(Editor's Note: The following is Brown & Williamson's summary of the tobacco companies' arguments against the FDA's proposed regulations restricting sales to minors and claiming jurisdiction over nicotine as a drug. Brown & Williamson contends that the FDA is incorrect in equating smoking with nicotine use. As Brown & Williamson points out, "Smokers want cigarettes, not nicotine delivery systems." Also, the consistency in nicotine delivery by different brands and different batches from year to year is "no more "remarkable" for cigarette manufacturers to achieve this than the consistency of quality achieved by any other producer of a consumer product based on an agricultural commodity, such as manufacturers of coffees, frozen orange juice or applesauce.")

Before The
United States Food and Drug Administration

Docket No. 95N-0253
Docket No. 95N-0253J

SUPPLEMENTAL COMMENTS OF
BROWN & WILLIAMSON TOBACCO CORPORATION TO

DOCKET NO. 95N-0253, REGULATIONS RESTRICTING THE SALE AND
DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO
PRODUCTS TO PROTECT CHILDREN AND ADOLESCENTS;
PROPOSED RULE

AND

DOCKET NO. 95N-0253J, ANALYSIS REGARDING FDA'S
JURISDICTION OVER NICOTINE-CONTAINING CIGARETTES AND
SMOKELESS TOBACCO PRODUCTS; NOTICE

Of Counsel:

Wiley, Rein & Fielding
1776 K Street, N.W.
Washington, DC  20006

Brown & Williamson
Tobacco Corporation
1500 Brown & Williamson Tower
Louisville, KY  40232

Submitted: January 2, 1996


TABLE OF CONTENTS
                                   Page
INTRODUCTION........................1

I. CONTRARY TO FDA'S ACCUSATION THAT
B&W SEEKS TO DELIVER A "PRECISE AMOUNT
OF NICOTINE," B&W DESIGNS AND MANUFACTURES
ITS CIGARETTES FOR CONSUMER ACCEPTANCE
BASED UPON THE TOTAL, COMPLEX,
MULTIFACETED SMOKING EXPERIENCE.....4

A. Competition in the U.S. Cigarette
Market Has Resulted In Several
Product Styles, Giving Adult Smokers
A Wide Choice of "Tar" Levels.......5

B. Consumers Preference Testing
Measures A Range of Product Attributes
To Determine Overall Consumer
Preference..........................8

C. Tobacco Blend Selection, Other
Components, and Design Features are
Adjusted to Improve or Maintain
Consumer Preference.................9

1. Tobacco Blend Selection and
Purpose.............................9

2. Casings..........................12

3. Flavors..........................13

4. Design Features..................14

(a) Papers..........................14

(b) Filters.........................15

5. Cigarette Manufacture and Quality
Assurance...........................17

D. B&W's Product Development Efforts Over
the Last 40 Years Have Led to Dramatic
Declines in Nicotine Delivery.......18

II. CONTRARY TO FDA'S MISCHARACTERIZATIONS,
B&W AND BATCo. HAVE CONDUCTED RESPONSIBLE
RESEARCH, INCLUDING RESEARCH INTO NICOTINE,
SMOKING BEHAVIOR, AND PRODUCT DESIGN, NONE
OF WHICH INDICATES INTENT BY B&W OR BATCo.
TO OFFER CIGARETTES AS "DRUG DELIVERY
DEVICES."...........................20

A. BATCo.'s Research Into the Properties
of Nicotine is Distorted by FDA.....22

1. BATCo.'s Project Ariel Was an Attempt
in the Early 1960s to Product a No-"Tar"
Cigarette in Response to a Cigarette
Market Concerned About Smoking and
Health..............................23

2. BATCo.-sponsored Research in the
1960s Was Comparable to Work Pursued
and Published by Others at the Same
Time................................24

3. FDA Misuses Statements in BATCo.
Documents About "Addiction".........27

B. B&W and BATCo. Research into "Low`Tar,'
Medium Nicotine" Cigarettes, Undertaken
Largely in Response to Government Initiatives,
Revealed that Consumers Did Not Want Such
Cigarettes..........................30

1. Y-1 Tobacco Was Never Employed to
Increase Nicotine in B&W
Cigarettes..........................32

2. The Barclay Cigarette Was Not
Designed to "Boost" Nicotine
Delivery............................33

3. FDA's Contentions Regarding B&W's
Use of Ammonia Compounds are Erroneous
and Misleading......................35

(a) The Role of Ammonia Compounds
in Cigarette Manufacturing..........36

(b) Ammonia and "Impact"............37

C. BATCo.'s Knowledge Regarding Smoker
Compensation Was No Different or Better
Than That Which Was Widely Known
Elsewhere...........................39

1. Compensation.....................40

2. Elasticity.......................41

D. BATCo. Also Researched the Role of
Nicotine in Smoking Behavior in an
Attempt to Understand How to Design
Acceptable Low "Tar" Delivery
Product.............................43

E. B&W and BATCo. Have Never Determined
That Smokers Cannot Quit Smoking....44

CONCLUSION..........................46



SUPPLEMENTAL COMMENTS OF
BROWN & WILLIAMSON TOBACCO CORPORATION TO

DOCKET NO. 95N-0253, REGULATIONS RESTRICTING
THE SALE AND DISTRIBUTION OF CIGARETTES AND
SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN
AND ADOLESCENTS; PROPOSED RULE

and

DOCKET NO. 95N-0253J, ANALYSIS REGARDING FDA'S
JURISDICTION OVER NICOTINE-CONTAINING CIGARETTES
AND SMOKELESS TOBACCO PRODUCTS; NOTICE

INTRODUCTION

The Food and Drug Administration's ("FDA's") attempt to
overthrow 90 years of Congressional history - and its own
long record of prior statements that it lacks authority
over cigarettes as commonly marketed - is based totally on
the agency's assertion that "tobacco manufacturers `intend'
that their products have addictive and significant
pharmacological effects."  60 Fed. Reg. 41454, 41471 (Aug.
11, 1995).  FDA purports to support its usurpation of
Congress' legislative prerogative by the misdirected charge
that, in substance, all cigarette manufacturers engage in
product development research and the "manipulation and
control" of marketed cigarettes "to ensure an adequate dose
of nicotine" - i.e., one that will create and maintain the
"addictive and significant pharmacological effects: FDA
claims are caused in cigarettes.  60 Fed. Reg. 41582, et.
seq.  As evidence, FDA points to a variety of internal
industry documents, including some from Brown & Williamson
Tobacco Corporation ("B&W") and its affiliated company
British American Tobacco Co. ("BATCo.").

However, as demonstrated below, the B&W and BATCo.
documents do not support FDA's position.  When stripped of
the distortions and false innuendos FDA attributes to the
documents - when the documents are not removed from their
proper contexts, as RDA has done - they do not reveal the
"intent" FDA aspires to demonstrate.  Rather, because
smoking pleasure is a complex, multi-faceted experience,
B&W cannot and does not design and manufacture its products
like a pharmaceutical company which produces medications
with the specific purpose of delivering a precise dose of
an active ingredient to the site of action in the body in
order to relieve or cure a specific condition.  Like
manufacturers of other consumer products based on
agricultural commodities, B&W must design and manufacture
its cigarettes so that they economically and reliably meet
consumer preferences.

The main staple of B&W products is tobacco leaf, which
naturally varies by type.  Further, the grade, quality, and
natural makeup of tobacco leaf is affected by weather, soil
conditions, disease, location grown, and numerous other
factors.  In the manufacturing process, B&W, like other
manufacturers of consumer products drawn from agricultural
commodities, seeks to produce a products that is of the
same, consistent high quality time after time, despite
these uncontrollable variations.  This process differs
dramatically from the pharmaceutical manufacturer, which
takes a synthetic drug and measures it into metered doses
in a laboratory.

It is also important to note that after tobacco is
purchased, subsequent steps in the process of producing
finished cigarettes consistently reduce the nicotine level
in the cigarette blend below the natural nicotine level in
the tobacco.  First the tobacco is subjected to mechanical
and physical processes such as physical agitation,
application of moisture, drying, and expansion, all of
which result in a loss of some nicotine.  In the blending
process, domestic tobaccos are blended with lower nicotine
oriental tobaccos as well as lower nicotine reconstituted
tobacco.  In addition, non-tobacco components such as
casings and flavorings are added, further reducing the
nicotine content of the blend.  This continual reduction of
nicotine levels further undercuts FDA's charges.

In the Joint Comments, B&W has joined with The Tobacco
Institute and other U.S. cigarette manufacturers to
demonstrate that FDA's legal definition of "intent" is
improper under the Federal Food, Drug and Cosmetic Act
("FDCA") and to refute FDA's assertions of purported fact
concerning "industry" knowledge and activities.  Among
other things, the Joint Comments show that the mild
pharmacologic effect of nicotine is not sufficient to meet
the legal standard of intent to affect "the structure or
any function of the body..." 21 U.S.C.  321(g)(1)(c)(1994),
and that nicotine is not "addictive" under traditional
definitions.

In these separate comments, B&W shows that its intent is to
design, manufacture and market its cigarettes to meet the
preferences of adult smokers over competing brands, not to
create and maintain "addiction" to nicotine.  FCA's
assertion to the contrary is not supported and is indeed
contradicted by the actual practices, experience, and
documents of B&W and BATCo.  We also show that the B&W and
BATCo. documents cited by FDA do not demonstrate that B&W
"manipulates" nicotine in its cigarettes for the purpose of
"addicting" smokers.

People smoke for many reasons, and have done so since as
early as 1604, when King James wrote perhaps the first
criticism of smoking, A Counterblaste to Tobacco.  The
reasons people smoke include a variety of social,
psychological and sensory factors unrelated to any mild
pharmacological effects of nicotine.  Nicotine is a natural
component of tobacco and is integral to tobacco smoke.  It
plays a part in the smoke's taste and flavor.  Smokers have
rejected both non-tobacco products which contain nicotine
and tobacco products which do not contain nicotine.

Moreover, for more than 30 years, B&W and BATCo. and other
manufacturers have sought to respond to anticipated changes
in the market because of public and governmental concerns
about the alleged relationships between smoking and health.
Much of the B&W and BATCo. research, product development,
and manufacturing processes FDA cites was in fact part of
an effort to address this changing market.  This effort has
resulted in dramatic reductions in cigarette tar and
nicotine levels since the 1950s, as demonstrated in the
Joint Comments.  FDA has sought to rewrite this history as
nicotine "manipulation" of selected and distorted facts and
assertions to support FDA's pre-ordained conclusion.


I. CONTRARY TO FDA'S ACCUSATION THAT B&W SEEKS TO DELIVER
A "PRECISE AMOUNT OF NICOTINE," B&W DESIGNS AND
MANUFACTURES ITS CIGARETTES FOR CONSUMER ACCEPTANCE BASED
UPON THE TOTAL, COMPLEX, MULTIFACETED SMOKING
EXPERIENCE.

FDA asserts that "ensuring adequate nicotine delivery is a
central objective of cigarette manufacturers."2  FDA
further broadly asserts that manufacturers control nicotine
delivery through "the design and careful, sophisticated
manufacture of the cigarette, to ensure that the smoker
obtains the precise amount of nicotine intended by the
manufacturer."3  As applied to the design and manufacture
of B&W cigarettes, these statements reflect a
misunderstanding and distortion of the process.  As noted
above, B&W's goal is to make a consistent product to meet
consumer preferences and ensure that those adults who
choose to smoke select B&W products.

B&W's main objective in designing cigarettes is to create
competitive products that smokers will prefer to those of
other manufacturers.  In addition to the primary challenge
of developing preferred products, the product development
personnel also work to develop innovations to maintain
product quality at reduced cost, to maintain quality where
product components must be replaced due to unavailability
of materials, and to ensure compliance with regulatory
requirements.

Products are developed and modified in order to meet
consumer preferences for the total smoking experience as
measured by consumer testing.  The ultimate goal is to meet
the expressed preferences of current adult consumers of
tobacco products.  Nicotine is a natural component of
tobacco which contributes to the taste and flavor of
smoking along with other tobacco components.  The various
ingredients and design components that go into the
production of cigarettes consumers will accept and prefer
result in difference levels of "tar" and nicotine delivery
for different brands.  The delivery of a "precise amount"
of nicotine is not, as FDA asserts, the goal of the
process.

A. Competition in the U.S. Cigarette Market Has Resulted In
Several Recognized Product Styles, Giving Adult
Smokers A Wide Choice of "Tar" Levels

Over the last 30 years, competition within the U.S.
domestic cigarette market has led to the development of a
wide selection of product styles based upon consumers'
expressed preferences.  The major defining characteristics
of these products are cigarette size, "tar" delivery, and
mentholation.  The choice of cigarette length, e.g., King
Size (80 to 85 mm) or Long (95 to 100 mm), is the primary
size factor, although circumference is a factor for some
niche products.  As for "tar," a variety of "tar" delivery
ranges, generally categorized in the U.S. as full flavor
(over 15 mg "tar"), light (7 to 15 mg "tar"), and ultra
light (6mg "tar" or less) has been recognized by the
industry and the Federal Trade Commission ("FTC") and is
provided to accommodate consumer preferences.  The third
characteristic is simply the absence or presence of
menthol.

Since the early 1980s, there have also been two price
categories, full revenue and value.  One product developed
in the value category and first marketed in 1984, GPC, has
become B&W's highest-selling brand.  Significantly, the GPC
blend is also among the lowest of B&W's blends in nicotine
content.

B&W and BATCo. distinguish between "research" and "product
development."  Research projects are undertaken to provide
broad exploration of various phenomena or theories related
to cigarettes in order to better understand our product and
to respond to governmental initiatives or perceived
marketplace trends.  "Research" is not always intended to
and frequently does not lead to any practical application.
"Product development" is a different process through which
B&W and BATCo. develop or modify actual marketed cigarettes
to compete more effectively in the marketplace.  FDA,
however, inappropriately supports its jurisdictional
analysis with the underlying assumption that any research
theory or conclusion, regardless of how tentative it may
be, constitutes intent by B&W regarding the actual use of
its products.  This underlying assumption is false.

Most product development projects are initiated based on
consumer tests which identify weakness in preference for
B&W products relative to competition.  Others are based on
opportunities to fill a gap in the market for one of the
cigarette styles, for example, King size, non-menthol
ultralights in a certain price range.  Finally, some
product development projects seek cost improvements or
material substitutions.  No products development projects
are initiated, driven, guided or controlled by a desire to
delivery any "precise" or "addictive" level of nicotine.

Once it has been decided to introduce or improve a
particular style of cigarette, the role of product
development is to formulate a product that smokers will
choose to purchase over competitors' products.  To meet
this challenge, B&W leaf blenders formulate a number of
tobacco blends based entirely upon their knowledge of smoke
qualities -- i.e., flavor, irritation, and "impact" levels
- of various types and grades of tobaccos.

In this regard, FDA mischaracterizes B&W's use of the work
"impact" as a euphemism for nicotine.  Such a
characterization has no basis in fact.  "Impact" is an in-
house term describing the immediate, split second sensory
perception the smoker feels at the back of the throat on
inhalation of the smoke.  It is similar to the immediate
sensation felt at the back of the throat from the fizz or
a carbonated soft drink or the spicy feel of a "hot" food.

In any event, after blends are selected, appropriate
ingredients such as cocoa, licorice and sugars (referred to
as "casings"), humectants and flavors are used to impart
desired smoking attributes.  These blends are incorporated
by product developers into a prototype using an appropriate
combination of filter, ventilations and ciagarette paper to
provide "tar" delivery within the specified range of the
product.  Through combinations of blends, casings and
flavors, and various design options, a variety of prototype
products is generated.

B. Consumer Preference Testing Measures A Range
Of Product Attributes To Determine Overall
Consumer Preference

Prototypes go through several preference testing stages
designed to determine which, if any, may warrant large
scale consumer testing and, ultimately, test marketing.
Potential new or changed products which survive preference
testing progress to consumer testing, which assesses the
test product against a competitive product, an existing B&W
product, or, occasionally, another test product, for
various sensory product attributes.  Consumers are asked to
rate cigarettes for attributes such as "strength,"
"smootheness/harshness," "amount of tobacco taste," "amount
of menthol taste," "amount of menthol cooling,"
"aftertaste," "satisfaction," and "likability."

The terms used in consumer testing such as "strength" and
"satisfaction" are not, as FDA asserts, "industry
euphemisms" for the pharmacological effects of nicotine.
Rather they are common-sense, plain words used to elicit
from consumers their preferences with respect to the
comparative sensory attributes of the cigarettes they smoke
in tests.  In large scale consumer testing, the terms are
generally undefined.

"Satisfaction" is a word applied by consumers to eating,
drinking and a whole range of human activities.  As used in
B&W's consumer testing, it is not a euphemism for
pharmacological response to nicotine, as wrongly asserted
by FDA, but rather reflects the consumer's total reaction
to the total smoking experience delivered by the
cigarettes.  Significant differences are found in
"satisfaction" ratings for cigarettes of similar smoking
machine delivery of nicotine and similar physical design.
Conversely, products with differing nicotine deliveries are
sometimes rated similarly, in "satisfaction" when tested
against each other.  Also, some smokers will rate low-
nicotine products as more "satisfying" than higher nicotine
products.  No conclusion about nicotine delivery can be
drawn from use of the word "satisfaction."

"Strength" is also not a euphemism for nicotine level.
Consumer test results for strength and harshness are highly
correlated.  Consumers reject cigarettes, and find them
unsatisfying, both for being too "strong" and not "strong"
enough.

C.  Tobacco Blend Selection, Other Components, and Design
Features are Adjusted to Improve or Maintain Consumer
Preference

Based on consumer testing, product developers adjust
product recipes and designs to improve or maintain product
preference.  Product developers employ blend components
(i.e., different tobacco varieties and different parts of
the tobacco leaf), casings, flavorings and cigarette design
features to achieve the attributes desired by consumers.
To meet consumer preferences, these characteristics must be
delivered on a predictable and consistent basis despite the
fact that tobacco is an agricultural product which varies
based on many factors such as soil, weather, agronomic
practices, insects, and diseases.  The product development
effort is to make a diverse agricultural commodity into a
product that is usable and consistent in all its
characteristics.

1. Tobacco Blend Selection and Purchase

Like all aspects of the product develoment process, tobacco
blend selection is driven by consumer preference.  The goal
is to develop a blend of tobaccos which balance sensory
characteristics such as flavor quality and amplitude,
irritation, and impact, so that no single attribute
dominates in type or amount.  This must be accomplished
within constraints of material cost, availability, and
physical quality requirements.  The tobacco blend consists
of various types of tobacco leaf.  In addition,
reconstituted tobacco, expanded tobacco and tobacco stem
are primarily used as filler components and for utilization
of tobacco that is not included in the leaf blending
process to achieve cost savings.

The types of tobacco leaf in a blend are selected based on
their sensory characteristics (such as taste, flavor or
"mouthfeel"), which vary widely among the major types of
leaf and by stalk position.  It is simply not true, as FDA
contends, that "[n]icotine is perhaps the most important
criterion employed by cigarette companies in the purchase
of tobacco leaf" or that "stalk position" is simply a
euphemism for nicotine content.4

Just as tobacco is selected for blending based on flavor
characteristics, tobacco buyers are trained to look at a
number of factors in leaf purchasing that experience shows
give the best indication of flavor characteristics.  Higher
stalk tobacco leaves do have more nicotine than lower stalk
leaves on the same plant.  They also provide more flavor
and have different physical characteristics.  Stalk
position is the initial indicator as to whether the tobacco
falls in a "flavor grade" (upper and middle stalk
positions) or a "filler grade" (bottom stalk position)
category.  Visual factors -- color, ripeness, length and
testure -- are also checked as indications of flavor.
Nicotine content of a particular tobacoo variety can vary
dramatically from year to year and even farm to farm and is
not evaluated at purchase.  Indeed, an accurate pre-
purchase evaluation of nicotine would be impossible given
the number of individual tobacco farms across wide
geographic areas on which tobacco is grown and the nature
of the auction process.

The fundamental flavor characteristics of the various
tobacco types and stalk positions utilized in B&W blends
remain relatively constant:

Flue Cured tobacco has a sweet, hay-like quality and lean
taste with some "nutty" type notes.  Bottom stalk leaves
have an eartheir, more irritating, less flue cured
character.  Top stalk leaves have more sweetness, a less
earthy, more flue cured flavor character, and better
balance of irritation and flavor.

Burley tobacco has a strong, earthy taste, and a heavy
flavor with chocolate notes, and a high impact.  Bottom
stalk leaves have less burley taste, more earthy flavor,
less impact, and are low to medium in irritation.  Top
stalk leaves have a greater burley taste, more impact and
medium to high irritation.

Oriental tobacco contains sweet, balsam, piney, aromatic,
spicy, cedar and sour flavor notes.  Again, bottom stalk
leaves will contain more of an earthy flavor, while top
stalk leaves will contain more oriental flavor.

The taste differences between top and bottom stalk leaves
are simply a fact of nature.  Bottom stalk leaves have less
taste, and generally have an earthier flavor.  They are the
oldest leaves on the tobacco plan and are thinner than the
top leaves.  However, bottom stalk leaves are important in
the leaf selection and blending process balance they have
a high fill value due to the fluffiness of the leaf and
contribute to the sensory balance of the smoke.

Leaf tobacco is purchased in lots, called bales in the case
of burley tobacco and burlap sheets in teh case of flue-
cured.  Lots from all three stalk positions are purchased
by B&W and used in B&W blends.  FDA's contention that B&W
regularly "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"5 is
simply not true.  A B&W representative stated to FDA in the
May 3, 1994 meeting FDA cites as its source that, in
exceptional circumstances, where a drought year resulted in
a particularly high-nicotine content, B&W might attempt to
adjust purchasing to buy thinner leaf to bring nicotine
levels down.  According to this representative, this type
of adjustment has occurred only twice in his 20 years of
purchasing experience, and did not, and as a matter of
practice, would not involve buying tobacco from a lower
stalk position.  FDA was expressly told at the May, 1994
meeting that B&W had made no attempt to adjust purchasing
to raise nicotine levels.  Except in the two isolated
instances where crop conditions made it necessary to
attempt downward adjustments, nicotine content is not a
relevant factor in leaf purchasing.

Tobacco purchasing is driven by consumer demand for the
sensory characteristics of B&W products.  Consumer demand
determines the content of the tobacco blends used in
marketed B&W cigarettes.  Contrary to FDA's charges,
nicotine is not "the most important criterion"6 employed by
B&W in the purchase of tobacco leaf, nor is that leaf
"blended to attain target levels of nicotine."7

2. Casings

"Casings" -- typically sugars, cocoa and licorice -- are
used to ameliorate harshness, reduce irritation, and add
flavor notes.

Historically, casings were used to protect burley tobacco
against break-up resulting from processing.  The word comes
from the treatments - such as molasses - applied to
tobaccos to enable them to be put into a case.  Many years
ago it was discovered that the smoke of cased burley
tobacco was smoother.  The use of casings is thus
historically based on serendipity, not nicotine
pharmacology.  Casings are not used, as the FDA asserts,
"to reduce the harshness of nicotine in high-nicotine
tobaccos,"8 but rather to allow use of burley for its
flavor contributions.  Burley and flue-cured tobaccos
exhibit a similar range of nicotine content, but flue-cured
tobacco is palatable to consumers in uncased form while
burley is not.  There is no clear correlation between
nicotine level and harshness.  High nicotine tobaccos do
not necessarily give a harsh smoke taste, and uncased low
nicotine burley is still harsh.

Casings are used to modify tobacco blend attributes to
improve consumer acceptability, match benchmark product
attributes, and, as in centuries past, improve
processability.  Tobacco and smoke attributes modified by
casings include moisture retention (retards staleness),
flexibility, smoke strength and harshness, smoke body and
fullness, and flavor notes.  Each casing ingredient
influences one or more of the above attributes to some
degree.  The selection of casing ingredients is based on
the reduction of undesirable attributes and the addition of
desirable attributes while still allowing natural tobacco
flavor to dominate.  Selection of casings is not based onor
related to any intent to control or increase nicotine
content, nor does it have that effect.

3. Flavors

Flavors are added to the tobacco blend to enhance natural
tobacco flavor, add missing flavor notes, provide
consistency of taste, and provide brand "signature" taste.
Flavors are developed and selected through an educated
trial and error process.  Total flavor weight is typically
0.1% or less of tobacco weight.  Some flavorings used until
reently contained among their ingredients tobacco extracts,
which in turn contain minute amounts of nicotine.
Previously, the total amount of nicotine in B&W cigarettes
attributable to flavoring had been estimated at
approximately 2-3 ppm, an insignificant amount compared to
the naturally occurring nicotine content of a typical blend
of approximately 20,000 ppm.  The use of flavorings does
not show any intent to control, manipulate or raise the
nicotine content of cigarettes, nor does it have that
effect.

4. Design Features

The dramatic drop in tar and nicotine levels achieved by
B&W and the industry as a whole since the 1059's is
principally a function of product design.  Cigarette design
refers in large part to the selection of cigarette and
tipping papers and filter materials to provide "tar"
deliveries appropriate to the particular style desired by
the consumer (full flavor, light or ultra-light).  Another
part of cigarette design, more related to economic factors,
is the amount of tobacco used in the cigarette - too much
is too costly, but too little is also readily perceived by
the consumer as poor physical quality and fast burn.
Reconstituted tobacco and expanded (puffy) tobacco were
developed primarily for economic purposes.  The use of
ammonia technology also enables these components to make
some contribution to flavor.9



(a) Papers

Cigarette papers are defined in terms of their porosity and
composition characteristics.  More porous papers provides
greater ventilation which reduces "tar" and nicotine
delivery.  The variation in porosity of paper used by B&W
is relatively narrow.  Paper composition serves mainly to
maintain coherence of the ash.  Historically, paper
composition has sometimes been used to effect slight
reductions in total "tar" and nicotine delivery by reducing
the number of avilable puffs.

(b) Filters

Filters are used to decrease "tar" and nicotine delivery.
Almost all cigarette filters used in the U.S. today are
made from cellulose acetate fibers which are bonded
together during filter manufacture by the so-called
placitcizer triacetin.

Cellulose acetate filter material, known as filter tow, is
defined in terms of the size and shape of the fibers and
the number of fibers in the filter.  The finer the fiber
size, and the more of them in a filter, the greater its
capability for filtering smoke aerosol particles.
Commercial filters generally can filter from 30% to 60% of
the smoke aerosol.10

Cellulose acetate filters, however, become too hard to draw
on if they contain fiber which removes high percentages of
the smoke aerosol.  A major product development effort in
the 1960s was for a cigarette filter which would reduce
"tar" more than the current cellulose acetate filters but
still give acceptable draw and good taste.  By the end of
the 1960s, filter technology had advanced to the point
where it was possible to lower "tar" to 10 to 12 mg range
with acceptable draw and taste characteristics.

At the same time, other methods were investigated to reduce
"tar" deliveries even further.  These investigations
resulted in the development of ventilation technology (the
provision of a number of small holds around the filter).
Ventilation was also effective to reduce carbon monoxide,
which had become a concern of the U.S. Department of Health
and Human Services ("HHS") and the FTC.  The development of
ventilation largely supplanted the search for other special
filter materials or designs.  Because of the physcial
properties of each of the three substances, ventilation
reduces carbon monoxide to a slightly greater degree than
"tar," and "tar" to a slightly greater degree than
nicotine.11

Ventilated filters enabled B&W and the industry generally
to respond to consumer demand for lower "tar" delivery
products and to the concerns of HHS and FTC by providing an
option not previously available - products with "tar" and
nicotine deliveries of as low as 1 mg and 0.1 mg,
respectively, as measured by the FTC method.  As
demonstrated in the Joint Industry Comments,12 the fact
that these ultra-light products have higher nicotine to tar
ratios than higher tar products is due to the way
ventilated filters operate according to the laws of
science, not to any manufacturer intent to "selectively
reduce 'tar' while delivering a higher percentage of the
available nicotine to levels that would not otherwise be
achievable, thus extending the range of product choice.

FDA's focus on nicotine to "tar" ratios in ultra light
products as evidence of manufacturer intent to manipulate
nicotine deliveries is disingenuous.  The extremely low
"tar" and nicotine levels of ultra light products are a
response to consumer demand and government concerns and do
not support any contention that manufactureres manipulate
nicotine to obtain "addictive and significant
pharmacological effects."  The key focus for the product
designer was and is to meet the market opportunity for
lower "tar" products.  In the process of producing ultra
lights products, both "tar" and nicotine are substantially
reduced.

5. Cigarette Manufacture and Quality Assurance

Once a prototype has passed through the consumer preference
process and is nearly finalized, the product recipe and
design are developed into a manufacturing specification.
As with virtually any any agriculturally based consumer
product, the manufacturing challenge is to maintain
constancy of product composition not only from day to day,
but month to month and year to year despite variation in
the raw material.  Non-uniformity is likely to lead to
altered taste, consumer complaints, and customer loss to
competitive brands.  It would also cause the product not to
conform to FTC measured "tar" and nicotine delivery levels
declared on packages and in advertising to inform
consumers.

To ensure uniformity, quality assurance procedures are
developed for both purchased materials and the various
steps in the manufacturing process.  These quality
assurance procedures are not "nicotine manipulation."  The
fact the "the nicotine content and delivery of each brand
of cigarettes is remarkably consistent from batch-to-batch
and year-to-year"/14 arises out of the competitive necessity
and consumer demand that B&W maintain a product that is as
consistent as possible given the variability of tobacco.
Consumers would not buy a product that varies widely in
quality from purchase to purchase.  It is no more
"remarkable" for cigarette manufacturers to achieve this
than the consistency of quality achieved by any other
producer of a consumer product based on an agricultural
commodity, such as manufacturers of coffees, frozen orange
juice or applesauce.  Product consistency has nothing to do
with nicotine pharmacology or intent to deliver a precise
"addictive" level of nicotine.  In fact, tobacco products
cannot be controlled for precise uniformity and the natural
variations of "tar" and nicotine even within the same brand
of cigarette, will vary by as much as + or - 15%.  Nicotine
content is not in fact among product parameters specified
and controlled by Brown & Williamson as part of its
manufacturing quality control.  "Tar" and nicotine content
of finished cigarettes are measured as part of B&W's
production monitoring process to confirm that product
uniformity is being maintained and to provide warning of
problems which may affect taste, or cause variance from
advertised FTC "tar" and nicotine values.

D. B&W's Product Development Efforts Over the Last 40 Years
Have Led to Dramatic Declines in Nicotine Delivery

FDA's attempt to paint every aspect of the product
development and manufacturing process as relating to
nicotine ignores one fundamental point - over the last 40
years, both "tar" and nicotine deliveries in American
cigarettes have declined dramatically.  As noted in the
Joint Industry Comments, published data demonstrates that,
since 1956, cigarette manufacturers have reduced "tar" and
nicotine deliveries by over 60%.15  Both the United States
Surgeon General16 and other authorities17 have recognized
this trend.  B&W products have demonstrated similar
reductions in "tar" and nicotine deliveries over time.

FDA, however, chooses to ignore this basic fact, claiming
that nicotine deliveries have increased since 1982.  As
explained in the Joint Industry Comments, the data upon
which these assertions are based appears to have been
chosen and manipulated to lead to pre-determined
conclusions.18

FDA also asserts that manufacturers have "manipulated"
nicotine delivery based on FDA's failure to recognize that
advances in cigarette design do not reduce "tar" and
nicotine to precisely the same degree.19  As described
above and in the industry response, this phenomenon is the
result of the physics of ventilations and filtration, the
very tools that have allowed B&W and other manufacturers to
meet consumer demand for low-yield products.20  Further,
FDA's reliance on nicotine/"tar" ratios to suggest that B&W
or other manufacturers manipulate the level of nicotine in
low-yield products wholly ignores the fundamental fact that
these products provide significantly reduced "tar" and
nicotine deliveries.  FDA uses nicotine/"tar" ratios to
create the illusion that for nicotine, somehow less equals
more.

B&W offers a range of products with different "tar" and
nicotine deliveries.  One of B&W's more successful brands
has a relatively low nicotine content and a relatively low
nicotine/tar ratio.  B&W develops and markets products for
flavor and taste, not to deliver a precise amount of
nicotine.  Smoker choice determines the mix of products
actually marketed and B&W's responses to government
initiatives and consumer preferences over the years have
driven "tar" and nicotine yields lower and lower.

II. CONTRARY TO FDA'S MISCHARACTERIZATIONS, B&W AND BATCo.
HAVE CONDUCTED RESPONSIBLE RESEARCH, INCLUDING RESEARCH
INTO NICOTINE, SMOKING BEHAVIOR, AND PRODUCT DESIGN, NONE
OF WHICH INDICATES INTENT BY B&W OR BATCo. TO OFFER
CIGARETTES AS "DRUG DELIVERY DEVICES."

In the early 1950s, publication of several epidemiological
and laboratory papers escalated the smoking and health
debate into a highly publicized controversy.21  The tobacco
industry in both the U.S. and the U.K. reponded broadly and
responsibly to this controversy and the consequent changes
in the cigarette market.  Over that time, B&W and BATCo.,
like the scientific community generally, have conducted
broad-ranging research, including that on nicotine and
smoking behavior.  They have also researched and
experiemented with modifications to cigarette designs.
Contrary to FDA's assertion that the research shows that
"tobacco manufacturers intedn nicotine-containing
cigarettes...to be used as drugs,"22 the research efforts
have been driven by competition to meet consumer demand,
the need to better understand the product, and, often, the
need to respond to government initiatives to alter design.

Much of this research has been of an exploratory nature to
evaluate what may be technically feasible without regard to
consumer acceptability or other constraints.  FDA chooses
to ignore the clear distinction between such exploratory
research on the one hand, and product development through
which B&W and BATCo. develop or modify actual marketed
cigarettes on the other hand.

Recognizing that without some new development to point to
it cannot possibly support its 180 degree change of its
long-held view that it lacks authority to regulate
cigarettes, FDA claims that "recently disclosed industry
documents" contain information on nicotine "not known to
FDA at the time of its earlier determinations about the
intended use of tobacco."23  Among other information from
"industry documents," FDA sets forth a scatter shot of
selective quotes from B&W and BATCo. documents.  The result
is an unfair characterization of the research, largely
deprived of context and meaning.  In particular, FDA paints
much of the industry nicotine and smoking behavior research
as "recently disclosed" when it has in fact been known to
the government or mirrored in published scientific
literature for years.  Beyond its mischaracterization of
old information as new, FDA is inaccurate in numerous
respects.  Some of the more egregious examples are
discussed here.

A. BATCo.'s Research Into the Properties of Nicotine
is Distorted by FDA

The FDA makes much of the tobacco industry's early research
into nicotine, asserting: "It is important to understand
why the tobacco industry has conducted this research."24
This latter point is undebatable.  Unfortunately, FDA
either does not understand or deliberately distorts the
purpose of the research it discusses.

Widely published research outside of the tobacco industry
and available in the 1950s and early 1960s explored the
effects of nicotine and the role it played in smoking.25
BATCo. also conducted research in this area, but reached no
conclusion about nicotine's alleged "addictive potential
and properties"26 which differed from that which was
generally known at that time in the scientific community.
FDA is plainly wrong when it claims that "tobacco company
researchers have known for several decades...that
nicotine's drug effects are the central reason that
consumers use tobacco."27  BATCo. research generally has
concluded that the presence and effects of nicotine do not
alone account for smoking enjoyment.

1. BATCo.'s Project Ariel Was an Attempt in the Early 1960s
to Produce a No-"Tar" Cigarette in Response to a Cigarette
Market Concerned About Smoking and Health

In the early 1960s, Sir Charles Ellis, a physicist,
proposed a project which became known as Ariel as a means
of replicating the smoking experience without "tar."
Epidemiological studies in the 1950s like those by Wynder
and Doll had suggested a link between cigarette "tar" and
ill-health.28  In response, Sir Charles theorized that
smokers might be satisfied with a product providing
nicotine but not "tar", and sought to design an alternative
product that provided only a nicotine aerosol.

In addition, as a result of Sir Charles' proposal, BATCo.
contracted with Battelle Memorial Institute, an independent
scientific laboratory in Geneva, Switzerland, to carry out
research in support of the Ariel project by increasing
BATCo.'s understanding of nicotine.  The Battelle research
was called Project HIPPO.  A nicotine absorption study,
"The Fate of Nicotine in the Body," was also conducted by
Battelle.  Sir Charles also believed that the Battelle
research might identify scientifically the beneficial
properties of nicotine.29       

HIPPO failed to support the tentative hypotheses put
forward by Battelle. HIPPO attempted to demonstrate that
nicotine produces some of its effect on the body by causing
certain glands to release hormones which presumably
affected specific bodily functions. HIPPO failed to show
that any of the hypothesized mechanisms of action were
valid.

Ariel was never commercialized. Test smokers found
prototype Ariel products harsh and irritating. The Ariel
product was patented, however, making its technology and
concept publicly available information in the 1960s. BATCo.
dropped Ariel and never developed it into a marketable
product.

The early work on Poject Ariel confirms what later studies
have consistently shown: the enjoyment of smoking is a
complex, multifacted phenomenon, which nicotine alone does
not and cannot explain. Cigarettes today thus retain the
same basic form as they have for over one hindred years.
Smokers do not want nicotine delivery systems, they want
cigarettes.

2. BATCo.-sponsored Research in the 1960s Was Comparable
   to Work Pursued and Published by Others at the Same Time

The result of Batelle contract research on nicotine were
consistent with work pursued and published elsewhere at the
time. /30 As early as 1945, for rexample, Finnegan observed
that nicotine alone cannot explain people's smoking
behavior. /31 Battele's nicotine pharmacology research was
also comparable to work being done elsewhere in the 1960s.
Just as Project HIPPO sought to evaluate the benefits of
nicotine scientifically, The Tobacco Manufacturers'
Standing Committee (TMSC) in the U.K., for example, was
planiing to study nicotine benefits at the same time. As
early as 1959, the TMSC publicly resolved to study both the
psychology of smokers (their personalities and hablits) and
why they smoked (the benefits they derived from smoking),
hoping to describe in objective scientific terms the
benefits ofsmoking in the midst of the ongoing smoking and
health controversy.  The TMSC disclosed these objectives in
its published annual report. /32

By 1963, the TMSC - by then renamed the Tobacco Research
Council (TRC) - publicly detailed its program for "research
into pharmacological effects of smoking which would provide
information on this subject that was valid and
authoritative." /33  The TRC planned to study nicotine
pharmacology both at its Harrogate laboratory and through
grants to oustide researchers.  Research at Harrogate would
study central nervous system effects of nicotine and
nicotine-free basic fractions of smoke condensate to test
whether other substances in smoke were active; whether
nicotine released adrenaline and noradrenaline; nicotine
injections in animals to test effects on blood-brain
barrier permeability; measurements of nicotine levels in
smoke,; and pharmacology of nicotine transformation
products. /34

The TRC published three reviews of its research covering
the period 1963-1974.  The TRC's reports summarized ongoing
research and published results obtained in the pharmacology
and psychology experiments at Harrogate or by its grantees.
The TRC ultimately sponsored nicotine research in the U.K.
at the University of London, the London School of Pharmacy,
Edinburgh University, Chelsea College, Cambridge
University, Birmingham University, Tavistock Institute, the
Hammersmith Royal Medical School, and Newcastle University.
This nicotine pharmacology research was descirbed publicy
in TRC research reviews.  Most TRC-sponsored work was also
published separately in the scientific literature of the
time.

Nicotine pharmacology research of the 1960s was also
discussed publicly in the 1964 Surgeon General's Report.
After reviewing published studies on nicotine pharmacology
not only from the 1950s and 1960s, but from as far back as
1905, the Report noted that "the pharmacological effects of
nicotine at dosage levels absorbed from smoking (1-2 mg per
inhaled cigarette) are comparatively small." /35  The
Surgeon General further noted that "nicotine in quantities
absored from smoking and other methods of tobacco use is
very low and probably does not represent a significant
health problem." /36  A review of Larson's classic text on
tobacco from 1961 also shows that extensive nicotine
pharmacology research had been published by that time. /37

3. FDA Misuses Statements in BATCo. Documents About
"Addiction"

FDA quotes Sir Charles Ellis as having ackownledged in the
early 1960s that people smoke because they are "addicted"
to nicotine. /38  FDA ignores the historical context in
which Sir Charles Ellis was speaking.  In fact, Sir
Charles' terminology mirrored virtually identical phrases
used by the Royal College of Physicians three months
earlier in their landmark report Smoking and Health.  The
fact that he picked up a phrase from a recently issued
government report does not support any conclusion about his
own views, let alone the views of B&W or BATCo.  FDA
improperly quotes a portion of one sentence in the Ellis
document as if it were a full sentence.  The full document
is a speech in which Sir Charles was describing to the
BATCo. research conferees his reaction to the RCP report.
In the speech, Sir Charles stated:

After reading the Report of the Royal College of Physicians
and the debate in the House of Lords the dominant
impression I received was that of people who had reached an
emotional conclusion in which they believed passionately
and sincerely.

Emotional judgments are often the basis of national
thinking, and since a national attitude to smoking may be
building up, it is essential for us to consider what are
the components in this emotion.

Lastly, smoking is a habit of addiction that is
pleasurable; many people, therefore, find themselves sub-
consciously prepared to believe that it must be wrong. /39

The Royal College uses similarly imprecise language:

There are "[w]ide spread popular beliefs (which doctors
mostly share..that it is, or at any rate can become, an
addictive habit." /40

The discomforts that ensue when smoking is stopped may thus
be genuine withdrawal symptoms due to addiction to
nicotine, but are also those to be expected when any well-
established and pleasant habit is discontinued,
particularly one which has become a valued element in
everyday life and is regarded as a prop or solace. /41

The Royal College did not conclude that smoking is
"addictive" in the sense FDA uses that term today.  To the
contrary, the Royal College reported that, between 1951 and
1961, the approximate percentage of doctors who did not
smoke increased by 39%, while the approximate percentage of
doctors who smoked declined by 33%. /42

Most important, in 1964 the U.S. Surgeon General carefully
and extensively analyzed the question whether smoking was
better characterized as a "habit" or an "addiction" and
concluded based upon science that the term "habit" was more
appropriate.  This careful conclusion clearly trumps the
earlier imprecise language quoted by FDA.

FDA also dwells on a three page letter from Battelle
scientists entitled "A Tentative Hypothesis on Nicotine
Addiction." /43  This is not as FDA asserts a report
written by "Tobacco Company Researchers." /44  The
"Tentative Hypothesis" is not research, it is not a BATCo.
hypothesis, it is not even Battelle contract work.

The "Tentative Hypothesis" document reports no research or
data.  The "addiction" hypothesis it discusses has never
been substantiated.  Indeed, at the very  same time that
"Tentative Hypothesis" was written, one of the same
scientists made a different observation in a study of
nicotine absorption and distribution he did conduct at
Battelle called "The Fate of Nicotine in the Body:"

In any case, the present results offer no conclusive
evidence for any particular mechanism involved in tolerance
to nicotine, nor do they indicate a lead to the phenomenon
of addiction. /45

The "Tentative Hypothesis" is nothing more than
speculation.  FDA's use of it is a further example of FDA's
manipulation and mischaracterization of bits of information
to fit its own pre-ordained conclusion.

B. B&W and BATCo. Research into "Low 'Tar," Medium
Nicotine" Cigarettes, Undertaken Largely in Response to
Government Initiatives, Revealed that Consumers Did Not
Want Such Cigarettes.

As set forth in the industry's "Comments on Scientific and
Manufacturing Issues," when demand for lower "tar" delivery
products grew, government policy beginning in the 1970s
encouraged the development and manufacture of a "low-'tar,'
medium-nicotine" cigarette./46 Although the tobacco
companies did not claim that lower "tar" delivery products
were "safer," scientists and the government published
concerns that smokers switching to lower "tar" delivery
cigarettes might change their smoking patterns if nicotine
levels were too low, effectively counteracting any
anticipated benefits from lower "tar" delivery products.

In the U.S., the government encouraged an effort to develop
cigarettes which were lower in "tar," but delivered a
higher level of nicotine than might be expected given the
"tar" reduction -- i.e., a low "tar"/nicotine (or high
nicotine/"tar") ratio. Dr. Gio Gori of the National Cancer
Institute, for example, suggested investigating a low
"tar"/nicotine ration, low "tar" cigarette./47 The surgeon
General also suggested that a low "tar"/nicotine ration
might be a desirable strategy for lower risk cigarettes./48

The push for a relatively higher nicotine level in low
"tar" delivery cigarettes was particularly strong in the
U.K., urged on by the government-appointed Independent
Scientific Committee on Smoking and Health (ISCSH). Its
report noted that "there should be available to the public
some brands with tar yields below those of the present
principal Low Tar brands . . . but with proportionately
higher nicotine yields."/49 The ISCSH's Fourth Report,
issued in 1988, also expressly stated that for product
development, "the overall aim should be towards reductions
in the tar/nicotine ratio."/50 The ISCSH proposed
continuing to follow its earlier suggestion that there
should be some brands "available to the public with
nicotine yields below 1 mg and with tar yields reduced to
a proportionately greater extent."/51

In response, BATCo. investigated a variety of techniques to
decrease "tar"/nicotine ratios in low "tar" cigarettes and
studied the role of nicotine in smoking./52 BATCo's
research found that smokers do not want cigarettes with
unusually high nicotine levels or with unusually low
"tar"/nicotine ratios, because they are sensorially
unbalanced. As a result, despite BATCo.'s investigations in
this area, corresponding product modifications were never
commercialized.

1.  Y-1 Tobacco Was Never Employed to Increase Nicotine in
B&W Cigarettes

FDA attacks B&W for allegedly "admitting" that Y-1, a high
nicotine tobacco, was intended as a "blending tool" to
enable the company to design products that were lower in
nicotine./53 Y-1 was initially developed by a government
researcher, Dr. James R. Chaplin, in the 1970s expressly as
part of the larger government inspired effort to develop a
low "tar," medium nicotine cigarette. B&W later took over
development and refinement of Chaplin's work and filed
patent appllications in the U.S. and Brazil for Y-1 in 1991
and 1992, respectively. U.S. Patent App. No. 761,312 (Sept.
17, 1991)(cited by the FDA at 60 Fed. Reg. 41701 n. 411)was
abandoned by B&W in March 1994. B&W never developed a
commercial cigarette which used Y-1 to lower the ratio of
"tar"/nicotine, largely because consumer panels rejected
the prototypes.

FDA wrongly implies that B&W in fact used Y-1 to maintain
or increase nicotine levels in marketed cigarettes by
stating without explanation that Y-1 was "used
commercially" in certain B&W brands./54  FDA's implication
is both false and unfair. Y-1 was never used by B&W for the
purpose of altering the ration of nicotine to "tar" in the
smoke of any commerciallized brands. In fact, to the
limited extent of its commercial use, Y-1 did not and does
not alter in any significant way the nicotine and "tar"
deliveries of the same brands made without Y-1. Therefore,
FDA's assertion that "tobacco could be bred to increase
nicotine levels." /55 is irrelevant to the actual purpose
for which Y-1 has been used in B&W cigarettes.

2. The Barclay Cigarette Was Not Designed To "Boost"
Nicotine Delivery

FDA asserts that B&W employeda channel-ventilated filter
design in Barclay cigarettes with a view to aiding smoker
compensatioin and "to boost nicotine delivery . . . ." /56
FDA does not cite a single B&W document to support this
erroneous claim. The channel-ventilated filter was not
intended to boost nicotine delivery. To the contrary, it
represented a new type of ventilated filter design, which
like most other ventilation designs, substantially reduced
"tar"and consequently nicotine deliveries compared to
historic deliveries of full flavor cigarettes.

B&W began research in the 1970s to improve the taste of low
tar cigarettes. The channel-ventilated filter was part of
that effort. Conventional ventilated filters use minute
holes which perforate the filter wrap and enter the filter,
permitting air to mix with and dilute the smoke. B&W
developed a new product which incorporated a
channel-ventilated filter design called the Actron filter.
The Actron filter was introduced in Barclay cigarettes in
1981 and provided substantial improvement in smoke taste
and flavor over competing low "tar" cigarettes using
conventional ventilation holes.

B&W had concluded that the Actron filter's four channels
running along the filter just beneath the filter wrap would
keep the air and smoke flows separate until each reached
the smoker's mouth. B&W believed that the channels would
then cause turbulence and a noticeable swirling effect in
the mouth which would enhance the sensory properties of the
smoke.

In mischaracterizing Barclay's Actron filter as a "nicotine
booster," FDA relies only on the FTC proceedings against
the Barclay advertising claim that it delivered "1 mg." of
"tar." This dispute is well documented in reported cases
cited by FDA. 60 Fed. Reg. 417179 n. 470 (FTC v. Brown &
Williamson Tobacco Corp., 580 F. Supp. 981 (D.D.C. 1983),
aff'd in part, remanded in part, 778 F.2d 35 (D.C. Cir.
1985)).

The FTD declared on June 25, 1982 that its machine testing
method for measuring smoke deliveries did not measure
channel-ventilated ciagrettes in a comparable manner to
conventional filtered cigarettes, particularly because of
its concern that in actual (rather than machine) smoking a
smoker's lips could block the channel vents and decrease
the air flow. FTC News Release (June 25, 1982)(App. Tab
14). Barclay was then removed from the FTC machine testing
program. B&W continued to claim a 1 mg. "tar" delivery
based on its own, internal machine testing. The FTC further
concluded B&W should drop the claim because consumers might
erroneously believe the measurement was substantiated by
the FTC method. The court affirmed that conclusion. Brown
& Williamson, 580 F. Supp. at 987. FDA fails to
acknowledge, however, that the court also found B&W's claim
that Barclay was "99% tar free" was not misleading: "Even
the FTC's own consumer survey suggests that the
overwhelming majority of consumers perceive `99% tar free'
as a general low tar claim.

Contrary to the FDA's incomplete discussion, the courts and
the FTC never found that B&W employed the Actron filter to
"boost nicotine" deliveries. B&W had argued that Barclay
was accurately labelled a 1 mg. "tar" cigarette by its own
scientifically valid testing method and the FTC and B&W's
competitors (principally RJR and Philip Morris) asserted
that 3-7 mgs. was a more appropriate claim pursuant to
other testing methods. The court concluded that regardless
of the precise tar delivery in dispute, any of "[t]hese
estimates would still place Barclay in the ultra low tar
range of cigarettes." Brown & Williamson Tobacco Corp v.
FTC, 778 F.2d 35, 38 (D.C. Cir1985). In sum, as the court
and the FTC recognized, the issue regarding Barclay was
correct measurement of "tar" and nicotine delivery, not
some latent "boosting" of nicotine.

Despite the enormous public record detailing over 5 years
of administrative and court proceedings, FDA makes the
completely unsubstantiated claim that the Actron filter
"represents an attempt [by B&W] to avoid some of the reduction
in nicotine that can accompany the use of ventilated
conventional filters." 60 Fed. Reg. 41718. Unsurprisingly
FDA has nothing to back up this unsupportable claim.

3. FDA's Contentions Regarding B&W's Use of Ammonia Compounds
Are Erroneous and Misleading

FDA contends that cigarette maufacturers add chemicals to
tobacco "to enhance the efficient extraction by the smoker
of nicotine fron tobacco in the rod." /57 FDA speculates
that ammonia compounds added in tobacco by B&W and other
manufacturers increase the rate at which nicotine is absorbed
into the bloodstream, thus allegedly enhancing the effect of
nicotine on the central nervous system. /58 As demonstrated
in th Joint Industry Response, FDA's speculation is
contradicted by the very evidence it relies upon.59 B&W
adopts and incorporates those comments herein, and provides
these additional comments.

(a) The Role of Ammonia Compounds in Cigarette Manufacturing

Ammonia compounds were first used in cigarette manufacturing in
the 1950's as a processing aid in making bandcast reconstituted
tobacco. In that process, ammonia compounds act to release pectins
in the stems, broken leaves, and fine particles of tobacco dust
that make up the reconstituted tobacco sheet from their naturally
occurring form to a form which is available to hold the sheet
together.

The addition of ammonia compounds also facilitates the development
of flavor. B&W is not completely certain of the mechanism by which
this occurs. However, B&W's understanding is that ammonia reacts
with naturally occurring sugars in foods and tobacco to form a
class of flavorful materials which has a characteristic roasted or
toasted flavor. This reaction, known as the Maillard reaction, has
been the subject of investigation in the food science literature
for decades.60 Proteins in tobacco break down into amino acids
that are capable of releasing ammonia during the curing process,
resulting in the formation of volatile flavors and flavor
precursors. This reaction occurs naturally in foods during cooking
and in tobacco during curing and aging.

As an example, raw dough has very little to no aroma. However,
when bread is baked, the entire house is filled with a pleasant
aroma. This aroma is a result of the Maillard reaction. Ammonia
compounds are added as leavening to baked products to facilitate
yeast reactions. In fact, ammonia compounds are used in hundreds
of food products. A walk down the aisles of any supermarket will
reveal that ammonia compounds are a standard additive in such
products as Wonder Bread, Stouffer's French Bread Pizzas, Chef
Boyardee ABC's & 123's Pasta, Pepperidge Farm Goldfish crackers,
Weight Watchers Smart Snackers cookies, Ghirardelli's Cookies and
Creme, and Budget Gourmet dinners, among many others. B&W
researchers found that cigarettes containing small amounts of
ammonia develop compounds similar to those in burley tobacco,
giving a greater burley-type flavor when smoked. This led them to
conclude that the interaction of ammonia and sugar improves the
flavor of tobacco smoke. The ammonia compounds added to B&W
products simply enhance processes that occur naturally during the
aging process and when tobacco is smoked. Ammonia is also believed
to be an ameliorant, reducing the harshness and irritation of
cigarette smoke.

(b) Ammonia and "Impact"

While ignoring the role of ammonia compounds in improving flavor
and reducing irritation and harshness, FDA focuses on a suggestion
in a stolen, confidential B&W document identifying 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 cigarette smoke and that is how ammonia can act
as an impact booster.61

As FDA itself acknowledges, B&W defines "impact" as "the hit or
punch in the back of the throat when [a smoker] first
inhale[s]."62 As discussed in Section I above, "impact" is an
immediate response, less than one second in duration. Further,
"impact" is a subjective response. Correlating such a subjective
impression with specific aspects of the chemistry of cigarette
smoke is, at best, an uncertain undertaking.

FDA asserts that "[a]mmonia increases the pH of smoke and thereby
enhances the absorption of nicotine by the body.63 FDA is wrong.
First, as stated in Volume IV of the Joint Industry Response,
Section F, the level of ammonia used in commercially marketed
cigarettes is too low to cause any significant formation of
extractable nicotine. Second, formation of extractable nicotine is
wholly irrelevant to the absorption of nicotine into the
bloodstream. As also demonstrated in the Joint Industry Response,
researchers on both sides of the debate have concluded that the
nicotine in cigarette smoke is absorbed efficiently by the smoker,
regardless of its form or pH level.64 BATCo. documents cited by
FDA demonstrate that B&W and BATCo. researchers knew this fact.65

In sum, FDA's conclusions regarding cigarette manufacturers' use
of ammonia in the manufacture of their products find no support
either in the documents relied upon by FDA or in established
scientific principles. The arbitrary and capricious nature of
FDA's claims on this issue is fully revealed by its contradictory
statements, noted in the Joint Industry Response, that cigarette
manufacturers simultaneously add ammonia to increase pH and add
sugars to decrease pH, both with the intent to increase the
absorption of nicotine by smokers. Such inconsistent and erroneous
conclusions demonstrate FDA's complete lack of understanding or
deliberate distortion of information concerning the use of ammonia
by Brown & Williamson.

C. BATCo.'s Knowledge Regarding Smoker Compensation Was No
Different of Better Than That Which Was Widely Known Elsewhere

FDA also cites BATCo. studies purportedly regarding "compensation"
-- the widely acknowledged potential for some smokers to vary the
way in which they smoke in order to increase or decrease the
levels of tar and nicotine they obtain from lower-delivery
products.66 FDA's discussion is significantly misleading in a
number of respects.

1. Compensation

First, FDA asserts that the phenomenon of compensation was
internally "recognized" or "acknowledged" by tobacco
manufacturers.67 This is hardly news. Compensation has been known
and studied by the scientific community (including tobacco company
researchers) and the government for decades.68

Second, FDA wrongly claims that BATCo. researchers "recognized" or
"acknowledged" that compensation is employed by smokers to obtain
a dose of nicotine required to satisfy their "physiological
need."69 In fact, some of the cited studies have nothing to do
with compensation. For example, the cited BATCo. report on "The
Effect of Puff Volume on 'Extractable Nicotine' and on the
Retention of Nicotine in the Mouth" makes no observations
regarding alleged "physiological need" for nicotine, or regarding
compensation for that matter.70 Others reach conclusions at odds
with the proposition for which FDA cites them. For example, one
cited article concluded that a series of butt analysis experiments
demonstrated varying degrees of incomplete compensation,71 Yet
another cited document in fact concluded that "compensation"
occurs to decrease intake of nicotine, rather than increase it.72

Third, FDA wrongly asserts that compensation is used by smokers to
obtain specific doses of nicotine. This claim is fully addressed
in the Joint Industry Response. Finally, notwithstanding FDA's
strained and frequently unfair references to BATCo. studies, it is
most telling that FDA cannot assert that the historic reduction in
"tar" and nicotine deliveries by B&W cigarettes has achieved
anything other than a reduction in the amounts of nicotine
obtained by smokers.

2. Elasticity

The FDA alleges that manufacturers have attempted to assist
smokers to compensate for nicotine by making cigarettes more
"elastic."73 FDA seeks to support its contentions by selectively
quoting from notes of BATCo. marketing and research meetings in
the 1970s and 1980s,74 including a brainstorming session called
the "Structured Creativity Conference."75

These theoretical discussions reflect the fact that BATCo.
explored the possibility of using its knowledge of
compensation in the development of low "tar" products.
BATCo. and B&W, however, have never marketed a product
which has used elasticity to enable smokers to compensate
for nicotine.  These theoretical discussions upon which FDA
relies bear no relationship to the actual products B&W has
marketed in the United States.

FDA erroneously concludes that "the documental reveal the
industry's concern with the trend toward the lower-tar
products, and the industry's intense preoccupation with the
need to provide adequate nicotine deliveries despite
lowered tar deliveries." /76  This "concern" is more
accurately described as a concern with understanding
customer acceptance of low "tar" delivery cigarettes
generally.  If smokers rejected low "tar" delivery
products, they might abandon them for more traditional
higher delivery brands.  The government and independent
scientific researchers publicly expressed this identical
concern in the 1970s: How can smokers be encouraged to
switch to lower delivery products and stay there? /77
BATCo. and B&W, like other manufacturers, naturally
responded by exploring many ways in which to maintain taste
and flavor in low "tar" delivery products.  In reality,
however, the manufacturers and scientists learned that
smokers' tendencies to compensate upward after switching to
lower delivery products waned over time and that they
adjusted to the taste of lower "tar" deliveries. /78  The
concern that, in general, smokers might reject lower "tar"
delivery products also waned.

D. BATCo. Also Researched the Role of Nicotine in Smoking
Behavior in an Attempt to Understand How to Design
Acceptable Low "Tar" Delivery Products

In the 1970s, BATCo. began research into motivations for
smoking (why do people keep smoking?) that was thought to
be of possible assistance in designing cigarettes for
consumer acceptance in a market increasingly dominated by
demand for lower "tar" delivery products and government
endorsement of lower "tar" delivery cigarettes.  Just as in
the published literature, BATCo. scientists observed that
nicotine played a role in smokers' motivations to smoke,
but it was clearly not the sole reason for smoking.  None
of BATCo.'s research was aimed at maintaining or enhancing
nicotine levels to "addict" smokers.

One of BATCo.'s studies into smoking motivation in
particular, Project Wheat, has been wholly mischaracterized
in the FDA report.  Project Wheat was based on work done by
Dr. A.C. McKennell for the British Ministry of Health.  In
1970, McKennell published "Smoking Motivation Factors," in
the British Journal of Social Clinical Psychology. /79  Dr.
McKennell tried to determine when people smoked, in the
hope of identifying the "needs" individual smokers believed
they were satisfying.  Dr. McKennell broadly categorized
smokers' motivations into "inner needs" and "social
factors."  He then described subcategories of "inner
needs," corresponding to five nonsocially-motivated times
for smoking: (1) nervous irritation; (2) relaxation
smoking; (3) smoking alone; (4) activity accompaniment; and
(5) food substitution.  Thus, these terms originated from
Dr. McKennell, not BATCo.

BATCo. saw McKennell's study as a potential opportunity to
segment consumers according to their motivations to smoke,
and then to design different cigarettes to meet their
different demands.  Part of Project Wheat was concerned
with the question of whether McKennell's "inner needs"
correlated with nicotine deliveries.  FDA, however, wrongly
and with no basis concludes that "a smoker's Inner Need"
was "defined by the extent to which the smoker used
cigarettes for the drug effects of nicotine." /80  Project
Wheat nowhere drew this conclusion.  Indeed, Project Wheat
failed to find any significant correlation between nicotine
levels and Dr. McKennell's "inner need" subcategories of
smokers.  It is false to suggest that Project Wheat
identified an allegedly "addictive" dose of nicotine.  To
the contrary, Project Wheat concluded - as Finnegan had 30
years earlier - that nicotine alone does not explain
smoking motivation. /81  Furthermore, BATCo. and B&W have
never implemented any particular cigarette design as the
result of Project Wheat.

E. B&W and BATCo. Have Never Determined That Smokers Cannot
Quit Smoking

The industry response demonstrates that - regardless of
time period - under scientifically verifiable criteria,
neither cigarette smoking nor the nicotine in smoke is
addictive.  People can and do quit smoking.  No BATCo. or
B&W research has ever determined to the contrary.  None of
B&W's or BATCo.'s efforts was aimed at, or resulted in,
control of smokers' ability to quit smoking.  B&W and
BATCo. never concluded that nicotine precludes smokers from
quitting.  B&W and BATCo. never researched nicotine to
manipulate levels in cigarettes to "addict" smokers.  And
nicotine does not foreclose consumer choice. /82

The FDA makes much of early quotes in which certain B&W or
BATCo. employees use the term "addictive" in reference to
smoking, or call nicotine a "drug."  As demonstrated in
these comments, however, phrases FDA selectively culls from
B&W and BATCo. documents, read in context, are nothing more
than language picked up from government and other external
sources.  They cannot be attributed to B&W or BATCo.

In addition, semantic gamesmanship and phrases taken out of
historical context do not and cannot change the basic facts
that:

* The enjoyment of smoking is a complex, multifaceted
experience which nicotine alone does not explain;

* Studies containing information comparable to and
consistent with the research on nicotine and smoking in
"recently disclosed" BATCo. and B&W documents have been
publicly available in the lay and scientific press for
decades;

* People have always known that smoking can be difficult to
quit; yet

* An estimated 46 million people have quit smoking in the
United States. 

CONCLUSION

As shown in these Comments and the Joint Industry Comments,
FDA's "Findings" concerning "Statements, Research, and
Actions By Tobacco Companies" are inaccurate and
disingenuous as applied to B&W and to the industry as a
whole.  FDA's basic premise that B&W and other cigarette
manufacturers "manipulate" nicotine levels to create and
maintain "addiction" is simply false.  Therefore, FDA's
"Findings" cannot provide a basis for FDA to decide that
nicotine is a "drug" and to regulate cigarettes as
"devices" even if FDA had the power to make those
decisions, which it does not.

Respectfully submitted,

BROWN & WILLIAMSON TOBACCO CORPORATION

By Scott Appleton, Ph.D.
Director of Scientific and
Regulatory Affairs
2600 Weaver Road
Macon, Georgia
31298

Of Counsel:
Andrew S. Krulwich
James M. Johnstone
William A. McGrath
of WILEY, REIN & FIELDING
1776 K Street, N.W.
Washington, D.C.  20006
(202) 429-7000

Submitted: January 2, 1996


ENDNOTES

1. See Joint Industry Comments at Vol. III, Sec. F and Vol. IV,
Sec. I.

2. 60 Fed. Reg. 41639.

3. 60 Fed. Reg. 41694.

4. 60 Fed. Reg. 41703-04.

5. 60 Fed. Reg. 41706.

6. 60 Fed. Reg. 41703.

7. 60 Fed. Reg. 41706.

8. 60 Fed. Reg. 41712.

9. See infra section II.B.3.

10. "Smoke aerosol" refers to total smoke and includes "tar,"
nicotine and water. "Tar" refers to particulate material from the
smoke captured by the Cambridge pad in the smoking machine used in
the FTC method, less nicotine and water.

11. For example, one article from the published literature reports
the finding that at a ventilation level of approximately 50%,
carbon monoxide was reduced 67%, "tar" 61%, and nicotine just under
50%.  V. Norman, "The Effect of Perforated Tipping Paper on the
Yield of Various Smoke Components," Beitrage zur Tabackforschung,
pp. 282-87 (Sept. 1974)(Appendix to Supplemental Comments
(hereinafter "App.") Tab 1).

12. See Joint Industry Comments at Vol. IV, Sec. H.

13. 60 Fed. Reg. 41717.

14. 60 Fed. Reg. 41732.

15. Joint Industry Comments, Vol. III, Sec. F.

16. U.S. Surgeon General, The Health Consequences of Smoking: The
Changing Cigarette, a Report of the Surgeon General, at 205-10 DHHS
(1981)("1981 Surgeon General's Report")(App. Tab 2)(noting the
approximately 50% reduction in tar and nicotine deliveries between
1954 and 1975).  See also U.S. Surgeon General, Reducing The Health
Consequences of Smoking, a Report of the Surgeon General, at 85-86
(1989)(cited at 60 Fed. Reg. 41759 n.545).

17. Ernst Wynder and Dietrich Hoffman, "Smoking and Lung Cancer:
Scientific Challenges and Opportunities," Cancer Res. 54:
5284-5295,  5285-5286 (Oct. 15, 1994)(showing a 63% reduction
in nicotine delivery since 1955)(App. Tab 3).

18. See Joint Industry Comments, Vol. III, Sec. F.

19. 60 Fed. Reg. 41722-31.

20. See Joint Industry Comments at Vol. IV, Sec. H.

21. U.S. Surgeon General, The Health Consequences of Smoking:
Nicotine Addiction,
at 10-12 DHHS (1988)(cited at 60 Fed. Reg. 41710 n.442).

22. 60 Fed. Reg. at 41583.

23. Id. at 41453.

24. 60 Fed. Reg. 41621-22.

25. In 1961, Drs. Larson, Haag and Silvette, all professors of
pharmacology at the Medical College of Virginia, published a
sweeping survey of scientific studies into tobacco and its
effects on the body.  See P.S. Larson, H.B. Haag and H. Silvette,
Tobacco Experimental and Clinical Studies: A Comprehensive Account
of the World Literature (Williams & Wilkins: Baltimore 1961)
(App. Tab 4).  The authors devote an entire chapter to summarizing
research into nicotine and the "tobacco habit."  Id. at
515.  Specifically, the authors cite published studies dating to
the beginning of this century which conclude  that nicotine is a
factor in smoking and cite to still other published studies of
equal vintage which examine nicotine's pharmacological effects.
Id. at 531-33.  See also U.S. Surgeon General, Smoking and Health,
at 69-76 (DHEW 1964)(cited at 60 Fed. Reg. 41539 n.33)(An entire
chapter surveys the published literature on nicotine
pharmacology, including, among other things, its effects on the
central nervous system.)

26. 60 Fed. Reg. 41621.

27. 60 Fed. Reg. 41584.

28. See, e.g., E.L. Wynder and E.A. Graham "Tobacco Smoking
as a Possible Etiological Factor in Bronchogenic
Carcinoma", The Journal of The American Medical Association
143 (4): 336 (May 27, 1950); R, Doll and A.B. Hill, "A
study of the Aetiology of Carcinoma of the Lung," British
Medical Journal 2:1271-1286 (Dec. 3, 1952).

29. This is consistent with Ellis' query at the 1962 BATCo.
Southampton research conference which FDA does not fully
quote: "One result of the recent public discussions on
smoking and health must have been to make each examine
whether smoking is just a habit of addiction or has any
positive benefits." Sir Charles Ellis, "The Smoking and
Health Problem," BATCo. Research Conference, Southampton,
England, at 15 (June 22, 1962)(cited at 60 Fed. Reg. 41600
n. 190)

30. P.S. Larson, H.B. Haag and H. Silvette, Tobacco
Experimental and Clinical Studies: A Comprehensive Study of
the World Literature. (Williams & Wilkins: Baltimore 1961
)(App. Tab 4): H. Silvette, E.C. Hoff, P.S. Larson, and
H.B. Haag, "The Actions of Nicotine on Central Nervous
System Functions," Pharmacological Reviews, 14, 137-73
(1962)(FDA Appendix, Vol. 415, Document No. 6944).

31. J.K. Finnegan, P.S. Larson and H.B. Haag, "The Role of
Nicotine in the Cigarette Habit," Science 102:94, 96 (July
27, 1945)(App. Tab 5).

32. TMSC, Report for Year Ended 31st May, 1959 at 4, 9-10
(App. Tab 6).

33. TRC, Review of Past and Current Activities at 13-14
(Jan. 1963)(App. Tab 7).

34. Id.

35. U.S. Surgeon General, Smoking and Health, at 74
(1964)(cited at 60 Fed. Reg. 41539 n.33).

36. Id. at 75.

37. P.S. Larson, et al., Tobacco: Experimental and Clinical
Studies (1961)(App.Tab 4).

38. 60 Fed. Reg. 41611. FDA also quotes on the same page a
privileged dated July 17, 1963, which was stolen from B&W.
B&W will not discuss this document here, has not waived and
does not waive the privilege, and strongly protests FDA's
use of stole privileged material.

39. Ellis, "The Smoking and Health Problem," at 4 (cited at
60 Fed. Reg. 41600 n.190).

40. Royal College of Physicians, Smoking and Health at 73
(March 7, 1962)(App. Tab 8).

41. Id. at 80.

42. Id. at 11, Fig. 5.

43. See 60 Fed. Reg. 41604-05 ns. 197-200; 41630 n. 249;
and 41635-36 n. 256.

44. See id. at 41604.

45. H. Geissbuhler and C. Haselbach, "The Fate of Nicotine
in the Body," Battelle Memorial Institute, at 27 (May 1963)
(cited at 60 Fed. Reg. 41623 n.243).

46.  Joint Industry Response, Vol. IV, Sec. I. See, also, M.A.H.
Russell et al., "Comparison of Effect on Tobacco Consumption and
Carbon Monoxide Absorbtion of Changing to High and Low Nicotine
Cigarettes," British Medical Journal, vol. 4 at 512 (1973) (App.
Tab 9); G. Gori, "Low-Risk Cigarettes: A Prescription," Science,
vol. 194, no. 4271, at 1243 (Dec. 1976) (App. Tab 10); M.A.H.
Russell, "Low-Tar Medium-Nicotine Cigarettes: A New Approach to
Safer Smoking," British Medical Journal, vol. 1, at 1430
(1976)(App. Tab 11).

47. See, e.g. G. Gori, "Low-Risk Cigarettes: A Prescription,"
Science, vol. 194, no. 4271, at 1243 (Dec. 1976) (App. Tab 10).

48. 1981 U.S. Surgeon General's Report, 185-86 (App. Tab 2).

49.  ISCSH Third Report at Paragraph 20 (Jan. 1983) (App. Tab 12).

50.  ISCSH Fourth Report at Paragraph 6 (Jan. 1983) (App. Tab 13).

51.  Id.

52.  Cf. 60 Fed. Reg. 41509 ("tobacco industry research activities
have focused on developing technologies for maintaining and
increasing nicotine level as tar is reduced").

53. 60 Fed. REg. 41701.

54. 60 Fed. Reg. 41701.

55. 60 Fed. Reg. 41701

56. 60 Fed. Reg. 41718

57. 60 Fed. Reg. 41710

58. 60 Fed. Reg. 41710-11

59 Joint Industry Response, Vol. IV, Sec. F.

60 See, e.g., James P. Danehy & Bernard Wolnak, "Maillard
Technology Manufacturing Applications in Food Products," reprinted
in The Maillard Reaction in Foods and Nutrition. American Chemical
Society Symposium Series 215, 303-304 (George R. Waller & Milton
S. Feather, eds., 1983) (App. Tab 15); James P. Danehy, "The
Ubiquitious Maillard Reaction," Chemtech (1983) (App. Tab 16).

61 60 Fed. Reg. 41710-711

62 60 Fed. Reg. 41705. Other documents cited by FDA also
demonstrate that "impact" is a sensory response limited to the
upper respiratory tract. See 60 Fed. Reg. 41588 (distinguishing
between pharmacological properties of nicotine and "impact"); 60

Fed. Reg. 41776 (identifying "impact" as sensory effect).

63 60 Fed. Reg. 41711

64 See Joint Industry Response at Vol. IV, Sec. F. See also J.E.
Henningfield, "Behavioral Pharmacology of Cigarette Smoking", 4
Adv. Behav. Pharm. 131, 148-49 (Academic Press, Inc. 1984) (App.
Tab 17).

65 See, e.g., BATCo. Group R&D, Method for Nicotine and Cotinine
in Blood and Urine, Report No. RD.1737-C, at 2 (May 21, 1980)
(cited at 60 Fed. Reg. 41586 n.167) ("During smoking, [nictoine]
is rapidly and almost quantitatively absorbed by lung tissue from
the particulate phase of whole cigarette smoke before entering the
blood stream."); Ayers, C.I., Notes from the GR&DC Nicotine
Conference, Jan. 1984 (cited at 60 Fed. Reg. 41588 n.172)
("Delegates were reminded that a smoker extracts virtually all of
the nicotine from the smoke even with a shallow inhalation.").

66 See generally 60 Fed. Reg. 41659-66.

67 Id. at 41659 & n.323.

68 See, e.g., M.A.H. Russell, "Nicotine Intake and Its Regulation
by Smokers," 31 Adv. Behav. Biol., 25, 36 (1987). (App. Tab 18)
("it was thus apparent by 1967...that smokers tend to alter their
smoking behavior to up-regulate their nicotine intake on switching
to a lower yielding brand and to down-regulate their intake from
smoking when receiving intravenous nicotine.").

69 60 Fed. Reg. at 41659 & n.323.

70 Compare 60 Fed. Reg. 41659 & n.3323 with S.R. Evelyn, "The
Effect of Puff Volume on 'Extractable Nicotine' and the Retention
of Nicotine in the Mouth," Laboratory Report No. L.314-R (Aug. 21,
1969) (cited at 60 Fed. Reg. 41659 n.323)

71 Compare 60 Fed. Reg. at 41659 & n.323 with J.R. Courtney, A.K.
Comer, "The Study of Human Smoking Behavior Using Butt Analysis,"
Report No. RD. 1608 (Aug. 7, 1978) (cited at 60 Fed. Reg. 41659
n.323).

72 Compare 60 Fed. Reg. at 41659 & n.323 with "Proceedings of the
BATCo. Smoking Behavior-Marketing Conference, Session III" (July
9-12, 1984) ("CONCLUSIONS . . . 'Downward' Compensation was More
Complete Than 'Upward' Compensation") (cited at 60 Fed. Reg. 41588
n.171).

73 60 Fed. Reg. 41690.

74 60 Fed. Reg. 41690-92.

75 Id. at 41692 and n.395.

76. Id.

77. See sources cited supra notes 46-51 and accompanying
text.

78. See Joint Industry Response at Vol. III, Sec. E.3.a.

79. A.C. McKennell, "Smoking Motivation Factors," Br. J.
Soc. Clin. Psychol., 9: 8-22
(1970)(App. Tab 19).

80. 60 Fed. Reg. 41644.

81. See J.K. Finnegan, P.S. Larson and H.B. Haag, "The Role
of Nicotine in the Cigarette Habit," Science 102: 94, 96
(July 27, 1945)(App. Tab 5).

82. FDA also relies on a handful of marketing studies for
Imperial Tobacco, Ltd., a BATCO and B&W affiliate, to
suggest that manufacturers have closely studied quitting
behavior, and to imply that any difficulty in quitting is
somehow related to nicotine. 60 Fed. Reg. 41670-72. 
Read in context, however, those studies, done by
independent market research firms and addressing a variety
of issues, present only anecdotal evidence of quitting
behavior.  Even the evidence presented, however,
demonstrates that the reasons for smoking are a complex mix
of factors.  In fact, as concluded by one of the studies
cited by FDA, environmental and social factors, not any
physiological effects, are the primary reason for failed
attempts to quit.  "Project Plus/Minus," Kwechansky
Marketing Research, Inc. (May 7, 1982)(cited at 60 Fed.
Reg. 41609 n.214).