[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices]
[Page 41693-41749]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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[[Page 41693]] THIS SECTION OF THE DOCUMENT CONTAINS INFORMATION THAT MAY BE
CONSIDERED TO BE OF A TRADE SECRET OR COMMERCIAL CONFIDENTIAL NATURE.
EACH PAGE CONTAINING SUCH INFORMATION BEARS A NOTE ON THE TOP OF THE
PAGE AND THE INFORMATION HAS BEEN PURGED FROM THE TEXT.


E. INDUSTRY MANIPULATION AND CONTROL OF NICOTINE DELIVERY IN MARKETED
TOBACCO PRODUCTS

1. Industry Manipulation and Control of Nicotine in Cigarettes

    FDA's investigation has revealed the painstaking attention that
tobacco companies pay to nicotine during every phase of cigarette
manufacture. This section details the methods used by the industry to
manipulate nicotine delivery at each stage of production and some of
the effects of these manipulations on the nicotine content (the amount
of nicotine in the tobacco rod) and delivery (the amount of nicotine
delivered in the smoke for absorption into the bloodstream of the
smoker) of modern cigarettes.
    At each step--from tobacco growing, purchasing of tobacco leaves,
and blending different types of tobacco, to cigarette design and
manufacture--ensuring adequate nicotine delivery is a central objective
of cigarette manufacturers. According to a tobacco industry official:

    Generally speaking, the nicotine yield of a cigarette is
determined by the nicotine content of the tobacco; the static burn
rate or amount of tobacco consumed during puffing; the pressure drop
of the tobacco column; porosity of the wrapper and or ventilation at
the filter; the pressure drop of the filter, the filter material,
the surface area of the filter material; and the affinity of the
filter material for nicotine particularly as a function of smoke pH.
Through the combination of these variables, plant genetics, and
commercial processes to remove nicotine from tobacco, it is possible
to manipulate the yield of nicotine from about .1 mg to

[[Page 41694]]
4 mg per cigarette.<SUP>395a [Emphasis added.]

    \395a\ Spears, AW. Lorillard Tobacco Co. Factors Affecting Smoke
Delivery of Nicotine and Carbon Monoxide. Presented at the 1975
Symposium- Nicotine and Carbon Dioxide. November 17-18, 1975. In
Symposium Proceedings-1, at p.12. FDA notes that when the author
testified before Congress, he stated that nicotine manipulation does
not occur and that nicotine yields simply follow tar yields. See
note 479, infra. In this article he does not mention tar yield as
factor in determining nicotine yield.
---------------------------------------------------------------------------

    The first manufacturing step in nicotine control is the development
and selection of raw materials. The tobacco industry has, through
breeding and cultivation practices, developed high-nicotine tobacco
plants that provide higher-potency raw material, giving manufacturers
greater flexibility in blending and in providing uniform and sufficient
nicotine deliveries.
    Even without the selective breeding and cultivation of plants for
nicotine content, careful tobacco leaf purchasing plans permit the
manufacturers to control nicotine content in their products. For
example, nicotine content varies among types of tobacco and from one
crop year to the next. Awareness of these basic differences and
monitoring of the nicotine levels in purchased tobacco allows the
companies to produce cigarettes with nicotine deliveries consistent to
a tenth of one percent, despite variations as high as 25% in the
nicotine content of the raw material originating in the same area, from
year to year.
    The primary control of nicotine delivery (the amount received by
the smoker), however, is in the design and careful, sophisticated
manufacture of the cigarette, to ensure that the smoker obtains the
precise amount of nicotine intended by the manufacturer. FDA's
investigation has revealed that despite reductions in the amount of tar
delivered by cigarettes over the past several decades, nicotine
delivery in low-yield <SUP>396 cigarettes has not fallen
proportionately with the reductions in tar. Instead, nicotine delivery
has apparently risen over the last decade, a result

[[Page 41695]]
that confirms that nicotine delivery is being independently and
carefully manipulated by tobacco manufacturers. This newly gathered
information, together with the other evidence of the industry's
breeding, purchasing, blending, and manufacturing practices, reveals
the extent to which manufacturers control the amount of nicotine that
is delivered to the consumer from cigarettes and provides further
support for the Agency's conclusion that tobacco manufacturers intend
their products to affect the structure or function of the human body.

    \396\ ``Low-yield'' is used to denote cigarettes advertised as
low-tar and low-nicotine.
---------------------------------------------------------------------------

a. Tobacco Leaf Growing
    The industry's control and manipulation of nicotine in the
production of cigarettes begins long before the cured tobacco leaf
reaches the manufacturing plant. The characteristics of leaf tobacco,
including nicotine content, are established by the genetic makeup of
the plant, developed during growing, and fixed by post-harvest
handling. Like other raw agricultural commodities, the physical and
chemical properties of tobacco, including nicotine, can vary widely,
depending on genetic differences, growing season conditions, and soil
type. This subsection describes the methods used by the tobacco
industry to control and manipulate nicotine through careful genetic
breeding and agronomic practices. As one industry expert stated,
``nicotine is the key chemical constituent of the leaf and smoke and
the reason for which tobacco is grown.'' <SUP>397

    \397\ Adapting agronomy to the needs of the low-tar era. World
Tobacco. October 1977. Page 137.
---------------------------------------------------------------------------

    Modern types of cultivated tobacco (Nicotiana tabacum L) have been
selected for a relatively high level of nicotine.<SUP>398 Five major
types of tobacco make up nearly all tobacco

[[Page 41696]]
products marketed in the United States: Burley, flue-cured, Maryland,
the Dark tobaccos, and Oriental. These tobaccos vary both in nicotine
levels and in pH. The pH of a tobacco can have a significant influence
on the amount of, and rate at which, nicotine is absorbed into the
bloodstream of the tobacco user and delivered to the brain.

    \398\ Id.
---------------------------------------------------------------------------

    Of the five major types of tobacco, Burley tobacco generally
contains the highest nicotine levels compared to other tobacco
varieties, and it has an alkaline pH. Flue-cured tobacco represents the
major tobacco ingredient in American cigarettes. In comparison with
other tobacco varieties, flue-cured tobacco has a medium nicotine
content and is somewhat acidic.<SUP>399 Maryland tobacco has a low
nicotine content in comparison with other varieties and has an alkaline
pH. The Dark tobaccos produce an alkaline smoke, and are the
traditional tobaccos for cigar wrappers and fillers as well as for
chewing tobacco and for many pipe tobacco mixtures. Oriental tobaccos,
cultivated in southeastern Europe and Turkey, are used for their
characteristic aroma; they have a low nicotine content, and low
pH.<SUP>400

    \399\ Browne CL. The Design of Cigarettes. Hoechst Celanese
Corporation; 1990. Page 43.
    \400\ Id. at pp. 22, 44.
---------------------------------------------------------------------------

    American tobaccos of all types have undergone cumulative increases
in total nicotine levels since the 1950's.<SUP>401 As the following
chart demonstrates, nicotine levels in the most widely grown American
tobaccos increased almost 10% for Burley and more than 50% for flue-
cured between 1955 and 1980:

    \401\ DeJong DW. The role of American tobacco leaf chemistry in
low-yield cigarettes: an agricultural viewpoint. Tabak Journal
International. May 1985. Pages 376-83. DeJong notes that higher-
nicotine American tobaccos are needed in limited quantities to
``spike'' low yield cigarette blends. He further notes that off-
shore tobaccos are invariably lower in nicotine, but serve to
provide ``filler'' style leaf materials deemed necessary for the
manufacturing of low-tar cigarettes, which comprise the majority of
the U.S. market.

[[Page 41697]]

------------------------------------------------------------------------
                                                       Percent nicotine
                    Tobacco type                     -------------------
                                                        1955      1980
------------------------------------------------------------------------
U.S. Burley.........................................      2.91      3.18
U.S. Flue-cured.....................................      1.93      3.07
------------------------------------------------------------------------

    Two tobacco industry activities over the last several decades
appear to be responsible for this increase: (1) the industry's active
and controlling participation in the Minimum Standards Program, which
ensures that nicotine levels of U.S.-grown and marketed tobacco are
maintained within specified ranges; <SUP>402 and (2) the industry's
breeding and cultivation of tobacco for high nicotine levels.

    \402\ Id. at p. 382.
---------------------------------------------------------------------------

    The Minimum Standards Program, which began in 1963 for flue-cured
tobacco and in 1977 for Burley tobacco, <SUP>403 is a component of the
tobacco price-support program administered by the U.S. Department of
Agriculture (USDA). With regard to domestically grown tobaccos, the
industry maintains control over which varieties are suitable for
growing in the United States

[[Page 41698]]
and thereby eligible for price support.

    \403\ See:
    Letter to M. Murray, FDA, from E. Wersman, North Carolina State
University, March 23, 1994, transmitting:
    (1) The Burley Tobacco Quality Committee-Varieties ``Testing
Procedure to Assure Acceptable Quality In Burly Tobacco Varieties''
revised February 24, 1993.
    (2) The Flue-Cured Tobacco Quality Committee-Varieties ``Testing
Procedure to Assure Acceptable Quality In Flue-Cured Tobacco
Varieties'' amended January 1991.
    Letter to M. Zeller, FDA, from E.M. Pfeifer, King & Spalding on
behalf of the Brown and Williamson Tobacco Corp., pp.1-8, with
enclosures:
    Attachment 1 ``Flue-Cured Tobacco Variety Committee'';
    Attachment 2 ``Burley Variety Evaluation Committee Membership'';
    Attachment 3 Slides, pp. 90025-90091.
---------------------------------------------------------------------------

    One key objective of the tobacco industry's involvement in the
Minimum Standards Program appears to be to ensure that nicotine levels
in marketed tobacco do not fall below specified levels. The program was
initiated in response to the emergence, in the 1950's , of several so-
called ``discount'' varieties of tobacco (e.g., ``Coker 139,'' ``Coker
187-Golden Wilt,'' ``Coker 282,'' ``Coker 140,'' ``Coker 316,'' and
``Reams 64'') that failed to meet current industry specifications
established, among other things, to control the amount of nicotine
delivery when used in manufacturing filtered cigarettes. To insure the
elimination of ``discount'' or low-nicotine varieties from the market,
the industry obtained the necessary cooperation from USDA to eliminate
these varieties from the price-support program. In fact, to be eligible
under this program, growers must certify, even to this day, that
``discount'' varieties are not being grown.<SUP>404

    \404\ USDA Agricultural Stabilization and Conservation Service
(ASCS) Manual. ``Identification of certain flue-cured tobacco
varieties under the price support program.'' April, 1964. Pages 3-5,
8, 10-11. Obtained on June 15, 1994, from USDA-ARS-SAA, Crops
Research Laboratory.
---------------------------------------------------------------------------

    In 1979, one major U.S. manufacturer requested that the tobacco
variety committee under the Minimum Standards Program lower the
acceptable nicotine range, established in 1967, for the specific
tobacco varieties used as the standard. Support for lowering the
acceptable nicotine range was not forthcoming from the rest of the
industry and the change was never adopted.<SUP>405 In fact, in spite of
the trend toward marketing cigarettes advertised as low delivery, the
criteria under the Minimum Standards Program for nicotine content of
new varieties have not changed since 1967.

    \405\ Collins WK. Cultural practices increase nicotine content
of U.S. flue-cured leaf. Tabak Journal International. [4] 1981:328,
330.
---------------------------------------------------------------------------

    While the Minimum Standards Program ensured that nicotine levels in
marketed tobaccos

[[Page 41699]]
did not fall, breeding and cultivation initiatives undertaken by the
industry caused nicotine levels to increase. When health concerns
prompted the tobacco industry to begin to market low-tar cigarettes in
the 1960's and 70's, the industry turned to tobacco breeders to develop
tobacco varieties that produced less tar. Breeders found that without
intervention in the breeding of these varieties, nicotine levels were
reduced along with tars.<SUP>406 Thus, the industry has long been able
to grow low-tar and low-nicotine varieties of tobacco for use in
manufacturing cigarettes.

    \406\ Tailoring tobacco plants to meet future demands. World
Tobacco. October 1978. Page 148. Abbreviation of talk by J.F.
Chaplin at meeting of CORESTA scientists in Sofia, Bulgaria.
---------------------------------------------------------------------------

    By 1978, however, the industry had abandoned its interest in the
development of low-tar/low-nicotine varieties of tobacco for
manufacturing low-yield cigarettes, and instead turned to the
development of higher nicotine varieties. According to one expert in
the field, it was necessary to focus on developing tobacco that was
higher in nicotine, not lower:

* * * manufacturers have means of reducing tars but most of the
methods reduce nicotine and other constituents at the same time.
Therefore it may be desirable to develop levels constant or to
develop lines higher in nicotine so that when the tar and nicotine
are reduced there will still be enough nicotine left to satisfy the
smoker.<SUP>407 [Emphasis added.]

    \407\ Id.
---------------------------------------------------------------------------

Industry experts agreed, stating in 1981 that the nicotine content of
tobacco ``will increase if the very low `tar' brands continue to expand
in market share,'' <SUP>408 They further stated that:

    \408\ Spears AW, Jones ST. Chemical and physical criteria for
tobacco leaf of modern day cigarettes. Recent Advances in Tobacco
Science. 1981;7:19-39, 37.
---------------------------------------------------------------------------

 [c]urrent research is directed toward increasing the nicotine
levels while maintaining or marginally reducing the `tar'
deliveries.<SUP>409

    \409\ Id at p. 31. See DeJong, note 401, supra, at p. 378. In
anticipation of a move toward low-yield cigarettes, USDA was once
petitioned by the industry to promulgate regulations to allow for
the growing of ultra-low nicotine tobacco. The regulations were
actually published in the Federal Register in June 1947. The
nicotine concentration was to be no higher than 0.8%, which is
significantly lower than the concentration of nicotine in domestic
tobaccos. These low-nicotine varieties were to be kept entirely
separate and marketed under contract. These regulations remain in
the Code of Federal Regulations (7 CFR 30), but they have never been
taken advantage of, indicating industry's lack of interest in the
development of ultra-low nicotine tobaccos.

[[Page 41700]]

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

The industry has elsewhere acknowledged that the role of American
tobacco is to provide high levels of nicotine in the finished product
to offset the diluting effect of bland foreign tobaccos and
reconstituted tobacco sheet.<SUP>410

    \410\ See DeJong, note 401, supra.
---------------------------------------------------------------------------

    FDA's investigation has revealed that at least one cigarette
manufacturer, Brown and Williamson, has developed and marketed a
tobacco so high in nicotine that it exceeded the limits imposed for
U.S.-grown tobacco under the Minimum Standards Program. These limits
cannot be exceeded without significant risk of losing government-
administered price support. However, foreign-grown tobaccos are not
subject to these specifications and are not subject to testing for
nicotine content upon entry into the United States. This high-nicotine
tobacco was therefore grown in South America.
    FDA found that Brown and Williamson was involved for more than a
decade in developing, through a combination of conventional and
advanced genetic breeding techniques, a high-nicotine, flue-cured
tobacco plant, named ``Y-1,'' for use in a number of low-tar brands of
cigarettes in the United States.
    Brown and Williamson characterized its achievement in a patent
filing in the following way:

    By the present invention or discovery, applicants have succeeded
in developing a tobacco plant that is agronomically and
morphologically suitable for commercial tobacco production, i.e. it
closely resembles SC 58, and provides a pleasant taste and aroma
when included in smoking tobacco products, yet it is possessed of
the N. rustica high-nicotine attribute. So far as we know, this has
not been

[[Page 41701]]
accomplished before * * * [Emphasis in original.] <SUP>411

    \411\ U.S. patent application No. 761,312 submitted on September
17, 1991.
---------------------------------------------------------------------------

    The development of Y-1 dates back to at least the mid-1970's. In
1977, James F. Chaplin, who was affiliated with both USDA and North
Carolina State University, indicated that tobacco could be bred to
increase nicotine levels, by crossbreeding commercial varieties of
tobacco with Nicotiana rustica. N. rustica is a wild tobacco variety
that is very high in nicotine, but is not used in manufacturing
cigarettes because of its harshness.<SUP>412

    \412\ Chaplin JF. Breeding for varying levels of nicotine in
tobacco. Proceedings from a symposium on Recent Advances in the
Chemical Composition of Tobacco and Tobacco Smoke. 1977. Page 334.
---------------------------------------------------------------------------

    By combining conventional and advanced breeding techniques, Brown
and Williamson succeeded in developing commercially viable Y-1 from
seeds initially produced by Chaplin's crossbreeding work. The nicotine
content of the leaf of this variety is about 6% by weight, which is
higher than that of any other varieties of tobacco commercially grown
in the United States. (Domestically grown varieties of flue-cured
tobacco, for example, naturally contain 2.5% to 3.5% nicotine.<SUP>413)

    \413\ Letter to D.A. Kessler, FDA, from J. W. Johnston, R.J.
Reynolds Tobacco Co. February 28, 1994. Pages 1-2.
---------------------------------------------------------------------------

    Company officials admitted to FDA that Y-1 was intended as a
``blending tool'' to enable the company to design products that were
lower in tar but not lower in nicotine.<SUP>414 The company disclosed
to FDA that Y-1 had been used commercially in the manufacturing of
Viceroy King Size, Viceroy Lights King Size, Richland King Size, and
Richland Lights King Size and it

[[Page 41702]]
constituted about 10% of the tobacco blend of these products.<SUP>415
These brands were manufactured and distributed throughout the United
States in 1993.<SUP>416 FDA's investigation revealed that, as of mid-
1994, Brown and Williamson still had between 3.5 million and 4 million
pounds of this high-nicotine tobacco on hand.<SUP>417

    \414\ Transcript of FDA meeting with Brown and Williamson. June
17, 1994. Pages 18, 29, 85-86, 124.
    \415\ Id. at pp. 153, 165.
    \416\ Regulation of Nicotine under the Federal Food, Drug, and
Cosmetic Act: hearings Before the Subcommittee on Health and the
Environment of the Committee on Energy and Commerce, U.S. House of
Representatives, 103 Cong. 2d Sess. (June 21, 1994) (statement of
David A. Kessler, M.D., Commissioner of Food and Drugs, ``The
Control and Manipulation of Nicotine in Cigarettes,'' at pp. 9-12).
The Commissioner's statement is included as Appendix 8 to this
document.
    \417\ See Transcript, note 414, supra, at p. 124.
---------------------------------------------------------------------------

    In addition to breeding high-nicotine tobacco varieties, the
tobacco industry engages in a number of agronomic practices that
increase nicotine levels in tobacco. Heavy application of nitrogen
fertilizers, early topping, and tight ``sucker'' (i.e., bud growth at
the junction of stalk and leaves) control have all acted in concert to
push nicotine levels upward.<SUP>418 In addition, tobacco varieties
have been selected for tolerance to brown spot, a leaf disease that
makes early harvest necessary. Leaves of disease-resistant varieties
tend to remain in the field longer, resulting in maximum nicotine
accumulation.<SUP>419 Since the introduction in 1965 of the acreage-
poundage control system, farmers have reduced the number of harvestable
leaves per plant and have tended to increase plant spacing. Both of
these practices tend to increase nicotine content in the leaf.<SUP>420
Finally, tobacco growers are transplanting tobacco crops earlier,
which, coupled with the widespread use of pesticides in the soil, often
results in slow early season growth, and also tends

[[Page 41703]]
to increase nicotine content in the leaves.<SUP>421

    \418\ See DeJong, note 401, supra, at p. 382.
    \419\ See Collins, note 405, supra, at p. 330.
    \420\ Id.
    \421\ See Collins, note 405, supra.
---------------------------------------------------------------------------

    These nicotine-raising agronomic practices have been adopted by
U.S. growers in recent years, even though over 50% of the U.S.
cigarette market is now characterized as low delivery. Thus, the
tobacco industry has developed a number of sophisticated methods for
manipulating nicotine levels through breeding and cultivation of
tobacco plants and has used these methods to maintain and increase
concentrations of nicotine in tobacco leaves. These methods enable the
industry to use high-nicotine leaf in low-tar cigarettes, so that,
paradoxically, certain low-tar cigarettes now contain more of the
higher nicotine tobacco in their blend than cigarettes with higher tar
deliveries.<SUP>422 See p. 261 infra. The use of these methods
demonstrates that the industry manipulates nicotine independently of
other tobacco components to ensure that cigarettes contain sufficient
nicotine to satisfy smokers.

    \422\ See Spears, note 408, supra, at p. 22.
---------------------------------------------------------------------------

b. Leaf Purchasing
    Nicotine is perhaps the most important criterion employed by
cigarette companies in the purchase of tobacco leaf. As one tobacco
company official stated over 20 years ago in an industry publication:

    It is believed that one important reason why the consumer smokes
cigarettes is for the nicotine which they contain * * *
Manufacturers, therefore, must have all options open in selecting
leaf to buy.
    They are most concerned with the nicotine levels in leaf, so
that after manufacture of their blends, the nicotine percentages in
the cigarettes will vary minimally both

[[Page 41704]]
from one to another within a packet, and from packet to packet.<SUP>423
[Emphasis added.]

    \423\ What changing technology means for leaf producers and
packers. World Tobacco. September 1971. Page 137. Based upon lecture
by J.S. Campbell, American Organisation of the Imperial Tobacco
Group Ltd. at a Conference on Social and Economic Issues Confronting
the Tobacco Industry in the Seventies, Lexington, KY.
---------------------------------------------------------------------------

THIS DATA HAS BEEN PURGED OF INFORMATION THAT MAY BE CONSIDERED TO BE
OF A TRADE SECRET OR COMMERCIAL CONFIDENTIAL NATURE

    The key factor related to nicotine in leaf purchasing is stalk
position. The concentration of nicotine is lowest at the bottom of the
plant and highest in the top leaves of flue-cured tobacco.<SUP>424
Thus, the position of the leaf on the stalk determines how much
nicotine the leaf will contain. In fact, ``stalk position'' is an
industry euphemism for nicotine content. The stalk position of a leaf
can be determined by its appearance, shape, color, and thickness, even
after harvest.<SUP>425 Therefore, an experienced buyer, whose
instructions are dictated by the manufacturer's chemists, <SUP>426 need
only be concerned with these physical characteristics in identifying
leaves of varying nicotine content.

    \424\ See 1977 World Tobacco article, note 397, supra. See also
Browne, note 399, supra, at p. 15.
    \425\ See 1977 World Tobacco article, note 397, supra.
    \426\ Evolving techniques of making cigarettes milder. World
Tobacco. April 1979. Page 95.
---------------------------------------------------------------------------

    The significance of stalk position in leaf purchasing was confirmed
when FDA visited cigarette manufacturers. X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X <SUP>427

    \427\ FDA officials Mitch Zeller, Kevin Budich, Barbara Frazier,
and Bob Spiller visited the sites of R.J. Reynolds Tobacco Company
on April 11-12, 1994, and Brown and Williamson Tobacco Company on
May 3, 1994. The following references refer to their summary notes
of the visits.
    Zeller notes from RJR visit at p. 2.
    Budich notes from RJR visit at p. 3.

[[Page 41705]]

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

    Furthermore, this RJR representative revealed that ``impact'' is a
criterion in leaf purchasing and that ``impact'' is ``basically a
function of nicotine in tobacco.'' <SUP>428 RJR also indicated that
``impact'' is measured in the company's laboratories if there is enough
time to do so prior to purchase.<SUP>429

    \428\ Zeller notes from RJR visit at p. 2.
    Budich notes from RJR visit at p. 3.
    Frazier notes from RJR visit at p. 2.
    RJR overhead was provided at visit.
    \429\ Zeller notes from RJR visit at p. 2. X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
---------------------------------------------------------------------------

    Representatives from Brown and Williamson also described the
significant role that nicotine plays in the purchase of tobacco leaf.
The company stated that stalk position is the ``first thing'' they look
for during leaf purchasing.<SUP>430 At Brown and Williamson, the lower
stalk positions are considered to have the least amount of ``smoke
quality,'' which was defined as including ``impact level.'' <SUP>431
The company defines ``impact'' as ``the hit or punch in the back of the
throat when you first inhale.'' <SUP>432

    \430\ Zeller notes from B&W visit at p. 2.
    Frazier notes from B&W visit at p. 2.
    Spiller notes from B&W visit at p. 2.
    \431\ Zeller notes from B&W visit at p. 2.
    \432\ Zeller notes from B&W visit at p. 2.
    Budich notes from B&W visit at p. 4.
    Frazier notes from B&W visit at p. 2.
    Spiller notes from B&W visit at p. 2.
---------------------------------------------------------------------------

    Nicotine levels are so crucial to leaf purchasing at Brown and
Williamson that the

[[Page 41706]]
company actually adjusts the stalk positions of its leaf purchases
based upon the results of nicotine analyses that are performed during
the course of the buying season.<SUP>433 In addition, Brown and
Williamson employs special measures when purchasing foreign tobacco to
ensure adequate nicotine levels. The company stated that foreign Burley
and flue-cured tobaccos are smoked prior to their purchase so that they
get some sense of the ``impact'' of the tobacco,<SUP>434 X X X X X X X
X X X X X X X X X X X <SUP>435

    \433\ Frazier notes from B&W visit at p. 2.
    \434\ Spiller notes from B&W visit at p. 2.
    Frazier notes from B&W visit at p. 2.
    \435\ X X X X X X X X X
---------------------------------------------------------------------------

c. Leaf Blending
    After purchase, tobacco leaves are blended to attain target levels
of nicotine and tar in the smoke. FDA's investigation noted particular
attention on the part of manufacturers to the nicotine content of the
leaf in the blending operation. As noted above, blending practices by
manufacturers are designed to: (1) control the naturally occurring
variations in nicotine and other components caused by genetics, growing
season conditions, and soil type within a given type and grade; and (2)
particularly for low-tar cigarettes, to increase nicotine
concentrations and thereby maintain an acceptable nicotine level in the
cigarettes.
    As described above, each type of tobacco has unique characteristics
of nicotine and tar delivery. Moreover, within each type, levels of
nicotine increase with ascending stalk position

[[Page 41707]]
(grade). Armed with this knowledge, tobacco manufacturers blend various
types of tobaccos and various stalk positions to achieve specific
nicotine levels in particular brands.
    Manufacturers also pay attention to other features of tobaccos that
can affect nicotine delivery during blending. For example, cigarette
filling power (bulk), pressure drop or resistance to draw, and static
burn rate are all decreased with ascending stalk position. Decreases in
burn rate increase the puff count, and thereby result in the delivery
of more nicotine to the smoker because less tobacco is burned between
puffs.<SUP>436

    \436\ See Browne, note 399, supra, at p. 12.
---------------------------------------------------------------------------

    The pH of cigarette smoke directly affects the delivery of nicotine
because it alters the amount of nicotine that is absorbed in the mouth
or lungs.<SUP>437 PH is controlled by the manufacturer in the selection
of the type of tobacco used and blended. For example, smoke-condensate
pH is higher from certain tobacco varieties as well as from leaves at
upper stalk positions.

    \437\ See Surgeon General's Report. Nicotine Addiction. 1988.
Pages 29-31.
---------------------------------------------------------------------------

    Blending techniques have been used to finely control nicotine
concentrations in marketed cigarettes. X X X X X X X X X X X X X X X X
X X XX X X X X X X X X X X X X X X X X X X X X <SUP>438 This is a high

[[Page 41708]]
degree of control even in a product manufactured from synthetic,
homogeneous materials. It is a remarkable degree of control for a
product such as cigarettes, which are made from highly variable
biological materials whose nicotine content is ordinarily dependent
upon such uncontrollable factors as weather and plant attack by insects
and plant diseases.

    \438\ X X X X X X X X X X X X X X X X X X X X X X X X X
    X X X X X X X X X X X
    X X X X X X X X X X X X X X X X X X X X
    X X X X X X X X X X X X X X X X X X X X X X X X X
    X X X X X
    X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X
---------------------------------------------------------------------------

    Significant evidence also demonstrates that tobacco manufacturers
have used blending techniques to increase nicotine concentrations in
low-tar cigarettes and thereby maintain nicotine delivery while
reducing tar delivery. FDA has observed the industry's use of
proportionately greater amounts of higher nicotine-containing Burley
tobacco in the tobacco blends of the lowest-tar varieties of
cigarettes. In fact, Thomas Sandefur, the chief executive officer of
Brown and Williamson, admitted to Congress that nicotine levels can be
adjusted ``up or down'' depending on the blend of tobaccos used in a
particular cigarette.<SUP>439 Industry scientists have also
acknowledged that tobacco manufacturers blend high-nicotine tobaccos to
compensate for the reductions in nicotine caused by innovations in
cigarette design and manufacturing to reduce tar deliveries.<SUP>440

[[Page 41709]]
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
<SUP>441 These examples demonstrate that tobacco manufacturers
deliberately increase the proportion of high-nicotine tobaccos in low-
tar cigarettes to prevent reductions in nicotine delivery that would
otherwise result in these products.

    \439\ Regulation of Nicotine under the Federal Food, Drug, and
Cosmetic Act: hearings Before the Subcommittee on Health and the
Environment of the Committee on Energy and Commerce, U.S. House of
Representatives, 103 Cong. 2d Sess. (June 23, 1994) (testimony of
Thomas E. Sandefur, Jr., CEO, Brown and Williamson Corp., transcript
at p.133).
    \440\ See:
    DeJong, note 401, supra.
    Spears, note 408, supra, at pages 22-24.
    \441\ Zeller M, Budich K. Notes from March 22-23, 1994 meeting
with Philip Morris and April 10-12, 1994, meeting with RJR. Mitch
Zeller's notes, at pp. 2-3, and Kevin Budich's notes at p. 9.
---------------------------------------------------------------------------

    Moreover, as described above, Brown and Williamson developed ``Y-
1,'' its ultra-high nicotine tobacco, for the purpose of having a
``blending tool'' that could be used to maintain nicotine delivery
while reducing tar.
d. Cigarette Design and Manufacture
    Cigarettes are not simply cut tobacco rolled into a paper tube.
Modern cigarettes, as sold in the United States, are painstakingly
designed and manufactured to control the amount of nicotine delivered
to the smoker. The following aspects of cigarette design and
manufacturing all affect the nicotine delivery of a finished cigarette:
    (i) the chemical manipulation of tobacco smoke;
    (ii) the use of flavors and casings;
    (iii) filtration;

[[Page 41710]]

    (iv) the use of reconstituted tobacco; and
    (v) use of wider tipping paper.
    (i) Chemical Manipulation
    Tobacco manufacturers add certain chemicals to the tobacco to
enhance the efficient extraction by the smoker of nicotine from the
tobacco in the rod. For example, certain additives can alter the pH of
cigarette smoke, which is known to affect the rate of absorption of
nicotine into the bloodstream of the smoker.<SUP>442

    \442\ Surgeon General's Report. Nicotine Addiction. 1988. Pages
29-31.
---------------------------------------------------------------------------

    FDA's investigation has disclosed efforts by the industry to
chemically enhance nicotine delivery. A major American tobacco
company's 1991 handbook on leaf blending and product development shows
that ammonia from such sources as diammonium phosphate (DAP),<SUP>443
ammonium hydroxide, and urea can be used in cigarette manufacturing to
increase the amount of nicotine delivered to the smoker.

    \443\ See Statement of David A. Kessler, note 416, supra, at pp.
9-12.
---------------------------------------------------------------------------

    The handbook states that ammonia in cigarette smoke:

can liberate free nicotine from the blend, which is associated with
increases in impact and `satisfaction' reported by smokers.<SUP>444

    \444\ Id. at p. 10.
---------------------------------------------------------------------------

The handbook goes on to describe ammonia as an ``impact booster'':

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

[[Page 41711]]
cigarette smoke and this is how ammonia can act as an impact
booster.<SUP>445

    \445\ Id.
---------------------------------------------------------------------------

    Ammonia increases the pH of the smoke and thereby enhances the
absorption of nicotine by the body.<SUP>446 FDA's investigation has
revealed at least one common site for the application of ammonia and
ammonia-like compounds: reconstituted tobacco. The agency has found
levels of these compounds to be as high as 10% in reconstituted
tobacco.

    \446\ Surgeon General's Report. Nicotine Addiction. 1988. Pages
29-31.
---------------------------------------------------------------------------

    The company handbook describes the benefits of the treated
reconstituted tobacco as a source of ammonia to absorb nicotine from
higher alkaloid-containing components in the blend. This company
handbook also describes the application of ammonia directly to the leaf
tobacco.
    With regard to the question of the efficiency of this technology in
increasing nicotine delivery, the handbook states that smoke analysis
shows that an experimental cigarette made of reconstituted tobacco
treated with ammonia has almost double the nicotine transfer efficiency
of tobacco.<SUP>447 This handbook also states that many U.S. tobacco
manufacturers utilize ammonia technology. One company has admitted to
FDA that it uses DAP in manufacturing cigarettes, and that such use
increases nicotine delivery.<SUP>448

    \447\ See Statement of David A. Kessler, note 416, supra, at pp.
10-12.
    \448\ See King and Spalding letter, note 403, supra, at p. 6.
---------------------------------------------------------------------------

    (ii) Flavors and Casings
    Various substances are added to tobacco components to affect the
flavor and palatability of smoke, alter smoke composition and yield,
modify burn rate, and alter pH to optimize nicotine

[[Page 41712]]
delivery. According to one industry expert,<SUP>449 the major
contribution of the tobacco flavor specialist is to:

    \449\ Hertz AN. The flavourist's role in the cigarette design
team. World Tobacco. March 1985. Page 97.
---------------------------------------------------------------------------

help provide a rich, clean, full-bodied tobacco flavour, to keep to
a minimum hotness and irritation in the mouth, and to ensure high
satisfaction from an adequate level of nicotine per puff * * *
requirements that guarantee the consumer a pleasurable smoke * * *

    So-called ``casings'' are solutions of usually water-soluble
ingredients that provide a means of incorporating flavorings and other
additives into the tobacco blend. Casings are often used in tobacco
processing to reduce the harshness of nicotine in high-nicotine
tobaccos, thus permitting greater use of these tobaccos in cigarette
manufacture. This use of casings is described by an industry
``flavorist'' in the following quote:

    It is assumed that nicotine is one of the primary satisfaction
factors for which tobacco products are used. However, in air-cured
tobaccos (cigar, burley, Maryland), the pH of the smoke is generally
alkaline and the flavor effect of nicotine is a ``harshness'' which
can be choking and unpleasant. In the case of tobaccos containing
sugars (flue-cured, oriental), the tobacco is weakly acidic, the
effect of the nicotine is greatly modified, and the harshness is
dramatically reduced. This same effect is often achieved by addition
of sugars to air-cured tobaccos to ``mellow'' the smoke and/or by
the blending of air-cured tobaccos with flue-cured and oriental.
[Citation omitted.] Thus, smoke pH and leaf sugar content are
factors which play an important role in the nicotine strength
perceived in the smoking process.<SUP>450

    \450\ Leffingwell JC. Nitrogen components of leaf and their
relationship to smoking quality and aroma. Recent Advances in
Tobacco Science. Volume 2. Page 9.
---------------------------------------------------------------------------

As is clear from this quote, casings are used to permit the
incorporation of high-nicotine tobaccos in cigarette blends, despite
their unpleasant taste. Casings composed of such additives as sugar,
licorice, or cocoa help to overcome the bitterness of nicotine in
smoke. The lengths to which tobacco manufacturers go to use high-
nicotine tobaccos, despite the harsh taste of

[[Page 41713]]
nicotine, reveals that the nicotine in these tobaccos is not being used
for its taste but for another purpose.
    FDA's investigation revealed the following example of the
application of casings to permit a use of a high-nicotine tobacco that
would otherwise have been unpalatable to consumers. X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X <SUP>451

    \451\ X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X
---------------------------------------------------------------------------

    Manufacturers also reduce harshness by routinely adding acids to
tobacco to lower the pH of the smoke.<SUP>452 Manufacturers also use
conventional casing materials, such as sugars and cocoa, to produce
acids in the smoke and reduce harshness.<SUP>453 Harshness from
nicotine is also reduced by spraying on top dressings after the tobacco
is cut and shredded for cigarette making.<SUP>454

    \452\ See King and Spalding letter, note 403, supra, at p. 6.
    \453\ Id.
    \454\ Id.
---------------------------------------------------------------------------

    Casings often include a humectant, usually glycerine or a higher
glycol, which serves to

[[Page 41714]]
keep the tobacco moist and less sensitive to changes in
humidity.<SUP>455 RJR acknowledged using glycerine as a
humectant.<SUP>456 Tobacco industry officials acknowledge that
controlling moisture content is essential to ensure that nicotine
content does not fall.<SUP>457 Humectants also act to control particle
size in the formation of the smoke aerosol, making the smoke
``smoother'' or less harsh on the back of the throat. Smoother smoke
facilitates inhalation, ensuring that the nicotine will be taken into
the lungs and rapidly and completely absorbed.

    \455\ See Browne, note 399, supra, at pp. 55-56.
    \456\ Budich K. Notes from April 10-12, 1994, meeting with RJR.
Page 8.
    \457\ DeBardeleben MZ, Clafin WE, Gannon WF. (Philip Morris
Research Center). Role of cigarette physical characteristics on
smoke composition. Recent Advances in Tobacco Science. Volume 4.
Page 98 (``Nicotine decreases on a per puff basis as moisture
content increases * * *. The decrease is dramatic as moisture
content rises above 12%'').
---------------------------------------------------------------------------

    Nicotine can also be added to cigarettes through application of
tobacco extracts in the processing of tobacco. Although calling the
contribution of flavored tobacco extracts to the overall nicotine
delivery from cigarettes ``trivial,'' tobacco companies admitted to
having used such extracts in testimony before Congress,<SUP>458 in
other public statements,<SUP>459 X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X

[[Page 41715]]
X X X X X X X X X X X X X X X X X <SUP>460

    \458\ Regulation of Tobacco Products (Part I): Hearings Before
the Subcommittee on Health and the Environment of the Committee on
Energy and Commerce, U.S. House of Representatives, 103 Cong. 2d
Sess. 592, 596 (April 14, 1994) (testimony of Edward A. Horrigan,
Jr., Liggett Group, Inc. and Andrew Tisch, Lorillard Tobacco Co.).
    \459\ Philip Morris press release. Philip Morris Statement on
Nicotine in Cigarettes. March 25, 1994. Page 2.
    \460\ See:
    Hunter J. FDA memo to the record. Conversation with Steve Block
of IFF. March 23, 1994.
    Layloff T, FDA. Memo to James Hunter, FDA. Tobacco Extract
Analyses. February 24, 1995.
    X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X The actual contribution of tobacco
extracts to total nicotine delivered to the smoker by tobacco so
treated is unclear. The industry has conducted research to examine
the specific activity of added versus naturally occurring nicotine.
See Jenkins RW, Comes RA. Exogenous vs Endogenous Transfer of
Nicotine During Smoking. Int. J. Appl. Radiat. Isotopes.
1976;27:323-324.
---------------------------------------------------------------------------

    (iii) Filtration
    The filter plug provides a mouthpiece that captures particulate
matter from the smoke and absorbs vapors. The filter can be used as a
vehicle to carry filter aids such as charcoal and other solids and
liquid additives that permit selective filtration of certain chemicals.
The manufacturer's selection of a particular filter is determined
largely by the target levels of nicotine and tar.<SUP>461

    \461\ See Browne, note 399, supra, at p. 66.
---------------------------------------------------------------------------

    Significant research has been conducted by the tobacco industry on
the use of filter additives to enhance nicotine delivery.<SUP>462 FDA's
investigation revealed that at least one major cigarette manufacturer
has added a chemical to the filters used on its marketed cigarettes
that increases the amount of nicotine delivered to smokers, by
increasing the amount of nicotine that is eluted from the filter.
``Elution'' is the process by which nicotine that is initially trapped
on a

[[Page 41716]]
filter is remobilized into the mainstream smoke by hot vapors and
becomes available for inhalation by the smoker. X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X <SUP>463

    \462\ Reynolds ML. Influence of filter additives on smoke
composition. Page 54. Undated.
    \463\ X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X X X X X X X X X X X X X X X
---------------------------------------------------------------------------

    Filter ventilation, which is accomplished by making holes in the
filter wrap and tipping paper, is also a major means of controlling the
nicotine delivery of a cigarette. Ventilation has apparently now
largely replaced interest in filter additives as a means of enhancing
nicotine delivery.<SUP>464 Ventilation holes allow fresh air to be
pulled in by the smoker's suction, thereby diluting the smoke.
Ventilation does not, however, simply reduce the concentration of each
smoke component in proportion to the degree of dilution. Instead (while
ventilation does reduce the tar and nicotine deliveries compared to a
non-ventilated cigarette), ventilation can be used to increase the
proportion of nicotine compared to tar.<SUP>465

    \464\ See Reynolds, note 462, supra, at p. 61.
    \465\ Kiefer JE. Ventilated Filters and their Effect on Smoke
Composition. In: Recent Advances in Tobacco Science. Volume 4.
Physical Parameters which Affect the Composition of Cigarette Smoke
from 32nd Tobacco Chemists Research Conference. October 30-November
1, 1978. Montreal, Canada. Pages 78,79.
---------------------------------------------------------------------------

    Tobacco manufacturers control filter ventilation by (1) changing
the number and location

[[Page 41717]]
of holes in the filter tipping paper, which surrounds the filter at the
smoker's end of the cigarette rod; and (2) by controlling the porosity
of the plug wrap, which underlies the tipping paper and surrounds the
filter.<SUP>466

    \466\ See Browne, note 399, supra, at p. 10.
---------------------------------------------------------------------------

    As the amount of ventilation increases, the amount of tar and
nicotine are not proportionately reduced. Instead, tar is reduced at a
greater rate than nicotine, thereby increasing the proportion of
nicotine to tar. For instance in one reported measurement, as the
proportion of filter ventilation went from 0% to 50%, mainstream smoke
tar dropped 47% (29.38 to 15.71 mg/cigarette), while mainstream smoke
nicotine dropped 37% (1.70 to 1.07 mg/cigarette).<SUP>467 The effect of
using such ventilation is that the manufacturer has selectively reduced
tar while delivering a higher percentage of the available nicotine to
the smoker.

    \467\ See Browne, note 399, supra, at p. 84.
---------------------------------------------------------------------------

    Filter ventilation can produce low nicotine and tar delivery
ratings when measured by the FTC smoking machine, yet still manage to
deliver higher nicotine levels to the smoker than indicated by the FTC
yield. Research has shown that, unlike the FTC smoking machine, 32% to
69% of low-tar cigarette smokers block the perforations in ventilated
filters with their fingers or lips. This behavior is not unexpected
because some smokers are unaware of these ventilation holes or their
function, and because the holes are generally tiny, laser-generated
perforations and difficult for the smoker to see. Blockage of these
holes results in greater nicotine yields to the smoker than those
measured by the FTC smoking machine.<SUP>468 This filter design
provides a

[[Page 41718]]
means of compensating for reductions in nicotine delivery that are
produced by unblocked filter ventilation. The ability to block
ventilation holes is thus a means of improving a cigarette's
``elasticity,'' i.e., a design feature that allows smokers to
``compensate'' for nicotine losses that would otherwise be caused by
tar-reducing modifications. See p. 229, supra.

    \468\ Kozlowski LT, Frecker RC, Khouw V, Pope MA. The misuse of
`less hazardous' cigarettes and its detection: hole-blocking of
ventilated filters. American Journal of Public Health.
1980;70(11):1202-1203.
---------------------------------------------------------------------------

    Another ingenious compensatory method to boost nicotine delivery
has been the development of the so-called channel-ventilated filter
system. This system has been employed by Brown and Williamson for its
BARCLAY brand launched in 1981, and represents an attempt to avoid some
of the reduction in nicotine that can accompany the use of ventilated
conventional filters. The channel-ventilated filter functioned
differently when tested on the FTC smoking machine than when used by
humans. In fact, in an investigation that commenced in 1981, the FTC
found that air flow through these channels is indeed compromised during
actual smoking and that BARCLAY's channel filter actually delivers
considerably more nicotine and tar to the smoker than is obtained using
the FTC's testing method.<SUP>469 In 1983, the FTC successfully sued to
enjoin Brown and Williamson from using nicotine, tar, and carbon
monoxide results obtained from the FTC's smoking machine testing method
in its BARCLAY advertising.<SUP>470 X X X X X X X X X X X X X X X X X X
X

[[Page 41719]]
X X X X X X X X X X X X X X X X X X X X X X X X <SUP>471

    \469\ Federal Trade Commission. ``Report to Congress Pursuant to
the Federal Cigarette Labeling and Advertising Act,'' for the year
1981 (July 1984) and 1984 (1986).
    \470\ FTCv. Brown & Williamson Tobacco Corp., 580 F. Supp. 981,
983, 987, n. 35, and 988 (D.D.C.1983), aff'd in part (affirmed
holding that the 1 mg tar claim had a tendency to deceive) and
remanded in part, 778 F. 2d 35 (D.C. Cir. 1985). RJR and Philip
Morris had complained to the F.T.C. that Brown and Williamson's
Barclay advertisement claim of 1 mg tar was inaccurate and
misleading, and that ``when the cigarette is smoked between human
lips its air ventilation system is inevitably obstructed and the
cigarette delivers disproportionately more tar and nicotine than
other comparably rated cigarettes.'' 778 F.2d at 37. Brown and
Williamson argued, among other things, that Barclay had a higher
ratio of nicotine to tar. 580 F. Supp. at 981, 984.
    \471\ Budich K. Notes from May 3, 1994, meeting with Brown and
Williamson. Page 12.
    Federal Trade Commission. ``Tar, Nicotine, and Carbon Monoxide
of the Smoke of 933 Varieties of Domestic Cigarettes.'' 1994. Pages
9-10.
---------------------------------------------------------------------------

    (iv) Reconstituted Tobacco
    Cigarette manufacturers claim that the development and use of
reconstituted tobacco sheet represents a cost-cutting measure to
minimize tobacco waste. But the role of reconstituted tobacco in
reducing tar and in controlling nicotine delivery is also apparent. The
first use of reconstituted tobacco occurred in the 1950's by RJR,
primarily as a method for reducing tar, in WINSTON cigarettes.<SUP>472
RJR estimates that reconstituted tobacco is used in virtually every
cigarette brand on the market.<SUP>473 U.S. manufacturers generally use
between 20% and 25% of this material.<SUP>474

    \472\ Chemical and Biological Studies On New Cigarette
Prototypes That Heat Instead of Burn Tobacco, R.J. Reynolds Tobacco
Co. Winston-Salem, NC. 1988. Page 29. By increasing the use of
reconstituted tobacco sheet in the cigarette rod (thereby reducing
the amount of cut tobacco leaf needed) and using increasingly more
efficient filtration, the levels of tar have been further reduced by
the industry since the 1950's.
    \473\ Id.
    \474\ See Browne, note 399, supra, at p. 47.
---------------------------------------------------------------------------

    In the reconstitution process, pieces of tobacco material undergo
treatment that results in the extraction of some soluble components,
including nicotine. The pieces are then physically formed into a sheet
of tobacco material, to which the extracted nicotine is re-added. Even
if this

[[Page 41720]]
reconstituted material contains only the original nicotine, its
recombination with the tobacco material may be viewed as adding
nicotine to the cigarette because the nicotine had been removed.
Although denied by tobacco executives,<SUP>475 it is publicly reported
that this process adjusts nicotine levels in the products, and that one
manufacturer ``readily admits to setting levels of nicotine * * * for
the tobacco sheet.'' <SUP>476

    \475\ Regulation of Tobacco Products (Part I): Hearings Before
the Subcommittee on Health and the Environment of the Committee on
Energy and Commerce, U.S. House of Representaives, 103 Cong. 2d
Sess. 543 (April 14, 1994) (testimony of William I. Campbell,
President and CEO, Philip Morris U.S.A.).
    \476\ Sisele S. Tobacco scrap: cigarette makers are taking heat
for adjusting nicotine levels. The Charlotte Observer. March 6,
1994. Page 1C.
---------------------------------------------------------------------------

    The agency has observed that the primary methods of producing
reconstituted tobacco sheet are closely monitored and controlled to
preserve the amount of nicotine in the tobacco components. These
processes enable the manufacturer to precisely control and evenly
disperse nicotine throughout this material, bringing a high degree of
uniformity and consistency to the composition of a raw agricultural
commodity. This control is so refined that despite the wide variability
in the nicotine content of unprocessed tobaccos, reconstituted tobacco
contains a generally uniform concentration of nicotine of around 1%,
industry-wide. And, as described below, the reconstitution process can
actually be used to elevate the level of available nicotine.
    At least one company, LTR Industries, LeMans, France, which is
involved exclusively in the production of reconstituted tobacco sheet
for the cigarette industry, has publicly acknowledged the extent to
which the production of such material can be controlled to precisely
affect nicotine and tar deliveries.
    According to an article appearing in the February 1983 issue of
Tobacco Journal International, LTR claims that its process can produce
reconstituted tobacco sheet to satisfy any

[[Page 41721]]
manufacturer's specifications for nicotine delivery. In this article,
LTR states that ``based on the idea that reconstituted tobacco could be
used as a nicotine regulator, we have developed products with reduced
or fortified nicotine.'' LTR has also been identified as having the
ability to manipulate nicotine levels in reconstituted tobacco either
by working into the scrap and waste new nicotine-rich tobacco of the
``rustica type,'' or by adding purified salts of nicotine into the
slurry, to boost the levels of nicotine in the finished reconstituted
tobacco sheet.<SUP>477

    \477\ Evolving techniques of making cigarettes milder. World
Tobacco. April 1979. Pages 93-101.
---------------------------------------------------------------------------

    (v) Use of Wider Tipping Paper
    Another means to compensate for nicotine losses from tar-reducing
design options is the industry's use of wider tipping paper overwrap.
According to a study conducted by Grunberg et al.,<SUP>478 between 1967
and 1978, the width of the overwrap was increased on 18 brands of
filter cigarettes, even though there was smokable tobacco under the
widened overwrap. The Grunberg study found that the wider tipping paper
reduced the amount of tobacco smoked during the FTC testing method,
because the FTC method prescribes that cigarettes be smoked down to
within 3 millimeters of the tipping paper rather than until all of the
tobacco is burned. Thus, use of wider tipping paper causes a decrease
in the FTC yields of tar and nicotine while permitting smokers to
obtain a higher yield of both tar and nicotine from the cigarette. Like
the use of ventilation holes, use of wider tipping paper constitutes a
form of built-in ``elasticity'' because it increases the amount of
nicotine a smoker can obtain from a cigarette over the advertised FTC
yield.

    \478\ Grunberg NE, Morse DE, Maycock VA, Kozlowski LT. Changes
in overwrap and butt length of American filter cigarettes. NY State
Journal of Medicine. July 1985. Pages 310-312.

[[Page 41722]]

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

e. Manipulation of Nicotine in Low-Yield Cigarettes
    The manipulation and control of nicotine in cigarette design and
manufacture is particularly apparent when low-yield cigarettes are
analyzed. Since the genesis of the low-tar cigarette, the industry has
recognized that the use of tar-reducing modifications, such as those
described above, can reduce nicotine delivery. This has led some
manufacturers to compensate for the effects of tar reduction to ensure
an adequate delivery of nicotine in the low-yield products.<SUP>479 As
one article in a 1979 industry publication states, the current practice
is ``to prefer tobaccos rich in flavour elements, even though that may
mean their having more nicotine and tar than is desirable, and seeking
to reduce the latter without doing too much harm to the former.''
<SUP>480

    \479\ The tobacco industry has repeatedly stated that reductions
in tar yields result in proportionate reductions in nicotine yields.
See, e.g. Regulation of Tobacco Products (Part I): Hearings Before
the Subcommittee on Health and the Environment of the Committee on
Energy and Commerce, U.S. House of Representatives, 103rd Cong., 2d
Sess. 363 (1994) (statement of R. J. Reynolds Tobacco Company);
Regulation of Tobacco Products (Part I): Hearings Before the
Subcommittee on Health and the Environment of the Committee on
Energy and Commerce, U.S. House of Representatives, 103rd Cong., 2d
Sess. 378 (1994) (statement of Alexander W. Spears, Vice Chairman
and Chief Operating Officer, Lorillard Tobacco Company); ATC letter
to the Honorable Henry A. Waxman, note 355, supra, at pp. 2- 3 of
attachment. The evidence in this section demonstrates that nicotine
levels in some cigarettes have not fallen proportionately with tar
and, in fact, are subjected to independent manipulation and control.
    \480\ See 1979 World Tobacco article, note 426, supra, at page
95.
    The manipulation of nicotine levels relative to tar levels in
European cigarettes was noted in The Lancet in 1979. The author
reported that the tarto-nicotine ratio had declined from 1973 to
1979 and concluded that ``the consistent fall in tar yield relative
to nicotine over a period of years suggests an element of conscious
manipulation.'' Tar: nicotine ratio of cigarettes 1973-79. The
Lancet. No. 8139. August 25, 1979. Pages 422-423. [Emphasis added.]
---------------------------------------------------------------------------

    To a remarkable degree, the cigarette industry has accomplished the
task of maintaining delivery of nicotine while decreasing tar in low-
tar products. In 1988, Jacob et al.<SUP>481 found that,

[[Page 41723]]
regardless of the labeled and advertised FTC nicotine yields and
manufacturers' claims of low-nicotine delivery for certain brands, all
cigarettes contained at least about 10 mg of nicotine in the cigarette
rod. Consistent with this finding, a study by Benowitz and Hall et
al.<SUP>482 in 1983 demonstrated that cigarettes advertised as having a
low-nicotine yield do not contain less nicotine than high-yield
cigarettes. Moreover, the nicotine yield of cigarettes, as defined by
the FTC smoking machine tests, correlates inversely with nicotine
concentrations in the tobacco.<SUP>483 In other words, cigarettes
advertised as low-tar and low-nicotine have higher concentrations of
nicotine, by weight, than high-yield cigarettes. This has been
accomplished by a combination of the methods described above for
boosting nicotine delivery to compensate for nicotine losses from the
application of tar-reducing design modifications.

    \481\ See:
    Jacob P, Benowitz NL, Shulgin AT. Recent studies of nicotine
metabolism in humans. Pharmacology, Biochemistry, and Behavior.
1988. Volume 30. Pages 249-250. In a more recent study, Benowitz
states that cigarettes currently contain 8 to 9 mg of nicotine.
Benowitz NL, Henningfield JE. Establishing a nicotine threshold for
addiction. N Engl J Med. 1994;331:123-125.
    Benowitz NL. Dosimetric studies of compensatory cigarette
smoking. In: Wald N, Froggatt P, eds. Nicotine, Smoking and The Low
Tar Programme. Oxford, England: Oxford University Press; 1989:chap
10.
    \482\ Benowitz NL, Hall SM, Herning RI, Jacob III P, Jones RT,
Osman A. Smokers of low yield cigarettes do not consume less
nicotine. New England Journal of Medicine. 1983;309:139-142.
    \483\ Id.
---------------------------------------------------------------------------

    FDA's analysis of marketed cigarettes has disclosed similar
results. There is little variation in nicotine content from one U.S.
brand to another. FDA also measured the actual amount of nicotine
contained in several brands of cigarettes, and the amount of nicotine
in three varieties of the Merit brand of cigarettes: one regular, one
low-tar, and one ultra low-tar. The results of this testing showed that
the variety labeled and advertised as the lowest in nicotine actually
had the highest nicotine concentration, suggesting that the nicotine
content was

[[Page 41724]]
manipulated to compensate for reductions caused by design features
intended to reduce tar.<SUP>484

    \484\ According to FDA's analysis, whereas Merit Regular 100's
contained 1.46% nicotine, Merit Low Tar 100's contained 1.67%
nicotine, and Merit Ultra Low Tar 100's contained 1.99% nicotine.
See Regulation of Tobacco Products (Part I): Hearings Before the
Subcommittee on Health and the Environment of the Committee on
Energy and Commerce, U.S. House of Representarives, 103 Cong. 2d
Sess. 121 (March 25, 1994) (statement of David A. Kessler, M.D.,
Commissioner of Food and Drugs, ``The Control and Manipulation of
Nicotine in Cigarettes,'' Chart P). The Commissioner's statement is
included as Appendix 7 to this document.
---------------------------------------------------------------------------

    In addition, FDA evaluated the tar and nicotine data for
domestically marketed cigarettes published by the FTC for 1994. These
data demonstrate that the lowest tar products have a markedly higher
ratio of nicotine to tar than higher tar products. None of the 153
products with 14 or more milligrams of tar (high tar) had a nicotine to
tar ratio greater than 1 to 12. By contrast, 88 of the 93 products with
6 or fewer milligrams of tar (ultra-low tar) had a nicotine to tar
ratio greater than 1 to 12.<SUP>485

    \485\ Federal Trade Commission. 1994 report of the tar and
nicotine content of domestic cigarettes. (FDA's analysis included
only those products that were evaluated by the Tobacco Industry
Testing Laboratory.) By contrast, only 2 of the 142 marketed
cigarettes included in the FTC report for 1972 had a nicotine to tar
ratio greater than 1 to 12. (Federal Trade Commission. 1972 report
of the tar and nicotine content of domestic cigarettes.) On a
percentage basis, only 1.4 percent of the 1972 products had a
nicotine to tar ratio greater than 1 to 12. In 1994, that figure
grew to 26.3 percent overall, and rose to 95 percent for the 93
products in the lowest tar category. This suggests that as the
market for lower yield cigarettes has grown over the last 20 years,
the cigarette industry has altered the traditional ratio of nicotine
to tar.
---------------------------------------------------------------------------

    The increase in nicotine-to-tar ratios between 1972 and 1994, see
note 485, especially in low tar cigarettes, is particularly revealing
in the light of industry research dating from the 1970's showing that
the ``optimum'' nicotine-to-tar ratio for acceptability of low tar
cigarettes is higher than the ``natural'' ratio. As described earlier,
a 1975 Philip Morris study showed that ``the optimum nicotine-to-tar
(N/T) ratio for a 10mg [low] tar cigarette is somewhat higher than

[[Page 41724]]
occurring in smoke from the natural state of tobacco.'' <SUP>485a
[Emphasis added.] The Philip Morris researchers went on to say that
this study would be used to ``attempt to make a 10 mg [low tar]
cigarette that will equal a Marlboro in subjective acceptability and
strength.'' According to these researchers, the naturally occurring
nicotine-to-tar ratio was 0.07, while the optimal ratio was about 0.1.
See p. 223, supra.<SUP>485B

    \485a\ Low Delivery Cigarettes and Increased Nicotine/Tar
Ratios, A Replication. Approved by W.L. Dunn and distributed to H.
Wakeham. October, 1975. In 141 Cong. Rec. H8009 (daily ed. July 31,
1995) (statement of Rep. Waxman). Also in Hilts PJ. Documents
Disclose Philip Morris Studied Nicotine's Effect on Body. New York
Times. June 8, 1995.
    \485b\ According to an analysis of FTC nicotine and tar delivery
levels conducted by a member of Congress, at least two Philip Morris
low-tar products show evidence that the data on ``optimal''
nicotine-to tar ratios was applied by the company to make changes in
the nicotine-to-tar ratios of marketed cigarettes. One marketed
cigarette underwent an increase in its nicotine-to-tar ratio,
beginning in 1978, that closely corresponds to the change from the
``natural'' ratio to the ``optimum'' ratio described by Philip
Morris researchers in 1975. From 1968 to 1978, tar and nicotine
levels in regular Benson & Hedges filtered cigarettes dropped from
21 mg tar and 1.29 mg nicotine to 0.9 mg tar and 0.06 mg nicotine.
Throughout this period, the nicotine-to tar ratio in the cigarettes
remained stable, i.e., tar and nicotine delivery levels were falling
proportionately. The ratio during this period was 0.7, the ratio
described by Philip Morris researchers as ``natural'' for tobacco.
Then, beginning in 1978, nicotine delivery from Benson & Hedges
began to increase, while tar remained stable. By 1983, the nicotine
delivery had jumped from 0.06 to 0.1, an increase of over 60%. The
result was an increase in the nicotine-to tar ratio to 0.11,
approximately the same level found by Philip Morris researchers to
be ``optimal.'' Congressman Waxman reported that the chance that
this change in the nicotine-to-tar ratio could have been due to
random fluctuations in tar and nicotine levels is less than 1 in
100,000. The tar-to-nicotine ratio for Benson & Hedges dropped back
to 0.07 in 1984 and 1985. Although the reasons for this change are
unknown, Congressman Waxman noted that the change could have been
due to a decision to phase out the product or to the use of
technologies that permit manipulation of the amount of nicotine
delivered to the smoker but that do not affect the amount of
nicotine measured by a smoke machine. Waxman also analyzed Philip
Morris product, Merit Ultra Lights. This product was introduced in
1981 with a nicotine/tar ratio of 0.11, which corresponds to the
``optimal'' ratio found by Philip Morris researchers, rather than to
the ``natural'' ratio of 0.07. The elevated nicotine-to-tar ratio in
Merit Ultra Lights has remained constant in the years since its
introduction. 141 Cong. Rec. H8009-10 (daily ed. July 31, 1995)
(statement of Rep. Waxman). Philip Morris denied that the changes
were deliberate. Hilts PJ. Philip Morris Denies Charge By Lawmaker.
New York Times. August 2, 1995.
---------------------------------------------------------------------------

    As noted above, tobacco industry officials have repeatedly stated
that nicotine yields are not manipulated and are simply a function of
tar yields, i.e., that reductions in tar yields result in proportionate
reductions in nicotine yields. For example, the chief operating officer
of Lorillard

[[Page 41726]]
---------------------------------------------------------------------------
Tobacco Co. testified before Congress in 1994 that:

    We do not set nicotine levels for particular brands of
cigarettes. Nicotine levels follow the tar level * * *. The
correlation coefficient of 0.975 is essentially perfect correlation
between tar and nicotine and shows that there is no manipulation of
nicotine.<SUP>485c

    \485c\ Regulation of Tobacco Products (Part I): Hearings Before
the Subcommittee on Health and the Environment of the Committee on
Energy and Commerce, U.S. House of Representatives, 103rd Cong., 2d
Sess. 378 (1994) (statement of Alexander W. Spears, Vice Chairman
and Chief Operating Officer, Lorillard Tobacco Company)
---------------------------------------------------------------------------

    The significant increase in the nicotine to tar ratio for low
delivery products contradicts these statements and provides strong
evidence that nicotine deliveries are independently manipulated. In
fact, an industry document states that the nicotine-to-tar ratios in
ultra low tar cigarettes are higher than would be expected if nicotine
fell proportionately with tar. In 1978, Philip Morris surveyed the
nicotine-to-tar ratios in its competitors' ultra low tar products (5-7
mg tar) and found that these ultra low tar cigarettes ``seem to be
higher in nicotine delivery than we would otherwise expect'' and found
further that ``nicotine/tar ratios go up as tar goes down'':

    The table [of nicotine-to-tar ratios for a range of low tar
brands] suggests that Philip Morris brands (asterisked) have lower
nicotine/tar ratios than do other brands with about the same FTC tar
delivery * * *. The table also suggests that nicotine/tar ratios go
up as tar goes down, and that our competitors' brands * * * seem to
be higher in nicotine delivery than we would otherwise expect from
our own experience with low delivery cigarettes * * *.
    It appears therefore that the mechanics of cigarette engineering
and the deliberate decisions of our competitors are such as to
suggest high nicotine/tar ratios be used at ultra low tar
levels.<SUP>485d [Emphasis added.]

    \485d\ Memorandum to T.S. Osdene from W.L. Dunn. Plans and
Objectives-1979. December 6, 1978. In 141 Cong. Rec. H7670 (daily
ed. July 25, 1995).
---------------------------------------------------------------------------

The Philip Morris researchers suggest that the high nicotine-to-tar
ratios in the low tar products of Philip Morris' competitors have been
achieved through certain kinds of filters and by ``the use of

[[Page 41727]]
high alkaloid blends,'' <SUP>485e i.e., the use of tobaccos containing
high nicotine levels.

    \485e\ Id.
---------------------------------------------------------------------------

    FDA also analyzed other information supplied by the FTC that was
derived from the FTC's database on nicotine levels in cigarettes. FDA's
analysis of the FTC data demonstrates two very important results.
First, there is an apparent increase in the sales-weighted FTC nicotine
delivery ratings, for all cigarettes, since 1982 (the earliest year for
which the computer database is available). Second, consistent with the
data on the increase in nicotine to tar ratios, when FDA segmented
FTC's sales data into high-tar, low-tar, and ultra low-tar cigarettes,
nicotine yields had the greatest increase in the ultra low-tar
group.<SUP>486 These findings are depicted in the following charts:

    \486\ See:
    Kessler, note 484, supra, at charts Q, R, S, T. ``Sales-
weighted'' nicotine delivery ratings represent the average nicotine
yield of all cigarette brands sold in a given year, adjusted
(weighted) to reflect the actual sales of the brands.
    Hoffman D, Hoffman I. On the Reduction in Cigarette Smoke. In:
Wald and Froggatt, note 481, supra, at pp. 200-201.

[[Page 41728]]

[GRAPHIC][TIFF OMITTED]TN11AU95.296

[[Page 41729]]

[GRAPHIC][TIFF OMITTED]TN11AU95.297

[[Page 41730]]

[GRAPHIC][TIFF OMITTED]TN11AU95.298

[[Page 41731]]

[GRAPHIC][TIFF OMITTED]TN11AU95.299

[[Page 4132]]

f. Conclusion
    The information in the preceding sections demonstrates that
cigarette manufacturers manipulate and control the delivery of nicotine
in marketed products. Cigarettes are designed to supply nicotine at
consistent levels despite the wide variations in the nicotine levels of
the raw materials, the immensely complicated combustion chemistry, and
the complex chemical flow properties of a modern cigarette.
    Manufacturers use many techniques to control nicotine deliveries.
The application of these modifications in cigarette design and their
interactive nature pose complex problems in maintaining brand
uniformity and consistency regarding nicotine delivery. Yet, the
nicotine content and delivery of each brand of cigarettes is remarkably
consistent from batch-to-batch and year-to-year. This level of control
is analogous to that of the pharmaceutical industry in the production
of prescription drugs. In fact, to determine how well nicotine content
is controlled in cigarettes, FDA laboratories compared the content
uniformity of drugs in tablet or capsule form to the content uniformity
of nicotine in cigarettes. The results showed that nicotine content
varies from cigarette to cigarette no more than the content of active
ingredients in marketed pharmaceuticals.<SUP>487

    \487\ FDA, CDER, DDA, Report on Analysis of Packages of
Cigarettes, April 4, 1994. See Kessler, note 416, supra, at p. 12.
---------------------------------------------------------------------------

    FDA's investigation has also disclosed that the tobacco industry
uses a number of methods to boost nicotine delivery in low-yield
cigarettes. The cigarette industry has successfully used these methods
to maintain adequate nicotine delivery from low-yield products. Without
the independent manipulation of nicotine, many of the techniques used
to reduce tar

[[Page 41733]]
would also substantially reduce nicotine. Instead, regardless of
differences in labeled/advertised FTC nicotine yields and
manufacturers' claims of low-nicotine delivery for certain brands, all
cigarettes contain approximately the same amount of nicotine in the
rod, and deliver about 1 mg of nicotine, enough to produce
pharmacological effects. See p. 108, supra. Moreover, studies by FDA
and others have demonstrated that the lowest-yield cigarettes have the
highest concentrations of nicotine, demonstrating that nicotine
delivery has been independently manipulated.
    The tobacco industry's control and manipulation of nicotine
delivery from cigarettes provides additional evidence of the industry's
intent to deliver pharmacologically satisfying levels of nicotine to
smokers.

[[Page 41734]]

2. Industry Manipulation and Control of Nicotine in Smokeless Tobacco

    Smokeless tobacco manufacturers control the delivery of nicotine
from smokeless tobacco to produce a line of smokeless products that
deliver nicotine in graduated amounts. Products that deliver lower
doses of nicotine are marketed to new users of smokeless tobacco.
Smokeless tobacco marketing then encourages them to ``graduate'' to
products that deliver higher doses of nicotine. Smokeless tobacco
manufacturers' manipulation of nicotine deliveries and marketing of
low-nicotine products to new users and high-delivery nicotine products
to experienced users demonstrates their intention to market products
that facilitate nicotine dependence, a significant effect on the
structure and function of the body. Smokeless tobacco manufacturers'
products are thus intended to affect the structure and function of the
body.
    Moist snuff is the most popular form of smokeless tobacco. U.S.
Tobacco Co. (``UST''), which accounts for 85% of the moist snuff sales
in the U.S.<SUP>488 markets a line of moist snuff products that
includes Skoal Bandits, Skoal Long Cut, Original Fine Cut Skoal, and
Copenhagen. Skoal Bandits deliver a very small amount of absorbable
nicotine, Skoal Long Cut and Original Fine Cut Skoal deliver
sequentially more absorbable nicotine, while Copenhagen delivers the
highest amount of absorbable nicotine. UST representatives in fact
acknowledge that the company's products provide users with a range of
nicotine deliveries.<SUP>489

    \488\ See Appendix 5.
    \489\ Marsee v. U.S. Tobacco, note 317, supra. (Remarks of Mr.
Finnegan, attorney for U.S. Tobacco.) In: 1.7 TPLR 3.202.
    See also deposition of Erik Lindqvist, Senior Vice President for
Marketing, U.S. Tobacco, in Marsee v. U.S. Tobacco. Transcript of
Jury Trial Proceedings, at pp. 1648-1676.
---------------------------------------------------------------------------

    Smokeless tobacco manufacturers produce graduated nicotine delivery
products primarily

[[Page 41735]]
by manipulating the pH of the tobacco.<SUP>490 Smokeless manufacturers
add compounds and manipulate the design of each smokeless product to
create a specific pH. The higher the pH of a product, the more nicotine
is transformed from the salt form to ``free nicotine.'' Both forms of
nicotine are highly soluble in saliva. However, the free form of
nicotine is absorbed more rapidly in the mouth of smokeless tobacco
users and into the bloodstream for delivery to the brain. Raising the
salivary pH from 7.0 to 8.0 increases the percentage of free nicotine
available for absorption from 10% to 50%, a fivefold increase.<SUP>491

    \490\ See:
    Henningfield JE, Radzius A, Cone EJ. Estimation of available
nicotine content of six smokeless tobacco products. (Submitted to
Tobacco Control November 17, 1994.)
    U.S. Food and Drug Administration. Report on study of smokeless
tobacco products: pH and free base nicotine. November 4, 1994.
    U.S. Food and Drug Administration. National Forensic Chemistry
Center. Cincinnati Laboratory. National survey of smokeless tobacco
products. December 13, 1994, memo from Laura Ciolino, Research
Chemist to Fred Fricke, Director.
    \491\ See:
    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.
Pages 86 (figure 2) and 87.
    Henningfield JE, Radzius AC, Cooper TM, Clayton RR. Drinking
coffee and carbonated beverages blocks absorption of nicotine from
nicotine polacrilex gum. JAMA. 1990;264(12):1560.
---------------------------------------------------------------------------

    Various documents show that UST understands the relationship
between the pH of its products and their nicotine delivery. For
example, in a deposition, UST's Senior Vice President for Marketing
acknowledged that he had written a memo in which he had recommended a
specific pH level for a new product and that he understood that there
was a relationship between pH and nicotine.<SUP>492 When asked whether
pH affected nicotine absorption, he agreed:

    \492\ Transcript of Jury Trial Proceedings, Marsee v. U.S.
Tobacco, note 317, supra, at pp. 1666-8.

[[Page 41736]]

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

    Q. Mr Lindqvist, is it your understanding that as the pH of the
product is lowered, that the rate of absorption of nicotine by the
user is also lowered?
    A. That would be my understanding, yes.<SUP>493

    \493\ Id. at p. 1668.
    See also:
    U.S. Tobacco Company documents discuss the pH of various brands,
also suggesting a knowledge of the relationship between pH and
nicotine absorption:
    Red Seal Menthol * * * 2. Lower pH than Skoal through flavor if
possible * * *. Premium project * * *. Full tobacco flavor, pH at
the level of Copenhagen or higher.
    U.S. Tobacco memo from Erik Lindqvist. (This document was
discussed in the trial in Marsee v. U.S. Tobacco, note 317, supra.
These quotes were authenticated by Erik Lindqvist, the author, in
his deposition. Transcript of Jury Trial Proceedings, at pp.1666-
1671.)
    According to the trial transcript of Marsee, UST recognizes that
pH can affect how much of the nicotine is free. (U.S. Tobacco
document No. 4486792, dated Oct. 5, 1981. In: 1.7 TPLR 3.208, July/
August 1986.)
---------------------------------------------------------------------------

    The major smokeless tobacco manufacturers in the United States each
market products that range from low to high pH, producing a
corresponding graduation in the amount of ``free nicotine'' delivered
by these products. The products with the lowest pH deliver the least
amount of absorbable nicotine, while those with the highest pH deliver
a significantly higher amount of absorbable nicotine.<SUP>494

    \494\ The amount of absorbable nicotine is dependent on the pH
and not the total amount of nicotine that is in the product. For
this reason, the total amount of nicotine in the products throughout
the product line can remain relatively constant and still permit
graduated nicotine delivery.
---------------------------------------------------------------------------

    FDA laboratories comprehensively analyzed several marketed snuff
products.<SUP>495 The following table demonstrates the characteristics
of marketed smokeless tobacco products related to nicotine
delivery.<SUP>496

    \495\ FDA laboratories in St. Louis and Cincinnati performed
these studies. The results are summarized in two separate reports.
See note 490, supra.
    \496\ This table reflects the two separate studies which were
performed by the two FDA laboratories in St. Louis, MO and
Cincinnati, OH. Both laboratories used the same analytical
procedures for these analyses.

[[Page 41737]]

----------------------------------------------------------------------------------------------------------------
                                                            pH              Percent free        Total
                                                  ---------------------       nictone*        nicotine
            Manufacturer/product name                                  ---------------------   content
                                                    St. Louis   Cinc.    St. Louis   Cinc.    (mg/gm)**
--------------------------------------------------------------------------------------------------------
U.S. Tobacco Co:
    Skoal Key....................................  ..........     8.22  ..........     61.3  ..........     12.4
    Copenhagen Snuff.............................        8.14     7.71        56.5     32.7        13.2     13.8
    Skoal L.C. Class.............................        8.04     7.92        51.1     45.5        12.7     13.8
    Skoal L.C. Wint..............................        7.50     7.57        23.1     26.0        12.7     13.9
    Skoal L.C. Mint..............................        7.35     7.52        17.6     24.0        13.2     13.7
    Skoal L.C. Spear.............................        7.20     7.50        14.0     23.3        12.5     13.8
    Skoal Or.F.C. Wint...........................  ..........     7.41  ..........     19.7  ..........     13.6
    Skoal L.C. Strai.............................        7.47     7.41        22.0     19.5        12.1     13.8
    Skoal L.C. Cherry............................        7.15     7.38        12.3     18.5        12.5     13.6
    Skoal Band. Mint.............................        6.83     7.06         6.4      9.9         6.7      8.8
    Skoal Band Wint..............................        6.56     6.72         3.3      4.8         7.8      8.2
    Happy Days L.C. Mint.........................  ..........     6.00  ..........      0.9  ..........     13.9
    Skoal Band. Strai............................  ..........     5.48  ..........      0.3  ..........     10.8
    Skoal Band. Class............................        5.61     5.23        0.39      0.2        10.4      9.9
Helme Tobacco Co:
    Redwood Full Flavor..........................  ..........     7.52  ..........     24.0  ..........     12.6
    Silver Cr. L.C...............................  ..........     7.22  ..........     13.7  ..........      6.0
    Cooper Wint. L.C.............................  ..........     6.99  ..........      8.5  ..........      5.7
    Gold River L.C...............................  ..........     5.77  ..........      0.6  ..........      6.4
C.C. Conwood Co:
    Kodiak Wint..................................        8.20     8.22        59.9     61.0        11.4     11.7
    Kodiak Choice Wint...........................  ..........     7.98  ..........     47.7  ..........     11.4
    Kodiak Straight..............................        7.39     7.82        19.0     38.4        10.6     10.4
    Hawken Wint..................................        5.56     5.58        0.35      0.4         4.4      4.0
Pinkerton Tobacco Co:
    Redman F.C. Ex. Wint.........................  ..........     7.58  ..........     12.3  ..........  .......
    Renegade Wint................................        6.81     7.17         5.8     13.2        11.8  .......
----------------------------------------------------------------------------------------------------------------
L.C.=long cut.
*Calculated using the Henderson-Hasselbach equation for acid-base equilibrium. This calculation strictly is
  dependent on the pH determination. Any error in the pH determination will affect the percent free nicotine
  calculation.
**Measured on wet basis.

[[Page 41738]]

    This table demonstrates that each of the smokeless tobacco
companies whose products were tested by the FDA laboratories markets
products that have low, medium, and high pH values, delivering
corresponding low, medium, and high levels of free nicotine to the
users of the products.<SUP>497 It is apparent from the data that
providing graduated nicotine deliveries through manipulation of pH is
an industry-wide practice. Other researchers have described similar
findings.<SUP>498

    \497\ In the chart, the first column lists the products marketed
by specific manufacturers. For each manufacturer, the products are
listed in descending order of nicotine delivery. The second and
third columns list the pH of each product as measured by two
separate FDA labs. The fourth and fifth columns list the amount of
absorbable (free) nicotine in each product, calculated from the pH
measured at each of the two labs. The sixth and seventh columns list
the total nicotine content of each of the products as measured by
each of the two labs.
    \498\ See Henningfield, note 490, supra, at p. 2. This study
found that Skoal Bandits have a pH of about 6.9, providing only 7%
of its nicotine in the free form. Skoal Long Cuts have a pH of about
7.4-7.5, providing 19%-23% free nicotine. Original Fine Cut Skoal
has a pH of about 7.6, providing 28% free nicotine. Copenhagen was
found to be a potent form of snuff, with a pH of about 8.6,
producing 79% free nicotine, a very high level for absorption. Page
2 and figure 1.
---------------------------------------------------------------------------

    Other features of these products demonstrate how the smokeless
tobacco companies use product design features to control nicotine
delivery. For example, UST's Skoal Bandits and Pinkerton's Renegades
are packaged in teabag-like pouches, which both limits the amount of
snuff that is placed into the mouth and creates a barrier that retards
nicotine release from the product. FDA laboratory analysis shows that
the effect of the Bandits' pouch is to delay nicotine release by an
average factor of three, compared to the same tobacco tested outside of
the pouch, during the first 2 minutes of the study.<SUP>499 Thus, users
of Skoal Bandits get less nicotine into their mouth, and the nicotine
is released into their mouths at a slower rate.

    \499\ Department of Health and Human Services, FDA, National
Forensic Chemistry Center. Relative Buffering Capacity of Saliva and
Moist Snuff and Moist Snuff Nicotine Content Code Date Survey.
Memorandum from Laura A. Ciolino to Elizabeth Berbakos and Thomas
Layloff. September 28, 1994.

[[Page 41739]]

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

    Smokeless tobacco products are also engineered in such a way that
users get a bolus dose of nicotine within the first 5 minutes of
inserting the product into the mouth.<SUP>500 After the first 5
minutes, nicotine is still released from the product but at a much
slower rate. An FDA study showed widely divergent results when
comparing Copenhagen and Skoal Bandits under typical use
conditions.<SUP>501 The amount of nicotine released from a usual
``pinch'' of Copenhagen (about 1.5 gm) was 12 times higher than from a
pouch of Bandits (about 0.5 grams) in the first 2 minutes of the
experiment. The bolus dose results in nicotine concentrations in the
bloodstream that produce a peak pharmacological concentration in users.
These pharmacological concentrations are then maintained by the slow
continued release of nicotine from the products following the bolus
dose.

    \500\ See:
    U.S. Food and Drug Administration, Center for Drug Evaluation
and Research, Division of Drug Analysis. Nicotine Studies of Chewing
and Smokeless Tobacco Products. Memorandum from Henry D. Drew,
Chief, Drug Monitoring Branch, to Elizabeth Berbakos. September 22,
1994. Table 4.
    U.S. Food and Drug Administration. National Forensic Chemistry
Center. Cincinnati Laboratory. Moist Snuff Nicotine Release Studies.
September 28, 1994, memo from Laura Ciolino, Research Chemist to
Fred Fricke, Director. Page 1.
    \501\ Id. September 28, 1994, memorandum.
---------------------------------------------------------------------------

    Both nicotine release and pH of smokeless products are also
affected by the tobacco fermentation process used to make smokeless
tobacco products. Tobacco fermentation causes an increase in pH with
fermentation time.<SUP>502 The age of packaged smokeless products is
thus a factor in each product's pH because fermentation can continue
within the package due to the high

[[Page 41740]]
moisture content of the tobacco.<SUP>503 Because fermentation increases
pH, and increasing pH increases free nicotine, continued fermentation
increases the amount of nicotine that is delivered to smokeless tobacco
users. Fermentation also breaks down the plant tissue. This results in
nicotine release from the plant intracellular tissue, causing much of
the nicotine to come to the surface of the tobacco leaf.<SUP>504

    \502\ Tso TC. Kirk-Othmer Encyclopedia of Chemical Technology.
John Wiley and Sons; 1970;20:510. This occurs because organic acids
are lost through oxidation and decarboxylation.
    \503\ Andersen RA, Fleming PD, Hamilton-Kemp TR, Hildebrand DF.
pH changes in smokeless tobaccos undergoing nitrosation during
prolonged storage: effects of moisture, temperature, and duration.
J. Agric. Food. Chem. 1993;41:968-972.
    \504\ This may explain the fast nicotine release from the
tobacco products studied by FDA under in vitro conditions.
---------------------------------------------------------------------------

    Manufacturers also add humectants to their products to increase or
maintain the moisture content. The resulting high moisture content of
smokeless products affects nicotine delivery by ensuring that tobacco
leaves are well wetted, thus allowing nicotine easily to go into
solution (i.e., saliva).
    The evidence demonstrates that smokeless tobacco manufacturers
design their products to deliver controlled amounts of nicotine to the
user by manipulating pH, placing starter products in pouches, and using
additives that control the moisture content of the products. Smokeless
manufacturers use these sophisticated design features to manipulate the
pharmacological response of the user to the product. In doing so,
manufacturers intend to market products that affect the structure or
function of the body.
    The marketing practices of the smokeless tobacco industry further
demonstrate the intent of manufacturers to factilitate nicotine
dependence among smokeless tobacco users. Until the 1970's, smokeless
tobacco companies were marketing only products with high nicotine
delivery.

[[Page 41741]]
Their market was steadily diminishing because these products were not
well tolerated by new users. Evidence from the files of smokeless
tobacco companies shows that, in the late 1960's or early 1970's, these
companies began to try to entice new users of smokeless tobacco,
including people as young as 15 years old.<SUP>505 To do so, they
developed low-nicotine products in teabag-like pouches to encourage
people to begin using smokeless tobacco. A UST document describes the
company's rationale for developing a new oral snuff product under the
code name ``The Lotus Project'':

    \505\ See documents on ``Lotus Project'':
    Undated document entitled ``The Lotus Project.'' From Marsee v.
U.S. Tobacco, note , supra, Trial Exhibit 159.
    U.S. Tobacco Co. Intra-company Correspondence from W.W. Watson,
President--United Scandia International to Mr. L.A. Bantle,
President. June 2, 1972. From Marsee v. U.S. Tobacco, Trial exhibit
158.
    Minutes from a Meeting in Greenwich at Mr. L.A. Bantle's Office.
July 18, 1972. From Marsee v. U.S. Tobacco, Trial exhibit 159.
---------------------------------------------------------------------------

    AIM: To make it easier for a new user to use tobacco in the
mouth.
    TARGET GROUP: New users, mainly cigarette smokers age group 15-
35
    PRODUCT: A. Strength
    1. Nicotine Satisfaction
    Mild like Happy Days [a low-nicotine product] Instant but not
shocking
    2. Feeling in the mouth
    As little harshness as possible on the gum and in the throat
    * * *
    PACK: A. Size of Pinch

[[Page 41742]]

    Small enough for a new user to manage * * * This point has to be
closely worked out, takes into consideration the desired effect
mentioned under ``Strength.'' <SUP>506

    \506\ Id. Trial Exhibit 159 (minutes from July 18, 1972,
meeting).
---------------------------------------------------------------------------

This document clearly discloses UST's intention to develop a low-
nicotine product suitable for ``new users,'' i.e., those not yet
tolerant to the harsh effects of nicotine on the gum and throat, and
not yet requiring high levels of nicotine for ``satisfaction.''
    Another UST document that discusses the ``Lotus Project'' and
product development discloses the company's intent to produce products
with varying amounts of nicotine.<SUP>507 The document states:

    \507\ See Watson, note , supra, at p. 2.
---------------------------------------------------------------------------

``[t]here should be three products of three different tastes and
strengths of nicotine * * *
    a. High nicotine, strong tobacco flavor * * *
    b. Medium strength of nicotine * * *
    c. Low nicotine, sweet product * * *'' <SUP>508

    \508\ Id.
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By acknowledging that the objective is to produce products with varying
strengths of nicotine and differentiating strength from taste, the
document demonstrates the company's intent to manufacture products with
distinct pharmacological effects based on the nicotine delivery.
    A document that posed potential questions and answers related to
UST's introduction of Skoal Bandits in a new market also demonstrates
the manufacturer's intention to provide nicotine for

[[Page 41743]]
absorption and thereby to produce ``satisfaction'' in the user of the
product.<SUP>509 The document provides the following questions and
anwers about Skoal:

    \509\ Potential Questions and Answers. Bate stamp nos. 2054948-
2054951, submitted in Marsee v. U.S. Tobacco, note 317, supra.
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    3.--How does it work?
    It gives the satisfaction from tobacco want [sic]. It is real
tobacco and contains nicotine * * *
    4.--How much nicotine does it contain? Is it absorbed?
    The nicotine contents are more or less equivalent to that of a
good quality cigarette of average strength. The nicotine is
absorbed, given [sic] satisfaction to the smoker.

A senior UST official stated in another memorandum that
``satisfaction'' refers to the ``kick'' that users obtain from tobacco
products.<SUP>510

    \510\ Marsee v. U.S. Tobacco, note 317, supra. Deposition of
Erik Lindqvist, Senior Vice President, Marketing. Transcript of Jury
Trial Proceedings, at p.1662.
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    Shortly after the ``Lotus Project'' documents were written, UST
began to aggressively market the low-nicotine ``starter'' products to
new users of smokeless tobacco. An early advertisement for ``Happy
Days,'' one of the first low-nicotine products, targeted the product
``for you guys just starting out.'' <SUP>511 The marketing of starter
products relied heavily on ``sampling,'' a technique in which company
representatives distribute free samples on college campuses and sports
events, and encourage nonusers to use smokeless tobacco.<SUP>512
Advertisements then

[[Page 41744]]
encouraged established users to graduate to higher-nicotine products.
For example, an advertisement for Copenhagen, the highest nicotine
product, said ``Sooner or Later, It's Copenhagen.'' <SUP>513

    \511\ Connelly GN. In the search for a perfect starter product:
manipulation of nicotine in oral snuff brands. August 1994.
(Unpublished.)
    \512\ U.S. Tobacco Company. College Representative Manual.
Revised July 31, 1985:
    Success in reaching the college students today will determine
the continued popularity and growth for our products in our adult
market segments tomorrow.
    Achieving these goals will require strong consumer sampling
efforts. Success in this area can only be achieved with an
aggressive, efficient program * * *
    \513\ Connelly, note 511, supra, at p. 5.
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    In the 1980's, ``long cut'' smokeless tobacco products were
introduced. An internal UST memorandum, dated June 8, 1984, reported
that customers and distributors of the Skoal ``Long Cut'' considered it
a `` `perfect' starter product,'' in part due to its relatively low
``strength'' (i.e., low delivery of nicotine).<SUP>514 This memorandum
also acknowledges the role of low-nicotine products in facilitating
graduation to high-nicotine brands like Copenhagen. In a long list of
positive anecdotes about the introduction of Long Cut, the memorandum
states that college representatives reported that ``Long Cut makes it
easier to become accustomed to using Cope[enhagen]'' as well as
``having sampled a person with Long Cut, and then seeing that person
weeks later as a regular Cope consumer.'' <SUP>515 The same memorandum
reports that Copenhagen sales ``continue to rise on a weekly basis
since the intro of Long Cut.'' <SUP>516

    \514\ U.S. Tobacco Company. Intra-company Correspondence from
K.C. Carlsen to O.M. Bryant. Skoal Long Cut. June 8, 1984. Page 1.
    \515\ Id. at pp. 2-3.
    \516\ Id. at p. 2.
---------------------------------------------------------------------------

    A chart prepared by UST's marketing department further demonstrates
the company's knowledge that consumer use of its products follows the
graduated nicotine deliveries of those products and shows the company's
desire to capitalize on a ``graduation process'' to enhance sales

[[Page 41745]]
of its highest nicotine products.<SUP>517 The chart is labeled
``graduation process'' and shows a hierarchy of products, with arrows
pointing from Skoal Bandits to Happy Days and Skoal Long Cuts, and
culminating with Copenhagen. This ``graduation'' corresponds exactly to
the progression of nicotine deliveries from the listed products.

    \517\ Marsee v. U.S. Tobacco, note 317, supra, Plaintiff's
Exhibit 100, ``Graduation Process.'' (Undated.)
    See also U.S. Tobacco Company. One-on-one interview with Mr.
Manuel Leitao, Executive Vice President, U.S. Tobacco and President
Tobacco Division. Up to Snuff. Autumn 1984:2:
    Some people will remain with the Bandits, and some people will
get into a sort of graduation process. The bottom line, and we must
never forget the bottom line, is that Bandits is a vehicle that is
going to expand the use of smokeless tobacco.
    Another company document sets out a similar strategy for
entering new markets. The strategy involved starting users on the
lower nicotine Skoal Bandits with an eye toward ``establishing a
normal graduation process.'' U.S. Tobacco Company. International
Division-Very Optimistic About U.S. Tobacco's Worldwide Expansion.
Up to Snuff. March 15, 1988. Page 2.
---------------------------------------------------------------------------

    The company's reliance on the graduation process is further
evidenced in a UST document entitled ``Expanding User Base'', which
depicts a ``bullseye'' chart that lists the company's moist snuff
products.<SUP>518 The chart follows:

    \518\ U.S. Tobacco Company. Expanding User Base. (Undated.) This
document was disclosed during discovery in Marsee v. U.S. Tobacco,
note 317,
    supra. The document was authenticated by Dr. Jack Henningfield
in a letter to Rep. Henry Waxman (D-Ca), in which Dr. Henningfield
states his awareness of the origins of the chart as ``provided by
the United States Tobacco Company to the plaintiffs in the Marsee v.
United States Tobacco Company law suit in which I served as an
expert witness in 1986. This chart was provided to me by the
plaintiffs attorney, Mr. Braly, to review.'' Letter from Jack E.
Henningfield, Ph.D., Chief, Clinical Pharmacology Branch, National
Institute on Drug Abuse to The Honorable Henry A. Waxman, Chairman,
Subcommittee on Health and the Environment, House of Representatives
(Dec. 13, 1994).

[[Page 41746]]

[GRAPHIC][TIFF OMITTED]TN11AU95.314

[[Page 41747]]

Outside the outermost ring of the chart is the label ``Prospective New
Users''; the subsequent concentric rings are labeled ``Bandits,''
``Long Cut, and ``Skoal,'' respectively, and a ring labeled ``Cope''
(representing Copenhagen) is the bullseye in the middle. The rings of
the chart thus progress from the lowest delivery nicotine products on
the outside to the highest nicotine delivery products in the center of
the bullseye. The chart's further annotations--``Consumer Promotions,''
``Peer Grouping,'' ``Spokesmen,'' ``Public Relations,'' ``Advertising
Expenditures,'' ``Advertising Media,'' and ``Sampling''--clearly
demonstrate the company's intent to advertise, promote, and provide
free samples of the lower delivery nicotine products, which are on the
lowest level of the ``graduation process,'' to new users. The highest
nicotine products, however, are to be advertised only to current users
in a highly focused manner.
    Several other company documents discuss the graduation process. A
UST document discussed in a trial transcript mentions Skoal Bandits and
the company's intent to use the product to fuel the graduation process:

    Skoal Bandits, which is at the bottom of the previous graduation
chart, `will continue to fuel the new user base to assure graduation
to our priority moist brands'.<SUP>519

    \519\ UST document No. 2077832, in Marsee v. U.S. Tobacco, note
317, supra. In:1.7 TPLR 3.209. Another U.S. Tobacco document (no.
1023186-89), discussed in Marsee mentions introducing a product that
will fill the gap between Bandits and Skoal in the graduation
process. In:1.7 TPLR 3.209.
---------------------------------------------------------------------------

Another UST document, discussed in the same trial transcript, again

* * * sample Skoal Bandits often and intensively in and around the
retail account to create new customers and feed the graduation
process.<SUP>520

    \520\ UST document No. 2101576, discussed in Marsee v. U.S.
Tobacco, note 317, supra (1.7 TPLR 3.210).
---------------------------------------------------------------------------

    These marketing strategies for smokeless tobacco have been
extremely successful in

[[Page 41748]]
recruiting new users. Use of smokeless tobacco products has risen
substantially since the 1970's: overall, consumption of moist snuff
almost tripled from 1972 through 1991; use by adolescent males aged 18
to 19 increased almost 1,500% between 1970 and 1991.<SUP>521 The
success of the graduation strategy in getting users to the point where
they want to consume the high-nicotine products is demonstrated by the
market share of various products. While the majority of advertising
dollars are spent on the low and medium nicotine products like Skoal
Long Cuts, the great bulk of the increased sales is in Copenhagen, the
high-nicotine product.<SUP>522 The consistently small market share for
the low-nicotine products shows that they serve only as a steppingstone
to the high-nicotine products. Consistent with the graduation strategy,
a recent study found that older smokeless tobacco users are more likely
to purchase the brands that deliver high levels of nicotine than are
younger smokeless tobacco users.<SUP>523

    \521\ See:
    Centers for Disease Control and Prevention. Office of Smoking
and Health. Unpublished data from 1970 and 1991 National Household
Interview Surveys. (Rate of snuff use among 18-19 year-old males was
0.5% in 1970 and 7.6% in 1991).
    Marcus AC, Crane LA, Shopland DR, Lynn WR. Use of smokeless
tobacco in the United States: Recent estimates from the current
population survey. In: Smokeless Tobacco Use in the United States:
NCI Monographs. 1989;8:17-23.
    Sullivan LW. Keynote Address. In: Smokeless Tobacco or Health:
An International Perspective: Smoking and Tobacco Control Monograph
2. National Cancer Institute. NIH Pub. No. 92-3461. 1992.
    \522\ See Connolly, note 511, supra, at p. 5.
    \523\ Hatsukami D, Nelson R, Jensen J. Smokeless tobacco:
current status and future directions. Brit. J. of Addiction. 1991;
86:559-563.
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    The evidence of manipulation of nicotine delivery in smokeless
tobacco and the deliberate marketing of higher and higher nicotine-
containing products shows clearly that smokeless tobacco manufacturers
intend consumers to become tolerant to, and dependent on, the

[[Page 41749]]
nicotine in smokeless tobacco. Both tolerance and dependence are
effects on the structure and function of the body produced by nicotine.
Accordingly, smokeless tobacco products, as designed and marketed by
the tobacco industry, are intended to affect the structure or function
of the body.