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U.S. Smokeless Tobacco Company ("USSTC") welcomes the opportunity
to participate in this hearing regarding tobacco harm reduction. This issue is
of immense importance to the 50 million adult tobacco consumers in the United
States, to the public health community, to medical practitioners and to tobacco
manufacturers.
For decades, the public health community in the United States has asserted that
cigarette smoking is the most deadly epidemic of modern times. For almost as
long, the message of the public health community to cigarette smokers has been
monolithic: stop all use of tobacco. Over the past several years, however, an
increasing number of public health advocates have voiced doubts about what some
have called the "quit or die" approach to smoking cessation.
Rather than rely entirely on programs intended to achieve total cessation of
tobacco use, this segment of the public health community is urging that a more
pragmatic goal be adopted - that of tobacco "harm reduction." One
method of achieving tobacco harm reduction, according to a growing number of
researchers, is to encourage those cigarette smokers who do not quit and do not
use medicinal nicotine products to switch completely to smokeless tobacco
products. This strategy, however, is complicated by the fact that the vast
majority of adult cigarette smokers in the United States - despite the generally
accepted scientific view to the contrary - believe that cigarette smoking and
smokeless tobacco use involve the same risk of adverse health effects.
The issue of tobacco harm reduction and the potential role of smokeless tobacco
products in that effort is at a crossroads. The debate is no longer about
whether smokeless tobacco is considered by the scientific community to be a
significantly reduced risk alternative compared to cigarette smoking. The
question now is whether that information should be communicated to adult
cigarette smokers or whether it should be suppressed.
Set forth below is a brief description of USSTC and its smokeless tobacco
products, followed by a review of some of the more significant issues relating
to smokeless tobacco in the context of tobacco harm reduction.
I. USSTC
USSTC is the leading U.S. producer and marketer of moist smokeless tobacco or
moist snuff. Copenhagen and Skoal -- two of USSTC's brands -- are America's
best-selling moist snuff products. Two other brands -- Rooster and Red Seal --
were introduced within the last five years, and hold established positions in
the marketplace. A new pouch product -- Revel -- has been test marketed. USSTC
maintains manufacturing and processing facilities in Franklin Park, Illinois;
Hopkinsville, Kentucky; and Nashville, Tennessee.
In 1997, USSTC was the only smokeless tobacco company to support the proposed
tobacco resolution. When the proposal failed to pass the Congress, USSTC became
the only smokeless tobacco company to enter into the Smokeless Tobacco Master
Settlement Agreement ("STMSA") with Attorneys General of various
states and U.S. territories. Pursuant to the STMSA, USSTC is providing up to
$100 million (plus an inflation adjustment), over a 10-year period, to the
American Legacy Foundation for programs to reduce youth usage of tobacco and
combat youth substance abuse, and for enforcement purposes. Moreover, USSTC
agreed to limitations on its advertising and marketing efforts, even though this
put USSTC at a competitive disadvantage with other smokeless tobacco
manufacturers.
As these facts and the remainder of this statement will make clear, USSTC is
truly a "distinctly different" tobacco company. Annexed as Attachment
A to this statement are copies of excerpts from UST Inc.'s (USSTC's parent
company) annual reports for 2000, 2001 and 2002
that discuss the ways in which USSTC is a "distinctly different"
tobacco company.
II. Smokeless Tobacco in the Context of Tobacco Harm Reduction
A. Introduction
Since the Surgeon General's Report in 1964 , there has been substantial public
health discussion about the potential health effects of tobacco use. Various
public health organizations have identified the risks of cigarette smoking as
including cancer (e.g., lung, oral cavity, esophagus, larynx, pancreas, bladder,
kidney), chronic obstructive pulmonary disease, myocardial infarction, and
stroke. The Centers for Disease Control and Prevention ("CDC")
estimates that cigarette smoking caused approximately 442,000 premature deaths
in the United States in 1999. The Surgeon General has indicated that the ideal
way to avoid such health risks is to abstain from cigarette smoking.
Nonetheless, 47 to 50 million adults in the U.S. continue to smoke cigarettes.
This number represents approximately 25 percent of all U.S. adults.
The Surgeon General reached a judgment in 1986 that use of smokeless tobacco
products "can cause cancer." Federally-mandated rotating warnings on
smokeless tobacco product packaging and advertising state:
WARNING: THIS PRODUCT MAY CAUSE MOUTH CANCER
WARNING: THIS PRODUCT MAY CAUSE GUM DISEASE AND TOOTH LOSS
WARNING: THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO CIGARETTES.
Numerous methods have been suggested by public health advocates for achieving
tobacco harm reduction, including urging cigarette smokers to smoke fewer
cigarettes, developing "less hazardous" cigarettes and creating
alternative sources of nicotine, such as nicotine inhalers. A growing number of
tobacco harm reduction proponents, however, are arguing for an additional method
for achieving their goal. Based on the generally accepted view in the scientific
community that smokeless tobacco use involves significantly less risk of adverse
health effects than cigarette smoking, they would encourage those cigarette
smokers who do not quit and do not use medicinal nicotine products to switch
completely to smokeless tobacco products.
B. The IOM Report
A logical starting point for discussion of smokeless tobacco in the context of
tobacco harm reduction is the 600 page report issued in 2001 by the Institute of
Medicine ("IOM") entitled: Clearing the Smoke. Assessing the Science
Base for Tobacco Harm Reduction ("IOM Report"). The IOM was
established in 1970 by the National Academy of Sciences to examine policy
matters pertaining to public health, and acts under the Academy's congressional
charter to be an advisor to the federal government and to assess issues relating
to medical care, research and education. The IOM tobacco harm reduction project
was undertaken at the request of, and was supported by, the U.S. Food and Drug
Administration. The IOM Report explains the need for a tobacco harm reduction
strategy as follows:
Despite overwhelming evidence and widespread recognition that tobacco use poses
a serious risk to health, some tobacco users cannot or will not quit. For those
addicted tobacco users who do not quit, reducing the health risks of tobacco
products themselves may be a sensible response. This is why many public health
leaders believe that what has come to be called "harm reduction" must
be included as a subsidiary component of a comprehensive public health policy
toward tobacco.
Tobacco "harm reduction" is defined in the IOM Report as follows:
For the purposes of this report, a product is harm-reducing if it lowers total
tobacco-related mortality and morbidity even though use of that product may
involve continued exposure to tobacco related toxicants. Many different policy
strategies may contribute to harm reduction. However, this report focuses on
tobacco products that may be less harmful or on pharmaceutical preparations that
may be used alone or concomitantly with decreased use of conventional tobacco.
(Original emphasis).
It is clear from this definition of "harm reduction" that, in the view
of the IOM, it is not necessary to demonstrate that a product is
"safe" or "harmless" in order for that product to play a
role in tobacco harm reduction.
The IOM Report had the following to say with respect to smokeless tobacco
products:
Smokeless tobacco products are associated with oral cavity cancers, and a
dose-response relationship exists. However, the overall risk is lower than for
cigarette smoking, and some products such as Swedish snus may have no increased
risk. It may be considered that such products could be used as a PREP [Potential
Reduced-Exposure Product] for persons addicted to nicotine, but these products
must undergo testing as PREPs using the guidelines and research agenda contained
herein.
There has been criticism of the IOM Report's recommendation that all products
proposed for use in the context of a tobacco harm reduction strategy require
substantial and elaborate scientific testing to demonstrate their harm reduction
benefits. For example, Clive Bates, former Director of the United Kingdom's
Action on Smoking and Health, has made the following comments:
The report places very substantial evidential requirement on those seeking to
bring PREPs to the market with a health related claim. The easiest approach for
the public health and regulatory community is to demand near complete certainty
before approving the marketing of any PREPs. At first sight this appears
prudent, but it is actually a transfer of risk from the regulator to the smoker.
With insurmountable evidential hurdles in place, the regulator may sleep easy in
a cocoon of professional skepticism.
The IOM Report's focus on the need for further research and demonstration of
harm reduction benefits may be understandable in the context of new or novel
tobacco products or so-called "safer" cigarettes. When it comes to
smokeless tobacco, however, there is considerable agreement in the scientific
community that the use of smokeless tobacco involves significantly less risk of
adverse health effects than cigarette smoking.
As Professor Lynn Kozlowski, Head of the Pennsylvania State University
Department of Biobehavioral Health, has stated in a commentary published last
year in the journal Nicotine and Tobacco Research:
The failure of governments to establish any effective regulation of tobacco
products can be seen as arguably the greatest failure of public health policy
for the past 100 years. I have recently been in a meeting with several
distinguished scientists and opinion leaders interested in smoking-related
public policy and regulation. The majority of these individuals expressed an
unwillingness to express any public opinion about would-be harm reduction
products for tobacco, until such time as proper regulatory/evaluation systems
were in place to unequivocally judge the degree of harm reduction afforded by
the products as used by society. (This might be viewed as in keeping with the
position of the Institute of Medicine report.) Clearly the best of all possible
research has not yet been done on snus or medicinal nicotine, but, equally
clearly, it is wrong to assume that we lack practical scientific bases for
estimating that there will be harm reduction to individual smokers from these
products. Though it is important to attain proper regulation over tobacco and
harm reduction products, this goal is logically and ethically independent of the
need to provide smokers today with what information we do have about the risks
of various products. (Emphasis supplied).
C. There is General Agreement in the Scientific Community Regarding the
Comparative Health Risks of Cigarette Smoking and Smokeless Tobacco Use
USSTC's February 5, 2002 Request to the Federal Trade Commission
("FTC") for an advisory opinion15, which is discussed below, contains
excerpts from 50 scientific publications, many of which were peer-reviewed, that
assert or support the proposition that the use of smokeless tobacco involves
significantly less risk of adverse health effects than cigarette smoking.
Additional scientific information and publications that became available
subsequent to February 5, 2002 is reviewed in USSTC's May 9, 2003 submission to
the FTC, which is also discussed below. Two of the publications referenced in
that supplemental submission reflect the generally held view in the public
health community regarding the comparative health risks of cigarette smoking and
smokeless tobacco use. Those publications can be expected to have a significant
impact on the tobacco harm reduction debate, and therefore merit some
discussion.
i. Royal College of Physicians Report
In December 2002, the Royal College of Physicians ("RCP") issued a
landmark report entitled Protecting Smokers, Saving Lives, which assessed
various issues relating to future tobacco regulation in the United Kingdom. The
RCP is England's oldest medical institution; among its main functions is to
advise the government, the public and the medical profession on health care
issues.
The 2002 RCP Report recognized that tobacco harm reduction must be an essential
element of any tobacco regulation program:
A tobacco and nicotine regulatory authority should have a clear objective:
…to reduce the overall burden of tobacco-related disease by contributing to a
reduction in smoking prevalence and by regulating to reduce the harm caused to
continuing nicotine users." (Original emphasis)
The 2002 RCP Report also recognized that smokeless tobacco would be a key
component of any tobacco harm reduction strategy:
Smokeless Tobacco:
As a way of using nicotine, the consumption of non-combustible tobacco is of the
order of 10-1,000 times less hazardous than smoking, depending on the product.
Some manufacturers want to market smokeless tobacco as a 'harm reduction' option
for nicotine users, and they may find support for that in the public health
community.
The issuance of the RCP's 2002 Report is not the first time that the RCP has led
the way on tobacco and health issues. In March 1962, the RCP issued a report on
smoking and health which concluded that cigarette smoking caused lung cancer.
Shortly after the issuance of that report, the U.S. Surgeon General, Dr. Luther
L. Terry, established the Surgeon General's Advisory Committee on Smoking and
Health to produce a similar report for the United States. That report was
released in January 1964 and is generally referred to as the 1964 Surgeon
General's Report. Its conclusions were similar to those of the 1962 RCP Report.
ii. White Paper on European Union Smokeless Tobacco Policy
In February 2003, a group of tobacco and health researchers and public health
advocates from the United Kingdom, Sweden and Austria published a white paper
entitled European Union policy on smokeless tobacco. A statement in favour of
evidence-based regulation for public health. The authors recommend that the
current European Union ban of smokeless tobacco be replaced with a regulatory
program based on the recognition that smokeless tobacco is substantially less
harmful than cigarette smoking and could play a significant role in tobacco harm
reduction. The group summarized the "public health case" favoring
smokeless tobacco as follows:
We believe that the partial ban applied to some forms of smokeless tobacco in
the European Union should be replaced by regulation of the toxicity of all
smokeless tobacco. We hold this view for public health reasons: smokeless
tobacco is substantially less harmful than smoking and evidence from Sweden
suggests it is used as a substitute for smoking and for smoking cessation. To
the extent there is a 'gateway' it appears not to lead to smoking, but away from
it and is an important reason why Sweden has the lowest rates of tobacco-related
disease in Europe. We think it is wrong to deny other Europeans this option for
risk-reduction and that the current ban violates rights of smokers to control
their own risks. For smokers that are addicted to nicotine and cannot or will
not stop, it is important that they can take advantage of much less hazardous
forms of nicotine and tobacco - the alternative being to 'quit or die' … and
many die. (Original emphasis)
Among other points made in the white paper are the following:
[F]or oral tobacco to play a role in harm reduction it is not necessary to show
that it does not cause cancer - it just needs to be substantially less hazardous
than smoking. Even allowing for cautious assumptions about the health impact,
snus - and other oral tobaccos - are a very substantially less dangerous way to
use tobacco than cigarettes. Smokeless tobaccos are not associated with major
lung diseases, including COPD and lung cancer, which account for more than half
of smoking-related deaths in Europe. If there is a CVD risk, which is not yet
clear, it appears to be a substantially lower CVD risk than for smoking.
Smokeless tobacco also produces no environmental tobacco smoke (ETS) and
therefore eliminates an important source of disease in non-smokers and children.
These are very substantial benefits in reduced risk to anyone that switches from
smoking to smokeless tobacco and we believe the public health community has a
moral obligation to explore this strategy. It is likewise ethically wrong to
actively deny users the option to reduce their risk in this way.
* * *
The risk to the user arising from use of a smokeless tobacco product varies by
product and is to some extent uncertain - notably in the area of heart disease
(though at worst the heart disease impact appears to be substantially less than
smoking). However, we are confident that the evidence base suggests that it is
reasonable to formulate the overall relative risk as follows: on average
Scandinavian or American smokeless tobaccos are at least 90% less hazardous than
cigarette smoking. In a spectrum of risk, snus is much closer to NRT [nicotine
replacement therapy] than it is to cigarette smoking. (Original emphasis)
D. Individual Risk Versus Population Risk
One concern raised by some in the public health community with respect to
"reduced risk" tobacco products is that, while a product might reduce
the health risk to an individual, the aggregate public health impact on the
population might be negative. Thus, for example, it is argued that if a
"safer" cigarette reduced the health risks associated with cigarette
smoking by 10 percent, but resulted in a 20 percent increase in cigarette use
(either through new smokers or by causing some smokers who otherwise would have
quit to continue smoking), the aggregate public health impact would be negative.
Professor Kenneth E. Warner of the University of Michigan gives the following
example:
[C]onsider the implications of Star Enterprise's advertising that its new
cigarette, Advance, yields fewer nitrosamines than conventional cigarettes.
Informed that most cigarette smoke contains nitrosamines and that nitrosamines
are carcinogenic, would smokers preparing to quit flock to the new cigarette
instead, believing that it would greatly reduce their risk of smoking-induced
lung cancer? The net health consequences are unclear: for those smokers who
would have continued smoking anyway, switching to Advance might well reduce
risk. For smokers who would have quit, or former smokers induced to start
smoking again by the availability of this purportedly 'safer' product, the
active marketing of a low-nitrosamine cigarette clearly would increase risk. The
net impact would depend on the unpredictable balance between such effects.
Professor Kozlowski has developed a "risk/use equilibrium" chart to
assess the issue of individual risk reduction versus aggregate population
impact. The chart compares the "decrease in danger (%)" displayed on
the horizontal axis to the "multiplier to achieve equal risk" on the
vertical axis.
According to Professor Kozlowski's analysis, a tobacco product that reduces
risk by only 10 percent raises a difficult public health issue because an 11
percent increase in use of the product would offset the risk reduction in the
population as a whole, and an increase in excess of 11 percent would result in a
negative public health impact on the population as a whole. On the other hand, a
tobacco product that results in a reduced risk in excess of 90 percent presents
a relatively easy public health issue since the increase in usage necessary to
offset the reduction in risk is so substantial - more that 1,000 percent - that
it is highly unlikely to occur.
Given the predominant view in the public health community that the risk of
adverse health effects associated with smokeless tobacco products is slight
compared to that of cigarette smoking, researchers believe it is highly unlikely
the public health benefit of cigarette smokers switching to smokeless tobacco
would ever be offset by increased usage of smokeless tobacco.
Professor Kozlowski expressed his agreement with this conclusion in a recent
publication entitled Harm Reduction, public health, and human rights: Smokers
have a right to be informed of significant harm reduction options, in which he
applied his "risk/use equilibrium" analysis to smokeless tobacco:
When risks from a product are relatively small, the level of increased use
needed to maintain a public health equilibrium (no changes in population-level
problems) becomes very high (Kozlowski, Strasser, Giovino, et al., 2001). . . .
For a product like snus, if the risk is even 1% that of cigarettes, use would
have to increase 100 times to equal the problems from cigarettes. If the risk
from snus were as much as 5% that of cigarettes, use would still have to
increase an unlikely 20 times for the public health problems to equal those from
cigarettes.
E. The Swedish Experience
Proponents of encouraging "inveterate" cigarette smokers to switch to
smokeless tobacco products point to the history of cigarette smoking and
smokeless tobacco use in Sweden as support for their view. Swedish males have
the highest rate of smokeless tobacco use and the lowest rate of cigarette
smoking of any Western country, and the daily use of smokeless tobacco by
Swedish males now exceeds that of cigarettes (18.2 percent daily smokeless
tobacco users versus 17.1 percent daily cigarette smokers). The following chart
illustrates the changing pattern of tobacco use in Sweden during most of the
past century, including the fact that smokeless tobacco use has overtaken
cigarette smoking in recent years for the first time since World War II.
Tobacco and health researchers have linked Sweden's low rate of
"tobacco-related mortality" to its high prevalence of smokeless
tobacco use and low prevalence of cigarette smoking:
Sweden, with a long tradition of smokeless tobacco use (16% of adult males use
smokeless tobacco daily) and the highest penetration of NRT [nicotine
replacement therapy] use, is the only European country that has reached (19%)
the World Health Organization's target of 20% smokers in the adult population by
the year 2000; about 35% of all nicotine consumed comes from nonsmoked deliver[y]
forms. The tobacco-related mortality in Sweden is by far lower than in any other
European or North American country, although nicotine consumption may not be
lower than in other countries.
In 2001, a New Scientist article summarized the Swedish experience in the
context of tobacco harm reduction:
[S]mokers [in Sweden] aren't faced with the quit-or-die dilemma. Instead of
using a nicotine replacement therapy with the aim of quitting both smoking and
ultimately nicotine, they can continue using tobacco as a recreational drug,
safe in the knowledge that it probably won't kill them. It's all down to a
product called 'snus,' a form of moist ground tobacco that you pop between your
lip and gum.
* * *
The 'Swedish experiment,' as it has come to be known, has inspired some health
campaigners to press for a more enlightened approach to the smoking epidemic.
It's a concept they call 'harm reduction.' 'If you look at Sweden, we have a
living example of the concept in action,' says Clive Bates, director of ASH.
Also of interest is Swedish survey data regarding the use of smokeless tobacco
as a smoking cessation aid presented at two scientific conferences in late 2002.
At the 3rd International Conference on Smokeless Tobacco: Advancing Science and
Protecting Public Health, held in Stockholm, Sweden in September 2002, Dr. Lars
M. Ramström, Director of Stockholm's Institute for Tobacco Studies, reported on
a recent nationwide survey of a representative sample 6,700 adults in Sweden
sponsored by the Swedish National Institute of Public Health. Dr. Ramström
reports the following in the press summary of his presentation:
"Among males snus is the most commonly used and most effective smoking
cessation aid." In support of this conclusion, Dr. Ramström cites survey
data indicating that "76% of male Ever Daily Smokers have made at least one
attempt to quit smoking. Around 40% of the 'triers' report that at their latest
attempt they have used some kind of smoking cessation aid. 36% of these males
have used nicotine gum, 20% nicotine patch and 55% have used snus as a smoking
cessation aid. No other kind of cessation aid has been used by as much as 10%.
The proportion of those who have succeeded to quit smoking completely is 50% for
gum users, 34% for patch users, 65% for snus users."
At the 4th European Conference of the Society for Research on Nicotine and
Tobacco: Improving Knowledge and Treatments of Nicotine Addiction, held in
Santander, Spain in October 2002, Clive Bates made a presentation entitled
"Harm Reduction and Smokeless Tobacco." One of the points made was
that "snus is an important factor in the low smoking prevalence in Sweden.
It is used for cessation and as an alternative to smoking." He cited data
from a 2001 survey commissioned by the Swedish Cancer Society reporting that,
among 1,000 ex-smokers, 33% used snus as a smoking cessation aid, compared to
17% who used nicotine replacement therapies.
The European Union white paper also points to smokeless tobacco as the
explanation for Sweden's low rate of tobacco-related mortality:
Evidence from Sweden suggests snus plays a positive public health role as a
substitute for smoking and as an aid to smoking cessation. It is impossible to
be definitive about this, because it is impossible to run a controlled trial on
a whole nation.
However, consider the following:
· Sweden has the lowest levels of tobacco-related mortality in the developed
world by some distance - approximately half the tobacco related mortality of the
rest of the EU.
· Sweden has the lowest male smoking prevalence in Europe (16% daily) and low
female (c. 22%) prevalence.
· However, it has comparable male tobacco prevalence and total consumption to
neighbours Norway and Denmark - suggesting the big difference is in the type of
tobacco used, rather than overall propensity to use tobacco or consume nicotine.
· About half of tobacco in Sweden is now consumed as snus - this share has
steadily grown since 1970s.
· 33% of ex-smokers report use of snus - almost twice the number that report
use of a pharmaceutical treatment (17%). Among males who have used a single aid
to stop daily smoking, and succeeded to do so, some 70% had used snus and some
30% had used some kind of NRT.
Some have raised a question as to whether the Swedish experience is applicable
to the United States, asserting that Swedish moist snuff products contain lower
levels of so-called tobacco-specific nitrosamines (some of which have been
reported to be laboratory carcinogens) than U.S. moist snuff products. For
example, Professor Newell Johnson in an article published in 2001 entitled
"Tobacco Use and Oral Cancer: A Global Perspective" conceded that
"on present evidence, snuff habits as they exist in Scandinavia and
probably in the United States carry lower risk of serious health hazards"
than cigarette smoking, but also made the following comment:
In Scandinavia it is clear that local snuff is not a major risk factor: two
recent case-control studies of oral cancer cases in Sweden have failed to show
an association. This is because Swedish snus is not fermented and contains much
lower nitrosamine levels than fermented tobaccos. The view that smokeless
tobacco use may be associated with a lower risk of oral cancer in the United
States has led to a movement to advocate the practice as a less dangerous
alternative to smoking and an aid to nicotine withdrawal in those addicted to
smoking.
In fact, there is currently no significant difference in tobacco-specific
nitrosamine (TSNA) levels in U.S. moist snuff products compared to Swedish moist
snuff. Data reported in scientific literature by researchers from the American
Health Foundation, together with data published by Swedish researchers, show
that the average levels of TSNAs in the major U.S. the moist snuff products
decreased 77% between 1980 and 1994 (the last time that data for both of these
products was reported in the scientific literature), and that currently there is
no significant difference between the levels of TSNAs in those products compared
to Swedish moist snuff products. A chart depicting this data follows:
TSNA
=Total of reported levels of NNN, NNK, NAT and NAB on dry weight basis in parts
per million
US = Average of reported TSNA levels for leading
American moist snuff products which, according to the researchers,
“accounted for 84% of the snuff sales on the US market (Maxwell,
1992),” excluding anomalous data for 1986
Sweden = Average of reported TSNA levels for three
unidentified Swedish moist snuff products
* No comparable data reported in the scientific
literature for any period after 1994
TSNA =Total of reported levels of NNN, NNK, NAT and NAB on dry weight basis
in parts per million
US = Average of reported TSNA levels for leading American moist snuff products
which, according to the researchers, "accounted for 84% of the snuff sales
on the US market (Maxwell, 1992)," excluding anomalous data for 1986
Sweden = Average of reported TSNA levels for three unidentified Swedish moist
snuff products
* No comparable data reported in the scientific literature for any period after
1994
This view is supported by a report issued in 1997 by the Swedish National
Board of Health and Welfare, which concluded:
Recent data suggest that the differences [in TSNA levels reported in American
and Swedish moist snuff] have grown smaller, and that it is now questionable to
make a sharp distinction between use of American and Swedish moist snuff when
assessing risks -- at least where TSNA content is concerned.
F. The Gateway Issue
One argument relied upon by those who oppose the use of smokeless tobacco as a
component of a tobacco harm reduction strategy is that smokeless tobacco may be
a causal "gateway" to cigarette smoking, that is, smokeless tobacco
use may cause consumers to later take up cigarette smoking.
The authors of the EU white paper reject the notion of a causal
"gateway" from smokeless tobacco to cigarette smoking based upon their
assessment of empirical data from Sweden and their analysis of the studies
relied upon by those who argue that there is a "causal" gateway
effect. Indeed, the authors of the EU white paper conclude that the Swedish data
suggest that smokeless tobacco prevents rather than promotes cigarette smoking:
Gateway effects. There is concern that smokeless tobacco will function as a
lead-in to smoking for people that would not otherwise smoke. Such 'gateway
effects' are always contentious, and they are hard to demonstrate for the simple
reason that we do not know what smokeless users would have done in the absence
of smokeless tobacco - they may have simply moved straight to smoking. Gateways
can act in the opposite direction too - they can be 'exits' rather than
'entrances'. Smokers may move to smokeless tobacco or use smokeless tobacco to
quit, where they would otherwise have continued to smoke. Starters on smokeless
tobacco may continue as smokeless users but otherwise have started with
cigarettes, so that smokeless tobacco is a diversion from smoking. In both the
US and Sweden, most smokeless tobacco use cannot be a gateway to smoking, either
because smokeless users never started smoking or because they started smoking
first. For the minority who started using smokeless before cigarettes they may
or may not have had their smoking caused by smokeless use.
Exit or entrance gateway? Understanding the order in which tobacco users take up
different products is an important and necessary factor in establishing a
gateway effect and whether the gateway is an exit from or entrance to smoking,
but it is not in itself sufficient to establish a gateway from smokeless to
cigarettes. The basic problem is that it is difficult to know whether those that
start with smokeless tobacco would otherwise have started on cigarettes in the
absence of smokeless tobacco. The data from Sweden suggest that the gateway is
more likely to be an 'exit' from smoking than an 'entrance'. Among Swedish males
with a primary use of snus no more than 20% ever started smoking, while 45% of
other males did become smokers. In addition to this compelling evidence from the
pattern of transitions, Sweden has the lowest rate of male smoking in Europe,
combined with high levels of snus use. There is no other credible explanation
for such low male smoking prevalence than the displacement and cessation of
smoking through smokeless tobacco use. In total therefore, the Swedish data
suggest that uptake of snus use prevents rather than promotes smoking and
therefore contributes a net public health benefit. There have been studies in
the United States that claim to show a gateway effect from smokeless tobacco use
to smoking for a minority of smokeless users. However, these studies or related
commentary have generally drawn causal inferences based on observation of
transitions between often poorly defined categories of tobacco use, and
sometimes from groups that are unrepresentative of the general population, such
as the military. Psychosocial predictors of smoking initiation (school
performance, parental smoking, risk taking etc.) can be used to assess which
smokeless tobacco users might otherwise have been smokers. When these
confounding factors are taken into account, the data do not show that initial
smokeless tobacco use adds to the propensity to become a smoker.
Additional data from Sweden contradicting the theory of a causal
"gateway" from smokeless tobacco to cigarette smoking was recently
published by Rodu et al. in a paper entitled Evolving patterns of tobacco use in
northern Sweden. The researchers report on their analysis of data from a
prospective follow-up study of approximately 3,400 men and women in northern
Sweden, and describe the evolving patterns of tobacco use in this population
over the period 1986 to 1999. While the researchers conclude that "the use
of snus played a major role in the decline of smoking rates amongst men in
northern Sweden," some of their data is of particular relevance to the
"gateway" issue. They report that among men who used moist snuff but
had never smoked at the beginning of the study, not a single person switched to
cigarette smoking during the follow-up period of 5 to 13 years, and only 1
percent of these men used both moist snuff and cigarettes during the follow-up
period.
G. Cigarette Smokers' Misperception that Smokeless Tobacco and Cigarettes
Involve Equal Health Risks and Their Right to Accurate Information
At the November 2001 meeting of the National Conference on Tobacco or Health in
New Orleans, Louisiana, Dr. K. Michael Cummings of New York's Roswell Park
Cancer Institute, and his colleagues, presented results of a survey of a
nationally representative sample of over 1,000 adult cigarette smokers regarding
their beliefs about tobacco products. Of particular interest was the fact that
82% of adult cigarette smokers responded that they believed smokeless tobacco
was just as likely to cause cancer as smoking cigarettes.
Given these survey results, it was not surprising that in a 2002 publication,
Dr. Cummings made the following comments regarding the comparative health risks
of smokeless tobacco and cigarettes, and the need to provide adult cigarette
smokers sufficient information to permit them to make informed choices regarding
the tobacco products they choose to use:
Competition to produce more consumer-acceptable medicinal nicotine products
would be helped by educating consumers about what factors in tobacco products
really contribute to disease risk. Ironically, many smokers do not perceive much
difference in health risk between smokeless tobacco products, nicotine
medications and cigarettes. Yet if all nicotine products were put on a risk
continuum the actual difference between smokeless and nicotine medications would
be seen as fairly minor compared to the difference in disease risk between
smoked and smokeless products (Stratton et al. 2001). Until smokers are given
enough information to allow them to choose products because of lower health
risks, then the status quo will remain. Capitalism, and not governmental
regulation, has the greatest potential to alter the world-wide epidemic of
tobacco-related disease. (Emphasis supplied)
Professor Kozlowski has also commented recently concerning the urgent need to
provide cigarette smokers with information regarding risk reduction options and
their right to receive such information:
Cigarettes kill about half of those who smoke them . . . It is urgent to inform
smokers about options they have to reduce risk. This needs to be done in ways
that inform smokers as fully as possible that never starting and complete
quitting as soon as possible are the best choices to promote health, while also
indicating that snus or medicinal nicotine (the latter more than the former)
would be preferable to continued smoking. Also, complete substitution of these
products should be encouraged over mixing them with continued smoking. The harm
reduction message will be complex. There will be many ways to give it. Some will
misinterpret even the most artfully framed message. Notwithstanding, public
health policy in this instance lacks compelling justification to override the
human rights of the individual. Individuals have the right to such health
relevant information.
H. USSTC's Request for FTC Guidance
On February 5, 2002, USSTC filed a request with the FTC seeking issuance of an
advisory opinion regarding the acceptability of communicating in advertising
that smokeless tobacco products are considered to be a significantly reduced
risk alternative as compared to cigarette smoking (See Website). USSTC noted in
its request that issuance of an advisory opinion by the FTC would address an
issue of significant public interest to adult tobacco consumers, USSTC, and
other smokeless tobacco manufacturers. USSTC explained the rationale behind its
request as follows:
USSTC requests that the Commission issue an advisory opinion supporting the use
of statements in advertising that provide the public with truthful and
substantiated information about the harm reduction that a growing number of
public health advocates believe can result from switching from cigarettes to
smokeless tobacco products. The benefits of making such information available to
consumers would be twofold: it would provide ready access to scientific opinion
that otherwise would be difficult or costly to obtain, and it would help adult
consumers make better educated choices about the tobacco products they use. As
the federal agency with authority over tobacco advertising, the FTC should act
affirmatively to provide guidance in this area.
USSTC believes that the types of information it proposes to communicate in
advertising are truthful, non-misleading and substantiated. At the same time,
USSTC recognizes that cross-category (i.e., smokeless tobacco advertisements
directed at adult smokers) comparative advertising of reduced risk tobacco
products raises issues which currently are the subject of ongoing public health
debate. Providing USSTC with an advisory opinion would inform USSTC and other
smokeless tobacco manufacturers of the criteria the FTC will apply when
considering such statements. At a minimum, FTC consideration of these issues
would advance the public debate on the issue of tobacco harm reduction, and
increase the amount of information available to the public regarding reduced
risk alternatives to cigarette smoking. Indeed, as part of its consideration of
this request, the FTC may wish to hold a public workshop or similar forum to
facilitate a full exchange of views on the issues involved.
USSTC's request made clear that any statement USSTC made would be truthful and
non-deceptive, and gave an example of the type of statement contemplated:
USSTC proposes to disseminate advertisements with the following or similar
statements:
The Surgeon General in 1986 concluded that smokeless tobacco "is not a safe
substitute for smoking cigarettes." While not asserting that smokeless
tobacco is "safe," many researchers in the public health community
have expressed the opinion that the use of smokeless tobacco involves
significantly less risk of adverse health effects than smoking cigarettes. For
those smokers who do not quit, a growing number of researchers advocate
switching to smokeless tobacco products.
Following the submission of its request to the FTC, USSTC representatives met
with FTC staff representatives on May 21, 2002 in order to present an overview
of various issues relating to its request, as well as to answer any questions
that might be raised by the FTC staff. Following the presentation and
discussion, USSTC provided to the FTC staff additional information and
documentation responsive to their requests. A similar meeting was held with
representatives of Department of Health and Human Services public health
agencies on May 30, 2002. Copies of the presentation materials relating to these
meetings are annexed as Attachments B and C.
In the spring and summer of 2002, smokeless tobacco and tobacco harm reduction
was the topic of discussion and debate at various scientific conferences and
public policy forums in the United States and abroad. On May 16, the subject was
discussed at a scientific conference in London entitled Harm Reduction, Smoking
and Smokeless Tobacco; on May 29, the issue was the subject of a forum entitled
Marketing Highly Regulated Products at Northwestern University in Chicago; on
June 20 through 22, the issue was discussed at the Third European Conference on
Tobacco or Health in Warsaw, Poland; on June 26, the issue was debated at a
seminar sponsored by the American Council on Science and Health in New York
City; and on July 16, the issue was the subject of debate at the CATO Institute
in Washington, DC.
In the summer of 2002, USSTC became aware of the scheduling of two very
important scientific conferences that would include a public debate directly
relevant to USSTC's request. On September 22 through 25, 2002, the Centers for
Disease Control, the National Cancer Institute, and the Stockholm Center of
Public Health, Center For Tobacco Prevention, would sponsor the 3rd
International Conference on Smokeless Tobacco: Advancing Science &
Protecting Public Health, in Stockholm, Sweden. The conference would bring
together leading experts on smokeless tobacco, and feature a session on tobacco
harm reduction. Similarly, the 4th European Conference of the Society for
Research on Nicotine and Tobacco was to be held on October 3 through 5, 2002, in
Santander, Spain. This conference would also include discussion and
presentations of research findings on current scientific issues relating to
smokeless tobacco, including harm reduction. In view of the pendency of these
scientific conferences, on August 12, 2002, USSTC temporarily withdrew its
request for an advisory opinion so that it would have the opportunity to provide
for the FTC's consideration significant new information expected to be presented
at these conferences.
On May 9, 2003, USSTC submitted to the FTC information regarding smokeless
tobacco as a reduced risk alternative to cigarette smoking that had been
presented or published subsequent to the August 2002 temporary withdrawal of its
request for FTC guidance. As expected, the Stockholm and Santander conferences
produced important new information relevant to USSTC's request. More
significantly, however, two publications had appeared in late 2002 or early 2003
that will have a major impact on the public debate regarding smokeless tobacco
in the context of tobacco harm reduction. Those publications, discussed above,
are a report from London's Royal College of Physicians and a white paper
prepared by a group of European tobacco and health researchers and public health
advocates. In addition, several other scientific publications or documents had
appeared that were relevant to USSTC's request for FTC guidance.
Significant new information from the above-referenced scientific conferences and
publications was reviewed in USSTC's May 9, 2003 filing, submitted together with
copies of the referenced materials (See Website).
USSTC suggested in its submission to the FTC that the Commission may wish to
consider holding a workshop or other forum to address the appropriateness of
conveying tobacco harm reduction information as part of smokeless tobacco
advertising. USSTC continues to believe that such a workshop would afford all of
the participants in this public health debate an opportunity to present their
views in a constructive and productive manner. It might also help form a
consensus as to how we move forward on this important public health issue and
could provide guidelines to ensure that any comparative risk communication is
directed at adult smokers to avoid any unintended consequences.
III. Conclusion
Some tobacco control activists have taken the position that USSTC should be
prevented from communicating to adult cigarette smokers the prevailing view in
the scientific community regarding the comparative health risks of tobacco
products. Interestingly, they also believe that neither the federal government
nor the public health community has any responsibility to undertake that task.
On the other hand, some in the public health community believe that
communication of that vital information could have a significant positive impact
on the lives of adult cigarette smokers. Indeed, some in the public health
community believe that USSTC must confront the question of whether it has a
responsibility to step forward and communicate this critical information to
adult cigarette smokers in light of the vacuum created by the federal government
and the tobacco control activists.
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