Anne Landman's Collection
Statement of R.J. Reynolds Tobacco Company Before the U.S. House of Representatives / Committee on Energy and Commerce / Subcommittee on Health and the Environment / Concerning Whether the Food and Drug Administration Has Jursisdiction to Regulate and Therefore Ban Cigarettes
Abstract
This is the famous 1994 testimony by the R.J. Reynolds Tobacco Company (RJR) to the House Committee on Energy and Commerce, where the company compared the addictiveness of cigarettes to that of tea, coffee, Twinkies and even carrots. While not stated, presumably the statement was given by James W. Johnson, CEO of R.J. Reynolds from 1989 to 1996. Mr. Johnson should not be confused with another former CEO of RJR named F. (Frederick) Ross Johnson, who was quoted that same year in the Wall Street Journal as saying the following about tobacco: "Of course it's addictive. That's why you smoke the stuff." [Eben Shapiro, "Big Spender Finds a New Place to Spend," Wall Street Journal , October 6, 1994, p. B1.]
Six years prior to this testimony by RJR, the 1988 U.S. Surgeon General's report focused on nicotine addiction and stated clearly:
"Cigarettes and other forms of tobacco are addicting. Nicotine is the drug in tobacco that causes addiction. The pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine." (http://www.cdc.gov/tobacco/sgr/sgr_1988/1988SGR-Intro.pdf)
Fields
- Quotes
[Starting at the bottom of page 17 of the statement, under the section entitled, "The 'Addiction' Hypothesis"]:
In 1964, the Advisory Committee to the Surgeon General recognized that cigarette smoking did not meet well-established criteria for "addiction." In 1988, the Surgeon General altered the definition to fit the existing data on smoking. In essence, the Surgeon General moved the goalposts after he located the ball on the field. We categorically reject the claim that cigarettes are "addictive", and we know that an objective review of the facts and science supports our position.
Dr. Kessler defined "addiction" in terms of four elements:
-- compulsive use -- psychoactive effect -- reinforcing behavior -- withdrawal symptoms
When each of these elements is carefully analyzed in an unbiased manner, it becomes clear that cigarette smoking is no more "addictive" than coffee, tea or Twinkies. Further, in spite of the efforts to expand the definition, it still does not properly encompass cigarette smoking.
1. Compulsive use. This concept of compulsive use, like the definition of "addiction" itself, has undergone a redefinition in an attempt to encompass cigarette smoking. The classic definition of "addiction", as used in the 1964 Surgeon General's Report, properly defines compulsive use seen with hard drug addiction as "an overpowering desire or need (compulsion) to continue taking the drug and obtain it by any means." This is precisely what is seen with truly "addicting" substances like cocaine and heroin. [Footnote: Using similarly vague definitions, researchers claim to have discovered addiction to love, jogging, television, credit cards and even eating carrots. See e.g. Peele, S. Love and Addiction, 1976; Hailey and Baily, "Negative Addiction in Runners," (1979); Winn, M. The Plug In Drug (1977); Parade Magazine, April 5, 1987, p. 28; Wright, MR "Surgical Addiction: A Complication of Modern Surgery?" Archives of Otolaryngology: Head adn Neck Surgery, 112: 870-872 (1986); Cerny and Cerny, "Can Carrots Be Addictive? An Extraordinary Form of Drug Dependence," Br. J. Add. 87:1195 (1992)] The desire is overpowering and leads to criminality and violence, if necessary, to satisfy the need for the drug.
- Company
- R.J. Reynolds
- Author
- R.J. Reynolds Tobacco 1
- Johnson
- Recipient
- U.S. House of Representatives 2
- Region
- United States
- Litigation
- Minnesota Ag
- Type
- STATEMENT/TESTIMONY
- Subject
- addiction
- testimony
- FDA jurisdiction over tobacco
- testimony
Annotations
- 1. R.J. Reynolds Tobacco Author
- Affiliation:
R.J. Reynolds Tobacco
- Affiliation:
- 2. U.S. House of Representatives Recipient
- Affiliation:
Committee Energy Commerce, Subcommittee Health Environment
- Affiliation:
Document Images
Statement of R. J. Reynolds Tobacco Company
Before the U.S. House of Representatives
Committee on Energy and Commerce
Subcommitlae on Health and the Environment
Concerning Whether lhe Food and
Drug Admini.~;,-ation Has Jurisdiction to
Regulate And Therefore Ban Cigarettes
April 14, 1994
TIMN 0046266
R.J. Reynolds Tobacco Company ("Reynolds Tobacco") welcomes this opportunity
to respond to the inaccalrate and misleading attacks that have precipitated these hearings.
For the past several weeks, Reynolds Tobacco and the rest of the tobacco industry have
been bombarded with spurious and inflammatory claims. Our responses to these charges
are simple and straightforward:
Does Reynolds Tobacco add nicotine to its products? No.
Does Reynolds Tobacco manipulate nicotine yields to create, maintain,
or satisfy "addiction"? Again, the answer is no.
Does Reynolds Tobacco hold patents for technology that relates to
modificatio~n of nicotine yields independent of "tar" yields? Yes. In
fact, for years some governments, smoking and health critics, and
international public health scientists have encouraged such
developments in cigarette design.
Is Reynolds Tobacco using such technology commercially? No.
Is dgarette smoking an "addiction"? No, cigarette smoking is not an
"addiction" under any meaningful definition of the term, including the
new definition presented by Dr. Kessler before this Subcommittee.
There is no factual or policy basis to regulate or ban cigarettes as drugs simply because they
contain nicotine or simply because dgarette manufacturers have the ability to reduce the
nicotine yields of their products. This company is not engaged in some sinister plot to
deceive the American smoker.
Pl'9~ess or Prohibition
If this Subcommittee fairly and objectively evaluates the true facts about cigarette
design, it must find that the efforts of Reynolds Tobacco and others in the industry
demonstrate a remarkable record of achievement and progress. This company is justifiably
proud of those accomplishments and of the dedicated and talented employees who have
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contributed and now contribute to them. We regret that others seek to advance an agenda
of prohibition over progress.
Today, we are here to discuss whether there is a basis for FDA regulation of
cigarettes as drugs. Contrary to many reports, this issue is not novel. In fact, the question
has been advanced and rejected many times before. For example, twenty-two years ago, the
Commissioner of the Food and Drug Administration (FDA), Dr. Charles C. Edwards,
testified at a hearing similar to this one before the Consumer Subcommittee of the Senate
Committee on Commerce. Dr. Edwards stated, "Cigarettes and other tobacco products
would be drugs subject to the Federal Food, Drug and Cosmetic Act if medical claims are
made for the product .... However, dgarettes recommended for smoking pleasure are
beyond the Federal Food, Drug, and Cosmetic Act."1 Dr. Edwards was echoing a conclusion
that has been consistently reached - both by FDA and the courts prior to and after his
statement,z
Three weeks ago, FDA Commissioner Dr. David Kessler appeared before this
Subcommittee and testified extensively concerning the "task facing the FDA," which he
characterized as "to determine whether nicotine-containing dgarettes are 'drugs' within the
To Amend the Federal Cigarette Labelimz and Advertising Act to Require
Federal Trade Commission to Establish AcceDtabl’ l.~v’l~ of Tar and Nicotine
Content of Cigarettes. 1972: Hearings on S.1454 Before the Consumer S~bcQmm.
of the Senate Comm. on Commerce, 92nd Cong., 2d Sess. 239 (1972) (statement of
Charles C. Edwards, Comm., FDA).
See. ~ FFC v. Liggett and Myers Tobacco Co.. 108 F.Supp. 573 (S.D.N.Y. 1952),
~ 203 F.2d 955 (2d Cir. 1953); Letter from Donald Kennedy,
Commissioner of Food and Drugs, to John F. Banzhaf, HI, Dkt. No. 77P-0185
(December 5, 1977); Action on Smoking & Health v. Harris. 655 F.2d 236 (D.C. Cir.
1980).
TIMN 0046268
meaning of the Federal Food, Drug, and Cosmetic Act." A/1 cigarettes sold are "n~cotine-
containing cigarettes," and indeed the tobacco plant is known as ~ in
recognition of the fact that it naturally contains nicotine. Moreover, the facts relevant to
whether FDA has jurisdiction over cigarettes today are substantial/y the same as when Dr.
Edwards testified in 1972 and when the FE)A rejected petitions to regulate cigarettes in 1977
and on other occasions. At those times, as is the case today, a variety of cigarette brands
was available to consumers which yielded a variety of "tar" and nicotine levels. Through
advances in cigarette design and in response to consumer preferences, however, the average
cigarette sold today yields one-third less "tar" and nicotine than when Dr. Edwards testified.
How and why have these reductions in "tar" and nicotine yields come about? To
evaluate these questions completely, it is imperative to consider the evolution in the design
of dgarettes over the last forty years - an evolution that, in its purpose and effect, differs
significantly f~om the grossly inaccurate allegations and misrepresentations by our critics in
these proceedings and recently in the press. In short, Reynolds Tobacco designs cigarettes
to respond to consumer demand and to attempt to address the many scientific and other
criticisms that have been leveled at our products for more than forty years. Today's
cigarettes reflect the enormous efforts to respond directly to consumer demand and those
criticisms and suggestions. A very brief discnssion of the history of cigarette design will
illustrate why these recent claims are mBguided.
Early cigarettes were primarily cut tobacco (much like pipe tobacco) wrapped in
paper, with flavorings such as the oil of citrus peels. The quMity of a cigarette depended
TIMN 0046269
primarily on the single type of tobacco it contained -- Turkish tobacco was used in premium
cigarettes and domestic air-cured or flue-cured tobacco was used in less expensive cigarettes.
The first American blend cigarette, which combined both Turkish and domestic tobacco, was
Reynolds Tobacco's Camel brand, introduced in 1913. Although slightly different blends
and differem materials were used in cigarette manufacturing, cigarettes remained largely
unchanged until the early 1950s.
At that time, most cigarettes produced in the United States were made from flue-
cured, burley and Turkish tobaccos. They were 70 mm long and unfiltered. When smoked,
these dgarettes yielded an average of 40 mg of "tar" and 2.8 mg of nicotine by methods
comparable to those used by the United States Federal Trade Commission (F'rc). (The
FTC methods became offidal in 1969).
A number of watershed developments in the early 1950s led m another evolution in
cigarette design. Several epidemiologic studies published during the early 1950s reported
that there was a statistical association between cigarette smoking and lung cancer. Also, in
1953, Dr. Ernst Wynder and others published the results of a mouse skin painting
experiment in which the researchers observed skin tumors on the backs of mice exposed to
cigarette smoke condensate. All these studies were widely publicized in the general
media and the media coverage a.fleeted consumer demand. Reynolds Tobacco in turn has
made extensive efforts to respond to these scientific theories and demands and the tastes
of its consumers to produce a broad array of products.
Since the 1950s, Reynolds Tobacco, among many other lines of research, has pursued
two basic lines of research and development in this area: (i) identification of individual
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TIMI 00462"70
constituents in tobacco smoke and development of technolo~ to attempt to reduce or
remove those of potential concern, and (ii) development of new technologies to reduce
yields of "tar" and nicotine generally. The first line of research has had limited success; the
second line of research has been remarkably successful.
During the 1950s and early 1960s, many researchers focused on one chemical
constituent of smoke (or a family of constituents) in the search for a "cancer-causing" agent
that would explain the epidemiologic and skin palming results. This focus turned to
disappointment, as reflected in the 1964 Report of the Advisory Committee to the Surgeon
General ("Surgeon General's Report"). From the mid-19S0s until today, a succession of
constituents has been targeted by the biomedical community. Even today, however, the
biomedical community has been unable to a~ree on which, if any, of those constituents is
responsible for the reported association be~een dgarette smoking and lung cancer.
Cigarette manufacturers and others explored and published numerous methods to
reduce or eliminate individual constituents (or a family of constituents) in cigarette smoke,
~ reducing the temperature at which the cigarettes burned, breeding tobacco plants to
change the chemical composition of the tobacco, and adding different types of filters or
other flit-at.ion mech~ni~n~s to the cigarette. Unfortunately, manufacturers faced a moving
target as the focus changed from constituent to constituent. Constituents of concern at one
point in time were later determined by the scientific community to be of no significance.
Moreover, techniques that might have selectively reduced a constituent in the laboratory
TIMN 0046271
commonly increased another constituent. In general, efforts to reduce individual
constituents have not been successful.
Gener_al Red~lction
During the snme period, Reynolds Tobacco and other cigarette manufacturers also
directed their research to attempt to reduce levels of all constituents. This approach, also
advocated by resemchers such as Dr. Ernst Wynder, offered advantages over selective
reduction because it led to the reduction of total smoke yields and the levels of individual
compounds more or less proportionately.
To understand the concept of general reduction, it is essential to understand what
smoke is. Smoke is a complex mixture -- it consists of a particulate or "tar" phase as well
as a vapor or gas ~hase. Since the mid-1950s, cigarette manufacturers have devoted
extensive resources to achieve a general reduction in "tar" and the vapor phase components
of cigarette smoke. Techniques incorporated in cigarettes over the last 40 years which
reduce "tar" include:
Filtration
Reconstituted tobacco
Paper porosity
Redu,_ed tobacco
Exp_anded tobacco ..
Filter ventilation
Design chan_r;es such as the development of more porous cigarette paper, improved
filtration, and the ,_,~e of expanded (or "puffed") tobacco and reconstituted tobacco made
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general reduction po:~sible. By utilizing one or more of these techniques, cigarette
manufacturers can off..~r smokers a variety of cigarettes with a range of "tar" and nicotine
levels. Cigarette desig.aers have been so successful in their efforts to respond to the demand
for these reductions tltat today there are commercially available cigarettes that yield "tar"
and nicotine at levels so low they cannot be measured reliably by the FTC's standard
procedure? In 1979, the Surgeon General listed more than 25 different design techniques
that reduce yields of "tar" and nicotine.4 Each of these techniques has been well-publicized
and known to the gov,;rnment, public health, scientific and even lay communities. A brief
analysis of these design achievements demonstrates the effectiveness of general reduction
methods to achieve Io ~'er yields of "tar" and other smoke constituents.
The earliest de-~elopments included the cellulose acetate filter, use of porous paper,
and use of reconstitu_t..'d tobacco. Each of these developments was in place by 1965, and
"tar" and nicotine yiel, ls had been reduced dramatically. After 1965, the principal design
See, ~ Fedel'al Trade Commission, "Far," Nicotine and Carbon Monoxide in the
Smoke of 207 ~/arieties of Domestic Cigarettes 2-3 (1985).
Public Health Service, U.S. Department of Health, Education, and
Welfare, Smoking
and Health: ~, Report of the Surgeon General 14:110 (1979)
("1979 Surgeon
General's Rep,_~rt"). The techniques identified in the 1979 Surgeon
General's Report
were genetics r~ad breeding of tobacco plants, planting density, nitrate
fertilization,
applying agrieu ttural chemicals, topping the tobacco plant at different
stages, altering
the type of tobacco, alteriiag the position of thestaiN changing the nitrate content, .....
i ..........
selecting tobacco with specific constituents (g~ proteins, carbohydrates, resins),
curing, homogc:nized leaf curing, grading, fermentation, solvent extraction, tobacco
expansion (fre-.~ze-drying), additives, blending, changing the amount of tobacco,
changing the amount of tobacco stems, utilizing varying amounts of reconstituted
tobacco, using expanded tobacco, varying the tobacco cut, using porous cigarette
paper, perforat'~ng the cigarette paper, smoke filtration, and perforating the filter tips.
Id. at 14:108-1-l.
TIMN 0046273
breakthroughs were ~xpanded tobacco and air dilution through perforation of cigarette
filters. Expanded tobacco resulted from the search for ways to reduce the volume of
tobacco in each ciga~'ette in order to reduce "tar" and nicotine yields. The tobacco is
"puffed" or expanded in order to allow the same amount of tobacco to occupy more space,
much like popping popcorn. As a result, each cigarette is filled withless tobacco, there is
less tobacco available; to be burned, and the yields of "tar" and nicotine are therefore
reduced. Reynolds Tobacco developed expanded tobacco and was the first to introduce it
commercially, in 196:1. In fact, Reynolds Tobacco licensed this process to others in the
industry for commerc'~al use throughout the world.
In the late 196 3s, scientists discovered that perforating the cigarette filter allows air
to mix with the mains~:ream smoke, thereby diluting the smoke and reducing the total yields
of "tar," and nicotine. Air dilution also reduces the burning temperature of tobacco and
causes less tobacco t, ~ be burned per puff, thereby further reducing the "tar" and nicotine
yields. Perforated filters were first sold commercially in about 1972. By 1981,
approximately 50% o ~ all cigarette brands sold had perforated filters,s
By 1981, the tobacco content by weight of the average cigarette had declined by
23.8% through the u:~e of expanded tobacco.6 In some ultra low-"tar" brands, expanded
Public Health Service, U.S. Department of Health and Human Services, The Health
Conseauences of Smoking: The Chan~ng Cigarette. A Report of the Surgeon
General 209-10 (1981) ("1981 Surgeon General's Report").
Id. at 209-10.
°8°
00 6 ' 4
tobacco was used to a much greater extent to reduce the weight even more dramatically.7
Thus, as part of the ,lesign techniques to achieve lower yields of "tar" and other smoke
constituents, the amount of tobacco in cigarettes has been reduced, with the corresponding
result that the smoke nicotine has also been reduced dramatically.
The dgarette d-,sign efforts discussed above have been reviewed and commended by
government and other scientists. For example, from 1966 through 1978, the National Cancer
Institute supported a program to develop a "less hazardous cigarette"i This effort involved
government, tobacco i adustry, public health groups, and universities. Reynolds Tobacco and
other dgarette manutacturers participated in this program. The NCI program evaluated
over 100 different ci.,-;arette designs -- many of which had already been incorporated in
commercial cigarettes by the major manufacturers. The results of this program indicated
that the general redu,:tion approach as described above was the best approach to respond
to the scientific eritici:;ms of cigarettes. Importantly, virtually every design variable
that was
evaluated by the NCI group had been developed by the United States tobacco industry and
utilized in a commer,_,~al brand.
In 1979, scientists involved in the field of smoking and health came together
at the
Banbury conference. This conference reviewed virtually all work that had been done to
modify cigarettes du,Sng the previous twenty-five years in response to the smoking and
................... health~ controversy. /dl of the papers presented at the. Banbu~ conference were.
published,
7 This point is ,;spedally significant because it addresses Dr. Kessler's
"surprise" at
finding that, f{)r some brands in the ultra low-"tar" category, the percent
nicotine in
the tobacco it;elf might be the same or slightly higher than the percent nicotine
in
the tobacco u:ed in higher-yield cigarettes. Reducing the amount of tobacco has a
major influen,:e on the nicotine yield to the smoker.
-
TIMN 004 27
together with all the d~.bate and discussions. The consensus among scientists participating
in that program was that overall "tar" and nicotine reduction was the most effective and
most appropriate approach. Several scientists, including Dr. Dietrich Hoffmann,
acknowledged the responsiveness of the tobacco industry:
I do thi~tk the tobacco industry, voluntary or not, adjusts very
well to ~:he demands of the logical reasoning of the scientific
commurity and that we should continue on this path?
In Dr. Kessler~s March 25, 1994 statement, he asked the cigarette companies to
address the intent of cigarette design developments. The clear intent behind cigarette
design developments l~as been and remains to manufacture and market a broad range of
cigarette products in cesponse to the demands and tastes of today's adult smokers and to
ensure cigarette to cigarette and pack to pack consistency within a brand. Within the
universe of cigarette products, there is a range of"tar" and nicotine levels. As noted earlier,
reducing "tar" yields automatically results in roughly proportional reductions in nicotine
yields. That is seen by the dramatic reduction in both "tar" and nicotine achieved by
Reynolds Tobacco an :1 other dgarette manufacturers since 1955.
In 1957, Dr. Ernst Wynder and others called for efforts to reduce "tar":
[F]or practical purposes, a filter-tip capable of filtering out 40
percent of the tar would be a step in the right direction ....
"Such a filter-tip.., placed on a regular-size cigarette which
normall~, yields 30 milligrams of tar in its smoke, would reduce
the smoker's tar exposure to about 18 milligrams. A reduction
to that level, as shown both by animal experiments and human
Dietrich Hoffi~aarm, Discussion in "Risk Reduction Achievements", Banbury Report
3 - A Safe Cigarette?, pp. 155-178 at 174 (1980).
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statistical studies would be a significant reduction in cancer
risk.''~
The tobacco industry i-as accomplished this objective -- and has gone much further. The
vast majority of today's cigarettes are 85-100 mm long, have filters and yield an average of
11.5 mg of "tar" and 0.8 mg of nicotine. Some cigarettes now available yield less than 1.0
mg of "tar" as measure fl by the FTC method.
These "tar" and nicotine reductions have largely been achieved through innovations
in cigarette design - in,lovations pioneered by Reynolds Tobacco and other members of the
tobacco industry. Sinc( the complexity of smoke provides a cigarette with its taste and other
sensory properties, rnmty of these reductions in "tar" and nicotine have come at the expense
of flavor. Some smokers are unwilling to sacrifice flavor for reduced "tar." This has
prompted a continuing effort to develop new cigarette designs.
It is ironic that in the face of the overwhelming recommendations of just such an
approach, certain publ .c and private critics of cigarettes have decided once again to attack
the industry - and to r;eek to stop, if not to reverse, the extensive design innovations that
other public and priva~:e critics have encouraged over the years.
"r~"/Nicotine Ratios
Reynolds Tobacco does not manipulate the nicotine in its products to create,
maintain,, or satisfy "a, idiction". Claims to that effect are false. As "tar" yields have been
reduced over the years_: nicotine yields have also been reduced, roughly in proportion to the
"tar." The fact that "t~r" to nicotine ratios are not exactly the same for all cigarettes is not
Mattox, L and Monahan, S., "Wanted -- And Available - Filter-Tips That Really
.-
Filter", Readers D~....D.~, pp. 43-49, 44 (August 1957) (quoting Dr. E.L Wynder).
TIMN 0046277
news to anyone famili~tr with tobacco products or to anyone who has reviewed the extensive
"tar" and nicotine rep,9 .r~ts published by the FTC.
Reynolds Tob~cco's cigarettes contain approximately one and one-half to two and
one-half percent nicotine, depending upon the tobacco blend. When burned, these
cigarettes yield varying amounts of "tar" and nicotine. "Far" to nicotine ratios, while not
constant, are very clo~-;ely linked because both are found in the particulate phase of smoke.
As "tar" yield is reduced, through filtration, paper porosity, expansion, and other design
parameters, nicotine field is also reduced. Filters, however, are slightly more efficient at
reducing "tar" yield than nicotine yield. This is due to the fact that cellulose acetate, the
primary fiter mated:at used by Reynolds Tobacco and others, was developed to reduce "tar"
yield. The ability Of these fiters to reduce the gas phase constituents is somewhat limited.
Since a small amount of nicotine (uniike "tar") is found in the gas phase of cigarette smoke,
as well as in the p:~'ticulate phase, slightly more "tar" is filtered out of the smoke,
proportionately, than nicotine. Thus, as yields are reduced, the ratio of "tar" yield to
nicotine yield is redu:ed slightly.
In response t,~ the fact that "tar" and nicotine yields are so closely and naturally
linked in cigarette smoke, many public health officials and others have suggested that the
tobacco companies s~ould attempt to develop cigarettes which break that link. In other
words, we have been encouraged to develop cigarettes with reduced "tar" while maintaining
nicotine yields. Notable among o~eials who have encouraged such development is the
Independent Committee on Smoking and Health of the United Kingdom, which
recommended in 19:-13 that "... there should be available to the public some brands with
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TIMN 0046278
low levels of tar and a proportionately higher nicotine yield.''1° According to one recent
publication cited by E~r. Kessler in his testimony:
One proposal has been to develop tobacco that is high in
nicotine but low in tar. This is not easy to do naturally;
nicotine and tar are highly correlated in the tobacco leaf. One
method would be to add nicotine to a low tar, low nicotine
cigaret-t-,.,ll
The fact is many scientists, government and/or public health officials have suggested
reducing "tar" to nicotine ratios as a way toward potential progress in cigarette design,lz
Much as the i, tdustry responded to calls to reduce "tar" and nicotine yields in the
1950s and 1960s, Reynolds Tobacco has devoted research to responding to these calls to
reduce the "tar" to n icotine ratios. Out of the hundreds of patents issued to Reynolds
Tobacco personnel o:~er the years, Dr. Kessler referred to nine Reynolds Tobacco patents
during his recent testi,nony to thi.’ Subcommittee. These patents reflect work that Reynolds
has done in this area. As Dr. Kessler recognized, however, patents do not necessarily reflect
what is being used i,a practice. While Reynolds Tobacco has been able to develop a
cigarette which dis~ociates "tar" and nicotine in the laboratory, it has not been able to
achieve an acceptable commercial product. As stated above, this is not easy to do because
Third Report of the Independent Scientific Committee on Smoking and Health of
the United Ki,tgdom (1983).
Schelling, T.C. "Addictive Drugs: The Cigarette Experience." Science Vol. 255:430-
433 (1992).
See..’.,g,, "UICC Tobacco Control Fact Sheet 3," Tobacco and Cancer Programme,
International ~Inion Agaimt Cancer (March 1993); Editorial, "Monsieur Nicot's
Legacy," Lancet. H (8249): 763 (1981); Russell, M.A.H., "Smoking and Society (There
Is No Question1)", Rehabilitation, 32 (1-4): 41-42 (1979).
-13-
TIMN 0046279.
"tar" and nicotine are :;o highly correlated. If we could develop such a cigarette acceptable
to the consumer, it would apparently be welcomed and encouraged by European
governments and public health officials, rather than being characterized as some sinister plot
by tobacco companies, as Dr. Kessler appears to characterize it.13 In fact. n0n’ of the nine
Reynolds Tobacco~a :en~ cited by Dr. Kessler has been used commercially.
Published F~C !q'~_r" ~nd Nicotine Yields
The amount ot' nicotine present in a cigarette is in large part a result of the choice
of tobaccos used in t~-e cigarette blend, which are chosen because of their taste and other
properties.14 It is noi: present as a result of a decision to "manipulate" nicotine levels to
some carefully contro tied "addictive level." The concept of an "addictive level", raised but
not defined by Dr. Kessler, is not a concept known to or understood by Reynolds Tobacco.
Neither that concept aor any similar concept is used by Reynolds Tobacco in the design of
its cigarettes. We do not know what the concept means, and we are unaware of any data
t3 In 1988, Reyn,)Ids Tobacco introduced Premier, a cigarette that heated rather than
burned tobacc ~. That cigarette addressed many of the scientific criticisms
that had
been made og ain.~t cigarettes for many years. It virtually e!~mirtated "tar";
it vastly
reduced envir,)nmental tobacco smoke; and it reduced cigarette ignition
propensity.
Despite these attributes, certain U.S. government officials, public health
officials and,
of course, ant i-smoking activists launched a vigorous attack on the
cigarette -- in
terms that sound strikingly similar to the anti-smoking rhetoric
surrounding this
current debat,;. European health offici.als, .on the other hand, and
some United
States scientis;s recognized the attributes of Premier and, indeed, encouraged the ...... "
..............
development ,~)f s~milar cigarette technologies. See,_C.,g,, "Smoking Pleasure Without
the Danger of Fire and Risks To Health," Die Neu Aerzt!iche (December 19, 1988);
Hoffmanrt, D:, .CA al., "Cancer of the Upper Aerodigestive Tract: Environmental
Factors and P~eventiort," Journal of Smoking-Related Diseases 3(2): 109-129 (1992).
t4 A variety of a_.jrieultural factors and practices influence these properties, including,
for example, t 3bacco type, stalk position of the leaf, curing practices, and crop year.
TIMN 0046280 ,
that give it meaning. Further, what is relevant is not what is present m the cigarette, but
what is present in the r;moke.
Dr. Kessler has made much of the fact that the FTC numbers do not necessarily
reflect the precise "tar" and nicotine yields for every smoker. This is certainly true, just as
EPA mileage estimate:~ do not reflect the precise fuel economy that will be achieved by
every automobile driver. The important point is that in spite of broad variations in how
individual smokers may smoke any given cigarette, the fact remains that the lower the yield
by I~I'C numbers, the 13wer the yield will be to any given smoker. The yield for any given
smoker will probably l:e different from the FTC yield; for some smokers it will be higher,
for some it will be lower, but overall, the FTC yields are generally predictive of the yield
to smokers as a group. The statement, however, that "in reality" low yield cigarettes do not
yield low "tar" and nicotine, is not true. In work published by members of the Swiss Federal
Institute of Technology, lower yield cigarettes were associated with reduced smoke
absorption.~
Another i/~dica ion of Dr. Kessler's misunderstanding of cigarettes relates to his
statements concerning low "tar" cigarettes. He stated that from 1967 to 1978 eighteen
brands of filter eigaret tes underwent increases in overwrap width, resulting in less tobacco
being smoked by madtine smoking in accordance with the FTC method. Since the FTC
method specifies that the cigarette is smoked to within 3 ~/nillime~rs 0f~he~i~ping
overwrap, and Dr. Keesler stated that the tobacco within the overwrap was still smokeable
t~ Hofer, et al., "Nicotine Yield as Determinai~t of Smoke Exposure Indicators and
Puffing Behaviar." Pharmacolo~ Biochemistry_ and Behavior. Vol. 40, 139-149
(1991).
TIMN 0046281
(and would be smoked by the consumer), he concluded that these brands deviously "cheat"
the FTC method. Tha: is not true. First, Reynolds Tobacco uses standard tipping overwrap
and has not increased ~:he width because that would reduce puff count and the value to our
consumers. But, mor~ importantly, the tipping overwrap simply is not smokeable. No
smoker would conscioltsly smoke the overwrap more than once. The tipping paper, because
it is not intended to b-'. smoked, imparts a significant off-taste to the cigarette smoke.
Finally, in his t zstimony before this Subcommittee, Dr. Kessler used several charts
(which have since been widely publicized) to support his contention that the nicotine/tar
ratio for the lowest "tar" cigarettes has increased since 1982 on a sales weighted basis. This
allegation surprised I',eynolds Tobacco as much °as it surprised Dr. Kessler. Company
scientists immediately tried to duplicate Dr. Kessler's charts, using the identical FTC data
and the only publicly-available brand sales data of which this company is aware. Despite
applying the same data allegedly employed by Dr. Kessler's staff, our scientists cannot
duplicate these find_i_n..-~s. In fact, our results show exactly the opposite'-- nicotine yields and
nicotine/"tar" ratios io the lowest "tar" category decreased slightly between 1982 and 1991 -
- the time period co,ered by Dr. Kessler's charts. We have, in fact, asked FDA staff
members to provide its data and complete methodology~ We would welcome the
opportunity to review the data and methodology used by FDA staff to prepare these charts,
so.that--we, would have~a full opportunity to understand an.d review the.proc~d.u_re~ us_ed ~and
.........
evaluate the eonclusi,~ns reached.
TIMN 0046282
The '!Addiction" Hypothesis
A major premi~-;e of the charges against the cigarette industry today is the claim
that
cigarettes are "addictive". Dr. Kessler and our other critics rely on selective and
incomplete
evidence to support this claim. They ignore significant and meaningful differences
between
cigarettes and truly :'addictive" drugs. When long-established criteria for labeling
a
substance or activity as "addictive" do not permit our critics to fit cigarette smoking
nicely
within the existing cri :eda, these critics resort to a simple tactic to further their agenda
--
they attempt to lower the standards and change the definition of "addiction" and its
alleged
components.
In 1964, the Advisory Committee to the Surgeon General recognized that
cigarette
smoking did not me(~t well-established criteria for "addiction.''16 In 1988, the
Surgeon
General altered the d,~finition to fit the existing data on smoking. In essence, the Surgeon
The 1964 Advisory Committee Report to the Surgeon General defined "addiction"
as follows:
"a state of periodic or chronic intoxication produced by the
repeate.] consumption of drug (natural or synthetic) whose
charact~;ristics include:
"(1) ,'Ua overpowering desire or need (compulsion) to
-ontinue taking the drug and to obtain it by any means;
............................ "(2).- . ,'k tendency to increase.the dose;
.........................................................
"(3) ,'k psychic (psychological) and generally a physical
,lependence on the effects of the drug;
"(4) i)etrimental effect on the individual and on society"
The Report c 9ncluded that tobacco smoking was properly classified as a
habituation. 1964 Surgeon General's Report, 351, 354.
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TIMN 0046283
General moved the goalposts after he located the ball on the field. We categorically reject
the claim that cigaret~:es, are "addictive", and we know that an objective review of the facts
and science supports :)ur position.
Dr. Kessler de fined "addiction" in terms of four elements:
compulsive use
psychoactive effect
reinforcing behavior
withdrawal symptoms
When each of these etements is carefully analyzed in an unbiased manner, it becomes clear
that cigarette smoking is no more "addictive" than coffee, tea or Twinkies.17 Further, in
spite of the efforts to expand the definition, it still does not properly encompass cigarette
smoking.
1. Compu!sive use. This concept of compulsive use, like the definition of
"addiction" itself, h~:~ undergone a redefinition in an attempt to encompass cigarette
smokix~g. The classic definition of "addiction", as used in the 1964 Surgeon General's
Report, properly deft aes compulsive use seen with hard drug addiction as "an overpowering
desire or need (compulsion) to continue taking the drug and obtain it by any means." This
is precisely what is seen with truly "addicting" substances like cocaine and heroin. The
U~ing similarl~, ~ague definitions, researchers claim to have discovered addictionto
love, jogging, television, credit cards and even eating carrots. See, _’.~, Peele, S.,
_Love and Addiction. 1976; Halley and Bailey, "Negative Addiction in Runners,"
(1979); Wina, M., The Plug In Drug (1977); Parade Magazine, April 5, 1987, p. 28;
Wright, M.R., "Surgical Addiction: A Complication of Modern Surgery?" Archives
of Otolarmagoto~: Head and Neck Surgev’_, 112:870-872 (1986); Cerny and Cerny,
"Can Carrots Be Addictive? An Extraordinary Form of Drug Dependence," Br. J.
Add. 87:1195 (1992).
-18-
TIMN 0046284
desire is overpowering and leads to criminality and violence, if necessary, to satisfy the need
for the drug.
In the 1988 Suigeon General's Report, the term "compulsive use" was expanded to
include behaviors driven by "strong urges".TM There is a world of difference between the
irresistible need of th.- hard drug addict and a "strong urge" to engage in a pleasurable
behavior or activity, t~eople have strong urges to eat sweets, drink coffee and watch their
favorite soap operas. It is misleading to label these types of "urges" as compulsions.
Smokers are frequently in situations where they resist the urge to smoke. They are not in
the throes of an overl:owering desire to use and obtain cigarettes by any means. They do
not remotely resemble cocaine addicts whose very real compulsion to take this highly
intoxicating drug totalty disrupts their lives, their families and their occupations.
Smokers are now constantly characterized as addicted and thus unable to quit.
Common sense belie.-, that conclusion. Since 1974, more than 40 million people have
stopi~ed smoking pet~,lanently without any outside intervention or assistance. As one ex-
smoker has candidly neknowledged: 'q'o quit, you have to decide you want to quit. Then
you quit."19
is The full definiiion states: "Highly controlled or compulsive drug use indicates that
drug seeking :~ ad drug-taking behavior is driven by strong, often irresistible urges":
It provides no ,.'fiteria for determining when a strong urge becomes "irresistible". In
fact, no such ,.riteria exist, as admitted by the American Psychiatric Association.
'The line betw-;en an irresistible impulse and an impulse not resisted is no sharper
than that between twilight and dusk .... " See "American Psychiatric Association
Statement on "7he Insanity Defense", Am. J. Psychiatry_. 140(6), 681-688, 1983.
19 Leonard Larson, Scripp Howard News Service. ~ -
-19-
TIMN 0046285.
This is not to say that stopping smoking, or changing any well-liked, habitual behavior
is easy. It takes effort ~d commitment. But, the process is not different from successfully
losing several pounds and maintaining the weight loss or developing a regular exercise
program. It is completely different from successfully recove.ring from hard drug addiction
or alcoholism. The t~ue addict must overcome severe physical withdrawal, rebuild every
aspect of his life, lea.'n new value systems, and approach life without being constantly
intoxicated. None of :hese impediments is present in stopping smoking.
2. Psvcho_a,:tive effect. Originally, the scientific community described the term
"psychoactive" to include, as a necessary component, distortions or disruptions in cognitive
and motor performan,:e, i.e., intoxication. Those concepts were in effect for decades and
were included in the .964 Surgeon General's Report.~° Smoking/nicotine, however, does
not produce intoxicati ~n. To eliminate this inconvenient truth, the 1988 Surgeon General's
Report redefined "psychoactive" to mean anything that gets to and produces effects in the
brain. Based on this imprecise and revised definition, nicotine is psychoactive. So too is
the caffeine in ehocol._'-.te, coffee and soft drinks. Sugar, warm milk, cheeses, and many other
everyday substances a ad common pleasant experiences (such as watching sporting events or
listening to music) also produce psychoactive effects similar to those from smoking. They
are quite unlike the pLofound effects caused by hard drugs and alcohol. It is the intoxication
of hard drugs and alct~hol that sets them apart and causes muddled thinking and loss of self
control.
Robinson, J.I i. and Pritchard, W.S., '"l'he Role of Nicotine in Tobacco Use."
Psvchot}harma It9.[_0.~, 108, (4): 397-407, 1992.
-20-
TIMN 0046286
Dr. Kessler testified that nicotine contained in cigarette smoke releases a certain
chemical (dopamine) i~ the "pleasure centers" of the brain, resulting in similar effects as
addicting drugs such _a_- heroin and cocaine. Dr. Kessler failed to acknowledge that many
different pleasurable and not so pleasurable experiences and activities also result in the
release of dopamine in these "pleasure centers". Once again, the attempted analogy
becomes meaningless ;~hen viewed objectively and without blinders. Dopamine release is
one part of the neuro,:hemical response to both pain and pleasure. It will occur if one
receives an electric sl.ock or slap in the face and also occurs in response to pleasant
experiences of all kind:~. Attempting to mystify a basic physical reaction and implying that
it only occurs with addicting drugs is misleading at best.
3. Reinforcing behavior. Dr. Kessler's third criterion, reinforcing behavior,
provides yet another e:.:ample of the attempt to invest commonplace concepts with scientific
mystique, combined ;;ith an erroneous implication that the condition only occurs with
addicting drugs. Such is not the case. As presented in the 1988 Surgeon General's Report,
reinforcing behavior ,aerely refers to the fact that a pleasant experience will likely be
repeated, whether it involves a chemical or activity,zl Dr. Kessler cites two lines of
evidence as support for his claims regarding reinforcement from nicotine:
1. That _animals can be trained to self-administer nicotine; and
2. The experiments which claim that nicotine causes activation of "pleasure
centers" in the brain involving dopamine.
zl The report arti 5cially attempts to separate reinforcement involving chemicals from
those involving activities. In reality, it is the magnitude of the effect that is most
important, not the source. Further, we reject the notion that the reinforcement, or
pleasure, dedv,;d from cigarette smoking is solely the result of ingestion of nicotine.
-
-21-
TIMN 0046287
Although it i.~ true that animals will self-administer nicotine under certain very
lindted eireumstance:~, this does not imply that the effects produced by or the motivation for
ingesting nicotine ar~: in any way similar to those of truly "addicting" drugs. Scientists at the
Bowman Gray School of Medicine, in association with a Reynolds Tobacco scientist, recently
published a peer-re'Hewed study demonstrating that nicotine and caffeine are very weak
reinforcers when co,npared to cocaine and methylphenidate (Ritalin').re Their findings
were in line with the overall weight of the scientific evidence, which has consistently found
caffeine and nicoti~te are both weak reinforcers,z~ Animals can be trained to self-
administer a wide variety of substances. Animals have been trained to self-administer very
painful electric shoc~, and morphine addicted monkeys have been trained to self-administer
opiate antagonists, preeipitating very painful withdrawal symptoms. However, none of these
self-administration behaviors proves the existence of an "addiction". Moreover, animals do
not have to be exte asively trained to self-administer cocaine or heroin. Once they start
receiving either dru~, they quickly become hooked and self-administer it to the exclusion of
food and water and until death if not stopped.
4. Withdrawal ~yTnptoms. Although nicotine withdrawal was defined in 1987 by
the American Psych iatrie Association (DSM-III-R) as an element of tobacco dependence,
zz Dworkin~ et al., "Comparing the Reinfordng Effects of Nicotine~ Caffeine,
Methylpheni, late and Cocaine." M’~!ical Chemistry_ Research~ Vol. 2:593-602 (1993).
za Griffiths, R.I~.., Brady, J.V., and Bigelow, G.E., "Predicting The Dependence Liability
of Stimulant Orugs" in Thompson and Johansen Behavioral Pharmacolo~ of Human
DrugDepen, .ence, N-IDA Monograph 37, 1981, p. 92. This position has not changed.
Griffiths, R., American Psychiatric Association Annual Meeting, San Francisco, CA,
._
(1991).
-22-
0046288 . .
TININ
the associated symptom.~ were identified in the 1964 Surgeon General's Report: restlessness,
anxiety, trouble conce~ttrating, and other "mild and variable symptoms".24 That report
stated that these symptoms were the same as those seen when any well-liked behavior was
suddenly stopped. Not_aing new has been established in this area. Caffeine withdrawal is
much more well-estabtished and well-defined, including the physical symptom of the
"caffeine headache." Under Dr. Kessler's definition, caffeine and heroin should be treated
equally.
Smoking cessa_tion never involves any of the severe physical and behavioral
disruptions involved ~ withdrawal from truly addicting drugs such as heroin, cocaine, and
amphetamines. In fac~_, the symptoms of hard drug withdrawal normally require medical
treatment. With mane drugs (.’,~, barbiturates and alcohol), the addict can die from
withdrawal if not medi :ally treated. An addict undergoing withdrawal from hard drugs is
unable to think clearly or control his actions wlaile in the throes of withdrawal. This is never
the case with cigarette smokers who quit. They continue to attend to their responsibilities
and lead normal lives. The symptoms reported by cigarette smokers when they stop are of
the same kind and magnitude reported by dieters and people changing sleep patterns (.’_~,
changing from the first to third shift at work ).25
24 1964 Surgeon ’_eneral's Report, supra, at 352.
25 It should be no!ed that DSM-III-R states that there is no evidence that, even at its
most severe lev,.'l, tobacco withdrawal prevents a person from successfully stopping.
The same can n 3t be said for barbiturates, alcoho,1 or crack cocaine. ~
Statistical Man~.l.a,1 of Mental Disorders. (Third Edition - Revised) American
Psychiatric Ass,,ciation, (1987), 151.
-23-
TIMN 0046289
Cigarette smoking is more like drinking coffee and eating chocolate than like using
cocaine, heroin, or any t.ruly addicting hard drug. Cigarettes, however, are unpopular, which
is why our critics strain so mightily to demonstrate that smoking is "addictive". The plain
truth is that, under any objective scientific (or common sense) measure, cigarette smoking
should not be considered "addictive".
Dr. Kessler an, i others support their assertions by repeating a deluge of facts
that,
in their judgment, prcve their conclusions. Let us examine just a few of these "facts":
First, Dr. Kessler quotes a 1993 Gallup Survey reporting that
75% of smokers say they are addicted. What Dr. Kessler does
not rep,~rt is that the same survey found that 69% of the same
smoker.- said they "could quit if I wan~;ed to." Moreover, this
survey was conducted after the well-publicized 1988 Surgeon
Genera~.'s Report, which equated cigarette smoking with cocaine
and heroin addiction. Does Dr. Kessler not believe that such
publicitTr could affect responses to this survey?
Dr. Kes ~ler states that "By some estimates, as many as 74 to 90
percent are addicted." He relies on a paper by Hughes, et al.
This paper also included the comment, "In addition, the fact
that thi:~ definition [referring to DSM-ITI-R] classified 90% of
the tobacco users in this study as dependent suggests that it is
over in,:lusive and thus may lack diagnostic discriminability".
Dr. K,~ssler makes repeated references to how certain
percentages of people "may" or "might" possibly behave in
certain circumstances. In one example, he discusses patients
who co,ttinue to smoke after surgery or a coronary event. Some
continu', to smoke; most quit. Some also follow their doctor's
advice and eat less fat, exercise regularly and lose weight.
...................... .- -Some don't. -The fact thavhuman behaviors run awide gamut
when f~eed with similar situations tells us something about
human behavior and little about smoking or nicotine.
Dr. Kcssler's "experts" tell him that most smokers reach for
their fiast cigarette within 30 minutes of waking. He concludes
that this fact is "a meaningful measure of addiction". By this
measur~ most coffee drinkers should be considered addicts.
TIMN 0046290
Manufacturers of coffee makers have even developed machines
which hnve coffee prepared by exact times to ensure that the
coffee "a.idiction" can be satisfied immediately upon awakening.
It should be pointed out that Dr. Kessler's "definition" of addiction would classify
most coffee, cola, and tea drinkers as caffeine addicts. Caffeine is psychoactive and the
effects last longer the, ~ those of nicotine.2~ Many people experience a "strong urge" for a
cup of coffee each mo ruing. There is a well-established physical withdrawal syndrome for
2-3 cups a day coffee drinkers who suddenly stop drinking coffee. Is caffeine similar to
cocaine and heroin be,:ause of this? Neil Benowitz, one of the editors of the 1988 Surgeon
General's Report, ad,~ fitted that caffeine meets their new definition of addiction:
Many pl ~ysieians have treated patients who continue to drink
large qltantities of caffeinated beverages in the face of
information that caffeine is harmful to their health and advice
to quit. Such behavior suggests that these people are addicted
to caffeiae. Addiction liability can be analyzed according to
criteria recently presented by the United States Surgeon
General. The three major criteria for addiction liability are
psychoa,_tivity, drug-reinforced behavior, and compulsive use.
That caffeine is psychoactive and that some people consume
caffeine compulsively is dear. That caffeine reinforces its
consumption has recently been demonstrated in people,
although reinforcement is highly dependent on the dose, with
excess doses producing dysphoria. Minor criteria for addiction
liability include the development of tolerance, physical
dependence, and recurrent intense desire for the drug, all of
which ate characteristic of regular caffeine consumers. Thus,
there is ~ group of coffee drinkers who appear to be addicted
See Jaffe, J. a, ~d Kantzer, M., "Nicotine: Tobacco Use, Abuse and Dependence,
Subst. Abuse, O(0): 256, 1981. See also Sawyer et alo, "Caffeine and Human
Behavior: Arol]sal, Anxiety and Performance Effects, J. of Behav. Med., 5(4): 415,
1982. "Caffein_,~ is, without question, the most commonly used psychoactive drug in
the World." -Iaffe, J.H., Comprehensive Textbook of Psychiatry_. Chapter 13,
.-
Psychoactive St tbstance Use Disorders, 1(0), page 683, 1989.
-25-
,TIMN 0046291
to caffeine, although the extent of caffeine addiction in the
populati:)n is unknown,zv
If the same "standard.~"" are applied to caffefne, should the FDA also be considering (or
should you suggest that it begin) regulating coffee and soft drinks as drugs?
One final point is important. Essentially every claim made about manipulating
nicotine in cigarettes ~y Dr. Kessler can be made about alcohol in beer, wine and spirits.
Spirits manufacturers constantly monitor the alcohol content of their products throughout
the fermentation pro,:ess to precisely control the level of alcohol. Beers and wines are
offered to the public ~th a wide range of alcohol content. Alcohol is added to fortified
wines. High alcohol _~_~alt liquors are also available to the public. While no one will dispute
that alcohol can be a truly "addicting" substance under any definition, there is no move to
regulate alcohol as a drug, and we do not believe there should be.
Wh~Peo~)le Choose_ i.o Smoke
Dr. Kessler dismisses the issue of why people smoke by concluding, as the anti=
smoking supporters he relies upon conclude, that smoking is an "addiction" and smokers
would quit if they co~Id break this "addiction". In the current climate of social disapproval
and "political correc~_~ Less", it is unpopular for smokers to honestly state that they smoke for
pleasure and enjoym,mt. Yet for hundreds of years smoldng has been accepted as a social
custom, prov/ding a p .easurable, enjoyable break from normal activ/ties. Smokers enjoy the
taste and other senso,y aspects of smoking. A few moments with a cigarette can be a break
~ Benow/tz, N.L., "Clinical Pharmacology of Caffeine." .Ann. Rev. Med., 41(0) 277-288,
1990.
-26-
TIMN 004 /292 '
during boring or intensive tasks, or a nice complement to a meal. All of these highly
subjective reasons for ~.moking have found support in scientific publications.
Dr. Kessler pej,~ratively refers to "top tobacco industry officials" when
referencing
internationally respect_,~d Reynolds Tobacco scientists who have published widely in
peer-
reviewed scientific journals because they do not believe that tobacco is addictive.
He then
goes on to mischaracte 5ze their data. In the journal article referenced by Dr.
Kessler, Drs.
Robinson and Pritchar:l summed up the evidence concerning addiction and tobacco use:
We believe that Warburton (1990) has developed a balanced,
ftmetion--_l theory of nicotine use that recognizes the beneficial
psycholor~ical effects of nicotine. This "resource" or
~psyehol, gieal tool" hypothesis holds that people smoke
cigarette:i primarily for purposes of enjoyment, performance
enhanceinent and/or anxiety reduction. This theory also passes
the eom~ aon sense test of why people smoke. They smoke, not
because daey are addicted to nicotine, but because they achieve
some beaefits from smoking, enjoy these benefits which are
totally cc.mpatible with everyday tasks and stresses, and choose
to continue to enjoy these benefits ....
We believe the distinctions are clear and cannot be stated more
clearly tl .an what was said in the 1964 SGR [Surgeon General's
Report]: "the practice [smoking] should be labeled habituation
to distin_guish it clearly from addictioru since the biological
effects of tobacco, like coffee and other caffeine-containing
beverages, . . . are not comparable to those produced by
morphin_.,., alcohol, barbiturates, and many other potent
addietinr; drugs~ (p. 350, emphasis in original). If we lose this
common-sense perspective of the role of nicotine in tobacco
use, those of us who enjoy the "lift" we receive from that first
efip of ,:offee in the morning or that cola drink in the late
afternooa may find that a few years from now a small group of
research-~rs have equated our coffee/cola-drinking behavior to
that of a hard-core crack or heroin addict.2s
2s Robinson and !'ritchard, ~upra, at 405-6.
-27-
- TIMN
0046293
No scientific kreakthrough has occurred since the 1964 Surgeon General's Report to
warrant classifying ci..,rarette smoking as "addictive". All of the essential facts describing the
behavior have been well known for years. The only thing that has changed is the political
climate surrounding cigarette smoking, and with it the ability of anti-smoking critics to
develop a new definition of "addiction" solely to include cigarette smoking within it.
Conclusion
The facts are clear:
Reynolds Tobacco does not add nicotine to its cigarettes.
Reynolds Tobacco does not manipulate nicotine yields in its cigarettes in
order to create, maintain, or satisfy "addiction".
Cigare~:te smoking is not an "addiction" under common sense and honest
compa,'ison with truly "addicting" drugs.
Simply put, there is ,to factual basis or policy reason for the FDA to regulate cigarettes as
drugs. The result of FDA regulation, moreover, would be a ban~ or prohibition, of
cigarettes. Dr. Kessler made this point clear in his recent statement before the
Subcommittee. Me~ tbers of this Subcommittee have stated that a ban or prohibition is not
their intent; the Am~rican public resoundingly rejects the prohibition of cigarettes as well.
We encourage a dialogue that will lead to progress rather than prohibition.
-28-
