Reports that Matter

United States v. Philip Morris USA Inc.: Amended Final Opinion

Cigarette Smoking Is Addictive and Nicotine Is the Primary Element of

Section 49 of 129

Cigarette Smoking Is Addictive and Nicotine Is the Primary Element of

That Addiction a. How Nicotine Operates within the Body 833. When a person puffs a cigarette, she inhales cigarette smoke, which consists of an

aerosol of particles and gases, including water, nicotine, and tar. Nicotine, a chemical found primarily in tobacco plants, has a structure similar to a chemical in the body called acetylcholine, a neurotransmitter which provides the pathway of communication from one nerve cell to another. Nicotine competes with and blocks the effects of acetylcholine in the body. When cigarette smoke is inhaled deeply into the lungs, nicotine particles impact the breathing tubes in the lungs and nicotine is rapidly absorbed into the blood stream. It then rapidly moves to the heart and from there through the arterial blood vessels to the rest of the body, including the brain. It takes about 15-20 seconds from the time a smoker puffs on a cigarette for its nicotine to enter the brain. Benowitz WD, 15:13-16:13.

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  1. The more quickly nicotine is absorbed, the higher its concentration in the body and the greater its effects. Smoking nicotine provides the fastest rate of absorption and highest blood levels of nicotine. On average, one cigarette delivers 1mg to 1.5 mg of nicotine. In comparison, when nicotine is absorbed from a skin patch, blood levels rise gradually over 4 to 6 hours; when it is absorbed from gums or lozenges, blood levels rise over 30 minutes. Again, in comparison, caffeine and alcohol absorb into the body over 30 minutes. Id. at 18:9-11, 18:18-24, 19:18-20:13.

  2. Nicotine binds to receptors that are intended to bind to the body's own neurotransmitter, acetylcholine. When nicotine binds to receptors, it artificially stimulates the acetylcholine system and causes the release of a number of hormones, including dopamine, norepinephrine, serotonin, and endorphins, which then affect mood and behavior. In addition, nicotine affects virtually every body organ. For example, nicotine increases the rate and force of heart contractions and constricts blood vessels. Id. at 16:14-17:23.

  3. Nicotine produces two different kinds of effects. First, there are certain primary effects of nicotine on the brain that smokers find desirable. For example, the first cigarette in the morning usually has a stimulating or alerting effect. Similarly, if a person is feeling stressed or anxious, nicotine may reduce that stress or relieve that anxiety and make a person feel better. Smokers may, however, develop tolerance to many of these primary effects. As occurs with the use of all psychoactive drugs, the brain attempts to adapt to the persistent presence of nicotine. This adaptation, or tolerance, produces actual changes in the brain's structure. Over time, the brain becomes tolerant to the effects of nicotine and needs even greater amounts of it to produce the same effects on hormones as it once did before the development of tolerance. Id. at 22:5-23:17.

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  1. Second, because the smoker's brain has adapted to the constant presence of nicotine, it becomes dependent on nicotine to function normally. When a smoker doesn't have nicotine, the brain functions abnormally and most people, approximately 80%, experience withdrawal symptoms. Those symptoms, which are the very opposite of the primary effects of nicotine, include irritability, lethargy, restlessness, sleeplessness, anxiety, depression, hunger, and weight gain. Withdrawal symptoms begin to occur as soon as nicotine levels in the body start to decline. When a person is experiencing nicotine withdrawal symptoms, ingestion of nicotine reverses the effects. This reversal of unpleasant withdrawal effects is perceived by the smoker as having beneficial effects on mood and arousal. Id. at 23:18-24:9. Thus, as tolerance develops, the smoker gets fewer pharmacological benefits from each cigarette and smokes more and more to avoid withdrawal symptoms. Id. at 24:18-20; See also Farone WD, 73:2-20. However, the smoker's need for even greater amounts of nicotine does eventually plateau. It take an average of seven years to reach a plateau level of cigarette consumption. Id. at 24:22-24.

  2. In commonly understood terms, smokers become dependent on the significant pharmacological and psychoactive effects of the nicotine in cigarettes, resulting in craving, compulsive use, difficulty in quitting, and relapse after withdrawal. Farone WD, 73: 2-20.

  3. There is compelling evidence that smoking behavior is motivated by a need to maintain a preferred dose or level of nicotine intake, leading to the phenomenon of nicotine compensation, or titration, in response to the use of cigarettes with lower nicotine yields. Although it may be correct that addiction to smoking is, in part, an addiction to a set of behaviors, i.e., opening a pack, taking out a cigarette, lighting up, tapping ashes, etc., the fact is that nicotine is the essential ingredient which creates and maintains the addiction. To give a simplistic example, denicotized cigarettes have attracted virtually no smokers even though the behaviors involved are the same. See Farone WD, 73:21-74:3.

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  1. This understanding supports the now overwhelming consensus in the scientific and medical community that cigarette smoking is an addictive behavior and that nicotine is the component in cigarettes that causes and sustains the addiction. Henningfield WD, 114:9-12; Burns WD, 13:16-14:19. However, it has taken over 50 years for this full understanding of nicotine's role and addictiveness to evolve.

b. Evolving Definitions of "Addiction" and Classification of Nicotine 841. In the last fifty years, as the scientific, regulatory, and public health communities have

developed greater understanding of drug use, they have adopted a more nuanced definition of what constitutes an addiction to drugs. As the definition of addiction evolved, so did the classification of nicotine.

  1. In its 1957 Report, the World Health Organization ("WHO") Expert Committee on Addiction Producing Drugs set forth criteria for determining both drug dependence and drug habituation:
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Drug Addiction Drug Habituation

Drug addiction is a state of periodic or Drug habituation (habit) is a condition resulting chronic intoxication produced by the repeated from the repeated consumption of a drug. Its consumption of a drug (natural or synthetic). characteristics include:

Its characteristics include:

  1. An overpowering desire or need 1) A desire (but not a compulsion) to

(compulsion) to continue taking the drug and continue taking the drug for the sense of to obtain it by any means; improved well-being which it engenders;

  1. A tendency to increase the dose; 2) Little or no tendency to increase the dose;

  2. A psychic (psychological) and 3) Some degree of psychic dependence on generally a physical dependence on the the effects of the drug, but absence of physical effects the effect of the drug; dependence and hence of an abstinence syndrome;

  3. Detrimental effect on the individual 4) Detrimental effects, if any, primarily on and on society. the individual.

See Benowitz TT, 11/2/04, 4621:28, 4623:1-20; Henningfield TT, 11/23/04, 6866:20-6867:11; (US

64057). The 1957 WHO Report emphasized the importance of intoxication as a component of addiction, which it labeled a personality disorder. A drug addiction was used to describe drugs that produced marked intoxication with concomitant impairment of performance and severe physical dependence. A drug addiction at that time also meant damage not only to the individual but to society (e.g., anti-social behavior and criminality). A drug habit, on the other hand, was considered to be a psychological dependence involving no physical dependence and/or no damage to society.

Henningfield WD, 114:18-116:14.

  1. In 1964, shortly before the issuance of the Surgeon General's 1964 Report, the WHO

Expert Committee on Addiction Producing Drugs published a new Report abandoning its prior definitions of habituation and addiction. Instead, the WHO committee recommended the adoption of the term "dependence," which it defined as "a behavioral pattern in which the use of a given psychoactive drug is given a sharply higher priority over other behaviors which once had a significantly higher value." Most importantly, the 1964 WHO Report determined that intoxication and personality disorder were not accurate criteria for determining addiction, replacing them with measurements of addictive effects including physiological dependence, withdrawal, reinforcement, and psychoactive effects. Henningfield WD, 109:3,20, 110:8-22, 114:18-116:14, 122:20-123:16.

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  1. Because the 1964 WHO Report was issued so shortly before the 1964 Surgeon General's Report, the Surgeon General was unable to take its new definitions into account when considering the proper classification of nicotine. Consequently, in his January 1964 Report, the Surgeon General, using the earlier criteria established by the WHO in 1987 for "addiction" and "habituation," concluded that smoking, nicotine, and cocaine were not addictions. Smoking in particular was termed a "habituation" rather than an "addiction." The criteria for addiction that the 1964 Report used were: (1) periodic intoxication; (2) overpowering desire or need; (3) tendency to increase dose; (4) psychic and physical dependence; and (5) detrimental effects on society. The 1964 SG report concluded, based on the 1957 WHO definition and the limited data available at the time, that smoking produced only a "psychiatric but not physical dependence." VXA1601844-2232 (US 64057); Henningfield WD, 114:18-117:5.

  2. Between 1964 and 1988, when the Surgeon General finally did apply the term addiction to smoking, many individuals and organizations within the public health community struggled with the classification of nicotine. Each examined the issue from the perspective of their own particular discipline and constituency.

  3. Despite the fact that there were a few early studies suggesting that nicotine could create pleasurable effects or withdrawal symptoms, the state of knowledge in the public health community about nicotine's role in behavior was limited. For example, in 1962, the Larson, Haag, and Silvette compendium was published, with the financial support of Philip Morris. This highly respected reference book summarized much of the world literature on the effects of tobacco and nicotine. Although it found that nicotine is a powerful and potent nerve acting drug, it did not address the issue of addiction. In addition, there was evidence suggesting that nicotine could serve as a reinforcer for monkeys, generated by work in the later 1960s at the University of Michigan. There was evidence suggesting the existence of a nicotine withdrawal syndrome dating to the Finnegan, Larson, and Haag study in 1945. There was evidence suggesting that injected nicotine could cause psychoactive effects and provide a substitute for tobacco from the Lennox Johnston study of 1942. While there was some indication of the important role played by nicotine, all such studies left too many significant gaps in the analysis of nicotine to draw definitive conclusions. Id. at 117:2-118:11.

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  1. In 1979, Michael Russell, one of the most prominent public health researchers on nicotine, wrote a chapter in a NIDA monograph, titled "Tobacco Dependence: Is Nicotine Rewarding or Aversive," exploring whether nicotine was an important factor in smoking. He concluded that it remained unproven "that nicotine is what smokers seek." ATX02 0068361-10068383 (US 65420). Dr. Russell noted key gaps in knowledge, and that animal models of nicotine self-administration had proven inconclusive. Henningfield WD, 126:18-127:10. At that point, the scientific and medical community simply did not have the knowledge of nicotine's pharmacological effects and the greater impact that a faster rate of delivery of the dose could provide. Id.

  2. It was not until 1980 that clinical psychiatrists determined that there was sufficient evidence of dependence and withdrawal from smoking to include these symptoms in the APA's

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Diagnostic and Statistical Manual ("DSM-III"). Even then, the syndromes were called "tobacco dependence" and "tobacco withdrawal" rather than "nicotine dependence" and "nicotine withdrawal," because of psychiatrists' insufficient knowledge and understanding of the specific role of nicotine. It was clear to the developers of the DSM-III that nicotine played a role in making smoking addictive, but there were unresolved questions as to the importance of nicotine as opposed to the numerous other constituents of tobacco smoke and behavioral components of smoking that were the possible addictive elements. Henningfield WD, 123:23-128:21.

  1. It was not until 1982 that the National Institute of Drug Abuse ("NIDA") concluded that scientific evidence demonstrated that nicotine is addictive. Id. at 132:10-13. The Director of NIDA, Dr. William Pollin, testified to that conclusion before Congress in 1982 and 1983. HHA5002584-2590; US 58808. NIDA applied the 8 factors listed in the Controlled Substances Act of 1970 ("CSA"), all of which were used by the Food and Drug Administration ("FDA") and Drug Enforcement Agency ("DEA"), to determine if a substance should be officially designated an addictive drug, which is a "controlled substance" under the CSA. NIDA concluded that smoking met the following criteria for nicotine drug dependency: (1) persistent regular use of a drug; (2) attempts to stop such use which lead to discomfort and often result in termination of the effort to stop; (3) continued drug use despite damaging physical and/or psychological problems; and (4) persistent drug-seeking behavior. NIDA also concluded that "not only has tolerance to some of the effects of smoking been demonstrated but metabolic tolerance to various components of cigarette smoke, including nicotine, has been documented." NIDA relied upon previously existing data as well as findings from its own Addiction Research Center showing that nicotine met key criteria as a reinforcing and euphoriant drug in animal and human studies. Id. at 133:1-134:13.
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  1. Finally, in 1988, the Surgeon General, in his Report on "The Health Consequences of Smoking -- Nicotine Addiction," reached the significant conclusion that the reason smokers smoke is because they are addicted to nicotine. After an exhaustive review of the literature on nicotine and smoking behavior, the Report found that cigarettes and other forms of tobacco are addicting, and that nicotine is the substance in tobacco that causes the addiction. The Health Consequences of Smoking: Nicotine Addiction: A Report of the Surgeon General (1988), VXA0300208-0848 (US 64591).

  2. Relying in part upon the APA and WHO clinical findings that nicotine dependence and withdrawal could occur with tobacco use and that nicotine was the key pharmacological agent, and in part upon the chemical and pharmacological evidence considered by NIDA, the DEA, and the FDA in determining if a drug is addictive, the 1988 Surgeon General's Report set forth three primary criteria for determining whether a drug, in this case nicotine, is addicting: (1) use is highly controlled or compulsive; (2) the use of the drug produces mood altering (psychoactive) effects; and (3) the drug reinforces behavior, resulting in continued intake or drug-reinforced behavior. Henningfield WD, at 143:20-144:3; VXA0300208-0848(US 64591); Benowitz WD, 27:6-13.

  3. The first criterion, highly controlled or compulsive use, refers to drug-seeking and drug-taking behavior that is driven by strong, often irresistible urges. Such use persists despite a desire to quit or even repeated attempts to do so. This type of behavior has also been described as "habitual." Benowitz WD, 27:21-28:2.

  4. Drug addiction, however, is distinguished from habitual behaviors not involving drugs -- such as habitual exercising or overeating -- by the second criterion, the presence in the blood stream of a drug with psychoactive or mood-altering effects on the brain. Food, for example, which is necessary to sustain life, is not a drug and does not satisfy the second criterion. Id. at 28:3-16. Smoking cigarettes involves a drug and is not comparable to non-drug "habits" such as jogging, playing tennis, or biting one's nails. Rowell TT, 3/23/05, 16685:5-16687:19.

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  1. Finally, to meet the third criterion in the Surgeon General's Report, the drug must be capable of functioning as a reinforcer that directly strengthens behavior leading to further drug ingestion. Such reinforcement exists where, for instance, the drug produces pleasant or rewarding sensations like stimulation, relaxation, or euphoria, or mitigates unpleasant withdrawal sensations experienced when a person stops using it. Benowitz WD, 28:17-29:7.

  2. The 1988 SG Report demonstrated that nicotine in cigarettes meets the same criteria for addiction that apply to heroin, morphine, and cocaine and that the pharmacological and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. Henningfield WD, 143:13-19. The Report specifically found that nicotine, heroin, morphine, and cocaine all met the criteria for addiction.

  3. Dr. Peter Rowell, one of the Defendants' experts, admitted that there are many similarities between the properties that determine tobacco addiction and those that determine heroin and/or cocaine addiction:

Q. And I want to direct your attention specifically to the third major conclusion expressed by the Surgeon General in 1988, which appears at page 9, and it reads, quote, the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. Do you see that? A. Yes, I do. Q. Do you agree or disagree with what the Surgeon General said about similarities existing between the pharmacologic and

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behavioral properties that determine tobacco addiction and those that determine addiction to drugs such as heroin and cocaine?

A. I agree there are similarities.

Q. Have you prepared an animation that -- well, before we get to that, let me ask you a further question. When you say that there are these similarities, what is the basis for your saying that there are similarities from a pharmacological point of view? What are you focusing on?

A. The dependence properties of nicotine and more dramatically cigarette smoking in regards to physical dependence, withdrawal symptoms, effects of neurochemistry in the brain on neurotransmitters, self-administration studies. Many of these things were done in the '80s just before the Surgeon General's report. So these were the similarities that led the Surgeon General to indicate that there were, in fact, these similarities between cigarette smoking and these other drugs.

Rowell TT, 3/22/05, 16549:23-16650:15.

  1. The 1988 Surgeon General's Report did not include intoxication as a criterion for addiction. As discussed earlier, in the 1950s and early 1960s, it was believed that significant intoxication or impairment were required to sustain addiction. That requirement of addiction has long been abandoned by the WHO, the APA, and the Surgeon General because many intoxicating substances are not addicting and because many addictive drugs are used and abused in dose levels that do not cause intoxication. Benowitz WD, 30:14-31:25; Henningfield WD, 145:20-146:5,

150:14-151:8.

  1. Defendants' own expert witness, Dr. Rowell, rejected the claim that intoxication was necessary for nicotine to be considered addicting:
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Q. And, sir, it is correct, is it not, that it's been your view since the early 1970s that to be addictive, a drug does not have to cause intoxication? A. Yes. Q. The suggestion, then, that a drug cannot be addictive because it is not intoxicating, you wouldn't agree with that statement, correct? A. I would not.

Rowell TT, 3/23/05, 16632:4-7, 16632:23-16633:2.

  1. In addition, the Surgeon General did not include either tolerance or withdrawal effects as criteria for addiction. However, the 1988 Surgeon General's report documented both tolerance and withdrawal and determined that nicotine met these additional criteria. See 1996 FDA Jurisdictional Determination, 61 Fed. Reg. 44619 (August 1996); VXA1242326-3211 at 2645-2651 (US 64323) (recognizing that nicotine is addictive even under the outdated 1964 SG Report/1957 WHO definition). However, neither tolerance nor withdrawal are the primary criteria of drug dependence/addiction.

  2. In 1994, the APA published its Diagnostic and Statistical Manual of Mental Disorders-IV ("DSM-IV") which defined "substance dependence" as "a pattern of repeated self-administration that usually results in tolerance, withdrawal, and compulsive drug-taking behavior." DSM-IV continued to recognize the diagnoses of both "nicotine dependence" and "nicotine withdrawal." American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders IV (1994) at 176-181 (JD 000460).

  3. In the DSM-IV section titled "Nicotine-Related Disorders," the APA concluded that nicotine can produce dependence in people who use all forms of tobacco, including pipes, chewing tobacco, or cigarettes, because the following criteria are present: tolerance, withdrawal, a desire to quit, a great deal of time spent using nicotine, and the continued use despite medical problems. APA, DSM-IV (1994), at 176-181, 242-247 (JD 000460).

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  1. In describing the diagnosis of "Nicotine Dependence," the DSM-IV authors stated that, "Tolerance to nicotine is manifested by the absence of nausea, dizziness, and other characteristic symptoms despite using substantial amounts of nicotine or a diminished effect observed with continued use of the same amount of nicotine-containing products." Id.

  2. The DSM-IV authors specifically rejected Defendants' oft-repeated public claim that smoking cigarettes does not produce withdrawal and therefore is not addictive: "Cessation of nicotine use produces a well-defined withdrawal syndrome that is described below. Many individuals who use nicotine take nicotine to relieve or avoid withdrawal symptoms when they wake up in the morning or after being in a situation where use is restricted." In addition, withdrawal symptoms "are typically more intense among individuals who smoke cigarettes than among individuals who use other nicotine-containing products." Id. at 243-244.

  3. By 1988, almost every major public health organization, including the Surgeon General, the National Institute on Drug Abuse, the World Health Organization, the American Psychiatric Association, the Harvard School of Public Health, and others, had declared that smoking is an addiction driven by the drug nicotine.14 The American Psychiatric Association focuses on behavioral and clinical symptoms indicative of drug dependence, compared to the WHO, Surgeon General, and FDA, which focus more on the pharmacological effects of the drug. -345- Benowitz WD, 26:3-36:8.

  4. Further reflecting the consensus judgment that nicotine is addictive, the investigation by the FDA leading to its Final Tobacco Rule issued in August 1996 confirmed that even under the stringent criteria employed by the FDA, nicotine in cigarettes is an addictive drug. Henningfield WD, 159:9-161:22. The FDA concluded in its August 1996 Final Rule that, "All major public health organizations in the United States and abroad with expertise in tobacco or drug addiction now recognize that the nicotine delivered by cigarettes and smokeless tobacco is addictive." 1996 FDA Jurisdictional Determination, 61 Fed. Reg. 44619 (August 1996) at xv, VXA1242326-3211 at 2572 (US 64323).

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  1. Defendants' own expert, Dr. Rowell, not only agreed that nicotine plays an essential role in cigarette smoking, Rowell TT, 3/23/05, 16625:12-25, but that "there is clearly addiction for cigarette smoking." Rowell TT, 3/24/05, 16790:4-16.

  2. As the documentary evidence laid out in great detail infra shows, over the last forty years, Defendants have been no stranger to the term "addiction" in reference to smoking. In-house tobacco industry research, research not disclosed to the 1964 Surgeon General's Advisory Committee, showed drug addiction-like effects, including tolerance, withdrawal, compulsive use, and craving. The actions of BATCo and B&W, described below, are particularly illuminating on the issue of how far superior the cigarette company Defendants' knowledge of nicotine and its behavioral and pharmacological effects was by 1964, compared to the relatively uninformed conclusion of the Advisory Committee to the Surgeon General who lacked that knowledge and its supporting research. See extended discussion at Section V(B)(3)(c-d), infra.

c. Consequences of the Addictiveness of Nicotine 868. Today, most daily cigarette smokers satisfy the Surgeon General's primary criteria

for addiction. First, as to highly controlled or compulsive use, addicted smokers smoke numerous cigarettes -- often at least one pack or 20 cigarettes -- throughout the day. Second, the nicotine in the cigarette tobacco stimulates the nicotinic receptors in the smoker's brain, producing a psychoactive reaction that affects the smoker's mood. Third, the smoking behavior is reinforced by the pleasurable effects of nicotine and/or by the mitigation of unpleasant withdrawal sensations triggered by the need for nicotine. Benowitz WD, 29:8-30:13.

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  1. Published research indicates that 77% to 92% of smokers are addicted to nicotine in cigarettes. 1996 FDA Jurisdictional Determination, VXA1242326-3211 at 2335, 2528 (US 64323).

  2. Many smokers and potential smokers are unaware of or do not fully appreciate the addictive nature of nicotine, the addictiveness of cigarette smoking, and the extent to which nicotine delivery and dosage are +highly controlled and engineered. Weinstein WD, 61:5-74:2.

  3. Every year, an estimated seventeen million people in the United States attempt to quit smoking. Fewer than one and a half million, or 8%, succeed in quitting permanently. Benowitz TT, 11/1/04, 4505:2-4506:13.

  4. Most smokers smoke cigarettes regularly in order to experience nicotine's effects on the brain and the body, and thereby become addicted to nicotine. People who try to quit smoking often experience withdrawal symptoms that can be extremely disruptive. Accordingly, it is usually very difficult for the smoker to stop smoking cigarettes. Id., 4503:17-4506:13.

  5. Most smokers who desire to quit require several quit attempts before they are successfully able to give up cigarettes, and many smokers die of smoking-related diseases before they are able to quit. Id., 4505:2-4506:13.

  6. Most smokers become addicted to smoking as teenagers. 88% of daily smokers tried their first cigarette before reaching age eighteen, and 70% of people who have ever smoked daily began smoking daily before they were eighteen years old. Because the addiction to nicotine develops in the first few years of cigarette smoking, most smokers become addicted to nicotine during adolescence or early adulthood. Benowitz WD, 38:15-39:2, 39:3-5, 9-10.

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  1. Research shows that 81% of adult smokers said that if they tried to quit for just a day, they experienced strong cravings for cigarettes. Of these, 95% said that the cravings were stronger than what they had expected when they began to smoke. Fewer adolescent smokers -- 46% -- reported that they would experience strong cravings if they tried to quit. Among those adolescents who said they experienced such cravings, 85% said that the cravings were stronger than what they had expected when they began to smoke. In short, people underestimate the addictive power of nicotine when they first become smokers. Weinstein WD, 66:3-69:19.

  2. As for quitting, most smokers give no thought to how long they will smoke when they first begin, apparently believing that quitting is something that can be decided later. By then, addiction makes it extremely difficult to quit. In a large national survey, 24% of youth smokers said they expected to smoke for less than a year, 10% said one to five years, and only 5% said they expected to smoke longer than five years. A much larger proportion, 61%, said they had never thought about it. The corresponding figures for adult smokers were: less than one year - 12%, one to five years - 5%, longer than five years - 7%, and never thought about it - 76%. Id.

  3. The Annenberg study, which surveyed 600 fourteen to twenty-two year olds in the forty-eight contiguous states, asked smokers who said that they planned to try to quit in the next year, "If we called you again in a year, would you guess you would have successfully quit smoking?" A very high 83% of youths and 78% of adults said they expected to succeed in their quit attempt. The reality was that only 28% of teenage quitters managed to quit smoking for a year, and only 7% of adults smokers who tried to quit were able to remain cigarette free for a year. Id.

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  1. In another study, smokers who were planning to quit in the next year, and who had tried and failed in the past, were asked about their next quit attempt. From this group, 88% of youths and 64% of adults said that they would be nonsmokers a year later. Even among those who stated that quitting was very hard or almost impossible for others, 83% of youths and 57% of adults predicted their own success. Id.

  2. These studies demonstrate that smokers and nonsmokers agree that quitting is difficult, and that teenage and adult smokers greatly overestimate the likelihood that their own individual quit attempts will succeed. Nearly half of teenage smokers think that quitting will be easy for them even though they think it will be very difficult for their peers. The evidence also indicates that people fail to consider the difficulty of quitting when they start to smoke and do not recognize how strong the cravings produced by addiction can be. In short, people, and youth in particular, have insufficient recognition of how difficult it will be for them to stop smoking even though they may have an intellectual understanding of the medical consequences of smoking. Id.

d. Conclusion 880. As the public health community's understanding of nicotine's pharmacological and

behavioral effects on the human body has evolved, so has the terminology used to describe nicotine. The scientific and medical community has struggled with the choice of the proper nomenclature to describe the human affinity for nicotine and has moved from "habituation" to "dependence" to "addiction." Since the mid-1980s, the scientific and medical community has viewed the terms "dependence" and "addiction" as virtually synonymous. In fact, many public health organizations, including NIDA, the American Association of Addiction Medicine, and the College on Problems of Drug Dependence, use the terms "drug addiction" and "drug dependence" interchangeably.

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Henningfield WD, 110:9-22. Indeed, the tobacco industry itself has used these terms interchangeably. See Section V(B)(3), infra.

  1. The Surgeon General chose the term addiction in 1988 in order to effectively convey to the public the severity of smokers' attachment to nicotine, the intense difficulty of breaking that attachment, and the fact that the attachment is physiological and not merely a lack of willpower to stop doing something pleasurable. See Benowitz TT, 11/2/2004 at 4647:4-7, 4647:25-4648:9, 4655:6-4661:21 (JD -054316). In light of these facts, this Court will use "addiction" and "dependence" interchangeably. Disputes over terminology to describe the workings of nicotine should not obscure the reality that Defendants long ago internally recognized the same phenomenon that the scientific and medical community have struggled to understand and describe: the extraordinary hold that nicotine has on the human nervous system and the fact that such hold stems from nicotine's pharmacological properties.