments, were obviously directed toward that industry's cigarettes. Is there anything that you can mention at this point that would be applicable to the smokeless tobacco industry?

DR. KESSLER: Sure. Andrew, do you have the chart on the graduation effect.

MR. FRANKS: Maybe I shouldn't be asking this question.

[Laughter]

DR. KESSLER: This is, actually, part of a -- I guess it was a promotional campaign document, an advertising campaign company document, that came out that we saw in --

MR. FRANKS: Excuse me. Do we have a copy of this in here?

DR. KESSLER: It was attached to my previous testimony, and we would be happy to submit that.

Do you have a copy of the old charts, by any chance?

We will certainly provide a close up, and I would be happier to bring it closer, Congressman, if you want.

MR. FRANKS: We can't see it.

DR. KESSLER: Let me just describe it. This was part of a promotional document, and other witnesses talked about this, and it was an exhibit -- Plaintiff's Exhibit 100 in the Morris v. U.S. Tobacco Company case.

You see various different products. You see products that start on the bottom, and then you move up to the top. There are, on this document, it's talking about the graduation process, and how you graduate from one to the next.

We have done some analysis and would be happy to share with you, Congressman, that if you look at nicotine bioavailability, and what's being suggested here is you start off with those products that have the least amount of nicotine, and then as you get to the top of the graduation process, as you graduate, you go to products that have higher and higher nicotine. Again, you need to focus on nicotine bioavailability.

I am aware of that document. Again, we would very much welcome the smokeless industry providing us with all documents on any nicotine manipulation, all nicotine control, all nicotine's physiological and pharmacological effects.

MR. FRANKS: I yield back the balance of my time, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Franks.

Mr. Kreidler.

MR. KREIDLER: Thank you, Mr. Chairman.

Dr. Kessler, I'm just sitting here trying to figure out maybe why the industry kind of responds the way it does. It kind of reminds me of back in the 1960s when the first Surgeon General's warnings came out, that there was denial on the part of the industry that there were any harmful health effects from tobacco smoking, they only acquiesced under pressure to the warnings, finally then being put on cigarette packages, and so forth.

I'm curious. Is the reason right now, if you have kind of a gut feel, or what you think the reasons are, as to why the tobacco industry right now is so adamantly fighting this connection with addiction with their product?

Is it because they feel that the admission will lead to FDA or some kind of controls on nicotine and how it's delivered with other chemicals, and so forth, if they admit to addiction, in the same way they were so apprehensive, perhaps, because of liability and other reasons to admitting to health effects?

DR. KESSLER: Congressman, I would very much appreciate if we were not asked to comment specifically on motives that we can't determine factually.

We asked Congress for guidance on the question of whether nicotine is a drug, and I feel obligated to present you with the facts as we have determined our investigation. I would not like to go beyond those facts in any conjecture. I apologize, Congressman.

MR. KREIDLER: No, I can appreciate that. I guess I'm just sitting here thinking about somebody who would be sitting out there wondering why there is this reaction on the part of the tobacco companies.

I think we've all recognized, for an awful long time, that nicotine was the means for getting people hooked on tobacco.

DR. KESSLER: I certainly would agree with that statement, Congressman.

MR. KREIDLER: You know, it's interesting to me, as I look at the recent ad campaign that's just started out here, and you've probably seen these full-page ads right now that RJR is running -- RJ Reynolds, that is -- is claiming that we're trying to prohibit smoking and abolish cigarettes. It compares cigarettes to alcoholic beverages, caffeine, and to high fat foods as targets for prohibition if you ever turn towards cigarettes.

How does FDA regulation affect alcohol, caffeine, and fatty foods? And how would you compare tobacco with alcohol, caffeine, and fat from a health standpoint?

DR. KESSLER: We regulate caffeine, fatty foods, and with out sister Agency, BATF, we regulate alcohol. There is no prohibition of any of those three other. We do not regulate nicotine in cigarettes. We do regulate other forms of nicotine.

There is no question, by orders of magnitude, cigarettes are much more harmful.

Now, caffeine and fatty foods and alcohol in excess could be harmful. Cigarettes are harmful, period.

MR. KREIDLER: I appreciate that.

I'm sure there's a good analogy of what this kind of represents, of trying to grab onto -- I'm surprised apple pie isn't listed, or something like that, and try and come up and say, look, this is God, motherhood, and apple pie, and so forth.

DR. KESSLER: Congressman, personally, I do not believe that prohibition is the answer. We're not focused on the regulation of cigarettes, we're focused on the regulation of nicotine in cigarettes.

It is a relatively crude tool, the current Food, Drug and Cosmetic Act, as we are looking at it. I would focus -- and a policy question, as I spoke to Congressman Greenwood -- I would focus on those policy options that really would reduce kids and teenagers becoming hooked for their lives.

MR. KREIDLER: Yes. Well, I think you're very appropriate to point that out. I don't know of anybody, at least among my peers here in Congress, that are talking about prohibition, and I've certainly never heard it from the FDA or anyplace else. I only hear it from the tobacco industry which is trying to raise some kind of specter here to avoid appropriate regulation if there's a health risk.

DR. KESSLER: Congressman, I need to point out that we are talking about, under the Food, Drug and Cosmetic Act, that nicotine, if the Agency were to conclude that nicotine in certain doses were, in fact, a drug in cigarettes, then that could affect the nicotine in the cigarettes, but that would not affect the other parts of the cigarette.

MR. KREIDLER: Good point.

Let me just switch here, going to the issue related to Y-1. Have you asked the Department of Agriculture whether they ever issued an export permit for Y-1 tobacco seeds, and do you have any information from USDA on this?

DR. KESSLER: Congressman, we've asked the companies, as I mentioned in my testimony, for copies of their export permits, and yes, I have been in communication with the Department of Agriculture, and I have some information. I would be happy to supply that to you privately.

MR. KREIDLER: Great. We appreciate it.

Do you have any information or reasons to believe that Y-1 tobacco has any other properties besides a high nicotine level that would make it desirable or useful as to cigarette manufacturers?

DR. KESSLER: Congressman, you have a chart on the characteristics of Y-1. As I read the English translation of the Portuguese patent, and these are some of the characteristics in Y-1, that patent stresses that the significant aspect of Y-1 is, in fact, its high nicotine content and the ability to grow that plant agronomically. That is the major characteristic of Y-1.

The other issue with regard to Y-1 -- and I had to learn some plant breeding, Congressman, as we were in this investigation -- was I had to learn about cytoplasmic male sterility, which is one of the things that DNA Plant Technology was asked to do for Y-1.

You undertake cytoplasmic male sterility for a number of reasons, but as we understand it, CMS, as it's called is undertaken when you have a seed value, for example, that you don't want others to be able to -- if I just hand you seeds and you can go and propagate it, but if, in fact, the seed is male sterile, then you can't grow further generations without my giving you a form of protection -- of commercial protection.

It's probably as good as a patent, or it may, in fact, be better than a patent.

The other characteristic of Y-1 was, in fact, the pollen-free Y-1 that is stated and talked about in the patent.

MR. KREIDLER: Thank you very much, Dr. Kessler. I wish you well in your endeavors.

Thank you, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Kreidler.

Mr. McMillan.

MR. McMILLAN: Thank you, Mr. Chairman.

I don't think that it does much good to go back and retroactively browbeat people for this or that, what they knew, when they knew it. I think that most of us in our lifetime have been aware of the potentially harmful effects of smoking, drinking, abusing alcohol or tobacco or other products, for that matter, and we certainly know a lot more about tobacco today than we did when I was a kid.

I don't know that we know much more about alcohol. We certainly don't focus on it to the degree that we're focusing on tobacco here today. I think that's an important thing for us to focus on.

Dr. Kessler, you've talked about the regulation of alcohol as if that was some paradigm that we should follow with respect to tobacco. What is it that we do regulate about alcohol, and do you have anything to do with it?

DR. KESSLER: Yes, we do. We share that regulation with BATF.

MR. McMILLAN: What specifically is it?

DR. KESSLER: What we deal with is both adulteration and misbranding. There are both of those provisions. We deal with adulteration of alcohol. We also deal --

MR. McMILLAN: Would you explain that, please?

DR. KESSLER: Any additives or any compounds that are added that could present --

MR. McMILLAN: Isn't most alcohol -- it's not pure alcohol --

DR. KESSLER: But what we did was --

MR. McMILLAN: -- anymore than a cigarette is pure nicotine. It includes a number of ingredients and a lot of different products that include alcohol.

DR. KESSLER: We regulate the adulteration of alcohol compounds that may render the product adulterated.

We also, in our agreement with BATF, alcohol, I believe it's below 7 percent, we regulate the labeling; they regulate the labeling.

MR. McMILLAN: Would you say that most alcohol products, or many of them manipulate the alcohol content in that final product?

DR. KESSLER: There are some alcohol-fortified wines, for example, Congressman, that have been of concern to a number of --

MR. McMILLAN: What is the natural alcohol content of a malt whiskey?

DR. KESSLER: Congressman, I'd be happy to supply that for the record. I don't have that --

MR. McMILLAN: I mean, is the natural content of alcohol -- isn't that manipulated by the manner in which you distill it in the order that you introduced?

DR. KESSLER: I've talked to our colleagues at BATF about the process, and with the exception of the alcohol fortified wines, they don't view, in fact, the distillation process, as far as adjusting alcohol levels, but I would be happy to supply and look into that questions for you.

MR. McMILLAN: Well, I would submit to you that the general public understands that there's a wide difference in the alcohol content of different products that they have a choice of consuming.

DR. KESSLER: But as I understand it, that is the natural result of the distillation process.

MR. McMILLAN: But over time, these are things that we've manipulated to achieve a desired result, and no one would drink a so-called alcoholic beverage if it didn't have alcohol in it.

DR. KESSLER: Congressman, the issue on manipulating, the cigarette industry has come before you and said they do not manipulate or control nicotine delivery in cigarettes. It --

MR. McMILLAN: No, I don't think they've -- I don't think they've said that exactly.

DR. KESSLER: Again, certainly the record could stand --

MR. McMILLAN: No, you said did not control.

DR. KESSLER: I'm sorry?

MR. McMILLAN: I think they basically said that they do try to control it.

DR. KESSLER: They do try to control --

MR. McMILLAN: That was in response to a question that nicotine content in a cigarette does not exceed what occurs naturally in the product of which it's made -- the blend of which it's made.

DR. KESSLER: Well, it --

MR. McMILLAN: Have you found evidence that they have exceeded in a total blend of a cigarette a nicotine content that is in excess of the constituent products that make it up?

DR. KESSLER: Well, obviously, the sum is going to be the total of what makes it up, Congressman. Your question is how --

MR. McMILLAN: Absolutely. Absolutely.

DR. KESSLER: -- you -- the question is how you -- let me show you some cigarettes over time. Actually, let me show you one variety --

MR. McMILLAN: No, I want you to answer my question. Do you have evidence of a cigarette being produced that has a nicotine content in excess of the constituent blends of tobacco that make it up?

DR. KESSLER: Obviously, your total can't be more the sum of your products, Congressman. Let me show you --

MR. McMILLAN: What standard, then, are you measuring on this, Dr. Kessler?

DR. KESSLER: Let me show you some examples, Congressman.

Could we go to the percent nicotine?

MR. McMILLAN: I can't read your writing. You'll have to --

DR. KESSLER: Well, I would be happy to read it.

MR. McMILLAN: Just zero in on one that you think --

DR. KESSLER: We'll give you a bigger one.

Here, for example, is percent nicotine concentration over time. This is percent nicotine in certain cigarettes over time.

In 1952, Chesterfield was tested in FDA laboratories, and the average nicotine concentration was 1.66 percent.

MR. McMILLAN: Was that a filter tip or a non-filter tip?

DR. KESSLER: I'm sorry?

MR. McMILLAN: Was that a filter tip or a non-filter tip?

DR. KESSLER: I don't know. I'd be happy to go back and submit that report.

MR. McMILLAN: Did it make any difference whether it was a filter tip or a non-filter tip?

DR. KESSLER: Well, we can discuss that, Congressman. Let me just show you the nicotine concentrations, if I may.

In 1952, Chesterfields was 1.66; in 1969, a Reference cigarette was 1.56 percent nicotine in the rod. One variety, as I mentioned last time in my testimony in FDA laboratories, of an Ultra Low brand cigarette had 1.98 percent nicotine.

MR. McMILLAN: Okay. What's good or bad?

DR. KESSLER: I'm sorry?

MR. McMILLAN: What is good or bad?

DR. KESSLER: I can't hear you. I apologize.

MR. McMILLAN: What is acceptable? What is good or bad? What does 1.66 mean relative to 1.96?

DR. KESSLER: I think there are two issues that that goes to, Congressman.

That goes to the issue of whether there was control, as you talked about, of nicotine level. If you are going to --

MR. McMILLAN: Well, since you regulate it, is 80 proof bourbon worse than, what, 12 percent alcohol content beer?

DR. KESSLER: The issue, Congressman, is whether there is manipulation and control of that level.

MR. McMILLAN: All these are manipulated. How do the end up with a --

DR. KESSLER: In fact, the issue with alcohol is that alcohol is regulated, in certain instances, as a food and in certain instances as a drug.

MR. McMILLAN: Well, that brings me, I guess, to my final question, because the question here is, I don't think it's whether or not there are health hazards to smoking or drinking, or whether or not, if misuse cannot be habit-forming or addictive, if you will. Clearly, they can and they have very different effects.

Some have enormous behavioral effects. You've tried to allude to the behavioral effects of nicotine as being a tranquilizer. Well, if that's the case, do you think they perhaps diminished the ability of Winston Churchill and Dwight Eisenhower to conduct operations on D-Day?

DR. KESSLER: Congressman --

MR. McMILLAN: They were both heavy smokers.

DR. KESSLER: -- Congressman, those were not my words. Those were words --

MR. McMILLAN: Well --

DR. KESSLER: -- of the tobacco industry --

MR. McMILLAN: -- I think it really --

DR. KESSLER: -- in the comparisons.

MR. McMILLAN: -- it gets down to what it is we are trying to consider here. I think if you think there is some level at which this needs to be addressed, then I think it's up to you to come up with a recommendation and make a proposal, and we've not heard anything specific in that respect.

DR. KESSLER: And we are looking at the question of whether nicotine is a drug for the purposes of the Act. We recognize that is a large question, has enormous societal consequences, and, as we look at that question, we wanted guidance from the Congress.

MR. McMILLAN: What are you going to do, arrive at some point at which nicotine becomes addictive and draw a line at that point? Are you going to try to regulate the number of units of a product one consumes in a day?

You say we regulate alcohol. We don't regulate the amount that one consumes unless we do it through driving under the influence legislation.

DR. KESSLER: Could you raise the old back-up chart on nicotine and alcohol, please. It's Chart N, please.

MR. McMILLAN: Well, forgetting the chart for a minute, what do you anticipate you will come back to us with in the form of a recommendation?

DR. KESSLER: Congressman, I will be happy to answer that in a second, let me just finish, for just two seconds.

There is a vast difference in the percent of people who use alcohol. You can use alcohol and only 8, 15 percent end up -- the estimates are -- that are addicted.

74 to 90 percent of people who use cigarettes end up addicted.

You can use alcohol --

MR. McMILLAN: Okay. But there has to be a reason why we have a concern about addiction. It's been said to me by plaintiffs' attorneys, for example, that perhaps as many as 90 percent of those incarcerated, in jail, today, because of a crime are there because of a crime related to drugs or alcohol.

DR. KESSLER: Congressman, you --

MR. McMILLAN: Would you include cigarettes in that category?

DR. KESSLER: Congressman, you are correct. Our focus, and the focus I think of this committee is not the fact that cigarettes are simply addictive. The problem is that cigarettes are addictive and they kill people.

MR. WAXMAN: Mr. McMillan --

MR. McMILLAN: So does alcohol.

DR. KESSLER: Not when used in moderation.

MR. WAXMAN: Mr. McMillan, your time is expired.

Before recognizing Mr. Hastert, I want to point out for the record that the tobacco industry has made public statements that they do not manipulate the nicotine levels. They have made those statements. They have tried to be very careful when they've testified under oath. They've tried to say specifically they don't spike the levels, but there have been public statements that they don't manipulate the levels, they don't control the levels, and I just want you to know that that is a reality, that you indicated they didn't make those statements, but they have.

MR. McMILLAN: Well, if I may respond, Mr. Chairman.

MR. WAXMAN: Yes.

MR. McMILLAN: I think it depends on your definition of manipulation. In any product that you make in which you have control over contents, you can charge as manipulated.

I think the important thing is to go back for the record and hear what they said in response to my question that said: Do you know of any cigarette maker who has produced a product in which the end product contains a higher nicotine content than the constituent tobacco that was put into the cigarette. And they all said no.

So I think --

MR. WAXMAN: I will be pleased to furnish you a transcript of a statement made by Brenda Dawson on behalf of the tobacco industry on Face The Nation, where she explicitly stated: They do not manipulate in any way the levels of nicotine, and nicotine --

MR. McMILLAN: Well, we'll have to discuss.

MR. WAXMAN: -- levels follow tar.

MR. McMILLAN: They said in here that they work at nicotine content to try to hit a standard target and in no case did it exceed the natural percentage of the constituent product, and I would let that stand.

MR. WAXMAN: Well, I guess the point is that they do control it, and the question is for what reason they control it.

DR. KESSLER: Mr. Chairman, can I just add one statement. The reason, Congressman McMillan, that control and manipulation, that we've raised that issue, is again, when you look at a definition of a drug, and that is an article except for food, intended to affect the structure and function of the body, the Agency -- I never thought that there would be direct evidence, direct information, that a tobacco industry intended to affect the structure or function of the body.

We have used the issue of control and manipulation as a surrogate, as one of the elements, perhaps of intent. I think the documents that I have referred to in my testimony, that this Committee has worked very hard to make sure that the American public -- the documents and is part of this investigation -- those documents may be relevant directly to the question of intent.

When I see a statement that is reported from a general counsel of a major American tobacco company, that says, we are then in the business of selling an addictive drug, that statement may go directly to the issue of intent. We may need not be focused on control and manipulation.

I would ask, Congressman McMillan, Mr. Chairman, that those documents, as well as any other documents, regarding nicotine, its physiological properties, its pharmacological properties, control, manipulation, or drug-like effects, or research on nicotine, be made available to this Agency so that we can thoughtfully and analytically determine whether, in fact, nicotine is an article that is intended to affect the structure and function of the body.

MR. WAXMAN: Thank you, Dr. --

MR. McMILLAN: Would you also recommend that the Committee have access to all documents of your Agency with respect to this issue?

DR. KESSLER: Congressman, I have --

MR. WAXMAN: Mr. McMillan, I really don't think it's important what Dr. Kessler recommends for this Committee -- for the subcommittee --

MR. McMILLAN: I thought that's why he was here. I thought that's why he was here.

MR. WAXMAN: -- and what documents we think are appropriate, are documents we are going to pursue.

It's Mr. Bilirakis' turn, and I want to recognize him.

MR. McMILLAN: Well, I would want, with the privilege of the chair asking them, as consent that the documents of the Agency be made available to this Committee.

MR. WAXMAN: We will give a unanimous consent and agreement to documents that are furnished us by the FDA, and we'll make them part of the record.

MR. McMILLAN: I thank you, Mr. Chairman.

MR. WAXMAN: Mr. Bilirakis.

MR. BILIRAKIS: Thank you, Mr. Chairman.

That was going to really be my first request. You've talked about your investigation, Dr. Kessler. And I wonder if you wouldn't, please, provide this Committee, for the record, all of the memoranda prepared by your investigators on their interviews, and any memoranda or draft memoranda, and the possible details and implications of potential FDA regulation of tobacco products.

I have a number of those types of questions, and I'm going to read them into the record and ask you and the FDA to respond. You'll let me know whether two weeks is too short a period of time --

DR. KESSLER: Mr. Bilirakis, I would be very happy to work with the chairman so that the chairman, or the chairman's designee, can verify that I have quoted from any document accurately and completely.

MR. BILIRAKIS: Dr. Kessler, frankly, I -- you know, over the years you have testified before this Committee, and I have been very impressed with you.

Now, you say you are going to work with the chairman. Well, that's fine. We all like to work with the chairman, believe it or not. But if you've got any memoranda prepared by your investigators or their interviews, and any memoranda or any draft memoranda on the possible details and implications of potential FDA regulation of tobacco products, then I am asking you to furnish them to the committee for the record, so that we can all look at them. Not just the chairman, but all of us. Okay, sir?

DR. KESSLER: Congressman, I need, respectfully -- and I appreciate your comments -- but I need to respectfully make it clear to this committee that those -- if we were in a situation where I could walk in and get information --

MR. BILIRAKIS: No. I --

DR. KESSLER: -- one second, please -- if I can get information freely and fully and have full cooperation and I don't have to be reading about Brazilian patents, if I can get information on all documents walking in through the front door of any major American tobacco company, then I would have no problem making available our records to you.

We have had to rely, unfortunately, on sources and confidential information.

Mr. Chairman, I am willing to allow the chair to verify the authenticity of anything I've said. But I am not willing -- I am not willing -- to make any available any document, or any memo, or any information that could possibly jeopardize a confidential source.

MR. BILIRAKIS: I'm talking about, I believe -- I'm talking about memoranda within your Agency as one staff member to another or memoranda to you, regarding this entire issue, Dr. Kessler. I mean, is that unreasonable? I don't understand. I would have thought you --

DR. KESSLER: Again, we deal with document requests all the time, but I just need to underscore that when one has information from confidential sources, again, those confidential sources, as you could understand, need to be assured of their confidentiality, as well as I follow the same general rule of --

MR. BILIRAKIS: There is information that you have received from confidential sources that you have not made charts of and that you have not shared with this Committee?

MR. WAXMAN: Will the gentleman yield?

DR. KESSLER: Congressman --

MR. BILIRAKIS: I don't understand, Mr. Chairman.

MR. WAXMAN: Let me pose it this way.

MR. BILIRAKIS: All right.

MR. WAXMAN: And it's not uncommon for us to get documents from the Executive Branch, but if there is any confidentiality information on it to have that part deleted. But you want memorandum within the Agency, and I think it's appropriate to get memorandum, so long as we don't infringe on any confidentiality.

Is that acceptable to you, Dr. Kessler?

DR. KESSLER: I cannot put any sources -- any confidential sources -- at risk, and I'm sure you would understand that.

Furthermore, I am -- and, again, I would be happy to work with the chair --

MR. BILIRAKIS: No, sir. Forgive me. As I said before, we're all happy to work with the chair, but I'm sure the chair would be the first one to tell you that this is a subcommittee hearing, and we are all members of this subcommittee, and you're talking about working with the chair, and I don't think the chair would ever hide from the rest of us any information that they have.

The chair would make that available, so you're sharing information with the entire subcommittee, Dr. Kessler.

DR. KESSLER: Congressman, any process --

MR. BILIRAKIS: I didn't think this was a combative type of a thing that I'm asking for.

DR. KESSLER: Congressman, any documents that you are entitled to, I would be happy to provide that. We would be happy to work with you on that.

I am not prepared to release documents that could, one, jeopardize any further investigation, because yes, Congressman, there is information that we have that we have not yet presented, that we are still investigating.

Two: There is information that could jeopardize sources.

Three: I think that I tried to follow a rule here in today's testimony, and I would hope you would appreciate it. That,

(1) Unless the name of a company was in a public document or that documents was a public document, then I did not mention that company by name.

MR. BILIRAKIS: I noticed that.

DR. KESSLER: And I tried to stay away from that, just as I did last time.

MR. BILIRAKIS: In your continuing investigations, are you telling us that there is -- Mr. Chairman, you know, I'm trying -- you know, you've never known me to be militant, but I'm trying to understand here.

Are you saying that there is information that would basically be in conflict with this your charts and some of the things you just said here today --

DR. KESSLER: No, I am not.

MR. BILIRAKIS: -- which you have not shared with this committee?

DR. KESSLER: I'm saying there is additional information, that we are still in the process of investigation.

We have an established procedure for handling requests for members of Congress, and we will use that process to consider any request.

MR. BILIRAKIS: Well, in other words, we are talking about, this is a subjective thing on your part, in terms of you will decide what documents you think are in order for this Committee?

MR. WAXMAN: Will the gentleman yield?

DR. KESSLER: We have an --

MR. WAXMAN: I think what Dr. Kessler is saying is that there are cases where documents are submitted voluntarily and in a cooperative way by the companies or anybody within his jurisdiction, and that will be made available.

But if there is information being furnished to him by a whistle blower or a confidential source, neither you nor I would expect them to give that information, of information submitted by a company with the expectation that the information be kept confidential. He has to respect that.

That means that he has to respect that with regard to you, and to me and to other members of Congress.

MR. BILIRAKIS: There is not distinction here between majority or minority; is that correct?

DR. KESSLER: I am willing, Congressman, to follow established procedures.

MR. BILIRAKIS: Established procedures. Now, those are the things that bother me, Mr. Chairman. I mean, words like established procedures.

Would you, in the process of furnishing information to us, make it known to us without divulging this, quote, confidential information that you apparently are going to be subjectively the determining factor in?

What information you are not furnishing to us -- and I don't want that to come across the wrong way -- but what I am trying to say is I am not going to -- without divulging the specific information, I would like to know and I think this Committee should know, that there is information regarding a particular subject that you are not divulging because you have subjectively determined that it is confidential and it's not in order for the majority or the minority of this committee. Can you do that?

DR. KESSLER: Congressman --

MR. BILIRAKIS: Can you add that to this submittal?

DR. KESSLER: No. Congressman, what I am prepared to do is that anything that I have brought before this Committee, you should be subject to make sure that I have quoted properly.

I am not prepared, at this point, to make those investigative files that could jeopardize either an investigation or jeopardize certain confidential informants.

That's why we have, Congressman, established procedures, and I am willing to follow those established procedures.

MR. BILIRAKIS: Do we know what those established procedures might be?

DR. KESSLER: Congressman, we've worked with this Committee for a long time, and I would be happy to have staff go over exactly the established procedures of what documents.

MR. WAXMAN: Will the gentleman -- MR. BILIRAKIS: Do you have at your fingertips what these established -- yes, sir?

MR. WAXMAN: Will the gentleman yield.

MR. BILIRAKIS: All my time is being taken up, Mr. Chairman, and I haven't intended that. But, yes, sir, I will be glad to yield, obviously.

MR. WAXMAN: All right. I do want you to understand that we want to work with you and make available information to you consistent with detecting confidential information. I think that is what Dr. Kessler is saying. Oftentimes, that is just a matter that has to be protected --

MR. BILIRAKIS: Well --

MR. WAXMAN: -- and certainly you would see it that way as well.

MR. BILIRAKIS: Yes. But, Mr. Chairman, this is the first time -- I'm flabbergasted -- and I've learned a lot in this hearing so far.

MR. WAXMAN: I'm glad to hear that.

MR. BILIRAKIS: Well, that's what a hearing is all about, I think. We should be coming in as open-minded as we possibly can be. Unfortunately, that isn't always the case.

But this is the first time that I've heard anything about confidential sources or anything of that nature. I'm just flabbergasted.

MR. WAXMAN: Well, where have you been?

MR. BILIRAKIS: Dr. Kessler --

MR. WAXMAN: You don't think that the people come in with information that they don't want given to the tobacco company or some other group that's being investigated? Or don't you think that people come forward when they know they're going to be respected and their confidentiality?

Don't you think industries will say to us, very frequently, we want to help you with your investigation, but we don't want this information out because we don't want our competitors to know this information?

MR. BILIRAKIS: Mr. Chairman, we've held executive sessions, I think, in a number of cases --

MR. WAXMAN: We'll be happy to.

MR. BILIRAKIS: -- to maybe get some of that confidential information that is no available to the general public, but is made available to the majority and to the minority, and to obviously the chairman.

DR. KESSLER: Congressman, I think we can certainly -- I think if we shift into a mode, and I would like to suggest that we shift into a mode, whereby we can get all relevant documents directly from the tobacco companies, then there is no issue here.

Why don't we shift into that mode so that the Agency has access to these documents -- to any documents?

MR. BILIRAKIS: Doctor, that isn't really my question. I don't know that it has anything to do with what my request is.

DR. KESSLER: Congressman, it does, because when you're in an investigative mode, as you know, and people are not going to give you information directly -- and we will move into that mode, and we will move into that mode today where we will start asking for documents directly from the tobacco industry -- so that we don't have to have this, and it'll be much easier.

But, honestly, you have to understand that when you conduct an investigation and the investigation, the people who have control over that investigation, are not sharing that information freely with you, then you rely on certain established investigational techniques.

MR. BILIRAKIS: But, Doctor --

DR. KESSLER: And people end up, who cooperate with an investigation, are scared.

MR. BILIRAKIS: But, Doctor, you're --

MR. WAXMAN: Mr. Bilirakis, your time has expired.

MR. BILIRAKIS: Well, God knows it has expired. I know that, Mr. Chairman. And I --

MR. GREENWOOD: Would the gentleman be glad to yield to me, please.

MR. BILIRAKIS: Well, I'm not sure, that my chairman has told me that my time has expired.

MR. WAXMAN: Let me --

MR. BILIRAKIS: I've already had two requests for yielding.

MR. WAXMAN: Mr. Greenwood, it's Mr. Hastert's time. Mr. Greenwood, did you --

MR. BILIRAKIS: Mr. Chairman, forgive me. I have a number of questions that I wanted to ask the gentleman.

MR. WAXMAN: Well, we'll have a second round.

MR. BILIRAKIS: I got stuck on the first one.

MR. WAXMAN: We'll have a second round if you want to stay around.

MR. BILIRAKIS: Well, I'm going to ask unanimous consent that all of these questions be given to the gentleman and that he has a period of two weeks, and if he feels that two weeks is not adequate, he can advise this Committee, to furnish the answers to these questions to the Committee -- not just to the chairman but to the committee.

I would like to put these questions into the record orally and, if I can, hang around for the second term -- for the second term -- for the second round, I will. But just in case, I don't, I want these put in the record, and ask unanimous consent, Mr. Chairman.

MR. WAXMAN: I will put it this way to the members of the subcommittee. We'll ask unanimous consent that all members have an opportunity to submit questions in writing to Dr. Kessler, and that he respond in writing, for the record.

MR. BILIRAKIS: But within what period of time, Mr. Chairman? I don't think this should be open-ended.

MR. WAXMAN: Well, I --

MR. BILIRAKIS: You know, we're going to be called upon to make decisions on some of these things --

MR. WAXMAN: Let's --

MR. BILIRAKIS: -- and we should have all of these answers available.

MR. WAXMAN: Two weeks seems like a reasonable time.

MR. BILIRAKIS: All right.

MR. WAXMAN: Without objection, that will be the order.

MR. BILIRAKIS: Thank you, Mr. Chairman. I can't really yield, because I --

MR. GREENWOOD: Mr. Chairman, may I ask unanimous consent to pose one question to the chairman about the process.

MR. WAXMAN: Any objection?

[No response.]

MR. WAXMAN: If not, Mr. Greenwood.

MR. GREENWOOD: Thank you.

As a new member of this Committee, this is sort of interesting to me, because I'm not familiar with what these policies are. If the members of this Committee knew that Dr. Kessler and his Agency were in possession of all of the documents that he has revealed to us about Y-1 today, if we knew that he were in possession of those documents, and we wanted them as part of our study here, and he refused to yield them to us because of his need to protect confidentiality, what would the chair and the members of this Committee do in an instance like that?

What are our procedures? Would we subpoena those records?

MR. WAXMAN: Dr. Kessler?

DR. KESSLER: Congressman --

MR. GREENWOOD: My question is to the chair.

MR. WAXMAN: Well, there are evidently procedures --

DR. KESSLER: Mr. Greenwood, the information -- I can furnish you the information on Y-1. We have a --

MR. GREENWOOD: No, I know that you can do that. My question is whether we need to --

DR. KESSLER: You can have the Brazilian patients and the translation. We have asked the patent office and received the patient application.

MR. GREENWOOD: That's not my question. My question has to do with the access of members of this Committee to documents that you have. I want to make sure that we are not selectively assuring that the documents that are useful arrive at the Committee, and the documents that may not be useful don't arrive at the Committee because we don't have a consistent policy.

I need to know, as a new member of this Committee, what is the policy that determines which documents we want, that we get?

MR. WAXMAN: Mr. Greenwood, if there are documents that we are requesting as a Subcommittee that are not given to us, we'll have the option of subpoenaing those documents. I think that is something that the members of the Subcommittee need to talk through, because there are times when confidentiality ought to be respected, and there are times when the Committee just should know, because it's our right to know.

Let me use as an example not something this theoretical. Brown & Williamson, in May of this year, told Dr. Kessler and his people that there was no feasible way to develop a genetically-altered kind of tobacco that increases the nicotine level.

Through Dr. Kessler's investigation, he found out that wasn't true, that he was being misled by Brown & Williamson. And then, finally, Brown & Williamson, once the information was laid out to them, admitted it, as of last Friday, in anticipation, I presume, of Dr. Kessler coming before us.

Would any member of this panel want Dr. Kessler to not be able to get that information because he couldn't protect the confidentiality of sources?

I would hope nobody in this Committee would want that result.

MR. GREENWOOD: Would the chair yield on that point?

MR. WAXMAN: Yes.

MR. GREENWOOD: What is the difference between Dr. Kessler protecting the confidentiality of sources and then several weeks ago we were having a hearing that was based on information that was illegally obtained by someone who had a relationship with one of the subjects of the discussion, which was clearly a violation of confidentiality, it seems to me? What is the consistency there?

MR. WAXMAN: We have not had a hearing on anything along those lines, and --

MR. GREENWOOD: There's a lot of information delivered in testimony that was illegally obtained.

MR. WAXMAN: I'm sorry. The gentleman is not correct. That is not an accurate statement.

It is Mr. Hastert's opportunity to ask questions. I want to recognize him at this time.

MR. HASTERT: I thank the gentleman, the Chairman.

Dr. Kessler, I've listened to this, and I'm kind of surreal here. Are you saying that you think that members of Congress, this Subcommittee, the whole Committee, have to make intelligent decisions, right?

But you're going to give us, or spoon-feed us only that information that you want to spoon feed us, that you're not going to give us all the information that is available to you, and you come up with decisions and pre-determine what things ought to be, and maybe you've shared some of that with the chairman because you have some type of operation or methods of operation here, but you don't think we should have that information because you don't trust us?

That's contempt. I think that's contempt of Congress, sir.

DR. KESSLER: Congressman, there are established procedures, and we will follow those established procedures.

MR. HASTERT: Well, what are those? Tell me what those established procedures are.

DR. KESSLER: I would be happy --

MR. HASTERT: Tell me them, right now. Here's members of Congress. What are the established procedures?

DR. KESSLER: We have --

MR. HASTERT: Tell me! What are they? What are the established procedures?

DR. KESSLER: Congressman --

MR. HASTERT: You're telling mumbo-jumble.

DR. KESSLER: Congress --

MR. HASTERT: Tell me what the established procedures are.

DR. KESSLER: Congressman, we are engaged in an investigation, we are --

MR. HASTERT: No, no, no. Wait a minute.

DR. KESSLER: Congressman --

MR. HASTERT: Don't -- don't go around.

DR. KESSLER: Congressman -- Congressman, I --

MR. HASTERT: You tell me what those established procedures are, or I think you're in contempt of Congress.

DR. KESSLER: Congressman --

MR. HASTERT: You said there's established procedures.

DR. KESSLER: Congressman --

MR. HASTERT: We should know what those established procedures are. What are they?

DR. KESSLER: I would be happy to have people go through --

MR. HASTERT: Tell me!

DR. KESSLER: -- the established --

MR. HASTERT: Here --

DR. KESSLER: -- procedures.

MR. HASTERT: -- here we are. Tell us.

No. You, sir. Your established procedures, what are they?

DR. KESSLER: Congressman, I am very good people at the Agency who are trained professionals and know those procedures. If you would like to know the procedures, I rely on them. If you would like to hear the procedures --

MR. HASTERT: Do you know what those procedures are?

DR. KESSLER: We have people --

MR. HASTERT: You can't tell us what those procedures are?

DR. KESSLER: Congressman, if you would like to know --

MR. HASTERT: You can't tell us what those procedures are?

MR. WAXMAN: The gentleman --

MR. HASTERT: I think you're in contempt.

MR. WAXMAN: The gentleman is a member of Congress. Do you know the procedures?

MR. HASTERT: I'm -- that's why I'm asking. We're evidently in the dark. We don't know what those procedures are --

MR. WAXMAN: Then perhaps --

MR. HASTERT: -- and the gentleman is not willing to tell us what they are.

MR. WAXMAN: Well, I think you give him a chance to answer it, and we'll find out.

Dr. Kessler.

While he's looking it up, if the gentleman will yield to me.

MR. HASTERT: Sure. Be happy to yield, Mr. Chairman.

MR. WAXMAN: You seem agitated about it.

[Laughter]

MR. HASTERT: Well, I'm sitting here, sir -- if you would yield back --

DR. KESSLER: Congressman, let me read a letter --

MR. HASTERT: Yes.

DR. KESSLER: -- dated June 20th, 1994.

MR. HASTERT: Fine.

DR. KESSLER: "Dear Mr. Chairman: This letter is in response to your request that I appear before the Health and Environment Subcommittee to testify regarding the Food and Drug Administration's ongoing investigation of nicotine containing cigarettes. I am pleased to have the opportunity to appear again before the Subcommittee on this subject.

"Since my testimony will relate to an ongoing investigation, I feel it necessary to apprise the Subcommittee of the limits that I must impose on the scope of my testimony. As I am sure you can understand, I am not in a position to disclose the names of confidential sources or any information, in my judgment, that could lead to the identification of those sources.

"I believe that this limitation is essential to protect the integrity of the Agency's prophecies and its ability to effectively investigate important public health issues. Moreover, this is consistent with past Agency practice whenever we have been called upon to discuss matters under investigation in a public forum.

"I appreciate your sensitivity to the importance of preserving the Agency's responsibilities regarding investigations. We stand prepared to continue to work with you in your deliberations on this issue."

MR. HASTERT: Well, thank you, and thank you for reading. Now those are your standards of procedures? Is that correct, sir?

DR. KESSLER: That is the letter dated on that date --

MR. HASTERT: Those are the standards --

DR. KESSLER: -- yes.

MR. HASTERT: -- of procedures you're referring to, then?

DR. KESSLER: That's correct.

MR. HASTERT: That's complete, everything?

DR. KESSLER: No. That -- I mean, I'm not making that assertion.

MR. HASTERT: Oh.

DR. KESSLER: There are a lot of established procedures, and I would be happy to have other people. Those are the ones --

MR. HASTERT: Would you agree, then, that members of Congress, all members of Congress, they have to make votes on this, and they ought to know what the information is, not just the information that you are willing to give us, but all what the information is.

I mean, how do we make intelligent votes if we don't have hearings and get information?

DR. KESSLER: Congressman, I have no problem with the process that determines the veracity and the quotes that I am saying are appropriate. I think you have every right --

MR. HASTERT: Because, really, if you --

DR. KESSLER: -- and I would --

MR. HASTERT: -- withhold information --

DR. KESSLER: -- like to assure that what I am saying, that those quotes that I have quoted accurately. I cannot -- please, understand -- I don't want to get in a back and forth with you.

I respect your need to know and have information, but please, understand, when you go into the front door and you're told one thing, and that, in the end -- again, I don't want to characterize that statement that was said to us -- but when you go in the front door and you're led to believe certain things, and other things you rely on, and our professionals, we rely on certain investigative tools. And there's a balance, sir. Every --

MR. HASTERT: And just tell me -- and let me tell you what my balance is, and the reason -- I guess I was a little bit upset there -- but when a member, who works for the federal government, who works for the taxpayers, such as you do, and is there with some responsibilities to Congress and members of -- and oversight that Congress has, to tell us, well, we can't give you this information to make decisions on, to me, that's --

DR. KESSLER: Congressman --

MR. HASTERT: -- contempt of --

DR. KESSLER: -- I am very --

MR. HASTERT: -- members of Congress.

DR. KESSLER: -- willing to work, to make sure that you can check the quotes that I said are accurate.

MR. HASTERT: And will you give us the rest of those procedures, so we know what those procedures are?

DR. KESSLER: We would be happy to share those, Congressman. MR. BILIRAKIS: Gentlemen, let me follow up.

MR. GREENWOOD: Will the gentleman yield for 15 seconds?

MR. : Let me just follow up.

What will you do, then -- you know, if you get jurisdiction over the tobacco industry and nicotine is a narcotic and viewed as a narcotic, what's your view? Would you want to regulate that, or do away with that industry, or what is your long-term view? What is your goal here?

DR. KESSLER: Congressman, I think that that obviously is a key question. We are very much, and we have been very much, in an investigative mode, and we continue in that mode. I think we are shifting somewhat.

There are some scientific questions that I think I raised with Congressman Greenwood.

What is the level of nicotine in cigarettes that would create and sustain an addiction? I don't know exactly what that level is. We want to ask our scientists what that -- what that --

MR. BILIRAKIS: Would the gentleman yield at this point?

MR. : I'll yield to the gentleman.

MR. BILIRAKIS: Doctor, you're still continuing an investigation. What is the source of that chart, percent estimate of all users who are addicted? I don't see a source on there.

DR. KESSLER: We will be happy to provide the footnote for it.

MR. BILIRAKIS: But you have come to a conclusion, sir. You have come to a conclusion. You have said to this subcommittee -- look, I've never smoked in my life; I don't have any idea how in the world this smoke, or whatever it is, affects an individual, or anything of that nature. I'm trying to learn it as much as I can.

I don't know whether you've ever smoked. Have you ever smoked?

DR. KESSLER: I smoked a pipe for a little bit.

MR. BILIRAKIS: Okay. But, anyhow, you have come to a conclusion. You've shown this chart to us -- percent estimate of all users who are addicted.

DR. KESSLER: Right.

MR. BILIRAKIS: And, yet, you don't have a source.

DR. KESSLER: We'd be happy to provide it.

MR. BILIRAKIS: You'd be happy to provide that source.

DR. KESSLER: We'd be happy to provide it. You can see my last testimony, I think, had in excess of 70 footnotes. I mean, there's --

MR. BILIRAKIS: Oh, yes. There's a long list of them, sir.

DR. KESSLER: -- there's no shortage of footnotes.

MR. BILIRAKIS: Well --

DR. KESSLER: I can assure that that kind of information is from the scientists --

MR. BILIRAKIS: David, if I may call you by your first name --

DR. KESSLER: Sure, Congressman. Absolutely.

MR. BILIRAKIS: You've appeared before this Committee so many times --

DR. KESSLER: Absolutely.

MR. BILIRAKIS: -- and we've talked to you, personally, one on one.

Your testimony is tempered by the virtue of the fact that you've come in here with testimony which would indicate completely one way, in so far as this issue is concerned. You haven't come in with any testimony the other way -- whether it be 90 percent here, and 10 percent here, anything of that nature -- it's all 100 percent. And, yet, you say you can't give us information, and yet you say the information is continuing.

You've come to conclusions which would indicate a completed investigation, and yet you say the investigation is continuing.

DR. KESSLER: Congressman --

MR. BILIRAKIS: And maybe that's not your fault, because you've been called in here to testify, but you certainly haven't made it clear, I don't think, that these are conclusions.

DR. KESSLER: Let me make it clear, if I can, Congressman, so that we can clear up the confusion where I think there are conclusions that have been reached and where there are not conclusions that have been reached.

On scientific conclusions, things that are in the medical literature, for example, the issue of whether nicotine is addictive, when you have every medical organization saying it is addictive, yes, I think that you have a consensus and you have a conclusion that nicotine is addictive.

The question that is not, for which we do not have a conclusion today, but which is before the Agency, is whether nicotine is -- you look at the definition of a drug: An article intended to affect the structure and function -- you have it, Congressman -- whether that definition, whether nicotine-containing cigarettes, meet the definition.

That is an issue for which there is no conclusion as I set here before you today, and one for which we are asking your guidance.

MR. : Will the gentleman and Mr. Hastert yield to me briefly?

MR. HASTERT: I'll yield to the gentleman.

MR. : Dr. Kessler, will you provide the minority members of this committee all of the documents that you have provided to the chairman and his staff, or other majority members of this Committee, with regard to this investigation?

DR. KESSLER: We certainly will treat absolutely both sides equally.

MR. : I am asking you very specifically. I am asking you to supply me a copy of every document that you have supplied the chairman with regard to this investigation. Will you do that today?

DR. KESSLER: I have no problem supplying documents fairly across the board. I think that's absolutely essential.

I would ask the Committee and the chair that if you want to verify something in --

MR. : I'm asking you a very specific question.

DR. KESSLER: And the answer to that question, we will --

MR. : There's nothing tricky about this question.

DR. KESSLER: Absolutely. We will treat --

MR. : I would like -- listen -- I would like you to supply to my office, within the next 48 hours, a copy of every document that you have supplied to the chairman and his staff with regard to this investigation.

DR. KESSLER: Absolutely.

MR. : This is not a trick question. Thank you.

MR. WAXMAN: The gentleman's time is expired.

Let me assure all of the members of this subcommittee, I didn't get any documents that you didn't also get. Whatever I have gotten, as chairman of the Subcommittee, the members have had it available to them.

Secondly -- secondly -- I just am somewhat amazed of the attitude of members here. I don't want information that's confidential from Dr. Kessler.

I don't want to hurt -- I don't want to hurt the whistle-blowers in coming to him and getting information and getting the facts out, and I would hope that members of the Subcommittee would feel the very same way, that we want to get the facts, and we want to get them on the record, and we want to get them in a way that will enable people to feel that they can come forward, sometimes taking a risk, and talk to Dr. Kessler, or any other agency of the government, in confidence.

If they talk to Dr. Kessler in confidence, he's going to respect that, vis-a-vis all of the members of this subcommittee.

MR. : If the chairman will allow, the problem is that our staff has told us that they have not been able to obtain information from Dr. Kessler's people that your people has been able to.

MR. WAXMAN: Well, I think --

MR. : Now, if our staff is --

MR. WAXMAN: -- your staff is misrepresenting to you the reality of the situation. We did not get Dr. Kessler's testimony until late yesterday. As soon as we got it, we gave them --

MR. : We're not talking about testimony, we're talking about --

MR. WAXMAN: Well, in terms of any documents -- any documents I have received, your staff has received them, or the minority side, other members have received as well.

MR. BILIRAKIS: Mr. Chairman, would you yield a moment?

Dr. Kessler -- You haven't said whether you would yield, but I will continue.

MR. WAXMAN: Well, you know, I'm not going to yield, because I want my second round, and then I'm going to go around and others can jump in and say what they have to say.

MR. BILIRAKIS: Well, I know, but, sir, to --

MR. WAXMAN: Well, look, I'm going to --

MR. BILIRAKIS: -- as to the statement you've just made --

MR. WAXMAN: Okay. I'm going to yield.

MR. BILIRAKIS: -- Dr. Kessler has emphasized that he would furnish the chairman with information. He's emphasized that. He's said it more than once. So, you know, I think that any reasonable person can conclude some information maybe has been furnished to the chairman that hasn't been furnished to others --

MR. WAXMAN: Well, that --

MR. BILIRAKIS: -- and some will continue to be.

MR. WAXMAN: He has said that if there's something of sensitive nature, he is willing to talk to members of the Committee, to verify a statement that he has made, and why he has come to that conclusion, but he does not want to submit documents -- is this a correct statement, Dr. Kessler? --

DR. KESSLER: That's correct.

MR. WAXMAN: -- to you or to us or to the Committee that would violate confidential information given him.

MR. BILIRAKIS: In the process of the Committee working with him to determine the merit of the comments, does that include the minority?

MR. WAXMAN: As to whether it's confidential or not?

MR. BILIRAKIS: Yes.

MR. WAXMAN: Well, I think we ought to work together and we ought to work with Dr. Kessler on that.

MR. BILIRAKIS: Well, I certainly think so.

DR. KESSLER: Mr. Chairman --

MR. BILIRAKIS: Absolutely.

DR. KESSLER: -- can I just --

MR. WAXMAN: Yes.

DR. KESSLER: -- so the record is complete.

Yesterday, I think we briefed both the minority and the majority yesterday afternoon. In fact, as I was told this morning, the minority actually may have asked more questions and has more information before this hearing than the majority, in fact, in those briefings.

So we briefed it at the same time, and we did not share documents with either side yesterday in those briefings.

MR. McMILLAN: Mr. Chairman, if you would yield just for one comment?

MR. WAXMAN: Yes, Mr. McMillan.

MR. McMILLAN: I think what we're concerned with here, there's been a pattern on this issue of selective documents being brought to the hearing room without any prior knowledge on the part of anyone else as to what was going to be considered.

MR. WAXMAN: Mr. McMillan, that has not happened. I think if you've been led to believe that, you have been informed incorrectly. There's no --

MR. McMILLAN: I've been sitting here in the room, Mr. Chairman. And all I'm asking is that we have equal access to the same information if we're going to respect confidentiality --

MR. WAXMAN: The gentleman is absolutely -- the gentleman is absolutely correct in what he's requesting, and I think that he ought to have, and has had, equal access to documents that any member of this subcommittee, including the chairman, has received.

Now, if I could, I am going to ask my questions, and then I am going to ask my questions, and then we'll recognize members on a subsequent round.

But I do want to make that point clear. We did not get any documents that the other members of the subcommittee didn't get. As far as briefings, they were given to the Republicans as well as to the Democrats.

But I do want to point out, and I do want to underscore, that what is being missed is that Dr. Kessler has been misled by a company, and then through his investigation found out information that they did mislead -- that they tried to mislead the FDA, and I don't think he ought to be mislead or that we should be misled.

But let me talk about times when people have been misled. The industry has asserted that nicotine is not addictive. They've just made that assertion, even as of a couple months ago when the chief executive officers testified.

The industry has asserted that they don't manipulate nicotine. Well, in fact, they do manipulate nicotine.

Brown & Williamson said that it is not feasible for them to develop a genetically-altered tobacco product that would be higher in nicotine levels, and that assertion was a few months ago, and now we find out that that assertion was incorrect.

The industry has also asserted that we didn't need to know about all of these additives because these additives were only for flavoring, and what we're learning today is that two of the additives were not just for flavoring, they were to give a jolt on the nicotine when the smoker smokes.

So I think that we ought to find out, if we're going to talk about credibility, the credibility of this industry that has attempted to mislead the American people and their representatives, both in the Congress and in the Executive Branch.

Now, Dr. Kessler, there are 599 ingredients added to tobacco. Few people have any idea what most of these ingredients are for. You have now told us that ammonia and substances related to ammonia are applied to reconstituted tobacco for a variety of purposes, including to increase nicotine transfer efficiency.

You also say that ammonia is added directly to the tobacco. Can you describe for us the mechanism by which ammonia would increase the nicotine received by the smoker?

DR. KESSLER: Congressman, I don't want to get into the complexities of acid-based chemistry and vapor chemistry. Let me explain it, as I understand it.

Nicotine in tobacco, in most instances, is in the salt stage. Ammonia, when it gets released into the smoke, according to the information we've learned from the industry, when that ammonia gets in the cigarette smoke, it changes the pH of the smoke, and it changes the nicotine from the salt state to the free state.

That free state has changes on the bioavailability as it gets into the body.

That's a simplified version. I hope I haven't misstated it.

MR. WAXMAN: Do you have information on industrywide practice with respect to the addition of ammonia? Is the addition of ammonia an industrywide practice?

DR. KESSLER: It's on the list. There are a number of different ammonia compounds -- diammonium phosphate, ammonium hydroxide, urea is an ammonia, on the list.

From the documents we've seen, there is, in fact, many companies use ammonia compounds. Only one company document that we have documents that that company is using it specifically for that intended purpose. Until we have access to other documents, Mr. Chairman, I can't tell you how widespread it is.

MR. WAXMAN: We were told by industry representatives that the FTC tests would measure whether there was an increase in nicotine or not. Have you verified whether ammonia added to the cigarette, in some way or other, increases the level of nicotine that comes into the FTC test?

DR. KESSLER: We've had to rely on industry studies. We don't have that capability. I just want one note of caution here, Mr. Chairman.

The FTC measurements, they do measure what the machine measures, but they don't measure what necessarily humans are consuming, and we have seen information that would suggest that there are human smoking measurements as well as machine smoking measurements.

We don't have access to that information, so until I have access to all information and all smoke analyticals from the cigarette industry, I'm just not going to be in a position to answer that question.

MR. WAXMAN: Brown & Williamson, you indicated to us, applied for a patent on this Y plant, or whatever it's called -- Y-1. They've applied for a patent, they seemed to have trouble with it, they were appealing the decision. They were pushing forward to get it. Perhaps we can get that chart up.

DR. KESSLER: I think it's Chart L, Andrew.

That's the chronology, to the best of our knowledge.

MR. WAXMAN: So this is the chronology that you understand it to be, at least at this point.

DR. KESSLER: Yes.

MR. WAXMAN: They filed this Brazilian patent in September '92. In February, they went to appeal, rejection of U.S. patent application. That was in February 1994.

Then less then a month later, March 14th, Brown & Williamson withdrew that application for the Plant Variety Protection Certificate.

Do you know why they withdrew it?

DR. KESSLER: I don't know why they withdrew that application.

MR. WAXMAN: That, coincidentally, was 12 days before you testified before us for the very first time about the issue of whether there was a manipulation of nicotine levels in tobacco.

I'll be interested to know from the Brown & Williamson representative, from Mr. Sandifer, the CEO, next Thursday, if there was any connection between the two.

Then the last question I wanted to ask you was, in this country, we don't control tobacco additives. There's no requirement that the company show that additives are safe or that they even disclose what the additives in cigarettes are for.

Do you have any information about whether other countries control additives in tobacco?

DR. KESSLER: Yes, as part of our reading of what industry practices were. In fact, other companies, like in Germany, we believe restrict the ability of certain additives, have much tighter regulation. In fact, we believe that there be certain other alternatives to certain ammonia compounds, for example, in other countries because they, in fact, do regulate the additives that are added to the tobacco in cigarettes. There's much tighter regulations, Mr. Chairman, in certain other countries.

MR. WAXMAN: Dr. Kessler, you have been asked repeatedly what your recommendations are going to be as to the level of nicotine. If you were to give us a recommendation without developing the record and getting all of the facts, I'm sure members of this Committee would be justifiably jumping all over you, so I think you're doing what you should be doing, what we expect of you:

To develop the record, to establish the facts, and then give us some thoughts on this subject of what the levels ought to be, and of course to criticize you for giving levels or not giving levels, when you don't have the legal authority to set them, or may not have that legal authority, seems to me a very peculiar way to raise this issue.

So, as I understand, you are going to have some conference on nicotine levels?

DR. KESSLER: We will, Mr. Chairman, I assure you. Yes, we are going to have an Advisory Committee meeting this summer, but I assure you that we will proceed thoughtfully and analytically as we address this question.

MR. WAXMAN: Thank you very much.

Mr. McMillan: It's my understanding that this patent application was disapproved; is that right?

DR. KESSLER: The initial application, yes. I think we said that it was rejected, yes.

MR. McMILLAN: And the language, or the reason, for rejection was that it was not remarkable?

DR. KESSLER: I've read the appeal. I have not read all of the patent documents. The issue, I believe, for the patent examiners, when they ran the computer searches, had seen that there were certain crosses made back in the '40s, '50s -- earlier times -- about those crosses.

What Brown & Williamson appealed and what they said was unique in their appeal was the fact that, for the first time, this plant could be agronomically viable, that it can actually be grown.

Other people had done some genetic breeding, but no one, to my knowledge -- according to the company -- this was the first time that anyone was successful in actually being able to grow a plant.

Dr. Chaplin, for example --

MR. McMILLAN: Well, when they turn something down as not remarkable, they meant it really offered nothing significantly new.

DR. KESSLER: Again, I am telling you what was in the patent application and what Brown & Williamson appealed. Brown & Williamson made the case that this was the first time that this plant was successful -- could be successfully grown.

For example, when we talked to Dr. Chaplin, Dr. Chaplin said, yes, there had been crosses, but he couldn't get the plant to actually stand up. I mean, it just didn't grow. It wasn't agronomically feasible.

So the real value, according to the company and Dr. Chaplin of Y-1, was the higher nicotine that can be grown, was agronomically viable, sir.

MR. McMILLAN: Is there anything wrong with experimenting to find out how you could deliver a nicotine product with less tar?

DR. KESSLER: There's nothing wrong with research at all.

MR. McMILLAN: Isn't that, in fact, why the industry, through research, developed filter tipped cigarettes, for example?

DR. KESSLER: The issue, Congressman -- and I think the question is still out, and I've asked experts in the area -- is does low tar, in fact, reduce your health hazard compared to a regular cigarette.

There are different opinions. The evidence is not concrete. There may be something --

MR. McMILLAN: There's a lot of legislation on the assumption that that's the case.

DR. KESSLER: Well, again, you need to inquire about compensatory mechanisms, how people smoke, elasticity of nicotine and tar, and what actually gets into the smoke before you can conclude that, in fact, the low tar cigarette is any less hazardous.

There are certainly those who believe that there may be a small benefit for the low tar cigarette, if you are addicted, and you have no other choice; but, on the other hand, there are certainly those experts who say that, in the end, you are going to get as much, and in fact there is no benefit to you from a health perspective.

What could be of use is, if you want to quit smoking, how do you do that? What information do we get?

Perhaps shifting -- first of all, not to cover the --

MR. McMILLAN: I understand that very well. I've done it a thousand times.

DR. KESSLER: A thousand; as far as quitting smoking. The question is, does low tar -- are these very low brands helpful in getting you to quit? For some people, cutting in half the delivery at periodic intervals, really does help them get off cigarettes.

MR. McMILLAN: Well, you seem to be hung up on addiction. The question is, what is harmful? That is what we need to address, and in order for us to do that intelligently, we need facts. And what we're getting here is speculation.

And so I would urge you to get on with the development of whatever it is that you are prepared to present, and then we should come back and take a real serious look at it and try to make some intelligent choices, because we are basically up here debating a lot of speculation and emotion rather than the facts.

I think it's the fact that you perhaps are in the best position to sift through and provide us with a recommendation on.

DR. KESSLER: Congressman, I certainly understand the need to move onto the policy aspect, but let me just make sure the record is correct.

We are interested in addiction, first of all, because of the definition of "drug," but leave no doubt, it's not just the addictive potential, it is the harm that that addiction causes. I think that there is no --

MR. McMILLAN: Absolutely.

DR. KESSLER: -- question about that --

MR. McMILLAN: That's what we --

DR. KESSLER: -- harm.

MR. McMILLAN: -- really need to get.

DR. KESSLER: Congressman --

MR. McMILLAN: What are the effects.

DR. KESSLER: -- I think there is no disagreement in the scientific and medical community, when you see 420,000 people die --

MR. McMILLAN: I would like you --

DR. KESSLER: -- each year --

MR. McMILLAN: -- to get the facts up here, Dr. Kessler, so that we can make some decisions instead of rehashing the same statistics over and over again.

DR. KESSLER: Congressman --

MR. WAXMAN: I thank the chair.

DR. KESSLER: -- those facts are, in fact, what cigarettes do. You can't deny -- we can't deny their hazard.

MR. WAXMAN: Thank you.

MR. McMILLAN: (inaudible)

MR. WAXMAN: The gentleman's time has expired.

Mr. Synar.

MR. SYNAR: I can't let that go unattended.

You know, I'm very disappointed with the tenor this debate has taken, at least on the Republican side, because I think Dr. Kessler has been religious in explicitly not making speculation and the presentation of facts.

In the last three hours, we have seen one of the most comprehensive presentations of fact with respect to this issue, unlike what we saw when we had our CEOs in here, under oath, who, at very best, skirted or stretched believability beyond any form.

There has no hiding of documents here. Documents are provided both to the majority and minority, and as the chairman said, have been provided.

You have been very forthcoming. I have not criticism. I think those who are criticizing you, would like that be the debate.

The fact is is that we've been here for three hours, and not one fact that you have presented has been refuted by either the tobacco industry or those people who would attack your credibility.

That said, let me go into specifics here. You said that nicotine released from cigarettes can be increased by adding ammonia. Is that correct?

DR. KESSLER: I am relying on what we have learned from the review of the industry information available to us. I am not asserting it for the truth of the fact, I am only saying --

MR. SYNAR: You're repeating a fact.

DR. KESSLER: -- I'm just repeating, Congressman, what we have learned.

MR. SYNAR: Now, adding ammonia, is really a way to adjust the acidity or the pH level of the tobacco smoke. Is that correct?

DR. KESSLER: What we have seen is ammonia as an impact -- quote, as an "impact booster," and that impact is correlated with nicotine and nicotine's effect.

And, yes, I believe -- I believe the chairman asked me about the biological mechanisms. From my basic chemistry understanding, putting one and one together, it has to do with ammonia is a base, it does affect pH chemistry. Nicotine, in the proteinated and unproteinated forms, act differently, so I'm putting one and one together.

MR. SYNAR: So the fact, and not speculation, of what we have learned today is that the tobacco industry has been manipulating nicotine by adjusting the pH or acidity of the smoke? Correct?

DR. KESSLER: They have been adding ammonia and, in their own words, that affects nicotine -- the liberation of free nicotine to the smoker.

MR. SYNAR: Okay. Thank you, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Synar.

Mr. Bilirakis, do you have questions?

MR. BILIRAKIS: Let me finally, very quickly, read into the record. I asked the general question previously. I didn't think I was going to start a small war in the process, and that question still stands, subject to the discussions we've had here and whatnot.

These are more specific questions.

Near the end of your March 25 testimony, Dr. Kessler, you discussed the legal question of whether nicotine as contained in cigarettes was a drug, for purposes of regulation under the FDA act.

It occurs to me -- how can it not -- that this is the kind of question that you or your predecessors would have put to your advisors. Will you please provide to the Subcommittee for inclusion in the hearing record, any memoranda that have been written on the subject of the regulation of cigarettes under the FDA Act, specifically the question of the possible regulation of cigarettes, on the grounds that they contain nicotine, which may have been written by anyone at the FDA, over the years, up to the present.

That is the question, for the record.

Next question: On page 27, of your March 25 -- and I will furnish these to you, sir, so please, you don't have to worry about writing them down.

DR. KESSLER: Thank you very much, Congressman.

MR. BILIRAKIS: On page 27 of your March 25 written statement, you acknowledge that, and I quote:

"There is the possibility that regulation of nicotine in cigarettes as drugs would result in the removal of nicotine containing cigarettes from the market," end quotes.

Isn't it true that, under current law, if FDA asserts jurisdiction over cigarettes on the grounds that they contain nicotine as a drug, you would have no alternative but to eliminate all nicotine-containing cigarettes from the market, because they would not be covered by any approved, new drug application on file?

That's the question. No answer required at this time.

The next one: You also state that there might be other possibilities, such as limiting the amount of nicotine in a cigarette -- you did that today, too, I believe -- to certain so-called non-addictive levels.

Surely, given the monumental societal consequences of your proposal, someone at the FDA must have made some type of analysis or proposal as to what those levels might be, and will you provide them to the subcommittee for inclusion in the hearing record, if they exist.

The next question: You have acknowledged the dramatic effects on our society that FDA regulation of cigarettes as drugs would have. Therefore, surely, you have outlined the precise steps that you would take if you asserted such jurisdiction.

Will you give the subcommittee all memoranda from your staff, or anyone else at FDA, concerning these steps.

The next question: You also state in your March 25 testimony that FDA might otherwise restrict access, to use your words -- otherwise restrict access -- to cigarettes, unless the industry could show that nicotine-containing cigarettes were safe and effective -- your words.

Do you expect this subcommittee to believe that there is any possibility that you could be convinced that any nicotine-containing cigarettes are safe and effective for some therapeutic purpose?

I'm sure you could probably take the rest of my time to answer that, and therefore I would ask your response be in the record.

Next, Dr. Kessler, I assume you have considered the manner in which FDA might restrict the sale of cigarettes. For example, would you require cigarettes to be sold only with a prescription from a doctor, indicating that it was his or her best medical judgment that the person should smoke?

Will you please provide the subcommittee with any memoranda that you may have concerning restrictions that might be placed on the sale of cigarettes, other than removing them from the market? That's the end of that question.

Finally -- and I appreciate the chair's indulgence -- on pages 27 and 28 of your March 25 written testimony, you stated that a black market could develop if the FDA asserted jurisdiction over cigarettes and either removed them or restricted their sale.

Has anyone at FDA made any type of analysis of the likelihood and the problems with such a black market, and, if so, will you agree to provide any memos relating to such analysis?

Dr. Kessler, those are the specific questions, which obviously, if you respond adequately to the first general question, they would probably all be covered therein.

Doctor, as I read Chapter 2 definitions, the term "drug" means: (A) Articles recognizing the official of the United States Pharmacopeia, et cetera, et cetera; and, then,

(B) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

Then Article sub-C goes on: Articles other than food intended to affect the structure of any function.

I guess my question is: Have you received any testimony that would show intent, consistent with the definitions of the term "drug" in the FDA regulations?

DR. KESSLER: Testimony?

MR. BILIRAKIS: Testimony, evidence, et cetera.

DR. KESSLER: There are certainly statements that are appearing that have been reported. A statement that says, for example, we are then in the business of selling an addictive drug.

A statement that says -- and I can't quote it exactly -- that we are in the nicotine business not the tobacco business, with nicotine's physiological effects.

Those statements, Congressman, may be relevant to the question of intent. We need to see all of those documents, see them in full context, the full analysis, before we can reach any decision.

MR. BILIRAKIS: Right. So what you're saying is, you have not reached any decision as yet?

DR. KESSLER: On the question of intent, that's correct.

MR. BILIRAKIS: Well, that is the key question --

DR. KESSLER: Absolutely.

MR. BILIRAKIS: -- it seems to me --

DR. KESSLER: Absolutely.

MR. BILIRAKIS: -- as I read the (inaudible).

DR. KESSLER: Absolutely. And I don't want to leave any misunderstanding.

MR. BILIRAKIS: And you will share --

DR. KESSLER: We have reached --

MR. BILIRAKIS: -- all of that -- all of your investigative reports and all of your information with us, to the extent that you --

DR. KESSLER: We will go through your questions. Again, I appreciate all of the questions, and we will respond.

MR. WAXMAN: Mr. --

MR. BILIRAKIS: But even though where you do not deem it fit, you're going to get together with the majority and the minority so that we might help you to determine whether or not --

DR. KESSLER: Congressman, as you know --

MR. BILIRAKIS: -- you are correct in deeming them not --

DR. KESSLER: -- Congressman, as you know, we have very good working relationships with this committee and --

MR. BILIRAKIS: Well, we have had, sir, and that's why I'm a little --

DR. KESSLER: -- and personally --

MR. BILIRAKIS: -- disappointed in --

DR. KESSLER: -- and we will make sure that you can do your job, and that we can do our job.

MR. BILIRAKIS: All right. Thank you, Mr. Chairman.

MR. WAXMAN: Thank you, Mr. Bilirakis.

Mr. Wyden.

MR. WYDEN: Thank you, Mr. Chairman. Let me ask a slightly different question of Dr. Kessler.

If the Congress said, we, as a collective body, are interested in a new federal policy with respect to smoking, that would, in effect, have the Congress working with your Agency and other health agencies, to gradually lower nicotine levels, over an extended period of time -- say 10 years -- to help smokers in this country defeat this horrible addiction, what would you say some of the policy issues would be in looking at something like that, and would, in fact, something like this be an area that you think would be fruitful for the Congress to work on?

DR. KESSLER: Congressman, it is a complex question. It requires very thoughtful analysis. There are those scientific experts who do believe that perhaps is a way to reduce ultimately the people's demand for cigarettes and people's addiction, if you actually deal with the level of addictive substance in the cigarette.

There are also other ways that are beyond any consideration for this agency, that you have, in fact -- this committee -- has discussed. There is the issue of advertising, there is the issue of restricting access even further, so there are many different ways.

Looking at nicotine levels and reducing dependence on that level is certainly one way that needs to be reviewed and thought about and discussed and debated, and we do not yet -- we will engage the scientific experts on that question over this summer. We don't have all of the answers.

MR. WYDEN: Is there research, for example, that shows that if you reduce nicotine levels, smokers will just smoke more of the cigarettes, suck harder on them, this sort of thing?

DR. KESSLER: I've read some of those studies.

Certainly for a short period of time, there may be certain compensation, but if you took nicotine down, if there wasn't the kind of elasticity that there is -- if you really took the nicotine down so you couldn't get out more, then perhaps you can overcome those compensatory mechanisms. They're complex questions; they need to be addressed scientifically, and then the policy aspects of those questions need also to be reviewed.

MR. WYDEN: Is your agency looking at those issues now, or do you see those issues as the province of another public health agency?

DR. KESSLER: Obviously when one looks at the question of whether nicotine-containing cigarettes are a drug for the purpose of the Federal Food, Drug and Cosmetic Act, one has to ask the question: in what dose would nicotine be considered a drug for the purposes of the Federal Food, Drug and Cosmetic Act? Perhaps it's all levels of nicotine, perhaps there is a range; we need to look at that question.

MR. WYDEN: I'm interested in exploring that with you, because along with my colleagues, I share the view that a ban on cigarettes would cause great chaos, but I think this question of in effect gradually lowering nicotine levels over an extended period of time is an important public health issue that ought to be looked it.

Let me ask you about just one other matter, and I have my friend, Mike Bilirakis here, and maybe we engage in this together.

On the matter of an agency request for documents from a tobacco company, if a tobacco company denies an agency, your agency specifically, documents that you feel are necessary, what can you do about it?

DR. KESSLER: We could proceed -- you get into the issue of jurisdiction to determine jurisdiction. And that would involve us going the route of an administrative warrant to get those documents. We have not gone that route as of this time.

MR. WYDEN: I ask this question, because as you noted to me earlier, you all made a request for documents May 8th of this year, that you felt would really flesh out and clarify questions with respect to manipulation and control of nicotine; that those documents, if they were forthcoming, would resolve the matter, and I think that what is really important on this, and I've worked with Mike Bilirakis on many occasions on lots of issues, is that majority and minority members work to make sure that documents are received from the best source, which is the tobacco companies; and historically it has not been possible to get these documents from the best source, -- which is the tobacco companies -- and that's why these whistle-blowers have been so important.

But I want to assure my friend from Florida that I'm going to work with him on all of these issues; and that's the way we've done it in the past and will continue to do it in the future.

Mr. Chairman, I yield back.

MR. WAXMAN: Thank you very much, Mr. Wyden.

This committee is conducting an investigation. We intend to get the information we need pursuant to that investigation; and by "we" I mean Democrats and Republicans alike; and we expect to get them from anyone, whether it's a government employee or the tobacco industry, and we will work together, I expect, to get the information; and if need be, we'll work together by way of subpoena to get the information, because we're determined to follow this investigation to where it will lead and to get the facts out.

The American people deserve to know what is going on in the area of cigarettes, tobacco and tobacco products.

Dr. Kessler, I want to thank you again, and commend you for your testimony and for your diligent work in this area, and we definitely want to work with you. Thank you very much.

DR. KESSLER: Thank you, Mr. Chairman.

MR. WAXMAN: That concludes our business for today. The subcommittee stands adjourned.