[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices]
[Page 41644-41673]
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[[Page 41644]]

C. INDUSTRY RESEARCH ON THE CONSUMER'S NEED FOR AN ADEQUATE DOSE OF
NICOTINE

1. Industry Research on Importance of Supplying Sufficient Nicotine to
Provide Consumer Acceptance and ``Satisfaction''

    The industry has conducted extensive research establishing that
smokers require a certain level of nicotine from their cigarettes and
that tobacco ``satisfaction'' is attributable to nicotine's systemic
effects after absorption, rather than to its immediate sensory effects
in the mouth, nose, and throat.<SUP>280

    \280\ BATCO Group Research & Development Centre. Research
Conference. Southampton, England. September, 1984. Page 1. Proposed
Revisions for 1985-87:
    Specific attention will be focussed on nicotine to identify its
contribution to product attributes, particularly acceptability and
satisfaction. A range of de-nicotinised tobacco blends, supplemented
with varying levels of nicotine, will be prepared. These will be
used in studies aimed at assessing the specific sensory properties
of nicotine and the relationship between tar and nicotine in terms
of product acceptability. The studies will provide an initial
opportunity to separate immediate product acceptability from longer-
term satisfaction.
---------------------------------------------------------------------------

    In the mid 1970's, BATCO Group Research & Development conducted
Project Wheat, a study whose purpose was to identify the different
motivations for smoking and correlate those motivations with what BATCO
characterized as a smoker's ``Inner Need level.'' <SUP>281 The
researchers established smokers' ``Inner Need level'' by identifying
the extent to which they smoked to relieve stress, to aid
concentration, and as a food substitute to avoid weight gain.<SUP>282
In other words, a smoker's ``Inner Need'' was defined by the extent to
which the smoker used cigarettes for the drug effects of nicotine. (See
description of the effects of nicotine on mood and weight in FINDINGS
Sec. I.D., supra.) The researchers hypothesized that the ``Inner Need

[[Page 41645]]
level'' would correlate with the smoker's preferred nicotine delivery,
and that smokers with higher ``Inner Need'' would prefer cigarettes
that delivered higher nicotine levels.

    \281\ See Project Wheat--Part 1, note 204, supra, at p. 1;
Project Wheat--Part 2, note 204, supra, at p. 1.
    \282\ See Project Wheat--Part 1, note 204, supra, at pp. 5, 10-
11, 16-25.
---------------------------------------------------------------------------

    Project Wheat was intended to help BATCO develop cigarettes that
were more acceptable to consumers.<SUP>283 The Project Wheat
researchers emphasized the importance of nicotine delivery over all
other product features (including taste) in achieving an acceptable and
satisfying cigarette:

    \283\ See Project Wheat--Part 1, note 204 supra, at p.1.
---------------------------------------------------------------------------

    In considering which product features are important in terms of
consumer acceptance, the nicotine delivery is one of the more
obvious candidates. Others include the taste and flavour
characteristics of the smoke, physical features such as draw
resistance and rate of burn, and the general uniformity of the
product, to name but a few. The importance of nicotine hardly needs
to be stressed, as it is so widely recognised.<SUP>284 [Emphasis
added.]

    \284\ See Project Wheat--Part 1, note 204 supra, at p. 3.
---------------------------------------------------------------------------

    The researchers found that ``Inner Need'' correlated positively
with daily cigarette consumption, depth of inhalation, and anticipated
difficulty in giving up smoking; i.e., a higher ``Inner Need'' smoker
would smoke more cigarettes, inhale more deeply, and anticipate greater
difficulty in quitting smoking than a lower ``Inner Need''
smoker.<SUP>285 The researchers concluded that ``Inner Need'' defined a
requirement for nicotine by the smoker.<SUP>286

    \285\ Id. at p. 2.
    \286\ BATCO Group R&D Conference on Smoking Behavior. October
11-12, 1976, at p. BW-W2-02295.
    The Project Wheat researchers also found that smokers of low
nicotine delivery cigarettes derive less satisfaction from their
cigarettes than smokers of medium or high nicotine cigarettes.
    Compared with the other two categories of smoker [medium and
high], those respondents who smoke low nicotine cigarettes (less
than 1.0 mg per cigarette) see their brand as milder, smoother, less
satisfying and with not quite such a good taste, comments which are
of course perfectly logical.
    Project Wheat--Part 2, note 204, supra, at p. 10.

[[Page 41646]]

---------------------------------------------------------------------------

    Tobacco industry documents show that smoker ``satisfaction'' is one
of the key attributes of consumer acceptance of tobacco products. These
documents also make clear that ``satisfaction'' is a tobacco industry
euphemism that refers to the pharmacological response to nicotine that
smokers seek to obtain from smoking.<SUP>287 A BATCO scientist, in a
1969 presentation describing the research activities of BATCO Group
Research & Development, stated that:

    \287\ Wood DJ. BATCO Group Research & Development. ``Aspects of
the R&DE Function. Notes for a talk given at Chelwood. September,
1969.'' (The document bears the date July 20, 1970). Page 7.
    See also:
    Proceedings of BATCO Group R&D Smoking Behaviour-Marketing
Conference, Session I. July 9-12, 1984. Session I discusses
nicotine's whole body dose and its relationship to smoker
satisfaction. See, e.g., p. BW-W2-03242: nicotine underlies smoking
maintenance ``and as a consequence probably provides the basis of
smoking satisfaction''; at p. 03243: nicotine's ``whole body
response [is] associated with satisfaction.'' Session II discusses
methods for assessing smoker response to changing deliveries:
    German butt analysis [testing of cigarette butts to determine
smokers' nicotine uptake] and switching experiments [exposing
smokers to cigarettes with varying deliveries] were used to indicate
the capacity of external studies [as opposed to laboratory measures
of smokers' nicotine uptake] to indicate * * * measurement of
smokers changing the way they smoke in order to satisfy their needs.
    Ferris, RP. Notes from the Proceedings of the Smoking Behaviour-
Marketing Conference. July 9-12, 1984. Page 21.
    Imperial Tobacco. Matinee Marketing Strategy. 1971. Page 11. ``A
cigarette that delivers physiological satisfaction, yet is low in
tar and nicotine, must surely be a major objective * * *.''
    BATCO Structured Creativity Conference. Southampton, England.
June 25-28, 1984. The purpose of this conference was ``to stimulate
genuinely innovative product-based project ideas.'' Moist snuff was
proposed as an alternative to cigarettes so as ``[t]o capitalise on
the potential downtrend of the smoking habit as the only means to
achieve nicotine satisfaction by participating in a parallel product
market free of social/health concerns and with attractive
profitability.'' [Emphasis added.]
    BATCO Group R & D. Research Conference. Rio de Janeiro, Brazil.
August 22-26, 1983, at p. BW-W2-01838.
    BATCO Group R & D. Nicotine Conference Outline. Southampton,
England. June 6-8, 1984, at p. BW-W2-01977.
---------------------------------------------------------------------------

    The presence of nicotine is the reason why the tobacco plant was
singled out from all other plants for consumption in this rather
unusual way.

[[Page 41647]]

    Nicotine has well documented pharmacological action. It is
claimed to have a dual effect, acting both as a stimulant and a
tranquilliser. It is believed to be responsible for the
``satisfaction'' of smoking, using this term in the physiological
rather than the psychological sense.<SUP>288

    \288\ See Wood, note 287, supra, at p. 7.
---------------------------------------------------------------------------

    The proceedings to the 1983 BATCO Group R&D Research Conference in
Rio de Janeiro state that:

    The basic assumption is that nicotine, which is almost certainly
the key smoke component for satisfaction, is fully released to the
body system before exhalation takes place. [Emphasis added].<SUP>289

    \289\ See BATCO Group R & D Research Conference, Rio de Janeiro,
1983, note 287, supra, at p. 10.
---------------------------------------------------------------------------

A 1984 BATCO Nicotine Conference similarly concluded that:

    Intuitively it is felt that ``satisfaction'' must be related to
nicotine. Many people believe it [is] a ``whole body response'' and
involves the action of nicotine in the brain.<SUP>290

    \290\ See BATCO Conference Outline, 1984, note 287, supra, at p.
BW-W2-01977.
---------------------------------------------------------------------------

    An RJR-MacDonald Marketing Summary Report from 1983 concludes that
the primary reason people smoke ``is probably the physiological
satisfaction provided by the nicotine level of the product.'' <SUP>291

    \291\ RJR-MacDonald v. Canada, 5.3 TPLR 4.26.
---------------------------------------------------------------------------

    The term ``satisfaction'' is also used by the smokeless tobacco
industry to refer to the physiological effects of nicotine on the user.
The senior vice president for marketing of the U.S. Tobacco Co. wrote
in a memo on new product development:

    Flavorwise we should try for innovation, taste and strength,
nicotine should be medium * * * Virtually all tobacco usage is based
upon nicotine, ``the kick,''

[[Page 41648]]
satisfaction. [Emphasis added.] <SUP>292

    \292\ Deposition of Per Erik Lindqvist, Marsee v. U.S. Tobacco,
Civil Action No. 84-2777R (W.D. Ok. 1986). Transcript of Jury Trial
Proceedings at p.1662. In: 1.7 TPLR 3.216.
---------------------------------------------------------------------------

    These documents show that tobacco companies know that tobacco
``satisfaction'' is provided by nicotine's pharmacological effects on
the brain and that the industry strives to offer products that meet
this need.

[[Page 41649]]

2. Industry Research to Determine the Minimum and Maximum ``Dose'' of
Nicotine Required by Consumers of Tobacco

    The tobacco industry has focused extensive research efforts on
methods to assay systemic nicotine absorption so that it may estimate
nicotine doses obtained and required by smokers.<SUP>293 Tobacco
company documents reveal that the primary purposes of these efforts are
to better understand the relationship between nicotine dose and
nicotine's pharmacological effects in smokers, and to establish the
level of nicotine that must be provided in tobacco to produce these
effects. Better knowledge of nicotine's dose-response effect in smokers
results in a better understanding of how smokers respond to cigarettes
with varying nicotine deliveries and how different doses of nicotine
may affect smoker satisfaction.

    \293\ See e.g.:
    BATCO. Fate of Nicotine in the Body. 1963.
    BATCO R&D. Relation Between `Extractable Nicotine' Content of
Smoke and Panel Response. March 17, 1967.
    BATCO R&D. Nicotine in Smoke and Human Physiological Response.
March 26, 1970.
    BATCO. Relative Contributions of Nicotine and Carbon Monoxide to
Human Physiological Response. November 15, 1971.
    BATCO Group R&D Further Studies of the Effect of Nicotine on
Human Physiological Response. June 5, 1973.
    Proceedings of the BATCO Group R&D Smoking Behaviour-Marketing
Conference. Session I. July 9-12, 1984. Page 16 (slides).
    See Ayres, note 172, supra.
    BATCO Group R&D Nicotine Studies: A Second Report. Estimation of
Whole Body Nicotine Dose by Urinary Nicotine and Cotinine
Measurement. March 31, 1981. Page 3.
    Proceedings of the BATCO Smoking Behaviour-Marketing Conference,
Session I (1984):21, slide at p. BW-W2-03243; Session II (1984):21,
slide at p. BW-W2-02406.
---------------------------------------------------------------------------

    As early as 1970, the tobacco industry had investigated and
attempted to determine the

[[Page 41650]]
minimum level of nicotine necessary for consumer acceptance. At a BATCO
---------------------------------------------------------------------------
R&D Conference held that year, the conferees agreed that:

    Nicotine is important, and there is probably a minimum level
necessary for consumer acceptance in any given market.<SUP>294

    \294\ BATCO Group R&D Summary Conclusions: Group Research
Conference. St Adele, Canada. September 11, 1970. Page 1.
---------------------------------------------------------------------------

    A 1972 Philip Morris document from a Council for Tobacco Research
conference addressing why people smoke reveals the basis of the
industry's concern about maintaining nicotine levels above a defined
minimum:

    Despite many low nicotine brand entries into the marketplace,
none of them have captured a substantial segment of the market. In
fact, critics of the industry would do well to reflect upon the
indifference of the consumer to the industry's efforts to sell low-
delivery brands. 94% of the cigarettes sold in the U.S. deliver more
than 1 mg of nicotine. 98.5% deliver more than 0.9 mg. The
physiological response to nicotine can readily be elicited by
cigarettes delivering in the range of 1 mg of nicotine. [Emphasis
added.] <SUP>295

    \295\ See Dunn, note 133, supra, at p. 4.
---------------------------------------------------------------------------

    Similarly, the 1984 BATCO Group R & D Nicotine Conference
concluded:

    Cigarettes which have a delivery of less than 0.7 mg of nicotine
per cigarette as measured on a smoking machine, do not achieve large
volume sales.<SUP>296

    \296\ BATCO Conference Outline, 1984, note 287 supra, at p. BW-
W2-01977.
---------------------------------------------------------------------------

    In Project Wheat, discussed in Sec. II.C.1., supra, a 0.7 mg
nicotine test cigarette was found to be unacceptable by smokers
regardless of the smokers' relative nicotine requirements; the low-dose
product was rejected by smokers with both high and low nicotine
requirements.<SUP>297

    \297\ See Project Wheat--Part 2, note 204, supra, at p. 47.
---------------------------------------------------------------------------

    An internal Philip Morris document from 1978, detailing plans to
study cigarettes with

[[Page 41651]]
different levels of nicotine at a given tar level, shows that Philip
Morris, too, conducted studies to find the minimum level of nicotine
---------------------------------------------------------------------------
delivery necessary to satisfy smokers' need for nicotine:

    Question 4. Tar delivery delivery being the same, what are the
behavioral consequences of smoking low nicotine rather than high
nicotine cigarettes?
    This question will be answered by conducting a series of shift
studies using cigarettes of similar low tar but differential
nicotine deliveries. The low nicotine delivery will ensure that the
total nicotine in the system remains at or near the nicotine need
threshold, thus maximizing the proportion of the day's cigarette
consumption which is smoked out of need * * *
    The results may shed light on the manner by which nicotine
control is achieved.<SUP>297a [Emphasis added.]

    \297a\ Memorandum to T.S. Osdene from W.L. Dunn. Plans and
Objectives--1979. December 6, 1978. In Cong Rec. H7670 (daily ed.
July 25, 1995).
---------------------------------------------------------------------------

Demonstrating the industry's continuing interest in determining the
minimum dose of nicotine that must be contained in a cigarette to
provide satisfaction, the BATCO ``Group R&D Research Programme, 1984:
Proposed revisions for 1985-87,'' states that studies would be done by
the industry

to establish the minimum dose of smoke nicotine that can provide
pharmacological satisfaction for the smoker. [Emphasis added.]
<SUP>298

    \298\ See BATCO, note 280, supra, at p. 2.
---------------------------------------------------------------------------

    One key to identifying the minimum and maximum doses of nicotine
was the development of a method to accurately measure nicotine in the
human body. A 1976 Council for Tobacco Research Annual Report
identifies a need for better methods to measure nicotine levels in
human smokers:

* * * an expansion of information on the actual ranges or durations
of plasma nicotine levels attained by human smokers (and users of
other forms of tobacco) under actual conditions of life should be
attainable * * * Sensitive, specific and rapid assays for plasma
nicotine and its major metabolites have

[[Page 41652]]
long been needed.<SUP>299

    \299\ Report of the Council for Tobacco Research--U.S.A., Inc.
Annual Report 1976. Page 12.
---------------------------------------------------------------------------

    Another series of studies conducted by Philip Morris was designed
to discover the relationship between the dose of nicotine provided by a
cigarette, the level of nicotine in the bloodstream following that
cigarette, and the length of time before the nicotine in the
bloodstream fell to the point that the smoker experienced the urge for
another cigarette. This required Philip Morris to develop an assay for
nicotine and saliva and correlate salivary nicotine with blood
nicotine:

    Our theorizing on the role of nicotine suggests that cigarettes
will be smoked whenever body nicotine content drops below a certain
(unknown) level * * *.
    We are engaged in systematic investigation of the changes in
salivary nicotine content as a function of the time since smoking
and magnitude of intake * * *.
    Assuming that salivary nicotine concentrations will reflect
blood nicotine concentrations, we can then proceed to a fourth stage
in the research, relating the easily obtained salivary
concentrations to the urge to smoke.<SUP>299a [Emphasis added.]

    \299a\ Memorandum to T.S. Osdene from W.L. Dunn. Plans and
Objectives--1980. January 7, 1980. In Cong Rec. H7672 (daily ed.
July 25, 1995).
---------------------------------------------------------------------------

A 1980 BATCO Group R&D study report, ``Method for Cotinine and Nicotine
in Blood and Urine,'' describes an improved analytical method for the
simultaneous measurement of nicotine and cotinine (nicotine's major
metabolite in man) in samples of blood and urine.<SUP>300

[[Page 41653]]
The method was developed to better study the systemic effects of
nicotine and the extent to which those effects influence smoking
---------------------------------------------------------------------------
behavior and smoker satisfaction. The report states:

    \300\ Read GA, Anderson IGM. BATCO Group R&D Method for Nicotine
and Cotinine in Blood and Urine. Report No. RD 1737-C. May 21, 1980.
Page 12 (established and validated an assay for nicotine and
cotinine in blood and urine that is sufficiently sensitive to
determine changes in ``* * * plasma levels of nicotine achieved in
response to varying concentrations of or different dose levels of
nicotine'').
    See also New Cigarette Prototypes that Heat Instead of Burn
Tobacco. Winston-Salem, NC: R.J. Reynolds Tobacco Co. 1988:457-557.
Comparative study of humans smoking the NEW CIGARETTE and a
Reference Cigarette. (Compared nicotine pharmacokinetics in smokers
smoking the New (heated tobacco) cigarette and a regular burning
cigarette to determine whether the New cigarette provided a nicotine
dose comparable to a regular burning cigarette. Researchers measured
smokers' plasma and urine concentrations of nicotine to compare
nicotine doses.)
---------------------------------------------------------------------------

    In some instances, the pharmacological response of smokers to
nicotine is believed to be responsible for an individual's smoking
behaviour, providing the motivation for and the degree of
satisfaction required by the smoker. [Emphasis added.] <SUP>301

    \301\ See Read, note 300, supra, at p. 2.
---------------------------------------------------------------------------

    Naturally, during any study of the biological effect of nicotine
it is of paramount importance to accurately assess the dose of
nicotine absorbed * * * [W]here the causal relationship between
nicotine and individual biochemical, physiological or psychological
responses are to be investigated, accurate information regarding
nicotine dose is essential. [Emphasis added.] <SUP>302

    \302\ Id. at pp. 2-3.
---------------------------------------------------------------------------

    A 1981 BATCO Group R&D study developed a rat model to estimate
``whole body nicotine dose'' by measuring urinary nicotine and cotinine
levels. The researchers concluded that the model would likely be a good
predictor of nicotine dose in humans and, therefore, would aid in
understanding the relationship between nicotine delivery and smokers'
choice of particular brands:

    These results strongly suggest that the whole body dose of
nicotine can be predicted from urinary levels of nicotine and
cotinine. The findings have immediate and obvious significance to
both animal toxicity and human behavioural studies. They are
particularly relevant to the development of an understanding of an
individual smoker's daily nicotine requirement and the relationship
between nicotine dose and smoking behaviour under conditions of
brand switching/delivery modification. [Emphasis added.] <SUP>303

    \303\ BATCO Group R&D Nicotine Studies: A Second Report.
Estimation of Whole Body Nicotine Dose by Urinary Nicotine and
Cotinine Measurement. March 3, 1981, at pp. 9-10.
---------------------------------------------------------------------------

    A presentation at a 1983 BATCO Smoking Behavior Conference
describes how to

[[Page 41654]]
design and execute a study of plasma cotinine as a function of
cigarette nicotine delivery.<SUP>304 It establishes that there is a
linear relationship between plasma cotinine and nicotine delivery. A
session on ``Nicotine Dose Estimation'' at BATCO's 1984 Smoking
Behaviour-Marketing Conference was intended ``to review the current
status of plasma/urinary measures estimates [sic] of nicotine dose and
to identify the significance of those measures for the smoker and
---------------------------------------------------------------------------
product design.'' It was concluded that:

    \304\ Deines WH. BATCO. Smoking Behaviour Conference: Overview.
1983. (Attended by eight B&W employees). Page BW-W2-03280.
---------------------------------------------------------------------------

[u]nder appropriate conditions plasma nicotine and cotinine measures
can be used to estimate daily nicotine intake.<SUP>305

    \305\ Proceedings of the BATCO Smoking Behaviour-Marketing
Conference, Session I. July 9-12, 1984. Montreal, Canada. Slide at
p. BW-W2-02641, ``Nicotine Dose Estimation.''
---------------------------------------------------------------------------

    Using assay methods such as those discussed above, tobacco
companies have discovered that smokers obtain a fairly consistent dose
of nicotine from tobacco. Moreover, tobacco companies are aware that
smokers obtain this dose to maintain a desired blood level of nicotine
throughout the day, and that achieving this dose results in smoker
satisfaction.<SUP>306 For example, following a presentation on the role
of nicotine in smoking behavior at the 1976 BATCO Conference on Smoking
Behavior, it was observed ``that smokers may be people suffering from a
nicotine disorder and needed a certain dose level per day.'' <SUP>307
The speaker agreed and referred to a Battelle study which found that
the nicotine level of smokers remained constant during the day, dropped
during the night, and was restored to near its

[[Page 41655]]
daytime constant level by the first cigarette of the day.<SUP>308 The
conferees then speculated that there may be a maximum dose of nicotine
and that after this dose is achieved smokers may use cigarettes for
---------------------------------------------------------------------------
reasons other than obtaining nicotine:

    \306\ Proceedings of the BATCO Smoking Behaviour-Marketing
Conference, Session I. July 9-12, 1984. Slides at pp. BW-W2-03243,
BW-W2-03236: ``whole body response: associated with satisfaction * *
* [whether] dose of nicotine is adequate or inadequate.''
    \307\ Proceedings of the BATCO Group R&D Smoking Behaviour-
Marketing Conference. (Mrs. A.K. Comer, speaker.) Discussion on
paper No. 2. October 1976. Southampton, England. Page BW-W2-02150.
    \308\ Id. at p. BW-W2-02151.
---------------------------------------------------------------------------

    A further question in this area was whether there is a maximum
nicotine level in smokers and, when this has been achieved, does the
smoker smoke for reasons other than to obtain nicotine? <SUP>309

    \309\ Id. at p. BW-W2-02151.
---------------------------------------------------------------------------

    A paper presented at the 1977 BATCO International Smoking Behaviour
Conference concluded that smokers adjust their smoking rate, depending
on psychological factors and even diet, to maintain a certain body
nicotine content.<SUP>310

    \310\ BATCO International Smoking Behaviour Conference. Chelwood
Vachery, England. 1977. Page 2.
---------------------------------------------------------------------------

    Relying on plasma nicotine/cotinine measurements, a 1984 BATCO
Nicotine Conference concluded that:

[such] measurements can give reliable estimates of the nicotine
uptake by groups of smokers, and with suitable precautions, by an
individual smoker. Many smokers appear to obtain 12-14 mg of
nicotine per day from their cigarettes.<SUP>311

    \311\ See BATCO Conference Outline, 1984, note 287, supra, at p.
BW-W2-01977.
---------------------------------------------------------------------------

    A BATCO presentation from the 1984 BATCO Smoking Behaviour-
Marketing Conference entitled ``Current Status and Future Direction of
Smoking Behavior Research'' contains a discussion of whole body dose
and whole body pharmacological properties of nicotine in relation to
smoking satisfaction.<SUP>312 A chart accompanying the presentation
plots a

[[Page 41656]]
24-hour nicotine blood level curve, with peaks representing the
nicotine dose obtained from cigarettes smoked during the day. Each peak
actually represents a series of smaller peaks that indicate the dose of
nicotine delivered by each puff. Each puff is characterized as a
``pulsed high concentration bolus dose of nicotine.'' <SUP>313

    \312\ Proceedings of the BATCO Smoking Behaviour-Marketing
Conference, Session I. Montreal, Canada. July 9-12, 1984. Page BW-
W2-03236.
    \313\ Id. at p. BW-W2-03238.
---------------------------------------------------------------------------

    The report states that among smokers there is broad consistency in
the whole body nicotine doses obtained by different groups and types of
smokers.<SUP>314 This is so despite the fact that smoking products have
a wide range of nicotine deliveries and despite wide variations in
smoking behavior, such as puff duration, puff intensity, puff volume,
puff interval, and depth of inhalation. The report states that the fact
that widely disparate smoking behavior nonetheless results in fairly
consistent whole body nicotine doses (12-14 mg per day) across a broad
range of smokers demonstrates that nicotine underlies smoking
maintenance.<SUP>315 Smokers maintain a fairly consistent whole body
dose or blood level and self-administer additional nicotine doses when
total body nicotine dose declines due to metabolism of nicotine.
Therefore, the report concludes, the dose of nicotine ``probably
provides the basis for smoking satisfaction'' <SUP>316 as it restores
the whole body dose to the desired level.

    \314\ Id. at p. BW-W2-03241.
    \315\ Id. at p. BW-W2-03241-42.
    \316\ Id. at p. BW-W2-03242.
---------------------------------------------------------------------------

    The smokeless tobacco industry has also investigated the dose of
nicotine that is absorbed into the blood and bodies of smokeless
tobacco users. Pharmacokinetic studies

[[Page 41657]]
performed by the U.S. Tobacco Co. (UST) reveal that the researchers
were interested in how much nicotine was absorbed into the body, how
much was metabolized, and how fast nicotine and its metabolites were
eliminated from the body. Documents admitted into evidence in a court
case reveal that the company investigated the disposition profile of
nicotine and its metabolite in both plasma and urine in naive and
habituated users of tobacco snuff.<SUP>317 The study found no
difference between these two populations. UST also performed a study to
compare the pharmacokinetics of nicotine and its metabolites following
administration of snuff and cigarettes.<SUP>318 According to a report
of the study, the purpose of this research was to ``delineate the
similarities and differences in nicotine pharmacokinetics after acute
and chronic use of smoked and smokeless tobacco products.'' <SUP>319

    \317\ U.S. Tobacco Co. Pharmacokinetics of Nicotine and its
Major Metabolites in Naive and Habituated Snuff Takers. Plaintiff's
exhibit 3.27 from Marsee v. U.S. Tobacco (W.D. Ok. 1986) (Civil
Action No. 84-2777R).
    \318\ U.S. Tobacco Co. Results of Comparison of Routes of
Nicotine Administration. Plaintiffs exhibit 3.28 from Marsee v. U.S.
Tobacco, note , supra.
    \319\ Id.
---------------------------------------------------------------------------

    The tobacco industry has also investigated the difference between
minimum acceptable and optimum nicotine levels. Project Wheat was
designed to test the assumption that the optimum level of nicotine
might vary for different types of smokers. The study report concludes
that the optimum nicotine delivery for U.K. male smokers is
approximately 1.5 mg of nicotine. An earlier Imperial Tobacco study
referenced in the Project Wheat report had similarly concluded that the
optimum nicotine delivery for U.K. smokers was around 1.4 mg per
cigarette and that stepwise reduction in nicotine delivery caused
progressive rejection of the

[[Page 41656]]
1.4-mg cigarette by consumers.<SUP>320

    \320\ See Project Wheat--Part 2, note 204, supra, at p. BW-W2-
01721-2.
---------------------------------------------------------------------------

    These documents make clear that the industry is aware that tobacco
products must deliver an adequate dose of nicotine, that there is a
minimum dose below which the desired pharmacological effects of
nicotine are not elicited, and that consumers will not accept a product
that does not deliver an adequate dose of nicotine.<SUP>321

    \321\ Although currently marketed low-delivery products may
``yield'' less than the amount of nicotine shown in these industry
documents to be the minimum accepted dose, machine measured yields
may underestimate the amount of nicotine smokers actually obtain
from cigarettes. See FINDINGS Sec. I.C. at p. 112.

[[Page 41659]]

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3. Industry Research on How Consumers ``Compensate'' to Achieve an
Adequate Dose of Nicotine

    When smokers are given cigarettes with a lower nicotine yield (as
measured by a smoking machine), than their regular brands, they often
``compensate'' by smoking the cigarette more intensely, e.g., by taking
larger or more puffs, or by smoking more cigarettes.<SUP>322 Tobacco
company documents reveal that the industry recognizes both that smokers
compensate and that the purpose of compensating behavior is to allow
smokers to obtain a dose of nicotine that satisfies their physiological
need for nicotine.<SUP>323 The industry's

[[Page 41660]]
study of compensation by smokers provides compelling evidence that the
industry knows that its market is based on nicotine dependence and that
tobacco products are nicotine delivery systems.

    \322\ See, e.g.:
    Guyatt AR, Kirkham AJ, Baldry AG, Dixon M, Cumming G. How Does
Puffing Behavior Alter During Smoking of a Single Cigarette?
Pharmacol. Biochem. Behav. 1989;33(1):189-195.
    Benowitz NL, Hall SM, Herning RI, Jacob P III, Jones RT, Osman
AL. Smokers of Low-Yield Cigarettes Do Not Consume Less Nicotine. N.
Engl. J. Med. 1983;309(3):139-142.
    Memorandum from P.N. Lee to H.R. Bentley. Tar Reduction and
Nicotine Compensation. July 19, 1979. Attached to the memorandum is
a document that reviewed the existing scientific literature on
smoking compensation prepared by Lee for the UK's Tobacco Advisory
Council, July 19, 1979. The author concluded, at page 4, that:
    Taken together, the evidence above seems to indicate that a
smoker, when switching to a brand with lower nicotine yield, will
tend to `compensate' mainly by altering inhalation patterns but
partly perhaps by a small increase in consumption.
    \323\ ``Compensation'' is acknowledged in the following
documents, among others:
    BATCO Group R&D Conference. The Effect of Puff Volume on
``Extractable Nicotine'' and on the Retention of Nicotine in the
Mouth. Laboratory Report No. L.314-R. Southampton, England. August
21, 1969.
    Creighton D, McGillivray LM. BATCO R&DE. Relative Contributions
of Nicotine and Carbon Monoxide to Human Physiological Response.
Report No. RD839-R. Southampton, England. November 15, 1971. Page
22.
    Armitage AK. Some recent observations relating to the absorption
of nicotine from tobacco smoke. In: Dunn WL, ed. Smoking Behavior:
Motives and Incentives. Washington, DC: VH Winston & Sons; 1973:83:
    The human smoker can and does adjust the dose of nicotine he
takes into his mouth very subtly, by adjusting either the size of
his puff or the rate at which he puffs (this was shown very clearly
by the elegant experiments of Ashton and Watson [1970], to which
Domino [this volume] referred); * * * and the smoke taken into the
mouth can be inhaled very deeply, moderately deeply, slightly, or
not at all.
    BATCO Group R&D Conference on Smoking Behaviour. October 11-12,
1976. Southampton. Table III. Page BW-W2-02251 (questions whether
increase in CO can result when a smoker compensates for reduced
nicotine delivery to the mouth.)
    Thornton RE. BATCO Group R&D Some ``Benefits'' of Smoking.
Report No. RD 1461. January 26, 1977.
    Courtney JR, Comer AK. BATCO Group R&D The Study of Human
Smoking Behaviour Using Butt Analysis. Report No. RD 1608. August 7,
1978.
    Lee, note 322, supra.
    Read G, Anderson IGM, Chapman RE. BATCO Group R&D Nicotine
Studies: A Second Report. Estimation of Whole Body Nicotine Dose By
Urinary Nicotine and Cotinine Measurement. March 31, 1981. Pages 9-
10.
    Proceedings of the BATCO Smoking Behaviour-Marketing Conference,
Session III. July 9-12, 1984. Slides at p. BW-W2-02748-02750, 02754-
02759.
    Id. Koehn E. Potential of nicotine addiction. Page 64, BW-W2-
02651.
    Id. Pangritz D. Discussion (Minutes). Page 65, BW-W2-02647-
02651.
    R.J. Reynolds, note 300, supra, at pp. 479, 482-3, 490-2.
    Tobacco Advisory Council. Reduction in Sales Weighted Average
Cigarette Brand Tar Yield: Problems Associated with the Suggestion
to Achieve Further Stages According to a Fixed Timetable (prepared
by TAC for members of the Independent Scientific Committee on
Smoking and Health) at p. 3:
    There are circumstances in which smokers, when switching to a
brand with a reduced tar yield, will tend to `compensate' whether
consciously or subconsciously, if they find some aspect of a new
cigarette less acceptable than that of their normal brand, in such a
way as to restore to some extent the loss of satisfaction associated
with the reduced tar yield itself, or associated with some
inevitable consequence of the reduced tar yield, for example reduced
nicotine yield * * * .
---------------------------------------------------------------------------

    Tobacco company researchers have repeatedly recognized the
phenomenon of compensation and acknowledge that it occurs because
smokers are seeking a specific dose of

[[Page 41661]]
nicotine from each cigarette. For example, Senior Philip Morris
scientist William L. Dunn wrote to an outside researcher in 1975 that
smokers compensate for reduced nicotine in cigarettes through a variety
of techniques designed to increase the amount of nicotine that enters
---------------------------------------------------------------------------
the bloodstream:

    The ultimate index [of nicotine consumption] is how much passes
over into the bloodstream * * * We're now looking at the fate of the
smoke entering the mouth; how much goes down, how much comes back
out, and related behavioral events that we anticipate finding to be
dose-regulating mechanisms of remarkable precision and sensitivity.
    Thus to accommodate to the 15 percent reduction in available
Marlboro nicotine, the smoker who was getting 50 percent of the
available nicotine over into his blood from the Marlboro delivering
1.1 mg of nicotine into a smoking machine now must get 59 percent of
what the current Marlboro offers him. He can take bigger puffs, or
inhale more from the supply drawn into the mouth * * * or for more
efficient extraction of the goodies, he can draw it in deeper or
hold it longer.<SUP>323a [Emphasis added.]

    \323a\ Letter to Stanley Schachter, Columbia University from
William L. Dunn. September 8, 1975. In Cong Rec. H7662 (daily ed.
July 25, 1995).
    See also:
    Memorandum to T.S. Osdene from W.L. Dunn. Behavioral Research
Accomplishments-1977. December 19, 1977. In Cong Rec. H7666, supra:
    [N]icotine compensation is a real phenomenon * * *
    In this report, the researchers describe a study confirming
their hypothesis that ``some people smoke for nicotine, and that
these people try to obtain a relatively constant amount of nicotine
from their cigarettes.'' The internal study showed that smokers they
called ``nicotine regulators'' obtained more nicotine from their
cigarettes following a period of deprivation than when allowed to
smoke freely.
    Dunn WL. 1600/Smoker Psychology/January 1-31, 1976 [Monthly
Report]. February 10, 1976. In Cong Rec. H7663, supra. This report
describes a new study being undertaken by Philip Morris ``to
identify nicotine regulators and non-regulators.'' The study design
involved measuring ``the daily nicotine intakes'' of a group of
smokers when allowed to smoke their own cigarettes, then measuring
their nicotine intakes when given cigarettes with higher or lower
delivery than their own brand:
    We want to find out if we can ``force'' our potential regulators
to modify their puff volumes, inhalation volumes, and/or smoke
retention times in order to obtain their usual nicotine dose.
[Emphasis added.]
    Memorandum from W.L. Dunn to T.S. Osdene. Quarterly Report--
January 1-March 31, 1975. March 25, 1975. In Cong Rec. H7662, supra.
Reports on a Philip Morris study showing compensation behavior in
smokers:
    Preliminary data suggest that more cigarettes are smoked and
more puffs taken when the observations follow a two-hour deprivation
period than following two hours when smoking is permitted.
    Dunn WL. 1600/Smoker Psychology/October 1-31, 1977 [Monthly
Report]. November 11, 1977. In Cong Rec. H7665, supra. Philip Morris
researchers describe a study on whether smokers who smoke many
cigarettes out of ``need'' will demonstrate compensation behavior if
given low nicotine cigarettes.
    Memorandum to T.S. Osdene from W.L. Dunn. Plans and Objectives--
1980. January 7, 1980. In Cong Rec. H7665, supra. This document
describes Philip Morris' development of specialized monitoring
devices designed to determine whether smokers, when given cigarettes
with different nicotine deliveries ``regulate or `titrate' the
amount of nicotine taken up via inspiration of smoke.''

[[Page 41662]]

---------------------------------------------------------------------------

    In 1984, the minutes of the BATCO Smoking Conference included the
following summary of the researchers' discussion of compensation:

    Compensation
    There are two general forms of compensation:
    (a) Number of cigarettes smoked eg. [sic] low tar smokers
increasing consumption.
    (b) Puffing/inhalation regime eg. [sic] increasing or
decreasing/puff volume, duration, puff frequency, amount
inhaled.<SUP>324

    \324\ Brooks GO. Minutes from BATCO Group R&D Smoking Behaviour-
Marketing Conference, Session III. July 9-12, 1984. Page 55.
---------------------------------------------------------------------------

The researchers further stated that:

it is accepted that nicotine is both the driving force and the
signal (as impact) for compensation in human smoking
behaviour.<SUP>325

    \325\ Id. at p. 56.
    Later at the same conference, there was a discussion of a study
showing that when given a cigarette with a significantly different
yield than his own, a smoker will alter his puffing behavior but
will not alter his inhalation pattern. To explain this phenomenon,
``[d]elegates were reminded that a smoker extracts virtually all of
the nicotine from the smoke even with a shallow inhalation.
Therefore what has he to gain by deliberately inhaling more
deeply?'' Id. at p. 69.
---------------------------------------------------------------------------

    In fact, the tobacco industry is not merely aware of compensation
behavior but has conducted extensive research on compensation. Company
researchers administer cigarettes that deliver a range of nicotine
doses to smokers and then measure the amount of nicotine

[[Page 41663]]
actually absorbed by the smoker, per puff or per cigarette.<SUP>326
These studies show that smokers tend to obtain close to the same amount
of nicotine from each cigarette, despite differences in yield as
measured by the smoking machine. In a 1974 BATCO conference,
---------------------------------------------------------------------------
researchers described the results of one such study:

    \326\ See:
    BATCO Group R&D Conference on Smoking Behaviour. Southampton,
England. October 11-12, 1976. Page BW-W2-02253-85.
    Adams PI. Research Dept., Imperial Tobacco Ltd. Changes in
personal smoking habits brought about by changes in cigarette smoke
yield. In: Proceedings of the Sixth International Tobacco Scientific
Congress. November 1976. Pages 102-108.
    BATCO, note 310, supra, at p. 2.
    Although conflicting results were presented, the prevailing view
is that smokers do tend to compensate in some way when going from a
high tar (nicotine) to a low tar (nicotine) cigarette, or vice
versa. Studies have been carried out with high and low nicotine
cigarettes, ``anti-smoking'' cigarette holders, and cigarettes with
shortened tobacco sections.
    Pritchard WS, Robinson JH. The sensory role of nicotine in
cigarette ``taste'', smoking satisfaction, and desire to smoke. As
abstracted in: International Symposium on Nicotine: The Effects of
Nicotine on Biological Systems II. Satellite Symposium of the 12th
International Congress of Pharmacology. Montreal, Canada. July 21-
24, 1994. Page 113.
    See also:
    Ashton H, Stepney R, Thompson JW. Self-titration by cigarette
smokers. British Medical Journal. 1979;2:357-360.
---------------------------------------------------------------------------

    The Kippa study in Germany suggests that whatever the
characteristics of cigarettes as determined by smoking machines, the
smoker adjusts his pattern to deliver his own nicotine requirements
(about 0.8 mg. per cigarette). [Emphasis added.] <SUP>327

    \327\ Notes on the BATCO Group R&D Conference at Duck Key, FL.
January 12-18, 1974. (Attended by Hughes, Sanford, Esterle of B&W).
Page 2.
    See also Notes from the German presentation. BATCO Group R&D
Conference 1979. Part I, February 5-9, 1979. Page BW-W2-03536:
    One of the interesting results from the KIPA studies is that
cigarettes which vary from 1.1-0.4 mg nicotine by machine smoking
are smoked by humans in the narrow range of 0.8-0.7 mg nicotine.

[[Page 41664]]

---------------------------------------------------------------------------

    At a 1984 conference, a BATCO researcher also reviewed several
other studies indicating that when smokers are given cigarettes with
higher or lower nicotine levels than their regular brands, they tend to
adjust both the number of cigarettes they smoke and the way they smoke
them to attain a steady dose of nicotine.<SUP>328 In support of this
conclusion, the BATCO researcher presented a chart showing that between
1965 and 1975, as the machine-measured nicotine yield of cigarettes
went down, the annual consumption of cigarettes per smoker went
up.<SUP>329

    \328\ Proceedings of the BATCO Smoking Behaviour-Marketing
Conference, Session III. July 9-12, 1984. Ferris. Pages BW-W2-02748
- 02750, BW-W2-02754-02759.
    \329\ Id. at p. BW-W2-02754.
---------------------------------------------------------------------------

    The researcher concluded that ``increased consumption is related to
reduced nicotine'' <SUP>330 but that the relationship is not one-to-
one. Instead, he found that a 10% reduction in nicotine resulted in a
1% rise in the number of cigarettes smoked, and a 50% reduction in
nicotine resulted in a 10% rise in the number of cigarettes
smoked.<SUP>331 As a result of this finding, he concluded that ``most
compensation must occur at the individual cigarette level;'' <SUP>332
i.e., by altering the way the smokers smoked individual cigarettes. In
fact, the data he presented showed that when smokers were given
cigarettes with a range of nicotine yields, their nicotine intake from
each cigarette hovered around the amount they took in from their
regular brand rather than varying to the degree that would have been
predicted from the

[[Page 41665]]
machine yields.<SUP>333

    \330\ Id. at p. BW-W2-02755.
    \331\ Id.
    \332\ Id.
    \333\ Id. at p. BW-W2-02757. Ashton, Stepney, and Thompson
(1979b). Expected and observed nicotine intake in a brand-switching
experiment. (Chart.)
---------------------------------------------------------------------------

    Other tobacco company studies show similar results.<SUP>334 A
report on research conducted by Philip Morris Europe in the early
1970's concluded that smokers tended to obtain the same amount of
nicotine from a cigarette, regardless of the nicotine content of the
cigarette or its machine-tested yield:

    \334\ See:
    BATCO Group R&D Proceedings of the R & D Conference. Montreal,
Canada. October 25, 1967. Page 4.
    The development of low TPM [total particulate matter], low
nicotine cigarette should be expanded. This raises the question of
the level of nicotine required and the consumer study by Bristol can
be helpful in determining this * * * there was evidence that in
Germany per capita cigarette consumption increased for the lower
nicotine brands.
    Proceedings of the BATCO Group R&D Smoking Behaviour-Marketing
Conference, Session I. July 9-12, 1984. Presentation slide BW-W2-
03231. Under the heading Brand Switching Down Delivery, the chart
provides a list of three ``means to achieve a higher dose[:] * * *
increase in puffing parameters, increase in numbers of cigs. smoked,
more puffs taken.''
    Read GA. Internal v. external studies. Proceedings of the BATCO
Smoking Behaviour-Marketing Conference, Session II. July 9-12, 1984.
Page 19.
    The German butt analysis studies have indicated how smokers
respond to reductions in machine smoked nicotine deliveries under
natural smoking conditions. This observation of product oversmoking
supports the laboratory findings of an increase in smoking behaviour
parameters in subjects switched to lower delivery products.
    R.J. Reynolds, note 300, supra, at pp. 479, 482-3, 490-2.
---------------------------------------------------------------------------

    The most frequent nicotine yield was 0.4 to 0.5 mg of nicotine
per cigarette. This yield is not dependent upon the nicotine content
of the tobacco and is not related to the nicotine yield under
Coresta (machine) smoking conditions. The difference between
nicotine yields obtained under standard laboratory procedures and
yields obtained under ``real'' smoking conditions is explained by
the existence of a compensation mechanism in the smoker. This
compensation mechanism seems to be in operation for a proportion of
the consumer population to adjust the nicotine yield to their needs
or liking.<SUP>334a

[[Page 41666]]
---------------------------------------------------------------------------
[Emphasis added.]

    \334a\ Gustafson and Haisch. PME Research: 1972-1974. In Cong
Rec. H7662 (daily ed. July 25, 1995).
---------------------------------------------------------------------------

    Thus, the tobacco companies' own studies demonstrate that smokers
use the cigarette as a nicotine delivery system and vary their smoking
behavior to obtain a specific dose of nicotine.

[[Page 41667]]

4. Industry Research and Knowledge of Tobacco Users' Inability to Quit

    Tobacco companies are aware of the large number of smokers who have
tried to quit using tobacco, and of the very small number who actually
succeed. The evidence known to tobacco companies about smokers'
unsuccessful attempts to quit shows that tobacco companies know that a
large percentage of their market consists of people who demonstrate one
of the characteristic features of addiction. See p. 81 et seq.
    The great difficulty smokers experience when they try to quit was
conceded by Joseph F. Cullman, III, the former chief executive officer
of Philip Morris. Mr. Cullman was called as a witness in the Cipollone
lawsuit and gave the following answers in response to questions from
one of the plaintiff's attorneys:

    Q. But it is difficult [to quit]?
    A. That's what it says here and I'm not disagreeing with it.
    Q. They said it was very difficult. Do you agree with that?
    A. I would say it's difficult.
    Q. And it's difficult for the vast majority of smokers, you
would agree with that, too, would you not?
    A. That's a question of semantics. What's the vast majority? A
lot of smokers have a hard time quiting [sic].
    Q. Let's see, most smokers have a tough time giving up
cigarettes?
    A. Well, if they didn't, there would be many fewer smokers than
there are today.<SUP>335 [Emphasis added.]

    \335\ Examination of Joseph Cullman, III, former chief executive
officer, Philip Morris, Inc. Cipollone v. Liggett Group, Inc., et
al., Civil Action No. 83-2864 (SA)(D.N.J.) . February 29, 1988.
Afternoon Session. Transcript of proceedings, at pp. 3311-3314.
---------------------------------------------------------------------------

    Furthermore, internal Brown and Williamson documents reveal that
the tobacco

[[Page 41668]]
industry is extremely interested in rates of attempted and successful
quitting, and keeps close track of these rates. At the 1984 BATCO
Smoking Behaviour-Marketing Conference, attended by representatives
from various BATCO companies, including Brown and Williamson, each of
the participating companies was asked to fill out a questionnaire that
asked how many smokers in their respective countries attempted to quit
in each of the previous 5 years and how many actually quit (for as long
as 6 months). Brown and Williamson's response to the questionnaire,
which covered quitting rates in the United States, reported that, for
the years 1981 through 1983, 32 million to 34 million Americans
attempted to quit each year, while only 9 million to 10 million of
those were able to quit for as long as 6 months.<SUP>336 Thus, Brown
and Williamson's own data reveal that while almost half the total
number of U.S. smokers attempted to quit each year, only about a third
of those who tried to stop smoking were able to quit for as long as 6
months. These tobacco industry data suggest that at least one-third of
U.S. consumers of cigarettes are purchasing cigarettes because they are
unable to stop smoking.

    \336\ Proceedings of the BATCO Smoking Behaviour-Marketing
Conference, Session I. July 9-12, 1984. Page BW-W2-03212. No figures
were provided by B&W on attempts to quit for the years 1979 and
1980.
---------------------------------------------------------------------------

    In fact, data reported at the same conference showed that the
percentage of smokers who continue to smoke even though they do not
want to is much higher than suggested by 6-month data. Data from the
Canadian tobacco company representatives indicated that rates of
permanent quitting were well below quitting rates reported at 6 months.
A Canadian participant reported to the assembled BATCO researchers that
only 10% to 12% of those Canadian smokers attempting to quit succeeded
for up to 1 year; less than 4% were able to

[[Page 41669]]
quit permanently.<SUP>337

    \337\ Proceedings of the BATCO Group R&D Smoking Behaviour-
Marketing Conference. July 9-12, 1984. Session IV. Page BW-W2-03381.
See also Session III at p. 83 (BW-W2-03379-03382). The researcher
also presented data showing that while 22% of smokers claimed that
they intended to ``cut down,'' in fact ``both the claimed and
calculated rate of daily usage (21.6 and 25.6 [cigarettes]
respectively) have increased since the introduction of lights.''
(BW-W2-02790, 03379, 033820). Other data reported at the same
conference provided additional confirmation of the large percentage
of smokers who would prefer not to smoke. A study on ``Smoker
Consonance-Dissonance Breakdown'' was presented which showed that
approximately 75% of smokers surveyed had attempted to quit, and
approximately 60% were currently serious about quitting. Session III
at p. BW-W2-03386.
    See also, Larsen PS, Silvette H. Tobacco Experimental and
Clinical Studies: A Comprehensive Account of the World Literature,
Supplement I. (1968), Chapter 15; Supplement II (1971), Chapter 17;
Supplement III (1975), Chapter 21, which contain discussions of
surveys concerning smokers' desire to quit and difficulty in
successfully quitting. This review was funded by the Council for
Tobacco Research.
---------------------------------------------------------------------------

    The presenter responsible for summing up the results of the
conference questionnaire agreed that, while a large percentage of
smokers do not want to smoke, most of those smokers feel compelled to
continue to smoke:

    Although intentions and attempts to quit are relatively high
(30-40% of smokers [in a given year]), the actual success rate of
quitting is relatively low and stable.<SUP>338

    \338\ Proceedings of the BATCO Smoking Behaviour-Marketing
Conference, Session IV. July 9-12, 1984. Page 12.
---------------------------------------------------------------------------

It was thus well known to the participating companies that a very large
percentage of their customers were smoking not out of choice but
because they could not quit.
    Other companies also understand that many of their consumers would
like to quit but are unable to do so.<SUP>339 A Philip Morris
researcher who studied a ``cold turkey'' campaign in

[[Page 41670]]
the small Iowa town of Greenfield in 1969 reported that those who
succeed in quitting smoking over the long term are a much smaller group
than those who would like to quit and who attempt to quit.<SUP>340 The
researcher cited the findings of Hunt and Matarazzo <SUP>341 in
proposing that most attempts to quit smoking are not long-lasting:
``[I]n summarizing many reports of long-term quitting using various
techniques, [the authors] show that the percentage of nonrecidivists
[successful quitters] decreases as a function of time * * * in a
negatively accelerated fashion.'' <SUP>342 The Philip Morris researcher
found that in Greenfield only 28% of those smokers who agreed to quit
as part of the cold turkey campaign were still not smoking after 7
months. The researcher then observed that the small number of
Greenfield residents who managed to stay off cigarettes for more than 7
months was, based on other published reports of success rates for
quitting smoking, about average.<SUP>343

    \339\ See:
    R.J. Reynolds Tobacco Company, response to Citizen Petitions 94-
0069/CP1 and 94P-0077/CP1. November 2, 1994. Pages 66-69.
    RJR-MI Brand Group and Ogilvy & Mather (Canada) Ltd. Vantage
Brand Positioning Statement. 1979. Page 80041:
    B. User Image
    Primarily female, white collar, extremely concerned about their
health, and would like to quit smoking.
    Kwechansky Marketing Research for Imperial Tobacco Ltd. Project
16. October 18, 1977. Page vi.
    Kwechansky Marketing Research for Imperial Tobacco Ltd. Project
Plus/Minus. May 7, 1982. Page i.
    \340\ Ryan FJ. Philip Morris Research Center. Cold turkey in
Greenfield, Iowa: a follow-up study. In: Dunn WL, ed. Smoking
Behavior: Motives and Incentives. Washington, DC: VH Winston & Sons;
1973:231-241.
    \341\ Id. at p. 233.
    \342\ Id. at p. 233.
    \343\ Ryan FJ. Bird-I. A study of the quit-smoking campaign in
Greenfield, Iowa, in conjunction with the movie, Cold Turkey.
Appendix 1, p. 1000348712. The author also appended to the
unpublished version of this report excerpts from internal company
memos, pointing out that although the cold turkey campaign in
Greenfield was as intense an anti-smoking effort as could be
imagined, ``carton sales at the Super Value store have shown a
strong increase since the dog days of August.''
---------------------------------------------------------------------------

    The researcher also described findings that revealed in part why it
is so hard for smokers to quit. He reported that smokers who quit for
more than 7 months continued to

[[Page 41671]]
suffer a variety of adverse effects related to quitting, including
weight gain, restlessness, depression, ill-temper, constipation,
nervous mannerisms, and loss of energy.<SUP>344 These are some of the
classic symptoms of nicotine withdrawal, described earlier.<SUP>345

    \344\ See Ryan, note 340, supra, at p. 234.
    \345\ See FINDINGS Sec. I.B., supra.
---------------------------------------------------------------------------

    Market research documents also show that tobacco companies have
conducted research in quitting behavior and have documented the reasons
why people quit and why they fail to quit, despite a desire to do
so.<SUP>346 A market research firm reporting on a survey of smokers'
views about the health implications of smoking observed that:

    \346\ See e.g. The Creative Research Group. Project Viking, Vol.
III: Product Issues. Prepared for Imperial Tobacco Ltd., Feb/Mar
1986.
    Kwechansky Marketing Research for Imperial Tobacco Ltd. Project
Plus/Minus. May 7, 1982. Pages 41-51.
---------------------------------------------------------------------------

a minority expresses a resentment about the addictive aspects of
smoking. Being ``out of control,'' unable to quit causes them to
feel somehow unworthy * * *. Nicotine is usually singled out as the
culprit here. However, even these smokers would be reluctant to give
up the satisfaction elements in smoking. So they are in a quandry
[sic].'' <SUP>347

    \347\ The Creative Research Group. Project Day-Exploratory Phase
in Edmonton. Prepared for Imperial Tobacco Ltd. August 1988. Page
11.
    See also Market System, Inc. Project Eli Focus Groups Final
Report. Prepared for Imperial Tobacco Ltd. July, 1982. Page 5.
Smokers refer to smoking as ``satisfying a craving.''
---------------------------------------------------------------------------

Another market research firm reported its findings about the inability
of young smokers to quit when they want to:

    However intriguing smoking was at 11, 12 or 13, by the age of 16
or 17 many regretted their use of cigarettes for health reasons and
because they feel

[[Page 41672]]
unable to stop smoking when they want to.<SUP>348

    \348\ See Kwechansky Marketing Research. Project 16, note 339,
supra, at p. vi.
    See also Kwechansky Marketing Research. Project Plus/Minus. May
7, 1982. Study Highlights. In a follow-up study, the same market
research firm reported the following results:
    The desire to quit seems to come earlier now than before, even
prior to the end of high school * * *. However, the desire to quit,
and actually carrying it out, are two quite different things, as the
would be quitter soons [sic] learns * * *
    According to a report in Newsday, a 1957 ``motivation survey''
prepared for Liggett on smoker attitudes about smoking amid growing
health concerns contained the following statement:
    What smokers are really saying is: `I wish I had never started
to smoke * * * but now that it's got me, I know that I can't stop.'
    Riley J. Smoke-Trial Documents Make Titillating Reading.
Newsday. July 19, 1988.
---------------------------------------------------------------------------

    The fact that many smokers smoke even though they do not enjoy
smoking is conceded in a candid marketing research document prepared
for Imperial Tobacco Ltd., which reported that it is particularly
difficult to sell cigarettes by ``trading on the positives'' because
the industry is ``vexed by the unique problem that users of the
category do not necessarily like the product.'' <SUP>349 Another
document reports that many smokers of ultra-low tar and nicotine
cigarettes want to quit and ``refer to their behavior in terms of
`satisfying a craving' while smokers of stronger cigarettes talk about
taste and satisfaction.'' <SUP>350

    \349\ See The Creative Research Group Ltd., note 346, supra, at
p. 64451.
    \350\ See Market System Inc., note 347, supra, at p. 5.
---------------------------------------------------------------------------

    In summary, the tobacco companies' data show that users find it
extremely difficult to quit smoking and that many tobacco users would
quit if they could. Their data also show that, of those smokers who try
to quit, only a small percentage succeed permanently. Consequently,
tobacco manufacturers are aware that the large percentage of their
customers who try to quit but fail continue to buy and use tobacco
products, in large part to satisfy their dependence on nicotine-
containing tobacco. Use of tobacco to satisfy nicotine dependence is

[[Page 41673]]
a use that affects the structure or function of the body.