Tobacco Documents Online

CR3 5601.'0 OM"_'/s jg 1 2 3 4 5 6 7 8 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 THE TOBACCO INSTITUTE * * * UNITED STATES HOUSE OF REPRESENTATIVES COMMITTEE ON ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT * * * HEARING ON THE SURGEON GENERAL'S REPORT ON "THE HEALTH CONSEQUENCES OF SMOKING: NICOTINE ADDICTION" ROOM 2123, RAYBURN HOUSE OFFICE BUILDING FRIDAY, JULY 29, 1988 9:13 A.M. TIMN 0025452 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4n10 01 01 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13': 14' 2 (9:13 a.m.) P R 0 C E E D I N G S CHAIRMAN SCHEUER (Presiding): In the absence of -- in the temporary absence of Chairman Waxman, I'm going to get things started this morning. We have an especially attractive and productive group of witnesses here this morning for this first hearing. It's a specia]l pleasure -- DR. KOOP:- is your microphone on? CHAIRMAN SCHEUER: It should be. I guess I'm not speaking out of it. It is on. Better now? All right. (Pause.) Okay, am I on? 15ii It's a very great pleasure for us to welcome back 16 to the Subcommittee Dr. C. Everett.Koop, the U.S. Surgeon 17; 18 , 19 20 ;i 21 II 22 ' ) 23 li 24 25 General. He has been a superb head of our government's health effort over the years and has given us repeatedly very productive and very helpful testimony. Dr. Koop is accompanied by Jack Henningfield, who is Chief of the Dependence and Abuse Potential Assessment Laboratory of the National Institute on Drug Abuses Addiction Research Center. We are also pleased to welcome back Dr. Frank Young, Commissioner of the Food and Drug Administration, who TIMN 0025453 ACE-FEDERAL REPORTERS, INC. Nationwide Covera e 202-347-3700 g 800-336-6646

"10 01 01 3 OMT/bc 1 also is an old friend of this Subcommittee's. 2 Now, Dr. Young, I understand that your schedule 3 is tight and it will be necessary for you to leave about 10 4 o'clock, no later than 10, and we very much appreciate your 5 willingness to spend even this limited time with us. 6 So I presume this panel will be over about 10 or 7 a few minutes after. All of us up here have agreed that we 8 will defer our opening statements so that we will have time 10 both to hear your tegtimony and to use that time most productively in questions and answers. And I very much 11 appreciate my colleagues' consideration in joining me in 12,; deferring our opening statements. ' 13 Your testimony, as it's prepared, will be printed 14'! in full in the record. So I suggest that each of you chat 15;: with us for perhaps 10 minutes informally, as if we were all H 161 ! in the living room together. - 171; And then, after the three of you have testified, 18;! we'll use the remainder of the period for questions and 19;' answers. Okay? 20 ;; So, Dr. Koop, why don't you begin. 2111 DR. KOOP: Thank.you, Mr. Chairman., I would 22 ( remind you that the time constraints apply to all of us and 23 24 25 we are grateful for the Subcommittee's understanding that, due to these prior commitments, we have to leave here at 10. CHAIRMAN SCHEUER: You all have to leave at 10. TIMN 0025454 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-33b-b641.

4010 01 01 4 OMT/bc 1 Let me ask you to keep your opening statements to 2 about six or seven minutes. 3 DR. KOOP: All right. 4 CHAIRMAN SCHEUER: That will be 20 minutes of 5 opening statements and another 25 minutes of Q&A. Okay? 6 DR. KOOP: Thank you. 7 STATEMENT OF DR. C. EVERETT KOOP, M.D., SC.D., 8 SURGEON GENERAL OF THE PUBLIC HEALTH SERVICE, 9- DEPARTMENT OF HEALTH AND HUMAN SERVICES, 10 DR. KOOP: I will be talking primarily about the 11 Surgeon General's Report, which was released May 16th, the 12: Health Consequences of Smoking, Nicotine Addiction. 13 This is the first such Surgeon General's Report 14 : that focuses exclusively on smoking behavior, and it 15' examines the question of why people continue to smoke 161` u despite a desire to quit, and despi,te the known health 17~j ' hazards of smoking. It represents a most comprehensive review of the 19: evidence that the use of tobacco is addictive behavior. 20j; Let me summarize the scientific evidence that led iV . 21;; to three overall conclusions in this report. 22II First, cigarette and other forms of tobacco are 23ii addicting. 24 25! Second, nicotine is the drug in tobacco that causes addiction. TIMN 0025455 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 01 01 OMT/bc 1 2 3 4 5 6 7 8 10 11 12 5 And, third, that the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. The determination that cigarettes and other forms of tobacco are addicting is based on standard criteria used to define drugs as addicting. And all of these criteria are met by tobacco just as they are met by other addicting drugs, such as heroin and cocaine. There are three primary criteria. One is that there is a highly-controlled or use of the drug. This means that drug-seeking and drug-taking 13. behavior is driven by strong, often irresistible urges and 14": can persist despite a desire to quit, or even repeated 15;• attempts to quit. .~ 161~ Second, the drug in thisL case, nicotine, has 17;; psychoactive or mood-altering effects in the brain. 81; • And, third, the drug itself is capable of 19. 20 '~ functioning as a reinforcing agent that directly strengthens behavior leading to further drug ingestion. 21~' The report also considers additional criteria i 22'i that characterized drug addiction. Nicotine, like.other 23;i 1 drugs commonly recognized as addicting, meets these criteria 24 i1 also. 25 For instance, the patterns of drug use are - UNIN 0025456 ACE-FEDERAL REPORTERS, INC. _0, ~ Nationwide Coverage _ z47-3700 R00-336•6646

9010 01 01 OMT/bc 1 2 3 4 5 6 7 8 9- 10 11 12 13; .14: 6 consistent and repetitive. Drug use may persist despite adverse physical, psychological or even social consequences. And after quitting episodes, the resumption of drug use or relapse often occurs; urges or cravings to use the drug may be recurrent and persistent, especially during drug abstinence, and diminished responsiveness to the effects of the drugs occurs over time, a phenomenon which is called tolerance. Withdrawal symptoms often occur after cessation of drug intake and, finally, the drug itself can provide effects which are considered pleasant and euphoric to the drug user. Like other addictions, tobacco can be effectively treated and a wide variety of behavioral interventions have 15;' been used for years. 16II Now we have even a physiologic response to be 17;1 used as treatment, and that is nicotine replacement therapy 18' in the form of a nicotine chewing gum. And these treatments 19: are not widely available to the smokers who need them, 20;, unfortunately.. Most third party insurance payers do not 21! provide coverage for smoking cessation but, on the other ~` 22:; hand, they do for alcoholism and elicit drug use. 2311 Many smokers are'able to quit on their own but, 24 25 similarly, many users of other addicting drugs are also able to quit on their own. These individuals have learned to TRMN 0025457 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nauonwide Coverage 800-336-6646

4010 01 01 7 OMT/bc 1 deliver effective treatment to themselves, or perhaps their 2 environmental circumstances have changed in such a way as to 3 support cessation and abstinence. 4 And I should like to emphasize that those who 5 want to quit should not be discouraged by anything in this 6 report that I presented. National surveys indicate that 75- 7 85 percent of smokers would like to quit; more than 40 8 million Americans have done so, despite the addiction. And, 91 for many smokers, a desire to quit and, if necessary, 10 persistent and repeated attempts to quit may be all that is 11 necessary. 12 There are public health implications to all of 13 -this, such as: 14 How should we address the problem of tobacco use 15`; now that we recognize it as an addiction? 161; Children especially should be warned about J! 17:: tobacco addiction through school and community education 18,; programs. Many children and adolescents who experiment with 19 tobacco believe that they will be able to quit in later 20;~ years, unaware that initial use can lead to a life-long 21~;: addiction to nicotine. 221 I And we, you and I, in concert with citizens of 23 24 25 this country, civic leaders, should establish appropriate public policies on how tobacco products are sold and distributed to our society. TIMN 0025458 ACE-FEDERAL REPORTERS, INC. 2n2_z47-17nn Nationwide Coverage 40n_136-6fi4A

9010 01 01 8 OMT/bc 1 Most importantly, we must give tobacco and 2 tobacco addiction the sincerity and attention that it 3 deserves. We have waged enormous resources in a war on 4 drugs, elicit drugs, but we should also give pri~irity to the 5 one addiction -- tobacco -- that is killing more than 6 300,000 Americans each year. 7 That's a very brief summary of my remarks, Mr. 8 Chairman. I'll be happy to respond to questions later. 9- CHAIRMAN SCHEUER: Dr. Henningfield. 10 STATEMENT OF DR. JACK E. HENNINGFIELD, PH.D., 11 CHIEF, BIOLOGY.OF DEPENDENCE AND ABUSE 12; POTENTIAL ASSESSMENT LABORATORY, 13 ADDICTION RESEARCH CENTER, ~14; NATIONAL INSTITUTE ON DRUG ABUSE 151' DR. HENNINGFIELD: Mr. Chairman and Members of 16i' the Committee, I'm Dr. Henningfield_. I am grateful for the 17, opportunity to participate in this hearing on nicotine 18;' addiction. 19;' Adam Hau, through the NIDA instrumental grant 20;j program and the Addiction Research Center, has supported 21: studies directed towards the understanding, treatment and 22!i prevention of tobacco use. 23 24 25 . This research has had practical public health benefits, such as more objective and accurate diagnostic criteria for nicotine dependence and withdrawal. The TIMN 0025459 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 01 01 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 9 research has also led to the development of more effective nicotine dependence treatments; since approximately 80 percent of the more than 50 million Americans who smoke would like to quit, these steps could have considerable public health impact. In addition, the involvement of nicotine dependence in the involvement and course of other addictions has also been increasingly recognized as one of the many factors to consider in the current war on elicit drugs, especially at the prevention level with programs aimed at youth. The conclusion that nicotine is a drug that can 13;:. result in a similar addictive process as that produced by 14` drugs such as morphine is supported by many lines of 15;; evidence, including surveys of polydrug abusers and even the 16 more recent neural research, which is investigating the 17' mechanisms by which nicotine activates functional nicotine 18; brain receptors. 19 Let me begin by describing some features of 20; nicotine dependence. ~~ - 21" Nicotine dependence, like other drug addictions, 2211 is a progressive., chronic and relapsing disorder. It can be 23i; objectively diagnosed. Levels of use range from low levels ~ 241. of intake to those which are highly resistant to change by 25I either the individual or others. TIMN 0025460 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage A00-?36-6646

9010 01 01 OMT/bc 1 2 3 4 5 7 8 9 10 11 12 10 Let me tell you how addictive nicotine can be as viewed by the so-called hard drug users and by alcoholic populations. Three surveys of cigarette smokers, some of whom were alcoholic and of whom abused elicit drugs showed that by several measures tobacco was highly addictive. The results of these three studies -- in Canada, Great Britain and the United States -- were consistent. They showed that when asked to rate how much they needed the drugs and how much they liked the drugs and how difficult it would be to quit that they rated cigarettes and other forms of tobacco as addicting as heroin and alcohol and that they 13' needed heroin and alcohol -- or tobacco as much as heroin 14 '' and alcohol. 15~~ Of course, many behaviors can become reigular, il 16!, habitual and hard to give up, and they may also involve the , - ; 17' ingestion of a substance. What sets drug addictions apart 18; from these other so-called addictive behaviors is primarily 19C that administration of the substance results in the delivery 20;; of a drug that is known to be addictive. 21;; For example, the drug in opium-derived products' 2211 is morphine. The drug in alcoholic beverages is ethyl 23!~ alcohol. The drug in marijuana is tetrahydrocannabinol. 2411 And the drug in tobacco is nicotine. 2511 Without the drug factor, none of these TIMN 0025461 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

6010 01 01 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12. 11 substances, including tobacco, provides a satisfactory substitute for users. The characteristics of tobacco as a vehicle for nicotine delivery have been most eloquently described by Dr. William Dunn of the Phillip Morris Research Center in 1972. Dr. Dunn wrote: "The cigarette should be conceived not as a product, but as a package. The product is nicotine. The cigarette is but one-of many packaged layers. There is the carton which contains the pack, which contains the cigarette, which contains the smoke. The smoke is the final package. The smoker must strip off all these packaged 13• layers to get to that to which he seeks. Think of the 14': cigarette pack as the storage container for a day's supply 15 of nicotine. Think of a puff of smoke as the vehicle of 16: nicotine. Smoke is beyond question'the most optimized 17 vehicle of nicotine, and the cigarette the most optimized . 18: dispenser of smoke." 19;; Many studies, including those conducted by NIDA, 20. 21 ;; ii 22 23 24 25 have supported Dr. Dunn's observations. These have shown that both smoke and smokeless forms of tobacco are efficient vehicles for nicotine delivery. They all produce substantial levels of nicotine in the blood of users and, in fact, the levels are often many times higher than would have been tolerated when the person first began to.use tobacco. TIMN 0025462 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

"10 01 01 OMT/bc 1 2 3 4 5 7 8 9 10 11 12 Such levels activate many physiological systems which can affect mood, behavior and general physiologic functioning. Once you know that substance reslilts in drug administration, the next question is: How does this drug compare to established addicting drugs? To find out, both animal and human studies are conducted. In the case of nicotine, both polydrug abusers as well as smokers who are not addicted to other drugs have been tested. Nicotine has been given by cigarette, by 12,: cigar, by a variety of routes, including intravenous 13 injections. 14i; The results with both animals and humans show 15;~ that nicotine is a potent and powerful psychoactive drug , , . 16'; that affects the brain, thereby altering mood and behavior. 17,; In fact, the potency is more than a thousand 18" times more potent than alcohol and five to 10 times more 19; potent than cocaine and morphine in producing like effects. 20;: In a technical sense, nicotine is also a 21" euphoriant drug. It can produce pleasurable feeling states 22~ in humans. When compared to cocaine and heroin-like drugs 23;; on standard tests, some of the results that are critical are 24 25 similar. These findings show that nicotine meets standard TIMN 0025463 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

Fn10 01 01 13 OMT/bc 1 criteria as a euphoriant and has the potentia7l to adapt. 2 This is, nicotine itself can produce much of the pleasure 3 and satisfaction sought by the smoker. 4 Addicting drt~Vs also reward users by their 5 chemical actions in the brain. That is how they drive or 6 compel behavior. The standard test of the basic biologic 7 power of a drug to drive behavior is to determine if animals 8 will self-administer the drug. 9 Several species of animals have been found to 10 voluntarily take nicotine in such studies. But there is 11 even more to nicotine addiction than what I've just 12: described. 13 : Nicotine use, like heroin use, also leads to 14;, tolerance and physical dependence. Over time, daily 15`! nicotine intake increases until levels are reached which 16~~ would have caused profound discomfo-rt when the person first 17I began using the tobacco product. ;` 18 ;' These increases then become necessary just to 19 sustain relatively normal mood behavior and physical 20 functioning. Also NIDA -- nicotine induced physical 211, dependence has also been.extensively studied by NIDA 2211 researchers. 23 The studies show that within the first day of 24 ;1 abstinence, symptoms such as discomfort, craving to take an 25~I additional dose, inability to concentrate, disrupted TIMN 0025464 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 01 01 OMT/bc 1 2 3 4 7 8 9 10 11 12 13 14 5 14 cognitive performance and mood changes occur. In addition, physiologic science such as changes in heart rate, hormonal output and electrical brain function occur. These effects are more severe in individuals who have been using higher levels of nicotine and they are reversed by readministration of nicotine. Withdrawal symptoms can also lead to relapse if they are not treated. In summary and conclusion, laboratory and clinical data confirm that nicotine is a highly-addictive drug. The strength of the resulting addiction varies among individuals but, as a drug, nicotine is characterized the features that result in addictions as strong as those seen for opiates, stimulants and sedatives. Therefore, we conclude that nicotine is the 16_P prototypic or-dependence-producing drug. More specifically, 17 i that the biological properties of nicotine can induce a ~, 18icompulsive use of tobacco. 19; This role is equivalent to the role of cocaine 20' and cocoa leaf use to ethanol and alcoholic beverage 21 i; i; consumption and to morphine and opium poppy use. 221( Thank you, Mr. Chairman. And I would be happy to 231; supply any papers to support any of these claims. 24 25 CHAIRMAN WAXMAN: Thank you very much, Dr. Henningfield. Yes, Chris. TIMN 0025465 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 01 01 15 OMT/bc 1 MR. BRUCE:. I'm sitting here concerned. The 2 panel -- it's now 9:27. As I understand from Dr. Koop, that 3 he plans to leave here at 10 o'clock, I certainly respect 4 his right to testify and leave, but it does put us who are 5 members of the Committee in the position of being mere 6 listeners to written testimony. 7 I wonder if their schedules are at least, at all, 8 flexible so that we don't get into the situation where the 9 three gentlemen here-testify and leave, because it leaves 10 very little Congressional role in the way of asking 11 questions or getting responses. 12:, Had I known that they were going to testify and 13 ' leave it would have been easier to exchange written 14' interrogatories. 15i; CHAIRMAN WAXMAN: The gentleman makes a good ~ 16'i point. We have -- Dr. Young will testify for five minutes , 17 under the rule, and then each member will have an ~ 18:, opportunity for a round of five minutes. 19 : That will put us pretty close to 10 o'clock. And 20~. I assume our witnesses, if need be, will stay a few minutes 21;` over. 22 2 3 I; 1! 24 11 25 MR. BRUCE: I would add that it seems particularly unfortunate that the witnesses are simply reading their testimony, which presumably we.already have. CHAIRMAN WAXMAN: The witnesses have five minutes TIMN -0025466 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 01 01 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14: 16 to present their oral testimony however they see fit. . Dr. Young. DR. YOUNG: Mr. Chairman, in respect to that, I will not read the written testimony as usual, As I usually do not, and will submit it for the record; and I will only make a few points for your consideration. I apologize. My deadline is 10 o'clock, and it is unavoidable. STATEMENT OF DR. FRANK E. YOUNG, M.D., PH.D., COMMISSIONER, FOOD AND DRUG ADMINISTRATION DR. YOUNG: Most tobacco products are regulated by the Bureau of Alcohol, Tobacco and Firearms. Tobacco products have not customarily, as marketed, been considered within the FDA jurisdiction and my testimony outlines that in detail. It has, under the way in which the manufacturer presents it, been at times considered in the extract of 17'' nicotine as a drug in the case of a drug called Nicorettes. 18 In other instances, tobacco products may also be 19 considered foods. The technology as it's developing i 20;i continues to be innovative and, thus, makes increased 21;j problems for the Food and Drug Administration, and thus we' 22i examine these on a case by case basis. 23!I We currently are reviewing petitions, two of them „ 24 25 II on the R.J. Reyno.lds Tobacco Company proposed cigarette product that involves heating without burning of tobacco, TIMN 0025467 ACE-FEDFRAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-.336-6646

9010 02 02 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 ; 17 18 19 20 21 22 23 24 25 ~i ~~ 202-347-3700 Nationwide Coverage 800-336-6646 17 and we have an additional petition that is before us on low tar cigarettes. We will examine these carefully on a case by case basis, recognizing t..ie past law. And I would call your attention to the fact that the Food and Drug Administration looks at all the facts that were raised by Dr. Koop and others and focuses on what the drug means under the law, and I quote: The term means (a) articles recognized in the official U.S. Pharmacopeia, Official Homeopathic Pharmacopeia of the United States or official national formulary or any other supplement to them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease-in man or other animals; and (c) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (d) articles intended for the use as a component of any articles specified in clauses (a), (b), (c), but does not include devices or their component parts or accessories." So that as we are looking at this problem as raised, despite our concern and compassion for the issue of smoking, we are looking at in our understanding a law and trying to work through the•statute as has been passed many -years ago and interpreted through a number of court cases. TIMN 0025468 ACE-FEDERAL REPORTERS, INC.

6010 02 02 18 OMT/bc 1 Mr. Chairman, this ends my informal remarks. 2 CHAIRMAN WAXMAN: Thank you very much, Dr. Young. 3 Mr. Scheuer, I'm going to let you lead off on 4 questions. 5 MR. SCHEUER: Dr. Young, I'm puzzled at our 6 failure to treat -- our failure as a society to treat 7 tobacco as a narcotic drug affecting the central nervous 8 system. 9 All of the testimony that we have heard this 10 morning and that we're going to hear this morning indicates 11 that the pharmacological impact on the human psyche and the 12 human body of nicotine is very similar, especially in its 13 addictive characteristics, to cocaine and heroin. 14 The American people don't know that. Congressman 15. Waxman and I and a couple of other members of the 16 Subcommittee -- Congressman Waxnan is Chairman of this - 17 Subcommittee -- arranged for us during last week when.we all 18 happened to converge on Atlanta to visit the Center for 19 Disease Control. And when we asked them what would be the 20 most effective research the government could perform to 21 improve our national health outputs -- outcomes -- would it 22,; be research on all of the systems? The operations, the 23 procedures, the drugs -- which worked? Which don't 24 work -- would it be research on arthritis, on mental 25' disability, on incontinence, they said, "None of the above. TIlVIN 0025469 i ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage !I 800-336-6646

F010 02 02 19 OMT/bc 1 It would be research on how we impress on the American 2 people that they should pay attention to the research we've 3 already developed about the dangers of alcoho7., tobacco and 4 drugs." 5 How do we get them to build and change their 6 behavior based on what we already know? We don't have to 7 know anything more for major health impacts --- for our major 8 health outcomes to improve. 9 Now, I ask you. We seem to be dancing around the 10 subject of whether tobacco is or ain't a narcotic drug, an 11 addictive drug affecting the central nervous system. 12 The three of you have all testified that it is. 13' Now, Mr. Henningfield says in the last sentence 14 of his testimony that he respects -- he respects the Food 15 and -- is this correct; Mr. Henningfield? I can't find it 16 right now. 17 That you respect the decision of the Food and 18 Drug Administration in their present interpretation that 19 it's not a narcotic drug under that act? 20 If the act doesn't describe tobacco or nicotine 21 as a drug or not a drug, as you say, Dr. Young, for goodness 22 sake, why doesn't our society through your agency say: 23 This is an addictive drug affecting the central 24 nervous system, very similar in its addictive 25, characteristics to heroin, and to cocaine, and we should TIMN 0025470 ~ ACE-FEDERAL REPORTERS, INC. Nacionwide Coverage II 202-347-3700 800-336-6646

cq10 02 02 20 OMT/bc 1 treat it as a very serious matter that has important 2 implications for morbidity to the American public. 3 Now I don't think there are many people among us 4 in the American society who would want to ?,an tobacco. We 5 tried that with alcohol a half a century or more ago. It 7 didn't work very well. But, short of banning it, wouldn't your 8 declaration that this is a dangerous, addictive drug similar 9 to cocaine, similar to heroin and that we should -- 10 especially young people should think most seriously. They 11 should stop, look and listen and think about the impacts to 12 their health of starting in on this awful, dangerous habit? 13 Aren't there'other things that we could do short 14 of banning this product, that nobody thinks would work, that 15; would do what the CD says is the first order of business for 16 . us as a society; namely, to teach the American public what 17 we already know? And teach them to adjust their behavior to 18 avoid these awful health threats to them and take charge of 19 their own behavior? 20 Isn't it incumbent upon your agency to say yes, 21 22, this is an addictive drug affecting the central nervous system. It has the same addictive characteristics as heroin 23 and cocaine. We do not advocate its ban. That's for 24 Congress and the American public to decide. But the 25 American public ought to be perceiving this as a dangerous TIMN 0025471 ~ ACE-FEDERAL REPORTERS, INC. Nationwide Coverage ~ 1-02-347-3700 800-336-6646

4410 02 02 OMT/bc 1 2 3 4 5 6 •7 8 9 10 11 12 13 14, 15 16: 17 18 19 20 21 22 23 24 25 21 drug, urgently affecting their health. And wouldn't this sort of set the discourse and help the CDC with its problem? DR. %ENNINGFrELD: Mr. Scheuer, the Surgeon General's efforts, which I applaud, have been very vigorous in trying to bring this forward as a major concern in the packages of cigarettes themselves contain the Surgeon General's warning and the Surgeon General's report clearly focuses on nicotine as an addictive agent. He also has, and I can truly attest, led these discussions at the World Health Organization, in the World Health Assembly and in other fora that we have been together. The issue that I'm focusing on is trying to understand the law and its clarifications on what the agency's responsibilities are. We do have three petitions before us. This is the first time that I personally have had an opportunity to review this. We will be looking back at the history of the Food and Drug Administration, which has been to not regulate tobacco products and cigarettes as a drug, let alone a narcotic drug, but instead as a substance. Cigarettes are substances that are used for smoking pleasure. Our keys, as we have to look at this, come not only as the intent of the particular product •-- and that's a TI]MN 0025472 j ACE-FEDERAL REPORTERS, INC. ~I) 202-347-3700 ~ Nationwide Coverage 800-336-6646

4n10 02 02 22 OMT/bc 1 very key part of the law that I raised -- but in the 2 petitions that we have received. They focus on, for 3 example, if I may refer to one of these, the petitioners 4 contend that this new nicotine delivery system introduced by 5 R.J. Reynolds Company falls within the statutory definition 6 of a drug because his product is intended to affect the 7 structure and function of the body of man; and because his 8 product is intended for the use in the mitigation, treatment 9- and prevention of disease. 10 Other individuals contend differently. That this 11 is not used as a drug. 12 So, this case by case analysis is what we're up 13 to now. I think the Surgeon General though has vigorously 14. led this educational effort and one which I'm sure he will 15 not flag from. I know his commitment. 16:; CHAIRMAN WAXMAN: Thank you, Mr. Scheuer. 17 Mr. Whittaker. 18 MR. WHITTAKER: Thank you, Mr. Chairman. 19 Dr. Koop, I'd like to ask you to place the role 20 of nicotine as a drug in a bit of perspective for us. 21 in your views, if nicotine-contained products 22;, were to be first invented at the present time, would they be 23 permitted to be marketed to the American public without 24' being treated as regulated drugs? 25 DR. KOOP: I don't believe for a minute that they TIMN 0025473 ii ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 02 02 23 OMT/bc 1 would, sir. 2 MR. WHITTAKER: Could you comment, Doctor, on the 3 desirability of legislation that would place nicotine- 4 bearing tobacco products under the drug jurisdiction of t'.ie 5 Food and Drug Administration? 6 DR. KOOP: I think, on the face of what Dr. Young 7 has just testified, the law doesn't seem to cover the 8 problem we're all discussing. And, therefore, I think the 9- law should be changed in order that that be done. 10 Whether it should be done specifically for 11 tobacco or be a broader concept, I don't know; whether FDA 12 should be the regulatory agency, I don't know-either. 13 But, certainly something has to change: 14. MR. WHITTAKER: Dr. Young, I would appreciate if 15,. you would take note of that comment. As you may be well 16 ~ aware, the Chairman and myself have a bill to introduce, or 17 it's already been introduced, to do just that, which I think 18 is long, long overdue. 19 So I would appreciate the FDA becoming more 20, active in its participation, sponsorship of that 21 legislation. 22;; DR. YOUNG: We appreciate the guidance that you 23 are giving and the actions that you are taking, and we'll 24'' provide whatever appropriate technical assistance we can and 25; should. TIMN 0025474 II e ACE-FEDERAL REPORTERS, INC. 202-347-3700 1' ationwide Coverage 800-336-6646 II

4010 02 02 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 . 19 20 211 22 ~ 23" 24 25'' 24 As to the best of my knowledge, there's no position been taken on that bill at this time. MR. WHITTAKER: Dr. Koop, from your recent report on the addictive nature of nico'.;ine and tobacco products, it seemed that a major part of the battle to reduce the health damage caused by smoking is change the behavior of young people who may be misled into taking up the smoking habit. Do you see a positive benefit from federal legislation to assure that cigarettes are not available to minors and are not sold in vending machines or distributed as free samples? DR. KOOP: Inasmuch as the earlier the youngster starts smoking, the greater is his addiction and the more difficult it is to get off of the drug, anything we can do to keep young people from starting is a better action for government to take than to try to correct the addiction after it has occurred. Thirty-seven some States already have laws on the books that prohibit the sale of tobacco products to minors but, in general, they are not enforced. And of course, with vending machines, where there is no one around to monitor what happens, that means that there's no possible way that you can keep a minor from buying those products. And in my report on Addiction, released in May, I was very clear and strong on the fact that vending machines TIMN 0025475 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

1a010 02 02 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15; 16. 17 18 19 20 21 22 23 24 25 available to youngsters should be abolished and that the laws should be enforced where they exist and enacted where- they do not. ?,'.R. WHITTAKER: It is a divergence, I'm sure you would agree, Doctor, that -- almost a contradiction maybe would be a better word -- in the current policy that makes it somewhat difficult for minors to obtain alcoholic beverages. And, yet, an addictive drug such as nicotine is readily available to'them. And anybody who has gone into a quick shop or stands by a vending machine sees what even laws we've got blatantly violated. Dr. Koop, I understand that, under the federal law, cigarette manufacturers must submit to you.a list of all of the additives that they use and put into their cigarettes, that these are required to be kept confidential. Do you see any gain of the health awareness to be realized from changing the law so that the public knows exactly what goes into those cigarettes that are being sold to them here in the United States? And specifically do you see a public health benefit from requiring the disclosure of all cigarette additives on cigarette packages and then permitting the FDA to ban additives that present an increased health risk to 25- . smokers? TIMN 0025476 I ACE-FEDERAL REPORTERS, INC. ~ ~ Nationwide Coverage I~ 02-347-3700 800-336-6646

9010 02 02 26 OMT/bc 1 DR. KOOP: I think that day may come, sir, and 2 probably it lies in the not too distant future. I've heard 3 it say that because I have not taken a stand against 4 additives that that means I don't think that they're 5 important. 6 That's a false assumption. Nothing could be 7 further from the truth. We have received from the tobacco 8 manufacturers a list of their additives, and that is work 9 that's being carried-out now in the Office of Smoking and 10 Health and not in the Office of the Surgeon General. 11 They are reviewing all of the toxicological 12, literature to see if any of the additives pose a health'risk 13 to the consumer. 14 And it's my understanding that that work will be 15 completed before the end of a calendar year. And when those ~~ 16 figures and observations are in, I think that is a time to 17 act if necessary. 18 MR. WHITTAKER: Doctor, just one last question. 19 Just give us a frame of reference here for the magnitude of 20 the health problem we're dealing with by smoking. 21 How does the numbers of deaths we can expect each 24 ' 22,; year from smoking compare to some of the other major causes 23 of death in the United States? DR. KOOP: Well, I think, pertinent to what we 25i' are talking about, the chart on the wall in red, white and TIMN 0025477 ~ ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 02 02 27 OMT/bc 1 blue gives you the same statistics I presented at the press 2 conference in reference to this subject. 3 But you'll see that, if you add up alcohol plus 4 other drugs and opiates and cocaine, the deaths each year 5 are 10,000. Tobacco, on the other hand, is 320,000. 7 MR. WHITTAKER: Thank you. CHAIRMAN WAXMAN: Thank you, Mr. Whittaker. 8 Mr. Bruce. 9~ MR. BRUCE: Mr. Chairman, I think I'd just like 10 to ask leave of the Committee to submit an opening statement 11 in whole before I ask questions, if that's all right with 12 the Chairman. 13 CHAIRMAN WAXMAN: Without objection, all members' 14; opening statements will be put in the record at the 15:., appropriate place. , 16 ; MR. BRUCE: Let me just make a couple of comments 17 from my opening statement though. 18 First of all, I do think that it is unfair to 19 have a hearing in which we are severely restricted in our 20 ability to ask questions. 21 Secondly, that this hearing is untimely. To have 22i, FDA decision-makers such as Dr. Young testifying before the 23' Committee today is improper, I believe. It exerts pressure 24 on the FDA to rule in favor of a pending petition. 2511 Such action I think is a threat to the TIMN 0025478 ;i ACE-FEDERAL REPORTERS, INC. ~~ 202-347-3700 Nationwide Coverage 800-336-6646

")10 02 02 OMT/bc 1 2 3 4 5 7 8 9~ 10 11 12 13 14 15:' 16. 17 18 19 20' 21 28 impartiality of the FDA. And that is why they were created by the Congress to make impartial decisions. In the Pillsbury decision in 1966, when a similar occurrence happened, the crJurt ruled in the 5th Circuit- that: Legislative involvement in the judicial function of the FDA was inappropriate. It denied the litigants a right to a fair trial. And also rendered the appearance of impartiality almost null. In the present matter, the FDA has not reached a decision on the pending petition to regulate a new cigarette. Once they render that decision, then I think it is quite appropriate for the Congress to review that decision-making process, see whether or not it was properly arrived at, hold hearings of the type scheduled for today. But, until that ruling is made, I strongly believe that we should leave matters to the sound discretion and expertise of the FDA. In any event, the hearing is going forward, and I will ask questions of Dr. Koop, if I might. Dr. Koop, in your press release in May and then again today, you draw very little distinction between 22i; cigarettes and hard drug addiction. 23 But, don't hard drugs distort perception, alter 24 ' personality and lead to bizarre behaviors on the part of the 25 ;; users? TIMN 0025479 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 800-336-6646 202-347-3700

xr)10 02 02 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14- 15 29 And wouldn't you agree with Dr. Charles Schuster, who is head of the National Institute of Drug Abuse, that where we have to -- and this is a quote: "Where we have to make a big difference between tobacco and other addictive drugs is that when one smokes tobacco, it does not alter your behavior or your ability to function so that you become dangerous or obnoxious or an embarrassment to society." He said that shortly after your statement in May. Do you agree with that statement that we ought to make a distinction between hard drugs and dependence on tobacco? DR. KOOP: I was not aware of that statement. I do think that over the years tobacco smokers.,,.hard drugs. I think one of the things people use is the --- 16;- MR. BRUCE: I don't believe your microphone is 17 on. 18 DR. KOOP: Thank you. 19; I think that one of the things that many people 20 confuse is the behavior of cocaine and heroin addicts when 21 they are deprived of the drug. That's the difference 22 ,, • between a'licit and an illicit drug. 23 - Tobacco is perfectly legal. You can get it 24 whenever you want to, satisfy the craving. People say 25;i there's no crime in the streets in reference to tobacco. i TIMN 0025480 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

')10 02 02 30 OMT/bc 1 That is true. But, if tobacco suddenly were as 2 unavailable and was as expensive as heroin and cocaine, I 3 thin you would find that the behavior of some tobacco 4 addicts would be very much like the behavior of some addicts 5 of heroin and cocaine. 6 MR. BRUCE: Dr. Koop -- 7 DR. KOOP: We're dealing with two different 8 issues and they should not.be confused. 9* MR. BRUCE: But, cigarette smoking doesn't impair 10 a smoker's performance or his mental functioning in the same 11 way as a hard drug, does it? 12 It isn't a question of price between the pack of 13 cigarettes and however you sell cocaine? 14~ DR. KOOP: Sir, the report that I gave had 15 nothing to do with which was more effective in the behavior 16 of people. My report was on the addiction to these three 17 substances. And I stand absolutely firm that the addictive 18 properties, pharmacologically and physiologically, are the 19 same for those three drugs: heroin, cocaine and nicotine. 20'" MR. BRUCE: And you have -- you don't see that 21 families are destroyed by drugs? That crime is increased by 22, hard drug use? That cigarette smokers don't break into 23 liquor stores late at night to get money to buy a pack of 24 ; cigarettes? 25i- I mean, you see no distinction between -- TIMN 0025481 II ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage ~~ 800-336-6646

9010 02 02 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15, 16 17 18: 19 20 21 . 22 , 23 24 31 DR. KOOP: You take tobacco off the street, sir, and there will be people breaking into liquor stores to get drugs to buy tobacco. MR. BRUCE: I guess I find that hard. Dr. Koop, you seem to be stuck on the word "addiction". DR. KOOP: I'm absolutely stuck on the word "addiction" and I am here discussing the report that I presented to the Congress on addiction, sir. MR. BRUCE: Right, but didn't you also in 1982 use the word "addiction" when you were talking about the use, quoted you as saying that "young people are addicted to video games"? And is that the same sense? I mean, are you saying that with video games, kids are going to be breaking into liquor stores to get money for quarters for video games in the same addictive sense to tobacco? DR. KOOP: Well, as a matter of fact, kids do that. But I was not talking about addiction in the same physiological, pharmacological sense. And I think most reasonable people understand that semantically we do use the term "addiction" when we more properly should use the term "compulsive behavior," which is what I was referring to in reference to the behavior of youngsters toward video games. 25,' But, none of those semantic differences have TIMN 0025482 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

~4010 0 02 02 32 OMT/bc 1 anything to do with altering my position or that of my 2 colleagues on the addictive properties of nicotine. 3 MR. BRUCE: And so it's not compulsive behavior 4 it is to video games, },ut it is addictive as tobacco? 5 Is that what you mean? 6 DR. KOOP: I don't think I understand your 7 question, sir. 8 MR. BRUCE: You're saying about you use the word 9 "addiction" as to mean compulsive behavior. 10 DR. KOOP: When I'm talking about video games, 11 that is what I meant, and I say that it is not a good choice 12 of words but that does not affect my statement about the 13 addictive properties of nicotine. 14, CHAIRMAN WAXrlAN : Thank you, Mr. Bruce. . ;: 15', MR. BRUCE: Thank you, Mr. Chairman. 16 CHAIRMAN WAXMAN: Mr. Bliley. 17 MR. BLILEY: Thank you, Mr. Chairman. 18 Dr. Koop, you have no treatment experience with 19 helping hard drug addicts or smokers attempting to quit, do 20 you? 21, DR. KOOP: Yes, matter of fact, I do, sir. I was 22. a surgeon with a broader understanding of medicine than just i 23 the surgical specialty. I have worked with drug addicts 24 over the years and since I have been involved in the 25 problems this country has with AIDS, I have been working TIMN 0025483 ACE-FEDERAL REPORTERS, INC. II 202-347-3700 Nationwide Coverage I~ 800-336-6646

,FO10 03 03 33 OMT/bc 1 with addicts not only in this country but also in Amsterdam 2 and in London and in two cities in Scotland. 3 I'm not a therapist, but I do have more than a 5 passing knowledge of these people. MR. BLILEY: Doctor, you use this term - "addiction". I want to read to you a statement and ask for your comment on it. This is a statement that was made by Professor Albert Hirsch, author of the report on Tobacco to the French 10 Minister of Health last October, and a vocal critic of the 11 tobacco industry. 12 Do you know Professor Hirsch? 13 DR. KOOP: By name. 14 MR. BLILEY: On Tuesday, May 17th of this year, 15 in an interview with French radio, Dr. Hirsch said -- 16 Professor Hirsch said, quote: 17 "Tobacco cannot be compared to drugs, especially 18 hard drugs like heroin or other narcotics. It is always bad 19 to fight an evil with misstatements or distortions of the 20 truth. It is completely excessive. We know that dependence 21 on a substance in tobacco, nicotine, for example, only ~ 22. accounts for the motivation in smoking about 10 percent, or 23 at most 20 percent of all smokers. 24 Therefore, talk of addiction would mean comparing 25 tobacco to something which completely alters the personality TIMN 0025484 ~i ACE-FEDERAL REPORTERS, INC. ~~ 202-347-3700 Nationwide Coverage 800-336-6646

A010 03 03 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 34 of the subjects, turning them into anti-social individuals, which we know is not the case with the overwhelming majority of smokers. We should resist this kind of discrimination and witch-hunt that can be observed in some of the excesses of the anti-tobacco campaign in the United States." DR. KOOP: My comment to that, sir, is that Dr. Hirsch, for all of his credentials and fame, has confused two things: ~ Addiction, on which he is absolutely incorrect in that statement; and the effects of hard drugs on the personality of individuals. They are separate. MR. BLILEY: Does the American Psychiatric Association use the term "addiction" when referring to tobacco? DR. KOOP: It lists it as a substance -- does it call it addiction? I think it does, I think. DR. YOUNG: Uses the term "dependence producing," which is used in technical and medical literature. 21: But, the National Institute on Drug Abuse, when' 22,; it's important to communicate information, uses the term 23 "addiction", whether it's to describe nicotine or cocaine. 241 MR. BLILEY: Dr. Young, you have made known your 25. concerns over the resource requirements that would be TIMN 0025485 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Na[ion wide Coverage 800-336-6646

9010 03 03 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 35 imposed on FDA as a result of enactment of the Medical Device Amendments, which just passed the House. What would be the resource impact on FDA if legislation giving FDA jurisdiction o,%er tobacco was passed? DR. YOUNG: We do not have the technical expertise at this time for the evaluation of the variety of additives that Dr. Koop mentioned, as well as the detailed scientific base to focus on the regulation of a product of this complexity. 22,. It was released at that time with great fanfare. 23 Can you shed some light on the coincidence of the timing of 24 the release of the report with the climax of the Chippalone 25 trial? Thus, it would be substantial resource requirements. I would also comment, as Mr. Bruce did, that I'm trying to be as objective as I can. And I have carefully said that we are looking at the petitions and, thus, all the options are open to the agency and we are not prejudging the issue. MR. BLILEY: Thank you.- Dr. Henningfield -- I'm sorry. Dr. Koop, your report on Addiction was the 1987 Report of the Surgeon General. And, yet, it was not released until May 1988, only a few days before the jury in the Chippalone case retired to begin its deliberations. TIMN 0025486 II ACE-FEDERAL REPORTERS, INC. !! 202-347-3700 Nationwide Coverage 800-336-6646

4010 03 03 36 OMT/bc 1 DR. KOOP: Yes. All of the reports that we 2 release on smoking and health are released with what you 3 call fanfare, sir. There was absolutely no p:Lanning on our 4 part to makFg those two dates coincide. 5 The reason that our report was late was because 6 the Office of Smoking Health was taken out of the Office of 7 the Assistant Secretary for Health, was placed in the 8 10 Centers for Disease Control without any moving geographically of that office. In addition, we brought on Dr. Ronald Davis to 11 head that department. With all of those changes, it was not 12 possible, when you consider the size of the effort to get 13 this report out, to produce it at the usual date in November 14 or December of 1987. 15~; Therefore, it came out in the spring of 1988. 16.; But, the date for that was chosen far in advance of any 17 knowledge that we had that there was to be such a thing as 18 , the Chippalone trial in New Jersey. 19 CHAIRMAN WAXMAN: Thank you, Mr. Bliley. Your 20 time is expired. 21 The Chair recognizes himself for five minutes. 22,; Dr. Koop and Dr. Henningfield, the tobacco 23 industry contends that your use of the term "addiction" to 24' apply to nicotine trivializes and almost mocks the serious 25' narcotic and other hard drug problems faced by society and TIMN 0025487 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nacion wide Coverage 800-336-6646

9010 03 03 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25; 37 undermines efforts to combat drug abuse. Dr. Koop, how do you respond? DR. KOOP: I don't agree with that. I think that the huge report that we produced made very clear that two terms are interchangeable -- dependence and addiction -- as Dr. Henningfield has already mentioned, because the public understands addiction and the scientists use the word dependence, we use them in the report interchangeably. But, we stand on the record that the pharmacological and physical aspects of addiction and withdrawal are exactly the same for hard drugs that you've mentioned as nicotine. And I don't think it trivializes the addictive problem in hard drugs. But, what it does is to bring to the attention of the public that smokers who are addicted are not just people who don't have the will-power to kick a dirty habit. These are people who really are depended in every true, medical sense of the term. And when they understand that, that they will seek help. And I think it also provides a better understanding on the part of the public as to why they continue to smoke when they, themselves, would like to quit. CHAIRMAN WAXMAN: Dr. Henningfield, the industry believes that there are no more similarities between nicotine and heroin than, say, nicotine and caffeine. They TIMN 0025488 ~; II ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

ti010 03 03 . i OMT/bc 1 2 3 4 5 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 38 state there's no substantial scientific evidence that smoking creates a physical dependence to nicotine. The specificity of the effect still after many hundreds of studies is still relatively unknown and variable. How do you respond? DR. HENNINGFIELD: The fact is, sir, that if we're being objective, we cannot avoid the comparison among those drugs. They a-ll produce tolerance, physical dependence. They're psycho-active drugs. Nicotine also can intoxicate. The reason we don't see it is because users become so highly tolerant. In addition, the data regarding nicotine go back 25;: nicotine other than cigarettes. to the turn of the century. Much of what we know about the functioning of the nervous system goes back to nicotine studies. These results in that sense are not fundamentally new. We have-reconfirmed findings that have been about for many decades. Now we have all of us -- we all think of cigarettes when we think about nicotine. This has been the primary way that people have become addicted to the habit that has produced this dependency. There are alternative delivery systems for TIMN 0025489 II ACE-FEDERAL REPORTERS, INC. ° 202 347-3700 Nationwide Coverage I~ 800-336-6646

4010 03 03 OMT/bc 1 2 3 4 5 6 7 9- 10 11 12 13 39 Dr. Koop, your report specifically addressed concerns over the safety of these alternative nicotine delivery systems. What products are we t=lking about when we talk about alternative delivery systems? DR. KOOP: Well, the products have been proposed from time to time. And Dr. Young is much more knowledgeable about these than I am. One that i have seen recently is that produced by R.J. Reynolds, which is a smokeless kind of cigarette, which produces a tremendous ignition temperature, contains nicotine as a drug in the cigarette-shaped dispenser; contains tobacco to give flavor but does not produce a smoke 14' that is taken into the lungs of the user. 15;; Instead, it produces a jolt of nicotine, which 16.: provides the addictive-producing problem of cigarettes 17 without some of the smoke that goes with it. 18.' CHAIRMAN WAXMAN: How about chewing gum with 19 nicotine? Is that another alternative delivery system? 20~. DR. KOOP: There is on the market, sir, a gum 21.; that contains nicotine, which was produced as a riicotine ,. 22,i delivery system in order i. 23 to smoking away from the 24; And it is not 251. It is a crutch for those to wean patients who are addicted nicotine in that delivery system. meant to be used in any other way. people who have made the decision TIMN 0025490 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nation wide Coverage 800-336-6646

'O10 03 03 40 OMT/bc 1 to quit and are trying to come off and are fighting the 2 problems of addiction. 3 CHAIRMAN WAXMAN: Now, that's been approved by 4 the Foo3 and Drug Administration as a -- 5 7 DR. KOOP: Yes, sir. CHAIRMAN WAXMAN: As a drug. And yet they found safety and efficacy in using it as an alternative to wean 8 away from cigarette smoking. 9 If we end•up with this so-called smokeless 10 tobacco, that would be a delivery system for nicotine as 11 well. 12 Are you concerned that rather than that be a way 13 to wean people off smoking it will be an alternative that 14 people will become addicted to and use as frequently as 15 smoking? 16 DR. KOOP: I don't know what all of the intent 17 was of the manufacturer. I don't believe that: that is a 18 good weaning device because it is attempting to assimilate 19 all of the other pleasurable things that go with the process 20 of smoking a cylinder that you hold in your hands and put in 21 your mouth. 22;; So I would not put that in the same category as a li 23 beneficial use of nicotine to treat addiction as I would the 24 nicotine gum. 25": CHAIRMAN WAXMAN: Gentlemen, I have additional !i TIMN 0025491 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 03 03 41 OMT/bc 1 questions and I'd like to submit those questions to you in 2 writing and have you respond. And I think you ought to have 3 the opportunity for other members to submit written 4 questions for a written response for the record as well. 5 7 8 10 Each member has had an opportunity to question you for one round and we'll perhaps be able to complete the record through these written interrogatories that will be in the record. I thank you very much for being with us.. We look forward to working with you. 11 DR. KOOP: We will answer your questions, sir, 12 and we appreciate your understanding about our other 13 problem. 14 CHAIRMAN WAXC+IAN : Thank you very much . 15 (Pause.) 16:. CHAIRMAN WAXMAN: Our second panel of witnesses 17 will present testimony on the potential health ramifications 18 of nicotine in general and the proposed smokeless cigarette 19 in particular. 20 Bi11.Schultz is an attorney with Public Citizen 21 Litigation Group. - 22 . Scott Ballin is Chairman of the Coalition.on ; 23! Smoking OR Health. 24 25: Jersey. n John Slade is a physician from New Brunswick, New TIMN 0025492 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

ti010 03 03 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13. 14 15' 16 17 18 19 20 21 22, 23 42 Greg Connolly is a representative of the American Public Health Association. I'd like to ask them to come forward. (Pause.) CHAIRMAN WAXMAN: We want to welcome you to our Subcommittee hearing today. Your prepared statements will be made part of the record in full. We'd like to ask you to limit your oral presentation to us to no more than five minutes. 24". CHAIRMAN WAXMAN: Could you pull the microphone a Mr. Ballin, why don't you begin? STATEMENT OF MR. SCOTT BALLIN, CHAIRMAN, COALITION ON SMOKING OR HEALTH MR. BALLIN: Thank you, Mr. Chairman. My name is Scott Ballin, Vice-President of Legislative Counsel for the American Heart Association. But, today, I appear before this Subcommittee on behalf of the Coalition on Smoking OR Health, which is comprised of the American Lung Association, the American Cancer Society and the American Heart Association. There are three reasons why this hearing is important today. First is the conclusive finding that nicotine in tobacco is an addictive substance. : Second -- 2 5 '• little closer? We're having trouble hearing you up here. TIMN 0025493 ACE=FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 03 03 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22,. 23' 24 25: 43 MR. BALLIN: How's that? CHAIRMAN WAXMAN: Much better. MR. BALLIN: Second, previously undisclosed tobacco industry documents rPveal that the tobacco industry has long been aware of the addictive nature of tobacco products, and that there was a need to develop products which the public would perceive as safer. And the tobacco industry has marketed its products with the intention that their products be drug delivery systems. These documents were produced and released only after a federal court order in 'the Chippalone case. For example, in 1972, in a research report by William L. Dunn, a high-level researcher for Phillip Morris, it was stated that: "A cigarette should be conceived not as a product, but as a package. And the product is nicotine. The cigarette is but one of many packaged layers. Think of the cigarette pack as a storage container for a day's supply of nicotine. Think of the cigarette as a dispenser for a dose unit of nicotine. Think of a puff of smoke as the vehicle of nicotine." In another report released by Phillip Morris, a confidential report, it's further stated that: "Even though nicotine is believed essential to TIMN 0025494 I` ACE-FEDERAL REPORTERS, INC. ii ?02-347-3700 Nationwide Coverage 800-336-6646

9010 03 03 44 OMT/bc 1 cigarette acceptability, a reduction in the level may'be 2 desirable for medical reasons." 3 Phillip Morris and the other tobacco companies 4 have done everything they can to suppress the release of 5 their own internal research memoranda and to publicly 6 portray as frivolous the scientific evidence that tobacco 7 use is a form of addiction, despite their knowledge to the 8 contrary. 9 The third-reason why these hearings are extremely 10 timely is that we have recently seen the announcement of the 11 introduction of a variety of new alternate nicotine delivery 12 systems designed to further abuse the traditional reluctance 13 of the FDA to assert its jurisdiction over tobacco-related 14 products. 15Last fall, the R.J. Reynolds Tobacco Company 16 announced its intention of introducing a new product, which 17 it labeled a "smokeless cigarette". In fact, this product 18 is nothing more than a cleverly-designed alternate nicotine 19 delivery system designed to try to circumvent the authority 20. of FDA. 21. You will hear this product described by other 22, witnesses thi.s morning, so I will not go into the details. i~ 23 But I want to emphasize that we view this product as clearly 24" falling into the statutory definition of "drugs" under the 25 ~ Food, Drug and Cosmetic Act. .~i J TIMN 0025495 ° ACE-FEDERAL REPORTERS, INC. I 202-347-3700 Nationwide Coverage I~ 800-33fr6646

'110 03 03 45 OMT/bc 1 No matter how carefully and how cleverly R.J.R 2 tailors its public statements about this product, there can 3 be no question that the product is intended to be used as a 4 nicotine delivery system, and it is intended to affect the 5 functions and structure of the body, as well as being 6 intended to be marketed to consumers who will believe that 7 this product will help them avoid the risks of disease 8 associated with smoking. 9 Ed Horg, Chairman and Chief Executive Officer of 10 R.J. Reynolds, publicly stated, and I quote: 11 "Since the tobacco does not burn, the majority of 12 the compounds produced by burning tobacco are eliminated or 13 greatly reduced, including most compounds that are often 14' associated with the smoking and health controversy." 15;~ We believe it will be well-received by those 16 people who object to tobacco smoke.. No one responsible for 17 protecting the public's health or welfare has any knowledge 18 or control over what chemicals have been or w:i.ll be included 19 in the so-called flavoring capsules. 20 We believe that the FDA has authority to take 21 jurisdiction against products like this. Despite the fact' 22, that cigarettes contain nicotine, are designed to have their 23' by-product inhaled into the bodies of consumers, and have 24 not explicitly been excluded from coverage by the FDA, 25.: historically, the FDA has not chosen to exert jurisdiction TIMN 0025496 II ACE-FEDERAL REPORTERS, INC. Nationwide Coverage I I 202_ 347-?7O0 800-336-6646

4010 03 03 OMT/bc 1 2 3 4 5 6 7 8 10 11 12* 13 14 15 16 17 18 19 20 21 22 23 24 25 46 over traditional tobacco products which are sold for smoking pleasure only. However, the FDA has and should assert jurisdiction over tobacco products when health claims are made for these products, or they otherwise meet the definitional standards of drugs under the act. The legislative history of the Food, Drug and Cosmetic Act clearly shows that Congress intended the definition of the term "drug" to be broad and not to be mutually exclusive. United States versus 46 Cartons of Fairfax Cigarettes, a 1950 case, which remains the law today, is instructive. In that case, the particular cigarettes were being marketed with the suggestion that they were effective in preventing certain diseases. The manufacturer contended that the cigarettes were only sold only to increase one's smoking pleasure, not unlike the same kind of specious claims we hear from the industry today. The court saw through the charade. As the court saw the issue, the question was whether the public, having' in the mind the specious statements of belief would buy these cigarettes for smoking pleasure or with the hope of mitigating or curing disease. In conclusion, Mr. Chairman, let me make two TIMN 0025497 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9R 10 03 03 47 OMT/bc 1 points. We think that the information that has been 2 presented so far this morning and will be presented leads to 3 two inescapable conclusions. 4 First, that the Food and Drug Administration 5 already has sufficient legal authority and power to regulate 6 cigarettes which make or imply health claims, and also the 7 new alternative nicotine delivery systems. 8 The failure of the Food and Drug Administration 9 to assert this authority will inevitably and unnecessarily 10 further jeopardize the health and safety of the American 11 public. 12. And, two -- 13 CHAIRMAN WAXMAN: Mr. Ballin, if you're reading 14' from your statement, that statement is going to be in the 15 record. We have to move on. 16 Thank you very much. 17 Mr. Schultz. 18 STATEMENT OF MR. BILL SCHULTZ, ATTORNEY, 19 PUBLIC CITIZEN LITIGATION GROUP 20.. MR. SCHULTZ: Thank you, Mr. Chairman. 21;. I was asked to testify on the question of whether 22.. R-.J. Reynolds' new tobacco product could be classified as a 23 ` drug within the meaning of •the Food, Drug and Cosmetic Act. 24'' As the Committee -- as the Subcommittee well 25 knows, traditional tobacco products have not been subject to TIMN 0025498 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nation wide Coverage 800-336-6646

4r)10 04 04 48 OMT/bc 1 the jurisdiction of the Food and Drug Administration either 2 as foods or as drugs. And there are really two main reasons 3 for this. 4 One is a historical reason. Congress 5 historically treated tobacco separately and the FDA has 6 concluded that, historically, Congress did not intend 7 traditional cigarettes to be regulated as drugs or foods by 8 the FDA. 9 But the second reason is equally important and 10 that is the FDA has made this decision as a matter of its 11 discretion. There are a wide range of decisions or options 12 that the FDA can choose on a variety of issues and where 13 either option would be upheld by the courts. 14; I cited the principal cases in my testimony, but 15' this is a point that I can't emphasize enough„ Even in the 16; famous action on Smoking and Health case, where the FDA was 17 asked to regulate all cigarettes as drugs, when the agency's 18 decision not to do so was reviewed by the court, the court 19. didn't conclude, as many seemed to think, that cigarettes 20;are not drugs. That's not what it said. 21; What the court said is: 221; The FDA has a lot of discretion in this area and iI 23', we don't think it's abused its discretion. 24'' Now, there are two basic theories on which the i: . 25 ; FDA could regulate R.J. Reynolds' new product. And I want JI TIMN 0025499 ~ ACE-FEDERAL REPORTERS, INC. II 202-347-3700 Nationwide Coverage II 800-336-6646

9010 04 04 49 OMT/bc 1 to emphasize that these are separate and if the agency were 2 to reach either conclusion, that would be sufficient to 3 justify regulation. 4 The first one is the agency conclude that this is 5 simply not a conventional cigarette. I included a diagram 6 of the product in my testimony; I believe there's a diagram 7 also included in the written testimony of the witness for 8 R.J. Reynolds. 9 But the diagram shows I think to anybody looking 10 at it that this is a very different product from a 11 conventional cigarette. It's a lot more complicated. It 12 has various filters. It has a flavor capsule. The tobacco 13 doesn't burn. And so on. 14~ It looks like a cigarette on the outside, but it 15 looks very little like a cigarette on the inside. Based on 16 that, the FDA concluded that this is not the traditional 17 kind of cigarette that Congress intended to exempt and, 18. therefore, it could classify the product as a drug subject 19 to regulation under the statute. 20 The second theory is quite different. Even if 21 the FDA -- even if this were a traditional cigarette, the 22., agency still.has to look at the question of whether R.J. 23 Reynolds is making health claims. 24 The closest example is, 20 years ago, a company 25 tried to sell cigarettes as a weight-reducing agent. It TIMN 0025500 II ACE-FEDERAL REPORTERS, INC. II 202-?47-3700 yationa•ide Coverage 800-336-6646

9010 04 04 50 OMT/bc 1 advertised: You take this product and you can lose weight. 2 The FDA said, Well, when you make that kind of 3 claim, that turns your cigarette into a drug. It prohibited 4 the product and was upheld in court. 5 Here R.J. Reynolds has walked a tightrope between 6 cigarette and drug. And I think a look at its press release 7 and other materials shows that, in fact, it.really has made 8 health claims for its product. 9 One of the comments by the chairman was read by 10 the previous witness, so I won't repeat it. But, on pages 11 one to two of the addendum to our testimony, we have 12 collected the various places where R.J. Reynolds has said 13 something to the effect that: 14: We believe that this product addresses the health 15`' concerns of tobacco consumers. 16 And there's even one place where an attorney for 17 R.J. Reynolds in a meeting with federal government officials 18 explicitly stated that this product should provide important 19 health benefits by reducing the risk of cancer in smokers. 20 So it's quite clear I think to any observer that 21 the reason the company is marketing this product is because 22, it believes people may buy it because they think it's safer. 23 And that is the justification -- could provide a 24 justification for FDA regulation. 2 5 .I ;i II Equally important is the perception how others, TIMN 0025501 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

A010 04 04 OMT/bc 1 2 3 4 5 7 8 9 10 11 12 13 14 15 16' 17 18 19 20 51 the press and others, have interpreted R.J. Reynolds statement. And we've collected quotations from the Washington Post, the Wall Street Journal and the New York Times on the last paVe -- two pages -- of our addendum, but I think they show that the statements have been interpreted just as R.J. Reynolds intended. I have made some other points in my prepared testimony, but I see that my time is up and so I'll conclude my oral statement. . CHAIRMAN WAXMAN: Thank you very much, Mr. Schultz. Dr. Connolly. STATEMENT OF DR. GREGORY'N. CONNOLLY, DMD, MPH, AMERICAN PUBLIC HEALTH ASSOCIATION DR. CONNOLLY: Thank you, Mr. CHAIRMAN WAXMAN: The mike is on and pull it right over to you. DR. CONNOLLY: My name is Gregory Connolly. I'm Director of the Office for Nonsmoking and Health for the Massachusetts Department of Public Health. I'm representing 21,. the American Public Health Association, which is a co- 22:; petitioner with the AMA and the American Dental Association ', 23 to require regulation by FDA of a smokeless tobacco product. 24 ' I'd like to go back to history a bit with tobacco 25 ' products. When FDA was first established in 1906, tobacco i! TIMN 0025502 iI ACE-FEDERAL REPORTERS, INC. i~ 202-347-3700 Nationwide Coverage 8p0_336-6646

FO10 04 04 52 OMT/bc 1 was used primarily by adult males who chewed tobacco, smoked 2 cigars and dipped snuff. The cigarette was new. It came in 3 a few years earlier and it was primarily popular with 4 a.dolescent boys. In fact, in 1906, six States had banned 5 the cigarette because of the high use by boys. 7 The exemption allowed the industry to proactively introduce new forms of tobacco and new products without 8 regulation. I think your predecessors here in 1906 would 9 never have dreamed that this product, the RJR smokeless 10 cigarette, this high-tech nicotine delivery device would be 11 allowed in the market without proper safety efficacy 12 testing. 13 Well, the industry used the exemption first to 14' bring in the Camel cigarette. And.after 70 years, it's 15 still killing -- not smoking. And this was an ideal product 16 for deep inhalation. People could inhale this, particularly 17 females. This allowed the spread of the smoking epidemic to 18 females. 19 After that, we brought in the filtered cigarette. 20 I have an ad here for the Kent filter, which, much like 35 21 years ago, I'm sure the manufacturer said: This is our new 22 miracle filter. And it says here "For Health Protection." 23 Well, one of the tragedies about the Kent filter, 24 it had something called .asbestos in it. In Massachusetts, 25 : unfortunately, we had the asbestos plant in our State. We TIMN 0025503 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4n10 04 04 53 ' OMT/bc 1 just finished a cohort study of the 35 workers in the Kent 2 micronite filter plant: 29 are dead, four are suffering 3 from asbestosis and the 13 billion filtered with asbestos 4 cigarettes sold in the United States of America, we have no 5 idea where those millions of consumers are today relative to 6 their health effects. 7 If we had tested the filter in 1954 for safety 8 and efficacy, we could have saved many of those men and 9 other people. 10 Then we brought in the light cigarette. And we 11 found out that filters didn't work. And the light cigarette 12 supposedly reduced risk to heart disease and cancer and 13 stroke. 14 I just want to talk about hypocrisy. This is a 15 package of lights not from the United States but from the 16 Philippines,.and the tar and nicotine content in this 17 product is twice that sold in the same light sold in the 18 United States of America. 19 It's hypocrisy they're selling overseas, and it's 20 hypocrisy they're doing today. 21. Finally, we realized there was no safe form of 22 tobacco. What did the industry do? They brought back ~ 23 smokeless tobacco, because we know the cigarette wasn't 24 safe. 25: But, this time used the exemption to develop a TIMN 0025504 I i II ACE-FEDERAL REPORTERS, INC. H 202-347-3700 Nationwide Coverage 800.336-664b

`110 04 04 -OMT/bc 1 2 3 4 5 6 7 8 9- 10 11 12 13 54 high-tech nicotine delivery device called the Skull Bandit. Good American know-how was used to drop the nicotine content from 14 milligrams to 4 milligrams, to allow dependence to occur among young people. And could I have that chart with the effects of that marketing program? • If you look at the chart, in 1970, the highest use rates were adult males. We can tolerate that. They can die off and we're not worried. But, after 15 years of good marketing by the industry using the exemption to develop specific products as part of a graduation strategy where these people are pushed up over time to higher nicotine brands, we had an epidemic of use among our young people. 14 The new products we have is the RJR smokeless 15;! cigarette. Believe me, this looks like an 18-•speed bike 16: compared to this product. This is like a tricycle for 17 teenagers. When the teenagers of America get a hold of this 18 product, that chart is going to go off the board. 19 What are our concerns with this product? 20 ' Well, if you ask RJR what's in•it, they tell you: 21 According to this chart, a lot of tobacco in a small flavor 22 capsule. ~~ 231 Well, I really have a hard time buying that, so I 24 took an x-ray of the product and looked inside. 25!; May I have the next chart, please? TIMN 0025505 ACE-FEDERAL REPORTERS, INC. 202-347-3700 ti ationwide Coverage * 800-336-6646

G~10 04 04 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1~ ~ '17 18 19 20 21 22 23 24 25: ij ~ iI 55 And according to that, you've got a much larger flavor capsule than what we see in this chart here. And in this product, they apparently forgot to put the tobacco in. And what do we have? U;e have a carbon fuel element at one end, which is ignited with some high-tech rods that go into a flavor capsule that looks like a set of bebes. It looks like something James Bond would use when he wants to kill one of his foes, and these bebes then blow in the back of his head. But these are flavor crystals. And the product has a flavoring agent, which RJR calls nicotine. Well, what's going to prevent RJR from taking the flavoring agent, nicotine, and putting it in Nabisco Shredded Wheat in a few years and having compulsive breakfast eaters? (Laughter.) There's little tobacco in that product. It's only there for regulatory exemption. It's a Reub Goldberg approach to give Americans nicotine, but more importantly, to give RJR an exemption from appropriate health and safety testing. We're concerned with this product because it still delivers carbon monoxide to users; RJR is not going to test the effects of carbon monoxide. We're concerned because this will be available to kids in this country in the convenience stores of America, where they can pick it up TIMN 0025506 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 202-347-3700 800-336-6646

4')10 04 04 56 OMT/bc 1 and become dependent upon nicotine. 2 We're concerned because many smokers who may want 3 to quit will see this as a cheap cessation device but only 4 be hooked on it. 5 And I would conclude, Mr. Waxman, with saying 6 that: 7 If this goes on the marketplace, the adult 8 smokers will probably suffer. But who will lose the most 9 but the American child. We have 75 million Americans in 10 this country, children below aged 20. Based on current 11 smoking rates, 25 million will take up the practice and five 12 million will be killed by the cigarette. 13 On their behalf, I would request FDA to act on 14 this petition. 15: Thank you, Mr. Chairman. 16 :; CHAIRMAN WAXMAN : Thank you very much, Dr. 17 Connolly. 18 Dr. Slake. 19 STATEMENT OF DR. JOHN SLADE, M.D., 20 ST. PETER'S MEDICAL CENTER 21 . NEW BRUNSWICK, NEW JERSEY 22,. DR. SLADE: Thank you, Mr. Chairman. 23 I'm a physician who treats addictive diseases. 24 And I also teach others how to treat them as well, and my 25: special interests are alcoholism and nicotine addiction. TIMN 0025507 ACE-FEDERAL REPORTERS, INC. 202-347-3700 - Nation wide Coverage 800-336-6646

&010 04 04 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16; 17 18 19 20 21 22 23 24 25 57 I'd like to in my few minutes provide a clinical dimension to what Dr. Koop and Dr. Henningfield have said about nicotine addiction and then finally share my profound concerns as a clinician and as a public health worker about the R.J. Reynolds nicotine inhaler. Nicotine addiction is the most common serious medical condition in the country if you figure that more than a quarter of adults smoke and about a thousand people a day die from nicotine, complications of nicotine addiction. It's also primarily a pediatric disease. Nine out of 10 adult smokers start in their childhood or adolescents. The average age for first cigarette is age 13 and, in New Jersey, about 20 percent of high school seniors smoke every day and another 20 percent smoke less than every . day. Seventy percent of teenagers who smoke want to quit exactly like the adults who smoke would 7Like to quit. Quitting involves a dynamic tension between the processes of thinking about not smoking and the processes of thinking about the things that are good and enjoyable about smoking. It's not a straightforward decision that someone wakes up one morning and says, "I don't want to smoke any more," although that's the way many people remember it. The cigarette companies know that there's a major dilemma about whether to smoke or not to smoke, even though TIMN 0025508 202-347-3700 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 800-336-6646

'~10 04 04 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15, 16 17 18 19 20 21 22. 58 their advertising is supposedly only directed at choosing a brand. An advertisement for R.J. Reynolds product 12 years ago called Vantage says: "To smoke or not to smoke." Or the second ad that I have from Vantage has a similar message. It says: "How many times have you decided to give up smoking?" And, pretty clearly, the ad is directed at people who are trying or thinking about quitting. I've given to.the staff copies of this book called, "If Only I Could Quit," which contained 24 personal stories of recovery from nicotine addiction. And these 24 individuals describe the ways in which they were trapped by smoking and what it took for them after trying time and again to finally stop and what their lives have been like after they've stopped. The Surgeon General's Report had as one of its recommendations that new nicotine delivery systems should be evaluated for their toxic and addictive effects. The next chart shows a drawing of, this product, as Dr. Connolly described, and you see the carbon fuel element-, the use of 23 charcoal leading to the aluminum chamber that contains the 24 mixture.of glycerine and nicotine, that people can inhale 2 5 1 . this, and this glycerine and nicotine solution. TIMN 0025509 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

"110 04 04 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13 59 R.J. Reynolds has been very close-mouthed about the exact data of results of this. They published a series of abstracts at the Society of Toxicology in February. The next chart shows some of their data in rats comparing rats inhaling cigarette smoke versus rats inhaling aerosol. And you see that the rats inhaling the aerosol continue to breathe just as well as rats not -- just breathing regular room air. But those with cigarette smoke cut down on their breathing because they're irritated by the smoke. The next chart shows the nicotine levels in rats in the same apparatus comparing -- no, you took two off -- comparing the nicotine levels and the nicotine levels in 22„ 21 devised. 14 levels in the rats exposed to the aerosol, suggesting that 15,: this is a much more efficient way to get nicotine in the 16 ; body and may well prove to be the m•ost addictive form of 17 nicotine ever developed. 18 The next chart outlines the major problems I see 19 from this device. The first is just what I've said, that 20 this may well be the most addictive form of nicotine ever ' cigarette smoking rats are much lower than the nicotine The second, that this inhaler will be attractive 23 to novice smokers. It will look and appear safe; it will be 24' high-tech; it will be a neat thing to try out. And very 25; likely lead a lot of them to continue to use. TIMN 0025510 ACE-FEDERAL REPORTERS, INC. 202-347-3700 '`tationwide Coverage g00-336-6646

4010 04 04 OMT/bc 1 2 3 4 5 6 7 8 9- 10 11 12 13 14 15 16 17 18 19 20 21 22 23' 24' 25 60 Third, the inhaler will make abstinence less attractive for smokers. It will make it less likely that people will decide to quit; rather they will shift over to this device. Fourth, clean air rules are designed to help nonsmokers protect themselves from tobacco smoke pollution, but a lot of people who smoke take advantage of those to stop smoking themselves. Such an inhaler will, make it -- if it's used in nonsmoking areas, will make it less easy for people to take advantage of Clean Air rules to stop smoking themselves when that's what they want to do. Fifth -- three more points, please. CHAIRMAN WAXKAN: Better do it in one minute. DR. CONNOLLY: Okay. ; (Laughter.) : DR. CONNOLLY: The inhaler may promote relapse to active nicotine dependence among people who used to smoke and see this as an attractive way to get back into using. Sixth, the inhaler will deliver nicotine and carbon monoxide. The Surgeon General's report outlines the ways in which nicotine itself is dangerous as a producer of chronic disease and carbon monoxide with nicotine are suspected of being the major components to produce heart disease and to produce maternal fetal damage in the pregnant woman. TIMN 0025511 I ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4'110 04 04 61 OMT/bc 1 And, finally, the inhaler potentially is user- 2 modifiable to deliver other drugs, although nobody outside 3 of R.J. Reynolds has examples of the product to look at 4 themselves. 5 Thank you very much. 6 CHAIRMAN WAXMAN: Thank you, Dr. Slade. 7 Start the questioning. I want to recognize Mr. 8 Scheuer. 9 MR. SCHEUER: Thank you, Mr. Chairman. 10 Dr. Connolly, did I understand you correctly to 11 say that of the youth cohort in our country of roughly 25 12 million people, that five million of them are going to die 13 of cigarettes? ' 14 DR. CONNOLLY: There are 75 million persons alive 15 in the United States today below aged 20, based on high 16 school -- 17 MR. SCHEUER: How many million? 18 DR. CONNOLLY: Seventy-five million below aged 19 20, based on current smoking prevalence rates among high 200 school students as reported by NIDA, we would expect 25 21 million to take up cigarette smoking. 22 . Based on that and current deaths from smoking, we 23'i would expect five million to be killed by the cigarette, far 24' more than will ever be killed by AIDS, cocaine, heroin 25 " combined. TIMN 0025512 i' II ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

0010 04 04 OMT/bc 1 2 3 4 5 6 7 9- 10 11 12 13 14: 15 16 17 18 19 20 21; 22 23 24 62 MR. SCHEUER: And you're saying that 20 percent of those who take up smoking will die from smoking? DR. CONNOLLY: Correct. Some data would suggest one out of four smokers, possibly somewh:it higher will be killed by cigarette smoking. MR. SCHEUER: Well, that's a staggering figure. It's a horrifying figure. As you know, we have required all kinds of warnings. I won't give you the whole history of the warnings. Congressman Waxman had some legislation a couple of years ago that changed the warnings because people were getting sort of accustomed to them. So, now we rotate the warnings. Has all of this accomplished anything? And if not, what is there -- and I would open this up to any of the members of the panel -- what can our society do to bring this appalling statistical probability to the attention of the 25 million young people -- 25 of the 75 million young people among us -- who smoke? Particularly in view of the several billion dollars a year that the tobacco companies spend in advertising,. and particularly in view of the fact that young girls seem to be the only cohort in our society, the only demographic group that is increasing in smoking, what do we 25`' do to address the young people, and particularly the young TIMN 0025513 202-347-3700 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 800-336-6646

`r)10 04 04 63 OMT/bc 1 2 3 girls? DR. CONNOLLY: Could I just make three brief comments? 4 5 Nurber one, every time our educational efforts catch u with t l t industr diti b t th d 6 p e y ra ona o acco pro s, uc just brings in something new and does an end run. So, 7 unless we regulate new products, we're going to be losing 8 this battle in the year 2010. 3 For current products, I think we have to restrict 10 marketing more in a drug model, that is, cut back on direct 11 marketing to consumer. We don't allow Emprin to be marketed 12 directly to the consumer. Cut down on free access by free 13 distribution, vending machines. Treat it more like a drug. 14;; So, for the current products, don't ban them but 155 treat their marketing more in a drug model. For new 16; products, don't let them.in. _ 17 CHAIRMP,N WAXMAN: Yes. 18' DR. CONNOLLY: I have a couple of modest 19 proposals. 20' CHAIRMAN WAXMAN: Yes, make them quick because I 21 t t -- h l wan o ear a so 22 DR. CONNOLLY: There's no information available 23 to consumers about what it is in tobacco, what the 4,000 24 substances are that cause cancer and other diseases. 25:. Congress could certainly make that kind of information i TIMN 0025514 ACE-FEDERAL REPORTERS, INC. 702-347-3700 Nationwide Coverage 500-336-6646

'110 04 04 OMT/bc 1 2 3 4 5 6 7 8 9 10 11 12 13' 14 15 16: 17 18 19 64 available and it might impress people. Secondly, people ought to have a chance. One of my concerns is that those who want to quit smoking will, instead of quitting, turn to a product such as this because they are misled into thinking it's safer. And if there's any doubt that the FDA has authority to exercise jurisdiction over this product, Congress ought to give the agency authority to exercise jurisdiction over products where companies are making these kinds of relative health claims. CHAIRMAN WAXMAN: Dr. Slade. DR. SLADE: Thank you, sir. I'm part of the Commission on Smoking OR Health, which has a set of recommendations about children and tobacco. Let me just...I have shared that with the Committee staff, and let me make three points from that. . First, our schools, including teachers' lounges, need to be smoke-free. There are signs all around our schools in New Jersey saying: Drug-free school zone. 20.` But that's only true for the three or four school 21 districts which are smoke-free. 22 Second, when we talk about drugs and alcohol, 23 nicotine has to be one of the drugs that we talk about up 24 front as part of the agenda on drugs and alcohol for all 25;, children. TIMN 0025515 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

`010 04 04 65 OMT/bc 1 And, third, you mentioned the tobacco industry's 2 advertising and marketing budgets. They spend about six 3 cents a pack on marketing. It would not be difficult for 4 the federal government and state governments to impose 5 excise taxes to vote the equivalent of six cents a pack on 6 counter-marketing. This approach is being tried in 7 Minnesota and in a number of countries around the world and 8 is a most effective means.of controlling this epidemic. 9 10 11 12 13 14, 15 16 17 18 19 20 21 22 23 24 25ii I TIMN 0025516 ACE-FEDERAL REPORTERS, INC. _0~ ~ 147-370(1 Nationwide Coverage _ 800-336-6646

"110 05 05 66 JOEpv 1 MR. SCHEUER: Thank you, Mr. Chairman. 2 CHAIRMAN WAXMAN: Thank you, Mr. Scheuer. 3 MR. WHITTAKER: Thank you, Mr. Chairman. 4 Mr. Ballin, do you think the FDA has the 5 authority to regulate all tobacco products if it really 6 wanted to, or do you think that legislation is needed to 7 specify and clarify FDA's authority over tobacco products? 8 MR. BALLIN: The Coalition's view is that we 9 believe FDA does have the authority to regulate tobacco 10 products that do make health claims, and we have filed 11 petitions with the FDA not only on the RJR product but also 12 low-tar, low-nicotine products as well. 13: With respect to the second part of your question, 14~: I think that legislation needs to be enacted that will 15 regulate all tobacco products in the same way we regulate 16' prescription drugs, both in the manufacture of those 17 products, the sale of those products, the distribution, and 18 the promotion. 19: MR. WHITTAKER: All right. 20 Dr. Slade, your written testimony indicates 21.. concern over the scientific community's access to details on 22:, data on R.J. Reynolds' new product. Yet in Mr. Cooper's 23 statement representing R.J. Reynolds, he states just the 24' opposite. 25i; Would you comment? TIMN 0025517 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 05 05 67 JOEpv 1 DR. SLADE: Certainly. To our knowledge, R.J. 2 Reynolds has made two attempts to communicate to the 3 scientific community. One was at a series of abstracts 4 presented at the Society of Toxicology in Texas in February 5 at a poster session, a poster session originally designed 6 for graduate student work. 7 Poster sessions are not fora for discussion. By 8 definition, it's a one-on-one kind of affair, and you don't 9 get an interchange, and it is not a peer-reviewed sort of 10 submission. 11 The other communication I am aware of are 12 invitation-only symposia for which R.J. Reynolds pays travel 13 expenses and gives a $750 honorarium to all participants. 14 At these symposia I have heard a rumor that R„J. Reynolds 15 discusses the ways in which this product in short-term tests 16~; looks-like an agent that doesn't ca.use cancer„ But I have 17 heard nothing about any information that addresses the 18 concerns I have brought to the committee today. 19 MR. WHITTAKER: Mr. Ballin, given the health 20 concerns about cigarettes and their addictive properties, 21 doesn't it make sense to develop a safer cigarette for those 222 individuals who are either unable to give up tobacco ~ 23 entirely or do not wish to? 24, MR. BALLIN: It may make sense, but do we know in 25; fact that these products are in fact safer? We don't know „ i ACE-FEDERAL REPORTERS, INC. (l 202_347-3700 Nationwide Coverage TIMN 0025518 800-336-6646

rr110 05 05 68 JOEpv 1 anything about these products, and that is the concern that 2 our organizations have. That is why we think that some 3 Federal agencies, be it the FDA or any other organization or 4 agency, needs to be looking at these products and subjecting 5 them to the tests as we do our foods and drugs. 6 MR. WHITTAKER: Further, from your testimony, I 7 assume that you strongly support the objective of the smoke- 8 free society by the year 2000. In your opinion, Mr. Ballin, 9 how are we progressing on achieving that goal, and how 10 should the Federal Government participate? 11 MR. BALLIN: I think there is a major change in 12,. the attitudes among smokers and nonsmokers in this country 13 and they are becoming more aware of the dangers of cigarette 14 smoking. I think the Surgeon General's report on nicotine 15. addiction has brought the seriousness of this product to the 16 attention of the American public. . 17 I think now we need to start focusing our 18 attention on the policy implications of how we go about 19 ensuring that this product is in fact regulated as a drug, 20 which the Surgeon General has branded it. That includes 21 such things as ensuring that minors don't have access to the 22 products either through vending machines or free sampling, 23 or restricting or prohibiting advertising. 24' We don't allow prescription drugs to be 25:: advertised because it would be drug pushing. But in fact, TIMN 0025519 ACE-FEDERAL REPORTERS, INC. 202z47 Z7q0 N acionwide Coverage 800-336-6646

`010 05 05 JOEpv 1 2 3 4 5 6 7 8 10 11 12 13 14 15;. 16`° 17. 18 19 20 21 22 ;; 23 24 69 tobacco is an addictive drug and in fact the advertising promotional activities of the industry is tantamount to drug pushing. I think we need to really seriously focus in on some of those activities. MR. WHITTAKER: Thank you. Thank you, Mr. Chairman. CHAIRMAN WAXMAN: Thank you, Mr. Whittaker. Mr. Bruce? MR. BRUCEi Thank you. Mr. Schultz, on page four of your statement you say that Action on Smoking and Health versus Harris held that, "The FDA has the discretion to exempt traditional cigarettes from its jurisdiction." That is a quote out of your testimony. Isn't it a fact that there was no discretion involved in that case? MR. SCHULTZ: I read the opinion fairly carefully, and the court held that the FDA's action was not arbitrary and capricious, and it talked quite a bit about how this was a matter for the FDA to determine and use its scientific judgment and so on. I read that as the court is saying that the FDA has the discretion here. The court did not really go further. 25;i MR. BRUCE: Did not the FDA hold as a legal TIMN 0025520 j ACE-FEDERAL REPORTERS, INC. ~ In?_147_i7no Nationwide Coverage 800-336-6646

r010 05 05 70 JOEpv 1 matter that it had no jurisdiction to assert and that, in 2 the absence of a therapeutic claim by cigarettes, they held 3 that they could not -- it wasn't discretion, they had no 4 legal authority? And didn't the court uphold that legal 5 determination? It wasn't a discretionary question; they 6 said they did not have jurisdiction? 7 MR. SCHULTZ: You may be correct in terms of what 8 the FDA said. 9 MR. BRUCE: Okay. 10 MR. SCHULTZ: But in terms of what the court 11 said, the court said this was a matter within the.FDA's 12 discretion. 13 .1 also think that in other contexts the FDA has 14 made it clear that health claims are not essential to 15 classifying a product within its regulation. This product 16, flavor, which was something that lo_oked like a cigarette but 17 basically gave you a shot of nicotine, I don't believe the 18, company there made any health claims, yet the FDA classified 19 the product as a drug subject to regulation. 20 21 I think it's useful to consider what if this product caused ten times the health problems of traditional cigarettes: ten times the cancer, ten times the heart 23 disease, and so on. Surely, the FDA there would have the 24 ' authority to regulate, and I think the type of analysis is 25 ;~ the same. TIMN 0025521 ACE-FEDERAL REPORTERS, INC. Coverage Nationwide 202-347-3700 800-336-6646

4010 05 05 71 JOEpv 1 MR. BRUCE: All right. The fact is that in 2 Action on Smoking Tobacco versus Harris the court held that 3 there was no legal basis and it wasn't discretionary. 4 On page five of your statement you have a diagram 5 of the new product, and you refer to the capsule as -- I 6 guess the company refers to it as a "flavor capsule," you 7 say it's a "nicotine capsule." 8 I take it you assume that nicotine is added to 10 the capsule? ' MR. SCHULTZ: Well, I realize that there are some 11 discrepancies not just between my testimony and the 12 company's testimony, but if you look through the various 13 submissions in the record, various people say the capsule 14: has nicotine, some people say it just has flavoring 15 components. 16'', I don't think it really matters. The point is we 17 don't know what's going to be in the capsule,'and one of the 18 reasons that the FDA ought to evaluate this question or that 19 some agency ought to evaluate it is so that we do find out 20. what will be in the product and an evaluation of its safety 21 is done. 22" MR. BRUCE: Mr. Schultz, let me ask you, do you 23 think that cigarette companies ought to try to develop a 24 safer cigarette, a cigarette that has less nicotine.and tar? 25;; MR. SCHULTZ: I think that that may be TIMN 0025522 202-747-1700 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 900-3 36-fib4fi

4010 05 05 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 .13 14' 15` 16, 17 18 19 20 21 22;; MR. BRUCE: I was just curious, if that is their i~ 23~ goal, as a public health official,'don't you think that 24~ would be a wise alternative for the people who are going to 25 'j smoke? TIMN 0025523 72 appropriate, yes. MR. BRUCE: All right. I think that's kind of basic to what we're really talking about. MR. SCHULTZ: Well, I'll tell you why I hesitate: because I think the best thing is for people to stop smoking, and I think in some sense it would be a shame if people who were going to stops smoking switched to a dangerous but less dangerous cigarette. On the other hand, if people who smoke are going to switch, then that's in the interest of the public health. But my point -- I haven't said anything about whether this product ought to be approved -- my whole point is it ought to be evaluated. Some agency -- and the FDA is the appropriate one here -- ought to make the determination as to whether in fact the product is safer. MR. BRUCE: Okay. Following up. on that, Dr. Connolly, I notice in your testimony, you state that Reynolds' cigarette -- and I quote -- "has been intentionally designed to prevent cancers associated with smoking conventional cigarettes." DR. CONNOLLY: Yes. ACE-FEDERAL REPORTERS, INC. ti ationwide Coverage R00-336-hh4F

`r)10 05 05 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 73 DR. CONNOLLY: Well, yes. MR. BRUCE: What is bad about a cigarette company developing a product, according to your own,quotation, that would prevent cancer associated with smoking? DR. CONNOLLY: Given the fact that we have more deaths from heart attack than we do from lung cancer, it's like jumping from the seventh floor rather than the tenth floor. I think if RJR can reduce the cancer risk, why not put it to the company to reduce the carbon monoxide risk, and do it publicly and do it through a regulatory agency, and then allow access to that product to come through a pharmacy as a smoking cessation device. Conceivably, this product could come into place and we could go from 33 percent of the adult population using nicotine to 80 percent in three or four years. So, I 17. think we should regulate it. ' 18 MR. BRUCE: But I am told that this cigarette 199 that is proposed would reduce nicotine intake by 92 percent, 20 and on your carbon monoxide question, it reduces it by 72 21. percent. 22" Now, having done that, would you not say that it 23 would be better for a smoker to convert or change or 24: whatever to a cigarette that reduces nicotine by 92 percent , 25ji: and carbon monoxide by 72 percent? TIIVIN 0025524 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'010 05 05 JOEpv 1 2 3 4 7 8 9 10 11 12 13 14 15„ 16: 17 18 19 20 21 74 DR. CONNOLLY: Well, I am happy the industry is talking with you. I wish they had given me the same data and let me take a look at it and let our health department take a look at it, r,•lmber one. Number two -- MR. BRUCE: Well, if that is true, if it does reduce nicotine by 92 percent and carbon monoxide by 72 percent, why would you want to keep that product off the market? DR. CONNOLLY: Oh, I am not saying that at all. MR. BRUCE: Okay. DR. CONNOLLY: I am saying due process, number one. Number two, if a person is addicted or hooked to the product, let them have it, but through a drug model. Let them go to a pharmacy and buy it at the pharmacy. Don't put it in the convenience stores of America where the 15-year- old kids can pick this thing up and become dependent on ' nicotine. History shows that. History has shown us that the industry has used these exemptions to hook each generation of children on their products. MR. BRUCE: But, Doctor, if we took your'paradigm 22;, and we say let's regulate this as a drug, we'd put it behind 23 the counter and then we continue to market cigarettes, 24 : aren't you concerned at all as a public health official that 25. you have committed more children to smoking the product that TIMN 0025525 i' ACE-FEDERAL REPORTERS, INC. ~! 202-347-3700 tiationwide Coverage 800-336-6646

9110 05 05 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 75 you find worse and restricting the access to a product that you and I would admit if it reduces nicotine by 92 percent and carbon monoxide by 72 percent, and we've restricted it to where they can't get access to it, why would you want to do that? CHAIRMAN WAXMAN: Respond to the question, and then we are going to have to move on. DR. CONNOLLY: Yes. MR. BRUCE: Okay. Thank you, Mr. Chairman. DR. CONNOLLY: We are winning the battle with cigarette smoking in this country. That's why that product is up there. If we were not winning the battle against 15'„ bring in now this new device to circumvent everything we've 16 done to curb smoking today. 17_ If we've got any intelligence, any concern about 18 the children alive today in this Nation, we've got to say to 19 this product we're going to control it the way we should 20 have controlled the cigarette in 1906. Allow access, yes_, 21 through a drug model; but not let them introduce this as 22; their new high-tech cigarette to replace the old ones. ; 23 CHAIRMAN WAXMAN: Thank you, Mr. Bruce. 24 MR. BRUCE: Thank you, Mr. Chairman, for your 25:allowing me to follow up on that last question. cigarette smoking, that product wouldn't be there today. And what are we allowing? We are going to allow them to TIMN 0025526 ii ACE-FEDERAL REPORTERS, INC. ~~ ~~Z j4~ z~00 Nationwide Coverage 800-336-6646

4010 05 05 JOEpv 1 2 3 4 5 7 8 9 10 11 12 13 14 15~ 16 17 18 19 20 21 76 CHAIRMAN WAXMAN: Mr. Bliley? MR. BLILEY: Thank you, Mr. Chairman. Dr. Slade, on page ten of your statement you point out that RJR told the Society of Toxicology that rats exposed to the smoke of the new cigarette had higher nicotine levels in their blood than rats exposed to the smoke of the reference cigarette. Isn't it true that in the same RJR presentation to the Society there-was a study showing humans had lower nicotine in their blood from the new cigarette than from the reference cigarette? DR. SLADE: I have seen no human data on the new 22; cigarette, as my colleague just pointed out, contains less i 23~ nicotine than 97 percent of the cigarettes currently sold R.J. Reynolds product. MR. BLILEY: I see. On page 13 of your written statement you state that, "While the new Reynolds cigar-ette might reduce the risk of lung cancer from cigarette smoking, it should be regulated because it contains carbon monoxide and nicotine which," you state, "cause heart disease." It seems to me that reducing lung cancer should be enough, but if it isn't, I am advised that Reynolds' 24 and less carbon monoxide than 72 percent of the cigarettes 25 currently sold. TIMN 0025527 I) ACE-FEDERAL REPORTERS, INC. Nationwide Coverage I~ 202-347-3700 800-336-6646

ar)10 05 05 JOEpv 1 2 3 4 5 6 7 9 10 11 12 13 14 15' 16 17 18 19 20 21 22, ! 77 I t seems to me these are significant gains, and I do not understand why you wish to deny the alternative to the American public. DR. SLADE: Mr. Bliley, let me _~xplain something that is gone into in great detail in the Surgeon General's report. The FTC smoking machine, the one on which your figures are apparently based, smokes cigarettes in a way entirely different from the way human beings smoke cigarettes. People regulate their nicotine intake so that there is no any difference at all in the nicotine blood levels of somebody smoking an unfiltered Camel and somebody smoking a Camel Light, in spite of the fact that the rated nicotine levels are very different.• If this product is a commercial success, it will contain and deliver addicting doses- of nicotine. Low- nicotine-containing products have been tried repeatedly since the 1950s and have not succeeded in the marketplace. MR. BLILEY: Well, it may be or may not be, but they've spent an awful lot of money on it, and they seem.to think it will work. And I suppose, you know, depending on' what the FDA does, we-may know or we may never know. 23 Moving on -- and since my time is limited -- 24 Dr. Connolly, on page five of your testimony you indicate 25: that the flavor capsule contains nicotine. Am I to assume TIMN 0025528 II ACE-FEDERAL REPORTERS, INC. II ~(1~_t4~_1700 Nationwide Coverage 900-336-6646

`n10 05 05 78 JOEpv 1 that you mean that nicotine is added to the capsule? 2 DR. CONNOLLY: According to their patent, there 3 is a couple of designs they have talked about. One is 4 adding nicotine co the glycerine in the flavo:r capsule. 5 Another one is sprinkling nicotine on tobacco leaf inside 6 the jacket or washing the tobacco leaf with nicotine to 7 increase the dose. 8 So, there is all kinds of stuff going around 9 here. Again, I think a couple of people know more than the 10 scientists know about this product and the independent 11 community. I would ask RJR to present that data to FDA for 12 vi :. re ew. 13 But we don't know. They may design a product 14; tomorrow or the next day, and-we don't know. We don't know 15, what the nicotine levels may be in.that product six months 16 from now. This may be just the foo.t in the door. They may 17 add something else to the capsule a year from now. We don't 18 ' know -- the way they put asbestos in the micronite filter 35 19 years ago. 20 MR. BLILEY: My time is limited, and you had your 21 five minutes. Let me get on with my questions. . 221; On page six you say that, "The nicotine in the 23 product is not derived from the tobacco leaf contained in 24 the product." What is your basis for saying 'that? 25d DR. CONNOLLY: My understanding is they are TIMN 0025529 ~ ACE-FEDERAL REPORTERS, INC. I) 202-347-3700 Nationwide Coverage 800-336-6646

"110 05 05 79 JOEpv 1 taking a tobacco extract, and again my understanding is it 2 could be from the leaf or it could be from nicotine 3 crystallines. We don't know. 4 I looked at the patents. I have looked at both 5 their international patent and U.S..patent. And again, the 6 problem I have is that they call nicotine a "flavoring 7 agent. " 8 MR. BLILEY: If you are mistaken then in your two 9 assertions, does that change your view of the product? 10 DR. CONNOLLY: No. I mean, you could wring coca, 11 you know, from the coca plant. You could take cocaine out, 12 and if the coca plant was legal, I don't think we'd allow 13 the sale of cocaine in this country. Just because we 14 extract nicotine from the tobacco leaf, we can't misclassify 15: nicotine then as tobacco. It no longer becomes tobacco when 16" it's extracted; it's a chemical called nicotine according to 17 the Surgeon General's report. 18.. MR. BLILEY: Are you saying then that we should 19 make tobacco illegal in the United States? 20 DR. CONNOLLY: Not at all. As I stated, for new 21 products don't let this industry do an end run using an 22., exemption from regulatory authority to hook the next 23 generation of kids on nicotine. The new products, you have 24 to take a hard line on. 25 ~~ The current products, my opinion is they should TIMN 0025530 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 05 05 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 80 remain legal, but we should restrict their marketing more in a drug model, based on.the findings of the Surgeon General's report. MR. BLILEY: Well, do you feel that the tobacco industry has any responsibility to try to make a safer cigarette? DR. CONNOLLY: They do, but based on history they haven't done it. MR. BLILEY: Well, if you don't give them a chance, they may never do it. DR. CONNOLLY: We have given them 70 years -- since 1906 -- 80 years now to come up with a safer product." And they have still got Camel out there killing. They brought in -- and I showed you these low-tar, low-nicotine brands, they hypocritically go into the Far East and they say, "Here's RJR Winston Light" -- _ with twice the nicotine sold in the U.S., twice the tar. Do we trust that industry? They developed the Skol Bandit. They use high technology to develop it as part of a graduation strategy. Then they send representatives onto college campuses to get kids to experiment with the 22;N i low-nicotine product; and the graduation strategy calls for 23 them to go from low-nicotine to Copenhagen, the high-dose, 24. over time. 25;; It's called corporate addiction. They know how TIMN 0025531 ACE-FEDERAL REPORTERS, INC. 202-z47_z700 Nation wide Coverage 800-336-6646

.9n10 05 05 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16, 17 18 19 20 21 81 to get people hooked onto nicotine better than any drug dealer in this country. CHAIRMAN WAXMAN: The gentleman's time is expired. The Chair recognizes himself. Dr. Connolly, is there any evidence that you are aware of that cigarettes could be marketed without nicotine, or is nicotine essential to the success of smo:king? DR. CONNOLLY: According to the Surgeon General's report, again, nicotine is the essential chemical for tobacco use. Without nicotine, people will not smoke. CHAIRMAN WAXMAN: Why not? DR. CONNOLLY: The chemical nicotine produces behavioral effects on the user, effects on the central 22i; that nicotine is essential because in order for people to 23' continue to smoke, that it has to be addictive? 24'i DR. CONNOLLY: Absolutely. You have to 25;; administer the nicotine to your system, once dependent, over nervous system. They create dependence. The person then will crave the nicotine and inject that to himself over time in a very orderly*fashion, once dependent. CHAIRMAN WAXMAN: So, if we just had some other kind of cigarette without nicotine, if they could reduce the nicotine, why wouldn't people just use that and try, insofar as they want to smoke? In other words, are you telling us TIMN 0025532 ~i ACE-FEDERAL REPORTERS, INC. Nationwide Coverage RQO-33h-hF4h

"010 05 05 82 JOEpv 1 time in regular doses during the day. 2 CHAIRMAN WAXMAN: Now, looking at the potential 3 new device for transmitting nicotine which may or may not be 4 a cigarette we have had some devices that are used to 5 convey nicotine, and those have been clearly determined to 6 be drugs, and the FDA has had the authority and 7 responsibility to review them, and people who use those S products have had to get prescriptions for them. 9 The new product that R.J. Reynolds is proposing 10 is what they claim a cigarette and, therefore, not subject 11 to regulation as opposed to a nicotine device, transmission 12 device. 13 Mr. Schultz, they claim, from R.J. Reynolds, that 14, their promotional material won't argue that it's any safety 15: or health claims and that it really, because it contains 16' tobacco, is a cigarette and shouldn_'t be regulated like a 17 cigarette, or really should be treated like a cigarette and, 18 therefore, not regulated. 19.. Do you believe the average consumer or the FDA 20 could reasonably construe the concept of a cleaner or 21 smokeless cigarette to imply a health claim about reducing' 22, the'risk of cancer or the diseases? 23 MR. SCHULTZ: Yes,'and I think it's quite clear 24" that that is what the company hopes people will assume. 25. addition, they've gone beyond that and have used the word TIMN 0025533 i ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage I) 800-336-6646

`010 05 05 83 JOEpv 1 "health" and are talking about how their product addresses 2 the health concerns of consumers. 14 I think they want people to assume that this 4 product is safer. Otherwise, they couldn't have any 5 competitive edge with it. 6 CHAIRMAN WAXMAN: So, the very purpose of their 7 product is to try to market it as something that is safer, 8 but they don't want an FDA review as to the safety medically 9 or effectiveness of this product the way we would any other 10 product that made these health claims? Is that your 11 position? 12: MR. SCHULTZ: That is my view. It is interesting 13 and, I think, significant that the patent apparently listed 14 the tobacco as optional. If tobacco weren't in the product, 15 I don't know that we'd be here. I don't know that there 16. would be much question. - 17 CHAIRMAN WAXMAN: In other words, if they didn't 18 have any kind of trace of tobacco inn the product, there's 19 no doubt that it would be considered reviewable by the Food 20 and Drug Administration under present law? 21` MR. SCHULTZ: Well, that's my view because the 22;i FDA did exactly that for another product called the Ij 23. "flavored, smokeless cigarette." It was a product that 24 looked like a cigarette that had nicotine but no tobacco, 25:; and the FDA did take that product within its jurisdiction. TIMN 0025534 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 202-347-3700 800-336-6646

4010 06 06 JOEpv 1 2 3 4 5 6 7 9 10 11 12 13 14 15/ 16 17 18 19 20 21 22;; CHAIRMAN WAXMAN: Does anyone else on the panel 23 have information? 24 (No response.) CHAIRMAN WAXMAN: Well, we will hear from other TIMN 0025535 84 CHAIRMAN WAXMAN: Dr. Slade, the RJR Company indicates that they are submitting the results of their research to peer-reviewed scientific journals. I want to know from you is this true? Have any reports been accepted, to your knowledge? And can you tell us whether any of their published research is available on the product's long-term chronic health effects or effect on the cardiovascular system? DR. SLADE: I am not aware of any peer-reviewed publications relating to the R.J. Reynolds product. I am delighted to hear that there are some that have been submitted. There has not been time for them to do long- term health effects research on this product. And getting back the question that I was asked earlier about human blood levels of nicotine, I would wonder if the studies in which human levels of nicotine were assessed with this nicotine delivery system were subjected to ordinary human studies protocols for approval before they were done. CHAIRMAN WAXMAN: You have no information then? DR. SLADE: I have no information. ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

"n10 06 06 85 JOEpv 1 witnesses in a short time. Maybe we can get some responses 2 to it. 3 I appreciate the testimonv you have given. 4 Members may wish to submit writte*. -- 5 MR. BRUCE: Mr. Chairman. 6 CHAIRMAN WAXMAN: Yes, Mr. Bruce, did you want 7 another round of questions? 8 MR. BRUCE: I am just curious about one thing 9 Dr. Slade has mentioned and you brought up in the 10 questioning. 11 RJR, as I understand it, made a presentation to 12 the Society of Toxicology. You referred to that. It is my 13 understanding that in that presentation they also talked 14 about nicotine levels in human blood after smoking and 15 compared it to the reference cigarette. ; 16:: Now, you said in your testimony that you didn't 17 know about that, and Mr. Waxman followed up with a question. 18 What I would like to know is did you read the 19 full presentation made to the Society of Toxicology, and was 20 there any reference in that study to the nicotine level in 21 the rat blood and the nicotine level in the blood of humans? 22.. That's all I needed. 23, . DR. SLADE: There were 11 abstracts presented in 24 a poster session. All I have been able to see are the 25 abstracts themselves. And none of the abstracts I have TIMN 0025536 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 06 06 86 JOEpv 1 reviewed talked about human studies. 2 MR. BRUCE: Thank you. That clears up the 3 question then. 4 CHPIRMAN WAXMAN: We may have written questions 5 from members of the subcommittee to you for the record. We 6 would appreciate it if you would respond to those questions. 7 Thank you very much for being here today. 8 VOICES: Thank you. 9 (Pause.) - 10 CHAIRMAN WAXMAN: Our final witnesses represent 11 the RJR Nabisco Company and the Tobacco Institute. 12 Richard Cooper is a Washington attorney 13 representing the RJR Nabisco Company. , 14 Charles Whittley is a consultant to the Tobacco 15 Institute. Mr. Whittley is accompanied by: Theodor,e Blau, 16 a clinical psychologist from Tampa,_ Florida; and Steven 17 Raffle, assistant professor of psychiatry at the University 18 of California at San Francisco. 19 Without objection, your prepared statements will 20 be in the record in full. What we would like to ask of you 21 is an oral presentation to us of no more than five minutes: 22 ; We will start with Mr. Cooper. 23: MR. COOPER: Mr. Chairman, my name is Richard 24' Cooper. 25!! CHAIRMAN WAXMAN: Would you pull the microphone TIMN 0025537 II ACE-FEDERAL REPORTERS, INC. II 202-347-3700 Nationwide Coverage 800-336-6646

9010 06 06 87 JOEpv 1 closer? Be sure it's on, and then pull it closer. There is 2 a little button on the base. 3 MR. COOPER: Thank you, Mr. Chairman. 4 My name is Richard Cooper. I am a partner in the 5 law firm of Williams and Connolly here in Washington, D.C. 6 I am happy to appear here today as counsel for R.J. Reynolds 7 Tobacco Company to address the legal issues raised by the 8 question put in the notice of this hearing concerning the 9 nature and extent of-the Food and Drug Administration's 10 authority to regulate nicotine-containing products such as 11 the so-called smokeless cigarette. 12 All of the facts that I will rely on in my 13 testimony have already been put in the public domain by the 14 company. 15.: R.J. Reynolds' new product, announced last 16 September, is a cigarette which will be marketed to adult 17 smokers solely for their smoking taste and enjoyment. The 18 cigarette contains tobacco, which is essential to its 19 performance. It is lit at one end, and when the smoker 20 draws on it, it produces smoke at the other end. 21 Now, the Surgeon General's comment that the 22;; product does not produce smoke that is inhaled is, with I respect, incorrect. Thus, in its essential characteristics, 23 24 25 ., this cigarette's function and purpose, its use of tobacco in production of smoke, it is just like any other cigarette. TIMN 0025538 II ACE-FEDERAL REPORTERS, INC. I~ 202-347-3700 tiationwide Coverage 800-336-6646

e'110 06 06 JOEpv 1 2 3 4 5 6 7 10 11 12 13 88 Like all cigarettes, this cigarette contains tobacco rolled in paper. At the tip is a highly refined carbon heat source which is wrapped in an insulating jacket and paper. The heat source and a small amount of paper are the only parts that burn. Inside the cigarette, in addition to the tobacco 14i At the smoker's-end is another filter made of 15.polypropylene. The key difference between this cigarette 16 and other cigarettes is that it heats but does not burn 17 tobacco. 18 Thus, this cigarette represents a significant 19 advance in cigarette technology, which has been evolving 20 since the 1950s through such innovations as filters, porous 21 cigarette paper, puffed tobacco, and reconstituted tobacco 22:: sheet. 23 These advances have been made by Reynolds and 24' other cigarette manufacturers in order to achieve lower 25: yields of tar, nicotine, and other chemicals produced by that the flavorings that are used here in the flavor capsule are two in number. One is a sugar, and one is an extract of a very common food. Those are the only flavorings added to the product. TIMN 0025539 ~ ACE-FEDERAL REPORTERS, INC. II 202-347-3700 Nationwide Coverage 800-336-6646 is a capsule with a small amount of added flavors and spray- dried tobacco extract, which is used in other cigarettes, and a tobacco paper filter. And the company has disclosed

"110 06 06 JOEpv 1 2 3 4 5 6 7 8 9- 10 11 12 13 14 15 16 17 18 19 20 21 89 burning tobacco in order to meet the demands of smokers. Reynolds' new cigarette reflects one more step in this continuing advance in cigarette technology. , All of the nicotine in the new ~.•igarette is naturally present in the three forms of tobacco in the cigarette. No nicotine is added. Reynolds has subjected the new cigarette to an extensive set of scientific tests and laboratory systems, animals, and humans. Reports of the methods and the results of that testing are being submitted currently to peer-reviewed scientific journals and are being presented in the scientific community before the cigarette is introduced to the market. Additional testing is under-way and will be reported similarly as results become available. In its advertising and labeling of the new cigarette, Reynolds will make no therapeutic claims for it. 23 cigarette, the new cigarette and its advertising will bear 221; other cigarette. On the contrary, precisely because it is a It will not make any claim or representation that the cigarette is useful in the diagnosis, cure, mitigation, prevention, or treatment of disease. It will also not make any claim or representation that the new cigarette is safe or that it is safer than any 24 the Surgeon General's warnings mandated by Congress for all 25, cigarettes. TIMN 0025540 ~' ACE-FEDERAL REPORTERS, INC. II 202-347-3700 Nationwide Coverage 800-336-6646

<<)10 06 06 90 JOEpv 1 In addition, the new cigarette will be labeled, 2 advertised, and marketed in conformity with the legal 3 requirements and restrictions applicable to all cigarettes. 4 And it will be tAxed in the same way as all other 5 cigarettes. 6 I can sum up the relevant law, I believe, 7 briefly. Whether the Food and Drug Administration has 8 jurisdiction over this product as a drug or device depends 9 upon its intended use, and it is well-settled law that the 10 intended use of a product such as this depends, in general, 11 on the claims and representations made by the manufacturer. 12 As I have indicated, Reynolds will make no claims 13 of a'therapeutic nature for this product. Consequently, the 14 Food and Drug Administration has no jurisdiction over it as 15. a matter of law. . 17 Thank you, Mr. Chairman.- I would be happy to answer questions. 18 CHAIRMAN WAXMAN: Thank you very much, 19 Mr. Cooper. 20: Mr. Blau, are you here to testify? 21 MR. WHITTLEY: If I may, Mr. Chairman. 220 CHAIRMAN WAXMAN: Yes, Mr. Whittley? ;! 23 MR. WHITTLEY: I would like to speak first on 24 behalf of the Tobacco Institute and introduce our other 25ii witnesses. TIMN 0025541 ACE-FEDERAL REPORTERS, INC. 202-347-3700 N ation wide Coverage 800-336-6646

9010 06 06 JOEpv 1 2 3 4 5 6 7 8 9- 10 11 12 13 14 15: 16, 91 With me today are Dr. Theodore Blau, a practicing clinical psychologist; and Steven M. Raffle, M.D., clinical psychiatrist and assistant clinical professor of psychiatry at the University of California School of Medicine in San Francisco. They will address the Surgeon General's assertion with respect to cigarettes and addiction from a clinical and scientific standpoint. Mr. Chairman, from an ordinary common-sense standpoint, to call cigarette smoking an addiction trivializes and almost mocks the serious narcotic and other hard-drug problem faced by our society. It has been mentioned earlier in testimony today that Dr. Koop in an earlier statement in all seriousness - said that in 1982 young people are addicted to video games. The escalation of rhetoric in his 1_atest report is similarly 17 without medical or scientific foundation. 18 As is attested to by the fact that 41 million 19 Americans -- and this is pointed out, Mr. Chairman, in the 20- same report -- that 41 million Americans have stopped 21 smoking, more than 90 percent of them without any kind of 22 outside help. 23 There is no way you can come up with any 24 comparable figures on hard drugs, the kind of drugs such as 2 5 ;, heroin and cocaine which he has compared nicotine and TIMN 0025542 ACE-FEDERAL REPORTERS, INC. ° 202-347-3700 Nationwide Coverage 800-336-6646

6010 06 06 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 92 smoking. Neither is there any justification, Mr. Chairman, for establishing any special regime of regulation of cigarettes by the Food and Drug Administration. The Food and Drug Administration has never treated cigarettes as exempt from regulation under the Federal Food and Drug and Cosmetic Act, but it has asserted jurisdiction when health claims have been made by vendors or manufacturers. And this has been upheld by the courts. But to subject cigarettes to general FDA regulation in the absence of health claims would; first of all, impose substantial new burdens on an agency that is already overburdened. It would fragment its regulatory focus and divert scarce resources from such essential tasks as the approval of new medicines. It has been mentioned earlier, I think, in a question by Mr. Bliley that the French Minister of Health, who is a vocal critic of the tobacco industry, referred to this latest Surgeon General's report in this language: "Tobacco cannot be compared to drugs, especially hard drugs like heroin or the narcotics. It is always bad 22.; to fight an evil with misstatements or distortions of the 23 truth. Talk of addiction would mean comparing tobacco to 24 something which completely alters the personality of the 25;; subjects, turning them into antisocial individuals, which we TIMN 0025543 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 06 06 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16' 17 18 19 20 21 93 know is not the case with the overwhelming majority of smokers." In making these statements, he has echoed the conclusions of the National Institute of Drug Abuse and the American Psychiatric Association and the World Health Association. Dr. Charles Shuster, the head of the National Institute of Drug Abuse, has emphasized the big difference between.tobacco and hard drugs in this language: "When one-smokes tobacco, it does not alter your behavior or function so you become dangerous or obnoxious or an embarrassment to society." Dr. Koop himself has acknowledged 'that the World Health.Association decided a number of years ago to stop using the term "addiction," having concluded 'that the term is so misunderstood and misused that it lacks any meaning. The American Psychiatric_ Association does not use the term either, presumably for the same reasons. Editorial writers across the country have also expressed immediate sharp disagreement with the Surgeon General's addiction report. The Boston Globe noted, "Smoking bears no resemblance to drug abuse or alcohol abuse. 22:, Smoking does not affect mental acuity or temporarily derange . i~ 23 a person or produce so much as a lull in anyone's contact 24 with reality. 25 ;i The Indianapolis Star said, "Classifying the T1MN 0025544 ACE-FEDERAL R`EPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 06 06 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15; 16 17 18 19 20 21 22;j 23 1! 24` 25: 11 94 dangers of nicotine with the horrors of heroin or cocaine is misguided zealotry. It downgrades, even discredits, the Nation's campaign against hard drugs. The Surgeon General's latest attark on smoking is itself generally irresponsible. His enthusiasm has turned to zealotry and is on its way to fanaticism." The Kansas City Star called the Surgeon General's contentions with respect to cigarette smoking and addiction "ridiculous." None of these publications, Mr. Chairman, has demonstrated any love for the cigarette industry or for smoking. But they say that in classifying tobacco as addictive that the Surgeon General is overreacting. Drs. Blau and Raffle will comment in detail on the medical and the scientific aspects of the Surgeon General's report. But I would note in closing that if the use of heroin is an addiction or stopping the use of heroin and cocaine is a measure of addiction, how difficult it is to stop, then the mere fact that people find it difficult is not enough, then any behavior that people engage in on a regular basis could be considered an addiction. Mr. Chairman, this report is a political document. It started off with a conclusion and assembled everything it could to support that conclusion. It makes no TIMN 0025545 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

9010 06 06 95 JOEpv 1 effort to show any conflicting evidence of any kind. 2 At this time I yield, on my left, to Dr. Raffle. 3 DR. RAFFLE: Mr. Chairman, members of the 4 committee, I am Steven Raffle, a physician who practices 5 psychiatry in Oakland, California, and an assistant clinical professor of psychiatry at the University of California 7 School of Medicine in San Francisco. 8 I appear before you today in order to provide a 9 perspective that is missing from the 1987 Surgeon General's 10 report, the clinical perspective, which in my opinion runs 11 counter to the conclusion that nicotine is addicting. 12 Some of the clinical features and properties of 13 addictive drugs are not -- and I emphasize that -- shared by 14 cigarette smoking. 15;, The first of those is intoxication,. A person on 16 hard drugs is intoxicated. Intoxic_ation is fundamentally an 17 organic brain syndrome whereby the person's state of 18 consciousness is altered, reasoning is impaired, 19 coordination is affected, memory and.concentration are 20 substantially altered. 21 Further, mood is visibly changed. Judgment is 22,, impaired. Delusions and/or hallucinations may occur. And „ 231 unconsciousness or sudden death will result from a 24' substantial overdose. 2 5 i! Intoxication does not occur with cigarette TIMN 0025546 il ' ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'r)10 06 06 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12, 13 14 15' 16 17 18 19 20 21. The most uncomfortable complaining cigarette , 22; abstainer does not remotely resemble a person who is 23 withdrawing from hard drugs. But and in fact, the symptoms 24" and complaints do resemble those of a dieter or other person 25i~ giving up a well-liked habit or a close relationship. i 96 smoking. The effect on mood and mental functioning of cigarette smoking is more akin to drinking coffee. Withdrawal: Abrupt cessation of hard drugs following regular use will inevitably and predictabl,%T result in a"classictt withdrawal syndrome. This generally requires medical hospitalization for clinical management because drug withdrawal can be a life-threatening situation. The symptoms of withdrawal due to physiological dependence include severe vaso-motor instability, muscle cramps and nausea, hallucinations and/or delusions, dangerous changes in body temperature, seizures, mood changes often accompanied by paranoia, and suicidal ideation and attempts. Death may even occur if the patient is hospitalized and properly medically managed. Cigarette smoking causes. none of these signs and symptoms. It is impossible to predict 'whether or not a smoker will have any tobacco abstinence discomfort based on the number of cigarettes smoked per day or the duration of smoking. TIMN 0025547 ~ ACE-FEDERAL REPORTERS, INC. II Nationwide Coverage I~ 202-347-3700 800-336-6646

`010 06 06 97 JOEpv 1 These people continue working while 2 "withdrawing," and continue to meet their responsibilities 3 without significant disruption in reasoning, :iudgment, 4 concentration, or efficiency. 5 There are differences in socialization between 6 hard drugs and tobacco. The pharmacologic effects of hard 7 drugs lead to a life style which is dominated by the drug. 8 Family responsibilities are shirked, employment becomes 9 unpredictable, morality is eroded. Illegal activity is 10 often resorted to in order to obtain the hard drug. 11 Marital discord is usually evident. Abuse and 12 the emotional scarring which results can last for 13. generations. 14 Cigarette smokers do not suffer these 15 psychological and sociological impairments. They are not 16 behaviorally dominated by a drug-in.duced state. 17 rn my experience, cigarette smokers are not 18 different from the general run of normal, honest citizens. 19 Cessation differences: For the hard-drug user 20 following detoxification and stabilization, a completely new 21 life style must be established. For many it will be a 22 lifelong undertaking requiring ongoing reinforcement. 23 Since 1964 more than 35 million people have 24 stopped smoking without any outside intervention or 25 assistance. For the cigarette smoker, my clinical TIMN 0025548 II ACE-FEDERAL REPORTERS, INC: ~~ 202-347-3700 Nationwide Coverage 800-336-6646

9010 06 06 JOEpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 98 experience and numerous studies have demonstrated that the components of successful abstinence are commitment, personal responsibility, and self-efficacy. By self-efficacy I mean a person reasonably believing he can accomplish an undertaking. As with successful dieting, the participant must abandon a pleasurable activity in order to obtain a greater long-term benefit. However, neither the dieter nor the smoker must rebuild his life to succeed. I have some additional observations in closing. The use of the word "addiction" to describe a particular behavior. is emotionally charged and open to misuse. The Surgeon General's 1987 report has redefined it, largely within a pharmacological context, and used se:Lected research to demonstrate that tobacco is addicting. However, his report ignores critical components of hard-drug addiction and, in so doing, renders tYiat term meaningless and overbroad. A logical question flowing from the Surgeon General's report is whether an addiction label on tobacco 22;; products would motivate smokers to stop and prevent 23 nonsmokers from starting. 24',~ 25 ;; This is my last point. Regarding smokers, it is easier to stop a habit TIMN 0025549 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

6010 06 06 99 JOEpv 1 which one believes is not an addiction because one must then 2 assume personal control and responsibility for his or her 3 behavior. "Addiction" provides a convenient external 4 excuse, an easy out, if you will, for not initiating 5 abstention or for giving up too easily at the first sign of 6 tobacco abstinence discomfort. 7 Many individuals who want to continue smoking 8 have already created the personal myth that they are 9 addicted, thereby excusing themselves for not trying to 10 stop. Endorsing that myth perpetuates and exacerbates this 11 situation. They are now officially forgiven their failure. 12' CHAIRMAN WAXMAN: Thank you very much, 13 Mr. Raffle. You're reading that statement, and that is all 14:going to be in the record. 15 :: 16.; 17 18 19 20 21 2 23 24 1 2 5 !' TIMN 0025550 ACE-FEDERAL REPORTERS, INC. 202-347-3700 N ationwide Coverage 800-336-6646

'010 07 07 100 OMTbur 1 STATEMENT OF DR. THEODORE BLAU 2 6 I DR. BLAU: Thank you, Mr. Chairman. 3 I appreciate the opportunity to appear before this distinguished committee. During the last 37 years, I have seen over 4000 patients of all ages. Among the disorders I have treated 7 are addictions to a variety of drugs. In addition to my 8 clinical practice, I have. assessed the merit of scientific 9 research for various'organizations, including the United 10 States Army, Department of State, National Institutes of 11 Education, various universities, law firms, and state 12, agencies. 13 I am also a past President of the American 14: Psychological Association, a scientific and professional 15i; organization of over 70,000 psychologists in the United 16'! States and Canada. 17 A list of other positions I have held is appended 18:to the statement. 19.: I am here today in the hope that I can provide 20.i some clarity and resolution to the confusion created by such 21: statements as "Smoking is addictive" and "Nicotine in 22I~ tobacco is as addictive as cocaine and heroin.t" , ' 23i; These statements are misleading, and they are 24: potentially harmful to the American public. 25'I The word "addiction" has been used widely and i 7CIMN 0025551 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'010 07 07 101 OMTbur 1 loosely to describe many habits and everyday behaviors such 2 as coffee drinking, jogging, falling in love, cigarette 3 smoking, and video game b7aying. 4 My view of -.ddiction is the view of a practicing 5 clinician, and that is the basis of my remarks today. 7 Addictive drugs cause intoxication when taken and significant withdrawal responses when given up. 8 Taking an addictive drug causes major 9 interference with thinking, with judgment. The drug addict, 10 either when intoxicated or in the grip of withdrawal 11 effects, cannot make reasoned decisions, including the 12; decision to use or not to use the drug. 13~" On the other hand, smokers are always able to 14' reason without interference from their habit. Smokers can 15. ~ make a personal decision to smoke or to stop smoking. The i 16;! vast majority of those who have stopped smoking have done so „ 17;, with no help and little distress. 18ii When a drug addict gives up his or her drug by 19.` choice or by legal mandate and jail, a severe withdrawal 20,;'i syndrome is very likely to result. Some withdrawals result 21ii 22i 2311 i24~~ 2511 in convulsions, significant pain, body dysfunction, and in some cases death. During this withdrawal phase and for months or even years afterwards, the former drug addict is often unable to think clearly or decisively in his or her own TIMN 0025552 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

-Ol0 07 07 102 OMTbur 1 interest or within legal or social expectations. 2 on the other hand, some smokers who decide to 3 give up the smoking habit experience what amounts to a 4 couple of days of mild irritation or irritability. Thinking is not distorted in those who give up smoking. Friendships, 6 work, social activities remain essentially intact. 7 Over the past 37 years, I have reviewed over 7000 8 research articles relating to the subject of smoking and 9 addiction. My evaluation-of this research supports the 10 following conclusions: 11 First, the use of materials containing nicotine 12:; is not equivalent to the use of addictive drugs such as 13!- heroin and cocaine. The. role of nicotine in tobacco smoking 14'' is much more like the role of caffeine in coffee drinking. 15Ij Secondly, people can and do choose to stop 16I1 smoking. The process of quitting the smoking habit is very 17 different from giving up addictive drugs. 18 Third, those who quit smoking on their own are 19;: more likely to continue to decide not to smoke than those 20; who seek external help or prefer to use their habit -- to 211: view their habit as something they cannot control 22 themselves. 23 I wish to briefly address the Surgeon General's 241 report and the statements made today by the Surgeon General 251) and by Dr. Henningfield. TIMN 0025553 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'010 07 07 OMTbur 1 2 3 4 5 6 7 8 9 10 11 103 They characterize smoking as an addiction equivalent to or worse than the use of drugs such as cocaine and heroin. These statements are misleading and unfortunate. The report is misleading for the following reasons: First, the report redefines addiction in its effort to include the smoking habit. Secondly,"conclusions are based on poorly designed studies -- and I have just a few more remarks. Third, the research interpretations which cast 12.: serious doubts on conclusions in the report are omitted, 13' reinterpreted, or rejected. 14;, Finally, 'it is unfortunate that Dr. Koop ~ 15;~ trivializes drug addiction. This could do extensive harm to 16'' those who are working in real drug -avoidance and efforts to i; 17 stop the drug trade and to bring about treatment of the 18 addictions. 19 Labeling cigarettes as addictive could result in 20 fewer people deciding to quit. 2111 Thank you, Mr. Chairman and members of the r li 221i committee. 23 1i MR. WAXMAN: Thank you, Dr. Blau. 24~i Mr. Cooper, Commissioner Young has testified that 25il the FDA-must attempt to differentiate between the TIMN 0025554 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

"'110 07 07 OMTbur 1 2 3 4 5 6 7 8 9 10 11 104 12;; The reasoning that underlies FDA's precedence 13' relating to cigarettes and the judicial decisions relating 14;' to cigarettes are not limited to cigarettes. The reasoning , 15~, applied in those instances were general principles of food I! 1611 and drug law that are applicable to a wide range of traditional tobacco product not regulated by FDA and newer innovations designed to deliver nicotine to satisfy a nicotine dependence or otherwise to affect the structure or function of the body. Do you agree that FDA has authority to differentiate between such products and has the statutory authority to regulate newer innovations designed to deliver nicotine to satisfy a nicotine dependence? . MR. COOPER: It depends, Mr. Chairman, on the nature of the innovation and the nature of the claims and representations that are made for it. 17 products.. There is nothing peculiar or anomalous about the 19~. FDA's treatment of cigarettes, and in my view, the new 201; Reynolds cigarette is a smoking article marketed for smoking 21;. pleasure -- ,~ 2214 MR. WAXMAN: You have already stated that. MR. COOPER: -- and should be treated in the same 231' 24':~ way. ;; . 251 ~ MR. WAXMAN: You have already stated that, but I TIMN 0025555 11 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'')10 07 07 105 OMTbur 1 am trying to -- you have already stated your conclusion, but 2 you do agree that under some circumstances -- and you have 3 tried to differentiate those circumstances -- FDA does have 4 authority to regul.dte these newer devices to deliver 5 nicotine? 6 MR. COOPER: Under some circumstances. 7 MR. WAXMAN: Okay. 8 Now, you have testified that Reynolds has 9 subjected the new ci-garette to an extensive set of 10 scientific tests and laboratory systems, animals and humans, 11 reports of the methods and results of that testing are being 12;: submitted to peer-reviewed scientific journals and are being 13 presented to the scientific community before the cigarette 14 is introduced to the market, additional testing is underway 15;i and will be reported similarly as results become available. 16! i That is on page 3 of your testimony. 17' Does Reynolds hope to demonstrate the product's 18;:; safety by conducting and disseminating the results of these 19tests? 20ii MR. COOPER: No. 21;, MR. WAXMAN: If RJR's scientific tests !I 2211 demonstrate that the product increases a smoker's risk of 23!I heart disease or cancer, would the company still bring the 24'~ product to market? 2511 MR. COOPER: That is a hypothetical that we ~ I ; TIMN 0025556 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

:'"'110 07 07 106 OMTbur 1 needn't speculate on. I don't think it is.present as far as 2 I am aware. 3 I am not a scientist, as you know, Mr. Chairman. 4 MR. WAXMAN: No, no, but I am asking what your 5 client intends to do. Your client is doing tests. They 6' want to find out whether it is a safer product. 7 What if it turns out through their tests they 8 find out it is an unsafe product? 9 MR. COOPER: I don't think that has been the 10 result. So I don't think they have to face that question. 11 MR. WAXMAN: But if they do -- 12;, MR. COOPER: That is a hypothetical question. 13 MR. WAXMAN: It is a hypothetical question, and I 14 want your answer to that hypothetical question. They are 15 ~; doing tests. When you do a test, you are trying to find out 17 ` the information. They find out it_is safer, they find out it is healthier. You have stated to us that they don't plan 18:: to disseminate that -- results of that information, but on 19;~ the other hand, if they find out it is increasing the 20; smoker's risk of heart disease or cancer, will they bring 21!; that product-to the market? ~ 22 MR. COOPER: Well, the full scientific results I 23`:; will be disseminated. The company is currently preparing 24!' for publ.ication an approximately 700-page report on the II 25;i tests that were done. Those test results will, be available TIMN 0025557 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nation wide Coverage 800-336-6646

'01a 07 07 OMTbur 1 2 3 4 5 6 7 8 9 10 11 107 to everybody. Indeed, the company would be -- MR. WAXMAN: They will make the results of their tests available to everyone? - MR. COOPER: Yes, indeed. MR. WAXMAN: Okay. So then we will be able to find that information out. MR. COOPER: Absolutely. MR. WAXMAN: Now, Mr. Hutt, when he met -- Peter Hutt, when he met with people at the National Cancer Institute, acknowledged that this new RJR cigarette would be useful because it could reduce the risk of cancer, and your 12; client maintains that there is a lower tar level in this new i! 13 product than in conventional cigarettes. If those claims 14'' are being made, you have testified that the company will not 5;; make any claim or representation that the new cigarette is 16!~ safe or safer than any other cigarette. 17;; Why then are you so concerned that we know you 18!~ are conducting and disseminating the results of your 19, research, and is your.research unrelated to health concerns? 20I' MR. COOPER: First off, Mr. Chairman, Mr. Hutt 21. : has stated that he did not make the statement attributed to I him by Mr. Davis. He denies that he made that statement. 22ji 23!i Second, Reynolds has done testing on the product. 2411 •I assume no one would object to a company doing testing on 2511 its product. Having done the testing, Reynolds is making I 7CIMN 0025558 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

`010 07 07 108 OMTbur 1 the test results available. 2 I can't see any basis for criticizing the company 3 for making the test results available. The company will not 4 make any claims or representation: for the product that it 5 is safe or safer than any other cigarette. It is a 6 cigarette. It will carry the Surgeon General's warnings 7 just like all other cigarettes, and it will marketed, 8 labeled and advertised as a cigarette. 9 MR. WAXMAN: So this is just a product, this is 10 just a new product. Some people suggested it is a valuable 11 new product because it is safer, but your client isn't 12. making that representation. It is just another product to 13 deliver, to market, to profit from, to deliver nicotine? 14;' MR. COOPER: No, not to deliver nicotine. To .~ 15~i provide smoking taste and enjoyment to adjust smokers. 16;i MR. WAXMAN: Do you deny there is nicotine in ~ 17 221, that product? MR. COOPER: Oh, no. I deny that that is the intended use of the product, however. MR. WAXMAN: Thank you very much. Mr. Whittaker. MR. WHITTAKER: Thank you, Mr. Chairman. 23,I The fantasy level is increasing. 24. ~ (Laughter.) 25;i Dr. Cooper, do you take the position that H ii TIMN 0025559 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nation wide Coverage 800-336-6646

4010 07 07 OMTbur 1 2 3 4 5 7 8 9 10 11 109 cigarettes are not dangerous to the health of the smoker and a.leading cause of death in this country? MR. COOPER: I am not a doctor. MR. WHITTAKER: I am sorry. MR. COOPER: I am Mr. Cooper, sir. MR. WHITTAKER: Mr. Cooper. MR. COOPER: And Reynolds' position is that the -- and it is well-known. I am sure you are familiar with it, Mr. Whittaker ---that there has been no proof as to the causes of the diseases attributed to smoking, that it is an open question. Reynolds has presented that position in many 12;; forums for some time. 13! MR. WHITTAKER: Dr. Blau, I would like to ask how 14: you can expect us as public officials to take the judgment 15,; of an industry that is literally making billions of dollars f 161,11 at the demise of our public health and in opposition to the 17' opinions of our nation's health officials who have nothing 18.. to gain monetarily, how you can be so opposed or in 19 contradiction of the evidence. 20;: DR. BLAU: Yes, sir. I will be glad to respond 21: to that specifically. i 22I I am here to talk about the quality of the 23; scientific evidence and the clinical evidence presented in ; 24!~ the Surgeon General's report, and the statements and il 25!I conclusions of that report are simply unsupported by the TIMN 0025560 ACE-FEDERAL REPORTERS, INC. 202-347-3700 N ation wide Coverage 800-336-6646

'0l0 07 07 OMTbur 1 2 3 4 5 7 9 10 11 12; 13 14; 16 110 data from even NIDA, which supposedly provides the data to support this. Regardless of the good intent of that report, bad science should not support a conclusion. The American people have the right to know that a conclusion is unsupported or partially supported as opposed to the implications of full scientific support for the conclusions presented in that report. MR. WHITTAKER: And you expect the American public to believe the Tobacco Institute, who has everything to gain by continuing to market tobacco products, versus our public health officials, who have absolutely nothing to gain monetarily? DR. BLAU: I expect the American public, by and 15!i large, to intelligently assess such statements as cigarette 17 8 19;; 20i: smoking is an equivalent addiction-to cocaine and to the opiates such as heroin. I don't know of anyone in my clinical practice that I have ever seen, no matter how emotionally disturbed they were, who would equate these two. Certainly, in my work with normal people and in my work in police departments 22!j around the United States, I couldn't think of a single ~ 23;i 2411 person who would not find that concept ridiculous. So I would count on the intelligence of the 25jj American people to see this as less than supported and not TIM 0025561 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

4010 07 07 OMTbur 1 2 3 4 5 8 g 10 11 111 in keeping with common sense and their own observations of what really is in the drug culture of America as opposed to the smoking of cigarettes as a personal choice of adults. MR. WHITTAKER: Well, Dr. Blau, you or. page 6 of your testimony make a statement to the effect that there is "no substantial scientific evidence that smoking creates a physical dependency to nicotine," and I am here to tell you that as a former three pack of cigarettes smoker who quit, you are crazy. ~ (Laughter.) DR. BLAU: With all due respect, sir, I smoked 12; three and a half packs a day for 25 years, and I quit and I suffered no after effects. I am sorry you did, but that is 13;: 14.~ a personal experience and not -- 15ij MR. WHITTAKER: I can't believe you. I 16ji DR. BLAU: -- based on scientific research. i 17~! MR. WHITTAKER: I just can't believe you. 18 1i MR. WAXMAN : Mr. Bruce. 19;i MR. BRUCE: Thank you, Mr. Chairman. 20~! I thank the panel, but I think I am going to „ - . 21i direct most of my questions to Mr. Cooper, since I have been 22I1 asking questions on the legalities of what we are doing 2311 today. 24~ 25 Has FDA ever asserted jurisdiction over cigarettes and, if not, why not? TIMN 0025562 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nation wide Coverage 800-336-6646

`010 07 07 112 OMTbur 1 MR. COOPER: FDA has asserted jurisdiction over 2 cigarettes that made claims of positive therapeutic 3 benefits, and there are two court decisions reflecting the 4 agency's actions in thpc regard. 5 In other instances, the agency has refused to 6 accept jurisdiction or take jurisdiction over cigarettes. 7 In 1977 and in 1980 it issued decisions denying petitions 8 from action on smoking and health which put before the g agency essentially the same kinds of allegations with regard 10 to nicotine and its pharmacological effects as have been 11 discussed recently as a result of the Surgeon General's 12;; report and petitions that also asked the agency to ban ,; 3 filtered cigarettes and to ban cigarette filters that are 14'- detached from cigarettes, and the agency, relying on its i 15Ii interpretation of the law, not exercising discretion, I 161 ~ declined jurisdiction, said it didn't have jurisdiction as a 17:; matter of law and it was upheld in the federa:L courts. 18;j That is the record of FDA precedent. , 19;1 MR. BRUCE: Right. In those two court decisions, 20;; was it a question of whether or not it was an abuse of ;~ . 21;': discretion or was it on the agency had operated correctly 221I under the law? 231 ' MR. COOPER: No, sir, there was no discretion 24~4 involved. I read the same cases that Mr. Schultz read, and 2511 I just read them differently. There wasn't any discretion. 'TIMN 0025563 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

~010 07 07 OMTbur 1 2. 3 4 5 6 7 8 9 10 11 12 . 113 FDA interpreted the law. The court upheld FDA's interpretation, deferred to FDA's interpretation,-said it was not contrary to the law. MR. BRUCE: And give me a layman's definition of FDA, the definition of a drug that would get this -- what is a drug, in layman's terms? MR. COOPER: Basically, a drug is a substance whose intended use is to deal with disease, to treat disease, to prevent a disease that is caused by something other than the substance itself, and it is a substance that is marketed with an expressed intent to affect: the human body : r. 13: The law distinguishes between a claim that a product will have no adverse effects or fewer or few adverse effects. That is not a drug claim. And a claim that a product will have positively beneficial, therapeutic effects, that is a drug claim. And the FDA precedents and 18.the judicial precedents are very clear on that distinction. 19I' MR. BRUCE: And does this new cigarette make any 201; claims that would bring it under this definition of a drug? 21:~' MR. COOPER: Reynolds has announced that it will 2211 make no such claim. 23ii MR. BRUCE: How about health claims about the 24': product? Will there be any health claims and,, if they were I 25 to make a health claim, what kind of health claim would they TIMN 0025564 ACE-FEDFRAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

i 9010 07 07 114 OMTbur 1 have to make to bring it under FDA jurisdiction? 2 NB2. COOPER: To bring it under FDA jurisdiction, 3 they would have to make a claim of positive therapeutic 4 benefit, and the company has said it will make no such 5 claim. 6 MR. BRUCE: For example, give me an example. It 7 will make you feel better, look younger? MR. COOPER: Well, look younger probably isn't a 9 drug claim. That is•probably a cosmetic claim. 10 MR. BRUCE: Well, give me a therapeutic claim. 11 MR. COOPER: A therapeutic claim is that the 121~ product will help you lose weight, prevent obesity, that the 13;. product -- if someone were to claim that a product would I { 14;! 15 16 positively prevent heart disease from overeating or from some other cause, that would be a therapeutic or medical benefit. 1I 17`' If I put out a cosmetic and I claim that it won't. 18i cause an allergic reaction, that it is a hypoallergenic 19; cosmetic, that is not a drug claim, and FDA has been very 20;: clear about that. 21!i MR. BRUCE: All right. We have been talking 2211 about nicotine today. 231' How does the question of nicotine fit into I~ 24;! jurisdiction? What has the FDA said about nicotine? Does 2511 it exert jurisdiction over nicotine products and, if it 'TIMN 0025565 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Kationwide Coverage 800-336r6646

;f `110 07 07 OMTbur 1 2 3 4 5 6 7 8 9 10 11 21 22 115 does, how does that fit into the whole question of this new product? MR. COOPER: Well, FDA in 1980 and in 1977 considered the question whether the presence of nicotine in cigarettes makes cigarettes a drug, and it said that even assuming that nicotine is a very pharmacologically active substance, assuming that all of the allegations of adverse effects from nicotine are true, making that assumption, nevertheless, cigarettes containing nicotine naturally are not a drug. MR. BRUCE: All right, one last question. There 12: ' has been discussion here about nicotine also in the ~ 13!: derivation -- people have said that the nicotine in this new 14I'I cigarette is not derived from the tobacco leaf in the 151'; cigarette. It is my understanding that the exclusive source A~I. - ': of nicotine will be a tobacco leaf,- and they have been 16 I I 17° talking about patents, international and national patents. 18i Where does the nicotine come from? 19,; MR. COOPER: The only nicotine in this product is 20;, naturally present in.the tobacco. No nicotine is added. i The patent matter is just a red herring. You don't patent'a product or a cigarette. You patent an invention, and an 231;1 invention can later be embodied in a variety of products. 24, If I invent an internal combustion engine, that i~ 25~i is the invention I patent. I can.later use it in four-wheel TIMN 0025566 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

~110 08 08 116 OMTbur 1 vehicles, three-wheel vehicles, tractors, whatever. Four 2 wheels are not essential to any particular embodiment of 3 that invention. 4 When I'..hen design a Chevrolet, four wheels are 5 essential. It won't go on three wheels. Similarly, tobacco is essential to the Reynolds 7 product as it will be marketed. 8 MR. BRUCE: Thank you, Mr. Chairman. 9 MR. WAXMAN: Will the gentleman yield to me? 10 MR. BRUCE: I will be happy to yie:ld, Mr. 11 Chairman. 12;; MR. WAXMAN: Is it your testimony, Mr. Cooper, 13' that the only nicotine that will be in this product will be 14!~ from the tobacco in the product itself and not from a 15( capsule that will contain nicotine? I 16; MR. COOPER: Well, let me explain, Mr. Chairman. i 17; The capsule will contain sprayed dried extract of tobacco, 18; which is tobacco that has been put through a water process, l ~ 19;: is used in many.cigarettes. Like all tobacco it has 201: nicotine naturally present in it. So there is nicotine that 2111 comes from that tobacco, which is in the capsule. Nicotine 22 23j~ 24 ;i 25 comes from the tobacco -- cut tobacco leaf, which is in the tobacco roll in the product. MR. WAXMAN: What percentage of the nicotine will be from the capsule as opposed to the tobacco that will be TIMN 0025567 ACE-FEDERAL REPORTERS, CNC. 202-347-3700 Nationwide Coverage 800-336-6646

'"10 08 08 117 OMTbur 1 in the product? 2 MR. COOPER: I am not certain of that. I believe .1 it is -- approximately 70 percent is from the tobacco 4 extract in the capsule. I will check on that, and if I am incorrect, I will submit a correction for the record. And 6 the rest of the nicotine comes from the tobacco leaf, and it 7 is not clear, it is possible that some comes from the 8 tobacco paper filter which is also made from tobacco. 9 But there-is no added pure nicotine or nicotine 10 from any non-tobacco source in that product, as I understand 11 it. 12:, MR. BRUCE: Thank you, Mr. Chairman. 13 :; MR. WAXMAN: Thank you, Mr. Bruce. 14;: Mr. Bliley. 5 , 16! 17 8 22 23 MR. BLILEY: Thank you, Mr. Chairman. Dr. Raffle, what do you.do to help people deal with the urge to smoke when they are trying to quit? DR. RAFFLE: The first thing I do is I explore with them the fact that it is not an addicting substance and that they are not going to go through a withdrawal the way that they would if they were using an addicting substance such as heroin or cocaine. I describe with them what -- that they may or may 24" not experience some tobacco abstinence discomfort and that 25 the amount of discomfort can be very variable and may not be TIMN 0025568 ACE-FEDERAL REPORTERS, INC. 202-347-3700 N ationwide Coverage 800-336-6646

4010 08 08 OMTbur 1 2 3 4 5 6 7 8 9 10 11 12 13 118 present at all. I am sorry that Mr. Whittaker isn't here. I would have added that the amount of discomfort that they can expect would in no way begin to approximate or even vaguely resemble the amount of discomfort and distress that a drug addict is experiencing during their withdrawal. So I try to reassure them. MR. BLILEY: Have you had extensive dealings with drug addicts, people- trying to withdraw from hard drugs? DR. RAFFLE: Yes. MR. BLILEY: I see. So you are speaking from personal experience? - DR. RAFFLE: Yes. This is my clinical 14: experience, both with drug addicts and with people who are 1511 stopping smoking. 161i MR. BLILEY: Well, Doctor, can people freely 177 choose to go back to smoking after having quit for a certain 18,:: period of time? ; 19;; DR. RAFFLE: That has been my experience, and in 20!! fact the curve that was presented earlier up here regarding return of smoking paralleling heroin and cocaine is the 'saine 21;! 221 ' curve that my clinical experience and research indicates 23::! occurs with dieters. People who start out a diet will go 24!l' through the diet for a while and then their rate of -- call 2511 it relapse or return to an old habit pattern is essentially TIMN 0025569 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'010 08 08 119 OMTbur 1 identical with this pattern. 2 - MR. BLILEY: You have dealt with dietists, too? 3 DR. RAFFLE: Yes. Oh, yes. I have treated many. 4 I have six in treatment now. 5 MR. BLILEY: I see. Dr. Blau, do people smoke cigarettes for reasons 7 other than to obtain the effects that may be associated with 8 nicotine? 9 DR. BLAU:- Yes, sir. 10 MR. BLILEY: Would you describe them? 11 DR. BLAU: Sir? 12;: MR. BLILEY: Would you describe some? i 13~i DR. BLAU: Certainly. 14;; People smoke cigarettes for a variety of reasons. 15ii They smoke cigarettes for the taste, for the sensation, 16!; because other people are smoking arid they socialize with ~ 19 1~ I! 17; them in that way. They smoke cigarettes to give themselves 18~i something to do with their hands. The main reason seems to be pleasure and taste. 20jj MR. BLILEY: Well, we have heard a lot of talk ~; . . 211.1 today about intoxication. 22 Clinically, what are the distinctions between the 23~, intoxication associated with heroin and cocaine and those I 24'! which are claimed to be associated with nicotine and I 251 smoking? TIMN 0025570 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

"110 08 08 120 OMTbur 1 DR. BLAU: First of all, Mr. Bliley, I do not 2 believe that people who smoke are intoxicated. Studies that 3 characterize nicotine as an intoxicating drug are describing 4 enormous dosaras of the drug to the point where it is toxic. 5 People, on the other hand, who take crack cocain or morphine or heroin are unable to reason. Their view of 7 the world is clouded. They cannot make reasonable 8 decisions. With the new epidemic of crack cocaine, they 9 become dangerous. People who are ordinarily mild mannered 10 and law abiding will attack and even kill other people. We 11 are talking about a very significant change in the 12!: personality of the individual whereby they become a danger 13,1 to themselves and a danger to others. 14ji When-we look at a chart such as that on annual 15~~ deaths and one sees alcohol and drugs at a very low level, I 16:I wonder where the concern is for the 60 percent of highway ~ 17;I deaths that are drug and alcohol-related, the 60 percent of 18~i suicides that are drug and alcohol-related, and the over 60 19i, percent of homocides which occur by or to an individual who 20;; is under an intoxicating addictive drug. 21;; MR. BLILEY: Dr. Blau, one last question. You " 2211 mentioned in your statement that the Surgeon General's 23 24 25 report may create false hope that nicotine gum is an effective way to quit smoking. Would you elaborate on the "false hope" ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage TIMN 0025571 800-336-6646

1-110 08 08 121 OMTbur 1 point? 2. . DR. BLAU: Yes, sir. When I read the Surgeon General's report, I was 4 very surprised to find that they had omitted reference to a large number of studies which clearly indicate that the use of nicotine as a therapeutic agent has a very low rate of 7 success and is exceeded by such simple things as advice from 8 a physician. 9 MR. BLILEY: Thank you, Dr. Blau. 10 DR. BLAU: Yes, sir. 11 MR. BLILEY: Thank you, Mr. Chairman. 121' MR. WAXMAN: Thank you, Mr. Bliley. 13 Gentlemen, we appreciate your testimony. We may 14;: have additional questions for members of the panel, and we 15'~ would like to ask you to respond in writing to those 6 11 questions for the record. _ Our last witness on this hearing this morning is 191:1 a colleague of ours, the very distinguished gentleman from 20`, the State of North Carolina, Congressman Steve Neal. 211; 1 I would like to ask him to come forward. 18; ; 17' Thank you for being with us. 22 MR. BRUCE: Mr. Chairman? 23' MR. WAXMAN: Yes, Mr. Bruce. 24!1 MR. BRUCE: While Mr. Neal and all the witnesses 25;i are trading places, let me just take the honorr of TIMN 0025572 I ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

-110 08 08 122 OMTbur 1 introducing my father to members of the panel here and to 2 the committee. 3 He has come out from Illinois today, and I am 4 happy to have him with me today. 5 MR. WAXMAN: We do want to welcome him. We are pleased to have you with us, Mr. Bruce. 7 MR. BRUCE: Certainly. 8 MR. WAXMAN: Mr. Neal, we are pleased to have you '9 with us. " 10 Your written statement will be in the record in 11 full. 12;i What we have done for every witness this morning 13 is to limit them to a five-minute oral presentation, and we 14': would like to ask you to keep to the five minutes as well. 1511 We are pleased that you are with us, and we want 16;' to recognize you now for your presentation to us. 17': STATEMENT OF THE HONORABLE STEPHEN L. NEAL, 8 REPRESENTATIVE IN CONGRESS FROM THE 5TH 19`; DISTRICT OF THE STATE OF NORTH CAROLINA 20 Ij MR. NEAL: Thank you, Mr. Chairman. 2111 I am just -- 22 MR. WAXMAN: There is a button on the mike that 23 ', will -- i 24l MR. NEAL: There is a little light on. 25 MR. WAXMAN: Pull it close. TIMN 0025573 202-347-3700 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 800-336-6646

''110 08 08 OMTbur 1 2 3 4 5 7 8 9 10 11 123 MR. NEAL: Mr. Chairman, my written statement is very brief. If you would indulge me, it might run a minute or so over, but I will try to keep it very brief, ar.d I thank you. Mr. Chairman, I appreciate the opportunity to comment on Surgeon General Koop's report, which claims that tobacco is as addicting as heroin and cocaine, and, Mr. Chairman, I want to point out here at the outset that the Congressional district which I represent is the home of R. J. Reynolds Tobacco Company, has a big.American Tobacco 12;; Company plant, and, in addition, I have thousands of 13 constituents who grow leaf tobacco. 14;; Tobacco is a very important agricu:Ltural product 15ii to my district and, in fact, to the whole economy of our H 16~~ state. - 17;; So I think you recognize that I have an interest ii 18' in this, clearly an interest in the subject. 19`:; I must point out, also, though, that I have been i 20;i highly impressed that a number of our colleagues here and a 21~i number of editorial writers from areas of the country which II 22' have no such interests have been highly critical of the 23~I Surgeon General's approach. ~i 24ili Our colleague Larry Smith of Florida, for 25 example, has authorized me to submit for the record a TIlVIN 0025574 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

?9010 08 08 124 ~. OMTbur i statement he made on the House floor on May 17th. I am told 2 that he would be in person here to deliver it, but that he 3 had a previous commitment in his district. Let me quote 4 from that briefly. 5 6 "The problem...," Mr. Smith says.... "The problem is that this 7 statement compared nicotine to 8 heroin. While I commend the 9 gentleman"for decrying the 10 effects of nicotine, I also 11 would suggest to the Surgeon 12;l' General that lumping nicotine 13:- and heroin is a terrible 14;, injustice to the American people. ~ 15~~ Heroin is a far more dangerous ~ 16!; drug from the standpoint of a 17:single dose usage. Heroin is a c 18: killer, and it kills now. It kills 19;, the first time you use it. It has 20!1 the capability of killing you 21;j immediately. Nicotine does not." 22~!, l He goes on to point out that comparing nicotine 23,, and heroin trivializes the problem with hard drugs and 2411 trivializes the terrible effects of heroin, and he urges the 25 Surgeon General to make a clarifying statement to that TIMN 0025575 ACE-FEDFRAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

<010 08 08 125 r OMTbur 1 effect to the American people. 2 Mr. Chairman, as you know, Mr. Smith is a member 3 of the Select Committee on Narcotics Abuse and Control, 4 also. 5 Our colleague Tom Delay, of Texas, again 6 representing a district which produces no tobacco and 7 manufactures no cigarettes, in a floor statement on May 18th 8 10 11 said this: "Lumping cigarettes in the same category as illegal, mind-altering drugs such as heroin, cocaine, 12,; PCP, and crack is wrong and frankly ~13 dangerous." 14 11' He says : 15 aI am not here to argue over the 16!1 relative physical health effects • 17'; of any of these substances, but 18;; I will say this. Nicotine is not 19;' tearing at the very fabric of our 20;~ society as are these drugs. 21i; Nicotine is not consigning ~ . 22 millions of our children to a 23I~ mindless, hopeless existence as 241) are these illegal drugs. Nicotine 251 is not behind the crime wave that TIMN 0025576 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage $00-336-6646

010 08 08 OMTbur 1 22 3 4 5 6 7 8 9 10 11 126 has made a normal existence in every inner city in our country impossible. Try walking a mere ten blocks from the very chamber we are standing in right now. It is not the cigarette smokers who will hold you up. I know of no law enforcement personnel killed in pitched gun battles fought by gangs of rival cigarette dealers." "We are spending billions of 12: dollars to stop the drug trade 131. with only marginal success. To 14'- put cigarettes in the same level r 15~; as this scourge is ridiculous," 16!j he goes on to say. :; - 17~ The Boston Globe, a major newspaper in the state 18 which has no economic ties to tobacco, on May 19th said in 19 an editorial: 20ij "Smoking bears no resemblance to 21!i drug abuse or alcohol abuse. ~ 22 Smoking does not affect mental 23 acuity nor temporarily derange a 241 1 person nor produce so much as a I 251 lull in anyone's contact with ~I TIMN 0025577 202-347-3700 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 800-336-6646

&010 08 08 OMTbur 1 2 3 4 5 6 7 8 9 10 11 12!, 13 141: . ;;. 1511 161i ~~ 17':I 18;~ , ~: 19~' 20;' 21;! 221j 23 I 24i 25II 127 reality. Smoking does not cause people to rob their neighbors to support the habit. Nobody beat their spouses or children in a mood-altered frenzy nor drive crazily nor aid international drug cartels. Smoking does not endanger neighborhoods or contribute to street crime, clogged courts, or filled prisons. For the right reasons smokers should stop," the editorial says, "but that goal is not advanced by equating smoking with drug abuse or alcohol abuse nor should it divert attention from - those ruinous addictions." In the same vein, the Indianapolis "Classifying the dangers of nicotine with the horrors of heroin and cocaine is misguided zealotry. It downgrades, even discredits the nation's campaign against hard drugs. Indeed, the Surgeon General's latest Star said: TIMN 0025578. ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

'010 08 08 OMTbur. 1 4 5 6 7 8 9 10 11 21 22 23 24 25 128 attack on smoking is itself generally irresponsible. His enthusiasm has turned to zealotry a.id is on its way to fanaticism. His concern for the people's health is no longer mixed with a healthy respect for individual rights and individual responsibility." The Kansas City Star added: "If you have any doubts as to the ridiculousness of Koop's 12;! contention, ask yourself a II 13;1 question. How many people have 14;: turned to crime to support a 15'1 tobacco habit?" 161 Mr. Chairman, a Mr. Leonard Larsen, writing in 17~" the Washington Times, put it this way: 18ii . "Meaning no offense to Dr. Koop ~. 19i1I and intending no support for ~ 2011 the tobacco industry, it is ii still appropriate to suggest that Dr. Koop has actually diminished the attack against a serious national health problem by hyping a dangerous TIMN 0025579 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646

r110 08 08 OMTbur 1 2. 3 4 5 6 7 9- 10 129 habit into an addiction. His commentary on tobacco smoking. as addiction may prove to be good for the business of the nicotine cure peddlers and the tobacco chasing lawyers, but for cigarette smokers he has just handed them a better excuse not to quit. -I can't, I'm hooked, I'm an addict. The Surgeon 11. General said so. When cigarette 12;h ' smokers say they want to quit 13;; smoking but they can't, then 14,! they haven't yet really decided II i 15ii they ought to quit smoking and 1611 that they are going to quit 17:' smoking. By telling them they 18;are addicted, Dr. Koop encourages 19:' them to push the decision 20j; farther away." 21i Mr. Chairman, I am no scientist, nor am I an 221 expert on the exact definition of the words and phrases used 23~i in the report, but for the Surgeon General to suggest that i 241; cigarette smoking is any way comparable to the abuse of hard 25 drugs is not only an insult to the intelligence and common TIMN 0025580 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage 202-347-3700 800-336-6646

f"'010 08 08 130 , , . OMTbur 1 sense of the American people, it is the wrong signal. I do not know a parent in America who.would not 4 prefer to have their son or daughter take up smoking than to take up heroin, cocaine, or other hard drugs, and to suggest. to young people that one is no more dangerous or habit 7 forming than the other is certainly counter-productive. Mr. Chairman, Surgeon General Koop's claim that 8 tobacco is comparable to heroin and cocaine addiction is 9 intemperate, inaccurate, and very counter-productive in our 10 nation's effort to successfully deal with our nation's 11 serious hard drug problem. 12i! And I thank you for the opportunity to address ~ 13: the committee. 141i MR. WAXMAN: Thank you very much, Mr. Neal. 15l~ Mr. Bliley, do you have any questions? ,16! MR. BLILEY: No. I just want to thank our n 17, colleague from taking time out of his busy schedule to.be 18,; with us this morning. 19ii MR. NEAL: Thank you. 20i; MR. BLILEY: And, Mr. Chairman, before you 21; 1 adjourn this hearing I would like to commend you on the fair 22! I and even-handed way that you have conducted this hearing. 23i Thank you. I 24 { MR. WAXMAN: Thank you very much, Mr. Bliley. 25 Mr. Bruce, any questions? 202-347-3700 ACE-FEDERAL REPORTERS, INC. Nationwide Coverage TIMN 0025581 800-336-6646

.'' 010 08 08 131 OMTbur 1 MR. BRUCE: Just to thank Mr. Neal for coming and 2 to the other witnesses who took their time to appear before 3 us today and for your conduct of the hearing. 4 Thank you. 5 MR. WAXMAN: Thank you. 6 Well, Mr. Neal, I do thank you, also, and I 7 appreciate the views you have expressed to us., 8 MR. NEAL: Thank you for holding these hearings, 9 M Ch i a rman. . r. 10 MR. WAXMAN: Thank you. 11 That concludes the business of this hearing. We 12: stand adjourned. I 131 14 * adj ourned . ) 15! 16 !i 17 8 19 20;; 2211 23 24 25 (Whereupon, at 11:55 a.m., the subcommittee was 'TIMN 0025582 ACE-FEDERAL REPORTERS, INC. 202-347-3700 Nationwide Coverage 800-336-6646