Tobacco Documents Online

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