The Sup-cvne C`L)LII.~ of C`alit~~rnia rejected the
preemption argument and held that the cause of dc-
tion against the nd\.ertisin~-that it improperI\
targeted minors--\vould stand. According to the tour;,
the ad\,ertising had apparently been effecti1.e in tar-
geting adolescents: Camel cl+
                 `t~3rettes rt'ere chosen b\
an estimated 0.5 percent of teenage smokers in lY&
(the last full year of sales before the Joe Camel cam-
paign) and by an estimated 25-33 percent in 1992 (as
quoted in the decision; other sources cite a substan-
tial, although smaller, increase (CDC 1991b]). In 1992,
teenage smokers accounted for about $176 million of
Camel sales, a vastly greater amount than the $6 mil-
lion in sales for 1988 (Mi711,yyi11i, p. 1060). The portion
of the MITJI@II~ lalvsuit regarding the Joe Camel ad\Ter-
tising campaign \vas settled September 8, lYY7, tvhen
R.J. Reynolds agreed to cease placing Joe Camel on
California billboards, placing Joe Camel materials in
magazines and ne\vspapers, and distributing proniu-
tional materials through retail mechanisms (M1711::i/li
il. R.]. Rel/rzo/& T&?ri-c~ Co., iitvil if? 12.5 TPLR 3.319
[1997]). it also agreed to pay the cities and counties
that had joined the action as co-plaintiffs SY million
for a counteradvertising campaign, presumable to dis-
pel the lingering effects of the Joe Camel marketing.

  In another state, Washington, a pri\,ate action
using that state's la\v failed to prohibit adiwtising
using Joe Camel (Sfmrii.; ~1. X.1. Rct//mlds 72wc-~-o Ccl., Ko.
CY4783C [W.D. Wa. Dec. 9, 194-I], citvll irk Y.6 TI'LR
2.171 [19Y3]). Nonetheless, the decision of the Supreme
Court of California indicates that at least in some in-
stances in some jurisdictions, private parties acting as
representatilres of the general public can bring an

Product Regulation

action normally brought only under specific federal
or state la\v against cigarette advertising.

  Thus, as tvith a number of other legal issues (see
"Litigation Approaches," later in this chapter), the
judicial response to aggressive pursuit of legal policy
options is still unfolding. Although the process of le-
galls regulating tobacco advertising and promotion
has-been under \vay for decades, the extent of such
regulation and its ultimate limits are not yet known.

  The most significant developments in this area
revol\:ed around the release of-and subsequent
reaction to-the FDA'sAugust 10,1995, preliminaryde-
termination. The determination accompanied a pro-
posed rule that sought to restrict the availability and
marketing of tobacco products to children and adoles-
cents. The FDA's final determination that it had au-
thoritv to regulate cigarettes and smokeless tobacco
products (released on August 28,1996) is discussed later
in this chapter, where the analysis of product regula-
tion focuses on "Further Regulatory Steps."

  Arguably the second most important develop-
ment in this area was the June 20,1997, proposed agree-
ment that \vould have settled lawsuits between 41 state
attorneF.5 general and the tobacco industrv. Because
the ad\wtising and promotion provisions of that agree-
ment directlv presupposed legislation that would have
upheld the FDA'S asserted jurisdiction to regulate to-
bacco products, this key multistate agreement is, like
the FDA announcemelit, discussed later in this chap-
ter, \vhcre the analysis of product regu!ation focuses
on "Legislati1.e De\.elopments" and "Master Settle-
ment I\greenient."

Introduction

  Cigarette smoke contains approximately 1,000
chemicals, including a number of carcinogens and other
toxic chemicals, such as hydrogen cyanide and oxides
of nitrogen (USDHHS 1989). Regulating tobacco prod-
ucts requires appropriate assessment of these primary
and secondary products of combustion and other sub-
stances that mav be inhaled. Current tobacco product
regulation requires that cigarette advertising disclose
levels of "tar" (an all-purpose term for particulate-
phase constituents of tobacco smoke, man\; of w,hich

are carcinogenic or otherwise toxic) and nicotine (the
psychoactiv-e drug in tobacco products that causes ac-
diction [USDHHS 19881) in the smoke of manufactured
cigarettes and that warning labels appear on packages
and on some (but not all) advertising for manufactured
cigarettes and smokeless tobacco;' the current federal


la\vs preempt, in part, states and localities from impos-
ing other labeling regulations on cigarettes and smoke-
less tobacco (see the pre\.ious major section,
"Ad\.ertising and Promotion").

  Since the mid-198Os, federal la\\- has required
makers of manufactured cigarettes and of smokeless
tobacco products to submit lists of additi\,es to the
tobaccos (but not to filters or papers) in their products
to the Secretarv of Health and Human Services (Com-
prehensive Smbking Education Act, Public Lalj. 98-371,
sec. 5; Comprehensive Smokeless Tobacco Health Edu-
cation Act of 1986, Public Laiv 99-252, sec. 4). Infor-
mation about the quantitv ofadditi\.es used ancl their
placement in specific brands is not required, and the
Secretary is bound by lalz to safeguard the lists from
public disclosure. In 1991, attornevs for six manufac-
turers released to the public the.list of ingredients
added to tobacco in 1993.

  Tobacco products are explicitly protected from
regulation in \.arious federal consumer safetv 1`~~~s
(L'SDHHS 198Y). Although regulation requirtis pub
lit reporting of some constituents in cigarette smoke,
cigarette manufacturers are not required to report to a
go\-ernmental body (or to include on product labels
for consumers) brand-specific information about the
nicotine content or anv other propertv (e.g., nitro-
samine le\.els, ammonia le\,el, pesticide resiclues,
heavy metals [lead, cadmium, mercury, or chromium],
pH, or sugar content) of the material that forms the
tobacco rod of their products. At the \`erv least, know,l-
edge of the upper bound of nicotine in the tobacco rod
of cigarettes is important because actual smoking ma\;
produce constituent levels that \.arv considerably from
that in smoke deliverv yields reported to the FTC
(USDHHS 1988; see also "Compensatory Smoking,"
later in this chapter). Those measurements were con-
ducted by the Tobacco Institute Testing Laboratory.

  The Comprehensive Smokeless Tobacco Health
Education Act of 1986 requires smokeless tobacco
manufacturers to report the total nicotine content of
their products to the Secretarv of Health and Human
Services (Public Law 99-252, sec. 4), but the Secretary
may not release the data to the public. A uniform pro-
tocol implementing this provision M'as published in
the March 23, 1999, Fedcrnl R~@~trr. No federal public
health laws or regulations apply to cigars, pipe tobac-
COS, or fine-cut cigarette tobaccos (for "roll-your-o\vn"
cigarettes) in anv manner other than prohibiting the
advertising of small cigars through electronic media
(USDHHS 1989).

The Constituents of Smoke From
Manufactured Cigarettes

  Since 1967, the FTC has regularly published
tables of tar and nicotine delivery of smoke from manu-
factured cigarettes. Since 1980, the tables have also
included a measurement for carbon monoxide
deliverv. The data are based on results of a standard-
ifed, machine-dri\ren test procedure (Pillsbury et al.
1969) that provides a basis of comparison among vari-
ous brands of cigarettes. Manufacturers are not re-
quired to print these values on the product package,
but "ultra Io~v" cigarette brands often include tar and
nicotine deliveries on the package, presumably to dif-
ferentiate these brands (Davis et al. 1990). No brand
ha\ing a tar yield above 11 mg prints this information
on the package. Carbon monoxide deliveries are not
listed either on packages or in advertising (USDHHS
1989).

Regulation by Tar Levels

  The FTC's tables of tar le\,els have provided some
jurisdictions \vith criteria for regulating tar content by
le\,ying taxes on higher-tar cigarettes or, in the case of
countries in the European Union, by altogether ban-
ning high-tar cigarettes. The apparent assumption be-
hind such action-that discouraging or banning
consumption of higher-tar cigarettes will result in
reduced morbidity and mortality from smoking-
related diseases-has been questioned, as is discussed
in the section "Compensatory Smoking," later in this
chapter.

   Tar content has in several instances served as the
basis for cigarette taxation, on the presumption that
the taxing structure would provide a competitive ad-
l'antage to low-tar brands-an advantage of interest,
for supposed public health reasons, to the jurisdiction
levying the tax. For several years beginning in 1971,
New York City taxed cigarettes that had either tar
yields over 17 rng or nicotine yields over 1.1 mg an
additional 3 cents per pack and cigarettes that exceeded
both thresholds, 4 cents (Lc~rrg Islnr~il K~bncco C~J., fr~c. ~1.
Limfqt/, 74 Misc. 2d 445,343 N.Y.S.2d 759 [N.Y. 19731).
Although the levy was upheld by the courts, the law
seems to have been repealed because of allegations that
unequal taxation across political boundaries was fos-
tering smuggling (Ranzal 1973). There are no reports
on the effects this tax may have had on consumption
patterns.

  In 1978, the British government imposed a
supplementary tax on cigarettes having a measured
tar yield greater than 20 mg (Gray and Daube 1980


Figure 5.1. Sales-weighted nicotine and tar levels in smoke as percentage of 1982 levels

1  Average of all brands*

YO(   1   ,   ,   ,   ,   (   (   ,   ,   ,   ,   ,   ,   ,   ,  901
1982  1983  1986  lY88  19YO  1992  1991  1996        1982 1984 1986 1988 1990 1992 1994 1996

                 Year                                      Year

1  Low-tar category (6-15 mg tar)*

90
1982  1981  1486  1988  1YYO  199' 19'34  1YYh

                \I'mr

                                -  Nicotine

*By Federal Trade Commission method.

1  High-tar category (>I5 mg tar)*

1  Ultra-low-tar category (~6 mg tar)#

YU/   ,   I   ,   ,   1   ,   ,   ,   ,   ,   ,   ,   ,   ,   ,
1982  1984  19%  1988  1990  1992  1994  1996

                Year

- Tar

Source: Kessler 1994b; Federal Trade Commission, unpublished data, 1998.

[note misprint in this publication: on page 93, line 3,
"more" should ha\,e been "less"; correction furnished
by Michael Daube, Februarv 13, 19961). Within three
months of the imposition of the tax, the market share
of such brands fell from 15 to 3 percent (Michael M.
Daube, letter to John Siade, February 24,1995). Asirni-
lar tax was used in Sweden, but it IVas repealed to
achieve uniformity Lvith tax policies of the European
Union (Paul Nordgren, letter to Da\,id T. Sweanor,
December 23,1994).

  Among countries in the European Union, a
fixed ceiling on tar content has been used as a regu-
latory method. The European Union has imposed a

graduated decline in the upper limit of tar deliveries
permitted for cigarettes sold in member countries. Be-
ginning January 1, 1993, the ceiling was 15 mg tar
delivery per cigarette; after December 31, 1997, the
ceiling \vas 12 mg (Council Directive 90/239/EEC
1990 O.J. [L 1371).

Implications of Nicotine Levels

   The FTC's tables on nicotine levels have revealed
a recent change in the ratio of tar to nicotine in ciga-
rettes. Kessler (1994b) has reported that for 1982-1991,
the ratio of average sales-weighted nicotine yield to


tar yield' in cigarette smoke has risen steadily for each
of three major tar-yield categories and for the overall
market (Figure 5.1). Gi\,en the addictive properties of
nicotine and its contribution to cardio\,ascular disease
(USDHHS lY88), this change may have important pub-
lic health implications. Moreo\-er, "lots-yield" and
"ultra lolz--yield" cigarettes in the same period had
higher nicotine yield to tar ratios than did brands in
the high tar-!lield categories. Consumers Ivho pay
more heed to the "numbers" for tar le\rels than to the
much smaller (but no less important) numbers for
nicotine levels may be under the illusion that the): are
reducing their health risks and increasing their
chances of quitting by smoking "lo\\`-tar" cigarettes.
(This illusion is further discussed in "The Lo\\.-Tar
`AlternatixTe,' " later in this chapter.)
  A manufactured cigarette generally contains

ii-10 mg of nicotine (USDHHS 19881, regardless of the
machine-measured nicotine deli\,erv in the smoke. L`n-
der usual smoking conditions, consumers absorb about
lo-30 percent of the nicotine contained in the tobacco
rod of the cigarette (USDHHS 1988; Beno'rvitz and
Henningfield 1994). Some thought has recently been
given to systematically lo\vering the nicotine content
of tobacco products to le\rels that \vould not pose a
threat of addiction (Benowitz and Henningfield 19%;
Douglas 1994). Benowitz and Henningfield (199-l) ha1.e
suggested that addiction is unlikely to be sustained
below a nicotine dose of about 5 mg ier day. This dose
is about one-fourth the dailv dose commonly ingested
by tobacco users. To achie\e such a ceiling for ciga-
rettes, the nicotine content of the tobacco rod Lvould
have to be 0.5 mg or less, assuming that the smoker
consumes about 30 cigarettes per day and receives 30
percent of the nicotine available. Ho\ve\,er, cigarettes
with such low levels of nicotine may not be popular
(Campbell 1994). The experience of Philip Morris
Companies Inc. in trying to sell a low-nicotine-content
cigarette, "Next," illustrates this point; the company
judged the test-marketing of this cigarette a failure.
Such failure provides indirect support for the impor-
tance of nicotine addiction to the tobacco industrv.

Mandating the reduction of nicotine for the
purpose of weaning smokers from tobacco products
\\-as contemplated as a strategy available to the FDA
in legislation proposed to enable the multistate settle-
ment agreement with the tobacco companies (see

"Legislative De\,elopments" and "Master Settlement
Agreement," later in this chapter). A similar strategy
is used in some voluntary stop-smoking programs (e.g.,
Gahagan 1987). But this strategy cannot work unless
accurate measures are available of the actual nicotine
uptake that smokers and other tobacco users receive.

  In 1994, the NC1 convened an ad hoc expert com-
mittee to determine the adequacy of the standard,
smoking-machine-based, FTC protocol for determin-
ing the tar and nicotine content of cigarettes. The com-
mittee concluded that "the FTC test protocol was based
on cursory observations of human smoking behavior.
Actual human smoking behavior is characterized by
\vide variations in smoking patterns, which result in
[Tide \.ariations in tar and nicotine exposure. Smok-
ers i\,ho slvitch to lolzer tar and nicotine cigarettes fre-
quently change their smoking behavior, which may
negate potential health benefits" (NC1 1996, p. vi).

  III 1496, Massachusetts enacted a law designed
to obtain reports of brand-specific nicotine levels that
more closelv approximate the uptake by actual smok-
ers of the& brands. The statute instructs the state
Department of Public Health to establish standards for
nicotine yield ratings that "accurately predict nicotine
intake for a\.erage consumers" (Mass. Gen. Laws ch.
93, sec. 3078). Each cigarette and smokeless tobacco
manufacturer must then report, in a manner consis-
tent \z,ith these standards, the nicotine yield rating of
each brand of tobacco products it produces. These
reports become public records.

Other Constituents in Cigarette Smoke

   Tar and nicotine measurements have tradition-
ally been used as surrogate measures for other toxic
constituents in cigarette smoke, because changes in tar
and nicotine levels presumably are predictive of
changes in the levels of most other particulates. Stud-
ies suggest otherwise. For example, tar level as mea-
sured by smoking machines is not a good predictor of
benzo[a]pyrene level (Kaiserman and Rickert 1992). In
general, declared tar values are not predictive of
tobacco-specific nitrosamine levels (Fischer et al. 1990,
1991b). Similarly, tar delivery is a poor predictor of
the delivery of gas-phase constituents, such as carbon
monoxide, hydrogen cyanide, and acrolein (Young et
al. 1981).

  In Canada, the Department of National Health and
Welfare (Health Canada) has undertaken a program to
develop methods for collecting and analyzing toxic
constituents, other than tar, nicotine, and carbon mon-
oxide, in tobacco smoke. Methods have been devel-
oped to measure the levels of benzo[a]pyrene, the


tobacco-specific nitrosamines, h!-drogen cyanide, ben-
zene, formaldeh\,de, I-amino-biphen~l, and hea\.v
metals such as lectcl and cadmium (Health Canada
lYY5a). The Department of National Health and Wel-
fare intends to require manufacturers to use these test
methods to provide quantita ti\,e reports on these chemi-
cals in tobacco smoke or, in the case of heavv metals, in
the tobacco itself (Health Canada lYY5a).

  Rickert (I 994) has described the presence of the
potent bladder carcinogen I-amino-biphenvl in the
sidestream smoke from all 10 brands of cigarettes
tested in a study for Health Canada. Under occupa-
tional safety regulations, the permissible level of ex-
posure to 4-amino-biphenyl is zero. Applying these
standards to cigarette smoke rvould require either that
this material be absent from cigarette smoke entirely
or that cigarette smoke not be permitted in spaces sub-
ject to regulation.

  An important de\.elopment indicating a possible
design flare in the manufacture of cigarettes has been
the report that cellulose acetate fibers are shed from ciga-
rette filters. Such fibers, coated ivith tar, have been ob-
served in the lungs of smokers; this obscr\.ation suggests
that these fibers may be long-li\.ed in human tissue and
may be associated with disease (I'aulv et al. lYY5).

Additives to Tobacco Products

  Hundreds of ingredients besides tobacco are used
in the manufacture of tobacco products. Additives
make cigarettes more acceptable to the COIISU~~~; thcv
can make smoke seem milder (and easier to inhalei,
prolong shelf life, prolong burning, and impro\.e taste.
These additives may be a single chemical used as a
humectant or a complex mix of chemicals used as a
flavorant.

Cigarette Additives

  The six major cigarette manufacturers reported
a pooled list of 599 ingredients that \vere added to the
tobacco of manufactured cigarettes as of 1991 (R.J.
Reynolds Tobacco Company 19%). The list is anno-
tated lvith references to Ivhich materials are approved
for use as food additives by the FDA (under the cat-
egor) "Generally Recognized as Safe") and are thought
to be safe by the Fla\,or and Extract Manufacturers
Association of the United States. HoFvever, that a
material is regarded as safe \vhtn ingested in foods
provides no assurance of its safety in a tobacco prod-
uct, Mrhere it \viIl be combined bzith other substances,
heated to high temperatures, and may be inhaled into
the lungs.

  The American Health Foundation (1990) has
pointed out the toxic potential of numerous cigarette
tobacco additives under expected conditions of use.
Heating and burning may lead to the formation of car-
cinogens from some of the additives used. For in-
stance, amino acids used as additives are known to
form compounds of various elements, including
genotoxic agents (known to damage DNA) and experi-
mental carcinogens, during heating. Licorice root ex-
tract contains glycyrrhizin, and both are used as
additives in cigarettes; glycyrrhizin produces carcino-
genic by-products when burned. The leukemia-
producing agent benzene is a component of cigarette
smoke that may be formed from the combustion of
many cigarette additives. Because the Federal Food,
Drug, and Cosmetic Act requires that a food additive
"be safe under the conditions of its intended use" (sec.
321), tobacco additives in manufactured cigarettes may
not fulfill the specifications of the law were the law
applied to tobacco.

  The use of additives may reinforce cigarette
smoking by strengthening the addictive effects of nico-
tine. At least one major domestic cigarette maker uses
some additives to boost the absorption of nicotine in
cigarette smoke (Kessler 1994~). Ammonia compounds
alter the pH of nicotine in tobacco, converting it from
the protonated, bound form (various nicotine salts) to
the unprotonated, freebase form. Freebase nicotine
more readily enters the smoke stream and has been
predicted to cross lung and oral cavity membranes
more quickly than nicotine salts do (Henningfield et
al. lYY5). The broader issue of enhancing the delivery
of nicotine is discussed in the introductory section of
"Further Regulatory Steps," later in this chapter.

  Sel,eral European countries regulate cigarette ad-
diti\,es, but onlv to a modest extent. In France, the to-
tal percentage df the cigarette that consists of additives
is listed on the side of the package. Among representa-
ti\re brands manufactured in the United States but sold
in France (e.g., Camel, Kent, Marlboro, and Winston),
the cigarette labels indicate that between 6.2 and 10.0
percent of each cigarette is composed of additives. The
British government maintains a list of "permitted" or
"nppro\red" additi\,es for smoking tobacco and ciga-
rette paper (Le\vis and Davis 1994, p. 206). The list,
ivhich had 474 ingredients in 1988, specifies the maxi-
mum le\,el permitted for each specific additive (Lewis
and Davis 19Y4). In Canada, the Tobacco Products Con-
trol Act (sec. 10; Department of National Health and
Welfare lY8Y) requires manufacturers to report a quar-
terly list of ingredients used in their products. Cana-
dian producers use far fewer additives-about 50 in
all-than do American manufacturers.


  Massachusetts, Minnesota, and Texas ha\,e en-
acted laws to require the disclosure of nontobacco in-
t?redients in tobacco products (Mass. Gen. Lalvs ch.
$4, sec. 307B; Minn. Larys ch. 227 [ 1997); Vernon's Texas
Statutes and Codes Annotated ch. 161, sec. 161.252
[199i]). Health officials in the Canadian province of
British Columbia ha\,e announced their intention of
taking similar steps there.

  The Massachusetts la\v, applicable to cigarettes
and smokeless tobacco, requires the manufacturer to
report, in descending order bv 12-eight, measure, or nu-
merical count, the identitv of each brand's added con-
stituents other than tobacco, reconstituted tobacco
sheet, or bvater. Ingredients that are recognized as safe
\\Then burned and inhaled are exempted. The Depart-
ment of Public Health is then instructed to disclose the
reported information to the public to the extent that
"there is a reasonable scientific basis for concluding that
the availabilitv of such information could reduce risks
to public health" (Mass. Gen. La\vs ch. Y-I, sec. 3078).

  The tobacco industry challenged the statute in
court on both preemption and trade secret grounds.
The Federal District Court ruled that nothing in fecl-
era1 la\v preempted Massachusetts from taking this
action, and the court of appeals affirmed (P/~i/i/l !l/lrll--
rig LITC. P. Hr7~s/~h7l;sy~~, 122 E3d 58 [lst Cir. 19971). Horn-
ever, the same Federal District Court thereafter issued
a preliminarv injunction that pre\.ented the state from
enforcing th'e ingredient disclosure provision of the
statute; the court ruled that doing so \vould expose
the trade secrets of the manufacturers (Pl~i/i/~ Morris
Irlc. :I. Hnrshha,~~~, Civil Action No. 96-113YY-GAO,
Civil Action No. Yh-11619-GAO, 1997 U.S. Dist. LEXIS
21012 [D. Mass. Dec. 10, 1997]). That ruling is cur-
rently under appeal. Texas has adopted a similar stat-
ute requiring the tobacco industry to submit a list of
ingredients and nicotine vield ratings to the Texas
Department of Health by -December 199X (Vernon's
Texas Statutes and Codes Annotated ch. 161, sets.
161.252, 161.254, 161.255).

  The Minnesota statute requires manufacturers of
tobacco products to publiclv disclose, for each brand,
ivhether the product contains detectable levels-in
either its unburned or its burned states-of ammonia
or ammonia compounds, arsenic, cadmium, formal-
dehyde, or lead. The industrv filed suit in Federal Djs-
tric;Court to enjoin the enfoicement of the statute but
agreed to drop the suit as part of its Mav 1998 settle-
ment of the state's Medicaid reimbursement la\vsuit
(discussed in "Recoverv Claims by Third-Party Health
Care Payers," later in this chapter) (Mirrrwsot~7 7'. Philip
Morris Iuc., citcll ill 13.2 TPLR 3.3Y, 3.45 [1998]).

  Most recently, British Columbia health officials
announced plans to require cigarette manufacturers
to disclose to the government all ingredients, includ-
ing additives used to treat the papers and filters.
Manufacturers ~~rould also have to test and report on
44 poisons that the health officials claim are contained
in cigarette smoke (Reuters 1998).

Smokeless Tobacco Additives

   In 199-f, ten manufacturers of smokeless tobacco
products released a list of additives used in their prod-
ucts (Patton, Boggs & Blot2 1994). As with the addi-
ti1.e list for cigarette tobacco, the smokeless tobacco
list notes ~~hich of the 562 materials listed have been
appro\.ed for use in foods by- the FDA and also notes
ivhich arc regarded as safe bv the Federal Emergency
Management Agency. As \vith cigarette tobacco, ap-
plying these safety standards to nonfood substances
is problematic; holz.ever, smokeless tobacco used in an
unaltered (unburned) state lessens some of the con-
cern o\`er the possible hazards of aclditives.

   The list of ndditit~es to smokeless tobacco in-
cludes sodium carbonate and ammonium carbonate,
\vhich are alkalinizing agents that increase the level
of "free" (chemically uncombined) nicotine in moist
snuff bv raising the pH le\rel (Slade 1995). A division
of the S\yedish Tobacco Company has stated that so-
dium carbonate is added to its moist snuff brands to
alkalinize the tobacco and thus enhance nicotine
absorption (Kronquist 1994). The pH of moist snuff
products-lvhich is not reported to consumers-
\-arks from acidic to alkaline, providing a wide range
of free-nicotine levels in various products (Djordjevic
et al. 1995; Henningfield et al. 1995). Products for per-
sons entering the market (such as those that have easy-
to-use unit dosages) are acidic (thus reducing
absorption) and have \`ery low levels of free nicotine,
Lvhercas products for more experienced users (such
as the Copenhagen brand) are alkaline and have high
levels of free nicotine. The epidemiology of moist snuff
use among teenagers and young adults indicates that
most no\Jices start with brands having low levels of
free nicotine and then graduate to brands with higher
levels (Tomar and Henningfield 1992; Tomar et al.
1995). These patterns are consistent with the industry's
marketing strategies as reflected in their advertising
and marketing activities and their internal documents
(Connolly 1993).

  Sweeteners and flavorings, such as cherry juice
concentrate, apple juice, chocolate liqueur, and honey,
are used in various smokeless tobacco products, and
dominant fla\,ors are often mentioned in the product


name (e.g., the Skoal Cherry, Long Cut brand). As with
manufactured cigarettes, these additivrcs increase pal-
atabilitv and may intensifv use of smokeless tobacco,
at least-among novices (Freedman 1994).

The Low-Tar "Alternative"

  As the health hazards of smoking have been in-
creasingly documented, the production of lower-tar
cigarettes has increased. The FTC's tables on avrerage
sales-weighted tar levels for cigarettes on the U.S.
market from 1968 through 1987 reflect this shift toward
lower-tar cigarette brands (USDHHS 1981,1989).' The
public health implications of this shift merit closer
inspection.

Compensatory Smoking

Considerations of product regulation must take
into account the variability in toxic exposure attribut-
able to specific smoking practices. The overall evi-
dence suggests that many smokers compensate when
smoking low-deliverv cigarettes by inhaling more tar
and nicotine than are measured by smoking machines
under standard conditions. Any potential health ben-
efit implied by machine measurements of loller tar and
nicotine yields may thus be mitigated bv such com-
pensatory smoking.

  Studies have shovzn that as consumers sl\-itched
to lower-yield cigarettes in Great Britain, they tended
to smoke more cigarettes each day (Ferris 198-l), al-`-
parently to compensate for the lovz,er nicotine yield
per cigarette. Similar compensatory measures may
have occurred in the United States. For example, smok-
ers in Cancer Prevention Study I, conducted during
the 1960s \zhen loM-er-yield brands were rare, smoked
fewer cigarettes per day than smokers in Cancer I+-
vention Studv II, which was conducted during the
198Os, by which time most smokers used louver-yield
brands (Thun et al. 1997). Strong evidence suggests
that smokers increase the number of cigarettes con
sumed as nicotine availabilitv is reduced, and vice
versa (USDHHS 1988; Kaufman et al. 1989; Palmer
et al. 1989; Stellman and Garfinkel 1989; I%egri et al.
1993; Thun et al. 1997). In addition, loller nicotine
delivery in the FTC test is associated Ivith smoking a
greater number of cigarettes (USDHHS 1988). This

compensatory effect has been confirmed in other stud-
ies (Benowitz et al. 1983; Bridges et al. 1990; Hofer et
al. 1991; Wood ward and Tunstall-Pedoe 1992; Coultas
et al. 1993); only one published study found no such
effect (Rosa et al. 1992). In an abstract, Byrd and col-
leagues (1994) reported no compensatory effect, but
their small study population may not have been rep-
resentative of all smokers; for instance, the nicotine
intake seen among the group that smoked the ultra
lo\\,-delivery cigarettes was smaller than that observed
bv others.

Health Risks From Low-Tar Cigarettes

Even when compensatory smoking is not ac-
counted for and calculations are derived from
machine-rated tar levels, the risk of lung cancer is only
slightly lower from using low-tar cigarettes than from
using high-tar cigarettes, and reduced tar level has little
if any impact on the occurrence of other cigarette-
caused lung disease or of heart disease (USDHHS 1981,
1989; Parish et al. 1995; Wannamethee et al. 1995).

  Giovino and colleagues (1996) have examined
results from several national surveys of tobacco use
for attitudes and behaviors related to the use of IoM,-
tar cigarettes. In these surveys, current smokers of low-
tar brands vvert found to be more likely than smokers
of high-tar brands to acknowledge the health risks of
smoking, to express concerns about these risks, to re-
port that they had been advised by a physician to stop,
and to report that they had experienced negative health
consequences from smoking. These smokers were also
more likely, hovvevrer, to believe that smoking a low-
tar brand reduced those risks. For example, in the 1987
National Health Interview Survey, 44 percent of smok-
ers reported that thev had switched to a low-tar
cigarette to reduce their health risk, and 48 percent of
lo\\,-tar brand users thought their brand was less haz-
ardous than most other brands (Giovino et al. 1996).
These attitudes were confirmed by a 1993 Gallup poll
in lvhich 49 percent of respondents stated that they
believed that the advertising message in terms such
`1S "low tar, " "101~ nicotine," or "lower yield" was that
the "brand [was] safer"; only 4 percent believed that
the advertisements were "false/misleading" (Gallup
Organization, Inc. 1993, p. 23).

The analysis by Giovino and colleagues (1996)
also suggested that many smokers of low-tar cigarettes
may have used these brands instead of quitting. Low-
tar &ers were more likely than high-tar users to have
tried unsuccessfully to stop smoking. Similarly, a
greater proportion of people who had successfully quit
smoking had been high-tar cigarette users. This latter


obser\ration has been confirmed in another survey:
those M.ho had stopped smoking tended to have been
higher-tar cigarette smokers (Cohen 1996). As was
previously suggested (Kessler 1994b), the higher ra-
tios of nicotine yield to tar yield in lower-tar cigarettes
than in higher-tar cigarettes could impede efforts to
quit among persons \vho smoke loiver-tar cigarettes.

  Assessment of consumer attitudes, as well as
epidemiologic consideration of health risks from
loafer-yield cigarettes, has raised concerns about the
reporting of FTC test results (Henningfield et al. 1994).
An ad hoc committee of the President's Cancer Panel,
convened in December 1994 (Jenks 1995), concluded
that consumers misunderstand the FTC test results and
should be given a range of values for smoke deliver-
ies (reflecting the M'av cigarettes are actuallv smoked)
and that these \ralues;hould be included on iach pack-
age and in all advertisements (NC1 19%). The com-
mittee also concluded that terms such as "light" and
"ultra light" are in fact health claims that mislead
consumers.

Nicotine Replacement Products

  The "safe cigarette," long sought, has not been
found (Gori and Bock 1980; USDHHS 1981,1989; Slade
1989,1993), and the axiom that no tobacco product is
safe wrhen used as intended remains true (USDHHS
1989). As long as tobacco products are sold, some
people \vill be unable to stop using nicotine (Kozlowski
1987). ILove nicotine deli\-ery devices have been tried
in test markets (R.J. Reynolds Tobacco Company 1988;
Slade 1993; Hilts 1994), and several tobacco compa-
nies have patents for various designs (David A. Kessler,
letter to Scott D. Ballin, February 25, 1994; Slade 1994;
Htvang 1995b). All designs share the ability to deliver
nicotine for inhalation with a minimum of, or no, tar-
thereby avoiding the smoking-associated increased
risk of cancer (although not the nicotine-associated
increased risk of cardiovascular disease) (USDHHS
1988).

  Nicotine replacement products have been devel-
oped and marketed by pharmaceutical companies as
adjuncts to help people stop smoking (Jarvik and
Henningfield 1993). As was discussed in Chapter 4
(see "Pharmacologic Interventions"), concerns over
possible intentional or unintentional misuse of these
products have been weighed against the health ben-
efits resulting from their effectiveness as a cessation
aid. Nicotine gum and nicotine patches, previously
approved by the FDA as prescription drugs for brief
use (months), \vere approved in 1996 for over-the-
counter use, concluding an intense examination of the

issues of nicotine availability. Both a nicotine nasal
spray and a nicotine inhaler were approved for pre-
scription use. The Drug Abuse Advisory Committee
(1994) of the FDA has expressed concern about the
potential abuse liability of the spray and the inhaler,
because the pharmacokinetics of their delivered dose
of nicotine comes closer than the gum or patch to what
occurs through using tobacco products. Benowitz and
Pinney (1998) concluded that the benefits from over-
the-counter availability of the gum and patch would
outlzeigh the risks. In December 1996, the FDA's Drug
Abuse Advisory Committee recommended approval
of the nicotine inhaler for prescription use (FDA Drug
Abuse Advisory Committee, draft minutes of Decem-
ber 13, 1996, meeting).

  Nicotine maintenance is not an approved thera-
peutic approach, but some observers have called for a
coordinated clinical and public health program to ex-
plore this option (Slade et al. 1992). A useful program
not only must substantially reduce health risks and
satisfy addicted individuals who cannot otherwise stop
using tobacco products but also must include realistic
safeguards to prevent the neM' onset of nicotine de-
pendence among the young, to prevent relapse among
those who have already stopped, and to further re-
duce overall smoking prevalence.

  The elements of such a program would include
research to (1) fully characterize the population that
lvould benefit from nicotine maintgnance, (2) identify
potential delivery devices for nicotine or an appropri-
ate analogue, (3) explore fully the safety of these de-
\rices as Mel1 as the safety of nicotine or the chosen
analogue (including assessments of potential cardio-
vascular, fetal, cognitive, and performance problems
consequent to use of the drug, as well as other poten-
tial health effects), and (4) design a drug distribution
svstem that would be acceptable to intended users but
&at would substantially limit access by novices to to-
bacco use and by those who have already been suc-
cessful at achieving abstinence from nicotine (Slade et
al. 1992).

Product Regulations for Consumer
Education

  The previous discussion of product regulation
centered on the contents of the tobacco product itself.
Another critical focus for product regulation is pack-
aging, a promising field for public information and
education on smoking and health. Government ac-
tions in this area have included product packaging to
convey health messages (see "Attempts to Regulate


Tobacco Ad\.ertising and Packaging," earlier in this
chapter). The goal of this packaging strategy, as dis-
cussed in the follo\ving section, is to help ensure that
the purchase of tobacco products occurs only as a trans-
action invol\?ng informed consumer choice. Also dis-
cussed is a related, more complex goal for this strategy:
to help ensure a situation of informed consumer con-
sent rather than simply choice.

Tobacco Packaging and Informed Choice

  The current required warning labels on U.S. to-
bacco packages are but a single, narrow means by
which package-based messages can promote informed
choice among consumers. The vast amount of infor-
mation available on the adverse health effects of to-
bacco use constitutes a \vide range of messages that
can be presented this way (USDHHS 1989). This in-
formation can appear on packages in many ways,
given the numerous variables such as size, wording,
placement, colors, graphics, typefaces, and package
inserts.

  The potential public education value of package-
based health messages is inherent in their exception-
ally large rate of exposure to consumer vierz. In the
United States, about 478 billion cigarettes \vere con-
sumed in 1997 (Tobacco Institute 1998). Each of these
cigarettes will be removed from a package that could
be vielved bv many cigarette users at exactly the time
they are preparing to engage in the activity such mes-
sages are intended to prevent. These messages can be
seen not onlv immediatelv before use but also at the
point of sale or at any time the package is in the pos-
session of the user. The messages do not have to be
directed only at tobacco users; any exposed package
can be vielved by, and can provide information equally
germane to, users and nonusers alike.

  An example of the potential inherent in package
messages is provided from Canada. In legislation
supplementing the Tobacco Products Control Act (sec.
9), the federal go\`ernment of Canada not only increased
the number of rotating messages from four to eight but
also made neiv stipulations regarding the messages'
size, location, and color (Department of National
Health and Welfare 1993; for details on these changes,
see "Examples of Product Labeling in Other Countries,"
earlier in this chapter). These changes follo\ved stud-
ies undertaken to determine the existing messages' leg-
ibility, readability, believability, and ease of
understanding. These studies had indicated that health
M-arnings were read about 1 .-I times per daV (t\romen,
1.8 times; men, 1.2 times) and that cigarette packs ivere
a primary source of tobacco-related health information

for 55 percent of smokers, second only to television (59
percent) and well ahead of newspapers (17 percent)
(Tandemar Research Inc. 1992; Kaiserman 1993).

Tobacco Use and Informed Consent

  Although many discussions of tobacco use in-
voke "free choice," the more rigorous legal concept is
"informed consent." As applied to tobacco use, in-
formed consent would obtain only when potential
purchasers of tobacco products could make fully in-
formed purchase decisions after carefully weighing the
health risks of using those products. Thus, like pa-
tients considering whether to undergo potentially
harmful medical procedures, consumers considering
whether to use tobacco would have to know which
health problems are caused by the product's use, what
increases in personal risk of these various problems
occur through this use, what the prognosis is should
any of these problems arise, and what effect ending or
adjusting the use could have on these problems.
Courts of law in this country and elsewhere have ar-
ticulated the duty of product manufacturers to warn
consumers about product hazards. A particularly clear
statement of the principles involved in informed con-
sent is found in an Ontario Court of Appeal decision
concerning oral contraceptives:

Once a duty to warn is recognized, it is manifest
that the warning must be adequate. It should be
communicated clearly and understandably in a
manner calculated to inform the user of the na-
ture of the risk and the extent of the danger; it
should be in terms commensurate with the grav-
itv of the potential hazard, and it should not be
neutralized or negated by collateral efforts on the
part of the manufacturer. The nature and extent
of any given warning will depend on what is rea-
sonable having regard to all the facts and circum-
stances relevant to the product in question (Bucl~r
i'. Orfho Plznrnlncclitical [Crrrzndnl Ltd., [ 19861 54
O.R.2d 101 [Ct. App.] [Can.]).

Similarly, a U.S. court has described an adequate prod-
uct Iyarning in the following way:

In order for a warning to be adequate, it must pro-
vide "a complete disclosure of the existence and
extent of the risk involved" (!&~/i&s ~1. GaliTejto/l
Ynchf B~sill, Itzc., 727 E2d 330 [5th Cir. 19841) citing
Almrr Brofhcrs Fnrrm ~5 Feed Mill, 117~. v. Diamomi
Laborntorics, 11x., 437 E2d 1295, p. 1303 [5th Cir.
19711). A warning must (1) be designed so it


can reasonably be expected to catch the attention
of the consumer; (2) be comprehensible and gi\re
a fair indication of the specific risks in\.ol\,ed lvith
the product; and (3) be of an intensity justified by
the magnitude of the risk (I'o:~/iil~~, p. 338).

  At issue, then, is IVhether consumers ha1.e re-
ceived adequate ivarning for informed consent to ap-
ply to tobacco use. Although public kno\\,lcdge about
the health effects of tobacco use has inipro~~ed o\-ei
the past 15 vears (FTC 1983; L:SDHHS lL)XY), widence
persists of iaps in understanding. An American Can-
cer Society (ACS) study sholred respondents a list of
selected causes of death and asked Ivhich \j.as respon-
sible for the greatest number of deaths (Marttila &
Kiley, Inc. 1993). The stud\, found that onlv one in fi1.e
Americans could corrtctl\' identif\, cigar&c smoking
as the listed cause associated \jith the most deaths. Sim-
lar studies in other countries (Hill and Gray,, I%-!; Gallup
Canada, Inc. 19%; En\-ironic5 Research Group Limited
lY91; Health and Welfare Canada lW1 [unpublished
data]) ha\-e found a similar lath of kno\~~lt~dgc.

  These studies indicate that the public continues
to underestimate the magnitude of the risks arising
from tobacco use. The resulting inabilitl, of consum-
ers to make fullv informed decisions about tobacco use
could be interpreted as a failure on the part of the
manufacturer to achie\.e informed consent from users
of the product. To date, this issue has not been legall!,
adclressed, and the pre\-iouslv discussed notion of in-
formed choice, lvhich carries clearer legal implications,
is generallv in\,oked.

Further Regulatory Steps

  Although some of the aforementioned product
regulations address the chemical constituents of to-
bacco use, none directly broaches the issue of whether
tobacco, as a nicotine deliverv svstem, should be sub-
ject to federal regulation as an addictive product. In
March 1994, the Coalition on Smoking OR Health
([CSH] composed of the American Heart Association,
the American Lung Association, and the American
Cancer Society) filed a petition with the FDA to de-
clare all cigarette products to be drugs under section
201 of the Federal Food, Drug, and Cosmetic Act (CSH
1994a). This petition follo\ved an earlier one bv the
same coalition requesting the classification of lov,-tar
and low-nicotine cigarettes as drugs and similarlv clas-
sifying the proposed nelv I~.]. Revnolds Tobacco Com-
pany "smokeless cigarette" as adrug (CSH 1WX).

  A felt- [2-eeks earlier, the FDA had made public
that it w.as in\.cstigating lvhether it might assert juris-
diction ol'er tobacco products (Kessler 1994a). The
legal basis for such a mo\`e requires demonstrating that
the manufacturers of tobacco products intend to af-
fect the structure or function of their customers bod-
ies (21 U.S.C. section 321 [g] [l]). The Commissioner
of the Food and Drug Administration, David A.
Kessler, M.D., had indicated in testimony before Con-
oress that there \vas evidence that pointed to this con-
Flusion (Kessler lYYJb,c).

  The FDA has concluded that w,ords used by to-
bacco companies to describe some effects of smoking
(e.g., "satisfaction," "strength," and "impact") are eu-
phemisms that actually describe pharmacologic effects
of nicotine (Kessler 1993b, p. 150). Dr. Kessler has
noted that cigarettes are sophisticated, carefully de-
signed de\.ices. Industry patents disclose a detailed
kno\vledgc of nicotine pharmacology and describe as
desirable those product refinements that increase the
efficiencv of nicotine deli\,erv. One company has pat-
ented a series of nicotine analogues having desired
pharmacologic effects, much as a conventional phar-
maceuCical company might develop a new drug that
produces effects similar to those of an existing drug.

  The FDA has disclosed several specific examples
of product manipulation to adjust the delivered dose
of nicotine in cigarettes (Kessler 1994~). The Brown &
Williamson Tobacco Corporation has used in cigarettes
sold in the United States a strain of tobacco (Y-l) that
had been geneticallv engineered to have a high nico-
tine content. According to a major American tobacco
company's handbook on leaf blending and product
de\,elopment, ammonia compounds can be used as
additives to boost the delivery of nicotine in smoke to
enhance the "impact" and "satisfaction" from smoke
(Kessler 1994c, p. 365). In an official prosecution
memorandum to the U.S. Attorney General, Represen-
tative Martin T. Meehan (D-MA) has asserted that
product manipulation of Eclipse brand cigarettes
has taken place. Meehan cites the addition of
high-nicotine-content tobacco near the filter and the
addition of potassium carbonate to change the pH of
the tobacco (or to enhance absorption through the mu-
cous membranes) (Meehan 1994; see "Criminal Pro-
ceedings," later in this chapter). Moreover, information
obtained from internal industry documents suggests
that at least some tobacco companies have long had
an accurate and detailed knoivledge of nicotine phar-
macology. Dr. Kessler told Congress that "such re-
search \~ould be of interest to the industry only if the
industrv \verc concerned with the physiological and
pharmacological effects of nicotine. Certainly, this is


not consistent It-it11 the inc~u5tr\.`5 wprcsentation that
nicotine is of interest to it onI\. hecause of flaI.0ur and
taste" (Kessler lYYlc, p. 36%

  Follolz,ing his testimony before Congress, in a
speech at Columbia University School of La\l-, Dr.
Kessler emphasized the importance of preventing nico-
tine dependence among children and teenagers. Call-
ing it "a pediatric disease" (David A. Kessler. Remarks.
Presented at the Samuel Rubin Program, Columbia
University School of Lalz, iXe\v L'ork Cit!; March 8,
1995, unpublished), he outlined a number of specific
priorities for public health action:

A comprehensi\-e and meaningful approach to
preventing future generations of young people
from becoming addicted to nicotine in tobacco is
needed. Any such approach should: First, reduce
the manv a\-enues of easy access to tobacco prod-
ucts available to children and teenagers; second,
get the message to our \;oung people that nicotine
is dddicti\,e, and that tobacco products pose seri-
ous health hazards--and not just for someone else;
and third, reduce the po'\verful imager\, in tobacco
ad\.ertising and promotion that encourages young
people to begin using tobacco products (p. 19).

   On August 10, 1995, the FDA announced the
result of its investigation. The agencv stated that e\,i-
dence appears to indicate that "nicotine in cigarettes
and smokeless tobacco products is a drug and [that]
these products are nicotine deli\-cr\- de\?ccs under the
Federal Food, Drug, and Cosmetic-Act" (Fc[f~~r~7/ R~;;is~
tcr 1YYJa). In August 1 YYS, the FDA issued in the F&
L'r17/ R~`;{isfc,r (1 1 a proposed rule of regulations
restricting the sale and distribution of cigarettes and
smokeless tobacco products to protect children and
adolescents and (2) an analysis of the FDA's jurisclic-
tion o\.er cigarettes and smokeless tobacco. The FDA
requested comments on its proposed regylations and
annlvsis of its jurisiiction, and indicated that it \\-ould
give-serious consideration to comments filed \Vith the
agencv concerning the evidence amassed during its
investigation. The Clinton administration also sug-
gested that Congress could eliminate the need for this
rulemaking bv passing Ned. legislation to affirm the
FDA's authority over tobacco products and address
the issue of tobacco use among minors.

  In its legal analvsis of its proposed jurisdiction
over tobacco products, the FDA argued that cigarettes
and tobacco products "affect the structure or anv func-
tion of the bode" (key language for ini,okihg the
agencv's authorizing legislation) and that it is the in-
tent oi tobacco manufacturers that their products have

addictive effects (Fed~al Rc~yisf~~r 1995a). The argument
XZ'~S presented as a logical chain of inference: the ad-
dictive properties of tobacco are "widely known and
foreseeable" by tobacco manufacturers; consumers use
the product to satisfy their addiction; and tobacco
manufacturers know of the addiction, know of con-
sumers use, and have facilitated that use (Fc~drral Rq-
ister lY95a). An extensive analysis, including internal
documents from tobacco companies, was used to elu-
cidate these assertions (Federal Register 1995a). The
FDA presented a further legal discussion of whether
the cigarette is a device and postulates that the ciga-
rette is "a consciously engineered instrument to
effectuate the delivery of a carefully controlled amount
of the nicotine to a site in the human body where it
can be absorbed" (Federrrl Rqister 1995a).

  The proposed regulations centered on restricting
the availability and appeal of tobacco products to chil-
dren and adolescents and consisted of the following
provisions:

The tobacco industry would be required to spend
at least $150 million per year to support smoking
pre\,ention education for children.

Tobacco sales would be prohibited to those under
18 years of age, and vendors would be required to
see photo identification as proof of age.

Vending machines, self-service displays, and mail-
order sales \vould be prohibited, as would the sale
of incli\.idual cigarettes or packs of fewer than 20
cigarettes.

The sale or gift of promotional items bearing brand
names, logos, or other brand identity bvould be
prohibited.

Free samples \~ould be banned.

Only black-and-Mhite text advertising for cigarette
products ivould be permitted in publications for
I\-hich more than 15 percent of the readership is
under age 18 and in publications with more than 2
million voung readers.

Outdoor tobacco advertising kvould be prohibited
\\.ithin 1,000 feet of schools and playgrounds. All
other outdoor tobacco advertising would have to
be in black-and-Mhite text.

Sponsorship of sporting or entertainment events
using specific brand names or product identifica-
tion would be prohibited, although the use of com-
pany names would not.


  The proposed regulations stirred immediate
action from the tobacco industrv. Four lan.suits
were filed immediatelv after the F~Jcvi7/ Rr,~isf~,~
announcement. A larvsu;t filed bv tobacco companies
in federal court in Greensboro, North Carolina, as-
serted that the FDA had no jurisdiction o\.er cigarettes.
The plaintiffs l\.ere Bro\vn & Williamson Tobacco Cor-
poration, Liggett Group Inc., Lorillard Tobacco Con-
pan);, Philip Morris, and R.J. Re\,nolds Tobacco
Company (Czir7ll Sfrwt /~lfivllrll lYY5).~ Parts of the ad-
\ ertising industr!: Ivhich has a large stake in the out-
come of the proposed regulations, also filed suit on
the grounds of infringement of First Amendment rights
(,-lffwrimf7 24di7~~rtisirig Fdt~ri7tioi2 i'. K~5slf~r. Civil Action
No. 2:95CVOO593 [M.D.N.C. Aug. 10,1995], cited i/7 10.5
PPLR 3.401 [lY95]). In addition, a smokeless tobacco
companv (UII;~& Stiltf5 Tr~lwcio CP 7'. Fwif iril[f Drfiq
.-\dllrillj~fl.l7fj~l,l, Ci\.il Action ho. h:Y5CV0066f
[M.D.N.C. Sept. 19, 19931) and a trade group repre-
senting con\.cnience stores (N~rtior7i7/ A5.5ch-ii7ti~~i1 (If Ctlff-
ili~llitvfc~~ S/r)fw il. k'twlflr, Ci\.il Action No. ?!:YSCVOO70h
[M.D.N.C. Oct. 1, 19951) filed suit.

  By the January 2, 1996, close of the public con-
ment period on the proposed rules, the FDA had re-
cei\-ed more than 95,000 indix-idual comments, the
largest outpouring of public response in the agency's
history. From March 18 to April 19, lYY6, the FDA re-
opened the comment period for the limited purpose
of seeking comments on the statements of three former
Philip Morris employees about that company's alleged
manipulation of nicotine in the design and production
of cigarettes and to seek comments on further expla-
nations of certain provisions in the proposed rule.

  The re\ie\v process culminated in a Rose Gar-
den ceremony at the White House on August 23,1996,
in ivhich President Clinton announced the publication
of the final FDA rules. To emphasize that the FDA's
central intent was to reduce tobacco use among young
people, these final rules essentially regrouped the regu-
lations from the original announcement into t\vo cat-
egories: reducing minors' access lo tobacco products
and reducing the appeal of tobacco products to m-
nors. The only notable changes to the former rules
\vere that the ban on mail-order sales \\ras eliminated
and the ban on vending machines and self-ser\+ce
displays was relaxed to allow exceptions for certain
nightclub and other "adults-onlv" facilities totallv in-
accessible to persons under the-age of 18. Similarly,
the limitation to black-and-white text for in-store
advertising excepted adults-onlv facilities if the adlw-
tising was not visible from the butside.

  In place of its original regulation requiring the
tobacco industry to spend at least 5130 million each

year to support tobacco prevention education for chil-
dren, the final rules lvere less explicit. The FDA pro-
posed to require the six tobacco companies with a
significant share of sales to minors to educate that
population about the health risks of using tobacco
products. This action \\fould be pursued under pro-
cesses dictntecl by section 518(a) of the Federal Food,
Drug, and Cosmetic Act (FDCA). Cnder the act, the
FDA may require manufacturers to inform the
consumer about unreasonable health risks of their
products.

  The various provisions were to be phased in be-
hveen six months and t\vo years from August 28,1996,
the date of publication in the Fcdcr-nl R~yisfcv. Two prin-
cipal hurdles to quick and full implementation of the
FDA regulations soon emerged. First, as noted above,
sel.eral tobacco companies, retailers, and advertisers
had sued the FDA to block implementation of the regu-
lations. Second, \.arious legislative proposals, which
began circulating in Congress both before and after
publication of the FDA's final rule, threatened to alter
or bar the FDA's regulation of tobacco products.

Judicial Developments and the Status of FDA
Regulations

  Three briefs filed on October 15, 1996, on behalf
of the plaintiffs in these suits moved for summary judg-
ment, arguing that the proposed regulations exceed
the agency's jurisdiction and are contrary to congres-
sional intent, that tobacco products are not "drugs" or
"de\.ices" ivithin the agency's statutory grant of au-
thority, and that the advert&g restrictions are a vio-
lation of the First Amendment (M~wlcy's Lifipfior~
R~~pol.t~: Toh7cic~ 1996b).

  On April 25, 1997, the federal district court in
Greensboro, North Carolina, ruled that the FDA pos-
sessed the authority to regulate cigarettes and smoke-
less tobacco products as drug delivery devices under
the FDCA (Coyrw Rcnlw, Ii~c. il. U.S. Ford C Dq Ad-
~r~irfistmtirv~, 966 F. Supp. 1374 [M.D.N.C. 19971). The
ruling, how-e\w, marked a considerably qualified vic-
tory for the FDA. Although the court upheld all of the
agency's restrictions involving youth access and label-
ing, the court temporarily blocked implementation of
most of these pro\,isions. Only the FDA's prohibition
on sales of cigarettes and smokeless tobacco to minors
and the requirement that retailers check photo identifi-
cation of customers who are under 27 years of age es-
caped the court's stay. These provisions went into effect
on Februarv 28, 1997; and remained in force until March
21, 2000, tl;e date of the Supreme Court decision.


  Notably, the court in\-alidated the FDA's restric-
tions on advertising and promotion ot cigarettes and
smokeless tobacco on the basis that thev exceeded the
agencv's statutorv jurisdiction. The pertinent federal
statut;, 21 G.S.C. section 360j(e), provides, in part, that
the government may "require that A de\.ice be re-
stricted to sale, distribution or use. upon such other
conditions as the Secretarv nmv prescribe." The FDA
had argued that it \vas au;hori/ed to restrict the "sale,
distribution or use" of tobacco products pursuant to
section 360j(e) and that its advertising nncl promotion
restrictions lvere valid becd~lse advertisitlg and pro-
motion constitutes an "offer of sale" (Cwrlc' R~w/fIf!,
p. 13%). Judge William L. Osteen Sr. disagreed. The
court reasoned that the \\.ord "sale" as emploved in
the statute did not encompass the advertising or pro-
motion of a product. The court also ruled that the
"section's grant of authoritv to FDA to impose `other
conditions' on the sale, distribution, or use of restricted
devices [does] not authorize FDA to restrict advertis-
ing and promotion" (p. 1398). Furthermore, because
the court ruled that the FDA \\`as not authorized to
restrict advertising and promotion, the court did not
reach or discuss arguments that these prol~isions
\.iolated the First Amendment to the United States
Constitution.

Most important, holzcver, Judge Ostetn agreed
lvith the FDA's contention that tobacco products fall
x1-ithin the "drug" and "dc\,ice " definitions of the
FDCA. To position its authority ivithin these defini-
tions, the FDA had to 1iai.e demonstrated that tobacco
products are "intended to affect the structure or an\'
function of the body" (21 U.S.C. section 331 Is111 Ilclj.
Judge Osteen ruled that the effects of tobacco prod-
ucts are "intended" I\-ithin the meaning of the FDCA
and that tobacco products affect the structure or funs-
tion of the body \\-ithin the meaning of that act. Thy
court also ruled that pursuant to its "de\.ice authori-
ties," the FDA could regulate tobacco products as
medical devices.

Both sides in the case appealed the decision
to the Fourth Circuit of the United States Court of
Appeals in Richmond, Virginia. The go\,ernInent
and the tobacco companies presented oral arguments
to a three-member panel of this court on August 11,
1997. The case became inacti\ e follmz-ing the death of
one of the panel judges on Februarlr 22, 19%. A neI\
judge ivas appointed, and on June?, 1998, the three-
member panel conducted a second hearing on the
appeal.

The Court of Appeals Ruling on FDA Authority

  On August 11, 1998, the Fourth Circuit Court of
Appeals overturned the lower court decision and ruled
in a 2 to 1 decision that the FDA lacks the authority to
regulate tobacco products (B~OXIII G Willin TO~CCO
COI./L ~1. Food & Drq Adnlirli~f,,atiorz, No. 97-1604 [4th
Cir. lY%]). The majority opinion (Judge H. Emory
Widener Jr.) found that the FDA had based its deter-
mination of authority solely on literal interpretations
of "drug" and "device" in the FDCA but did not con-
sider statutorv language as a whole, the legislative his-
tory, and thee history of evolving congressional
regulation in the area, including consideration of other
relevant statutes. Judge Widener held that there is an
internal inconsistency in the FDA's claim of authority
to regulate tobacco under the FDCA, since a declara-
tion that cigarettes are unsafe (the basis of the FDA's
claim) necessitates a ban on cigarette sales-an action
that lsould be opposed by polverful economic and
political forces. Widener reasoned that although the
FDA M-ould ha\,e the authority to grant exemptions to
the ban because potential public health benefits might
out\veigh harms, such exemptions M-ould undermine
the agency's essential vie\\, that cigarettes are unsafe.
The only exemption open to the FDA would thus be
based on social and economic rather than health-
related considerations. A rvell-known catch \~ould
then corme into play: social and economic consider-
ations are within the pur\.icc\~ of Congress, not the
FDA. Judge Widener pointed out that Congress had
been a\vare for decades that the FDA lacked the au-
thority to regulate tobacco on social and economic
grounds, had rejected attempts to gi1.e the FDA such
authority, and had enacted numerous pieces of legis-
lation that did not grant such authority.
  The dissenting opinion (Judge Kenneth K. Hall)
took the position that the intrinsic contradiction in the
FDA's authority under the FDCA is irrelel,ant: ".
ivhether the regulations contravene the statute is a
question ~,holl>, apart from IVhtther any regulations
could be issued. It is no argument to say that the
FDA can do nothing because it could have done more"
(BIVZ'II & W~//~~~~~~S`CIII, p. 48). The opinion proposed
that the FDA's current position is a response to "the
increasing level of knoll.-ledge about the addicti1.e
nature of nicotine and the manufacturer's deliberate
design to enhance and sustain the addictive effect of
tobacco products" (p. JO). Judge Hall stated that prec-
edents in administrative la\v clearly indicate latitude
for an agency to change its approach in the light of
ne\v information. He further asserted that earlier toll-
qessional action clid not ha\.e the benefit of the lel,el
h


of elidense gathered LX. the FDA in forming its cur-
rent position. Finall\,, iie pointed out that the term
"sale, distribution and LIW" (p. 58) is not full\. defined
in the FDCA and is therefore subject to agencl' inter-
pretation. This term "can reasnnabl!~ be construed to
include all aspects ot a product's journev from the fac-
tow to the store and to the home" (p. 5X). Thus, the
judge reasoned, the authorit!, to regulate tobacco pro-
motion should be upheld. The full Fourth Circuit
Court of Appeals declined to rc\-ie\\- this rc\.ersal. The
i?o\.ernment petitioned the United States Supreme
?ourt for re\-ielv, and the United States Supreme Court
accepted the case in April 1999. Oral ar:;unient l\.ds
held December 19YY, and the Court, in a 5 to 1 deci-
sion, upheld the Fourth Circuit's decision on hlnrch
2 1 , 2000.

The U.S. Supreme Court Ruling on FDA Authority

  On March 21, 2000, b\, a 5 to 1 \ ate, the United
States Supreme Court affi&ned the Fourth Circuit dc>-
c&ion and o\.erturncd the FDA's asserticon of jurisdic-
tion o\-er cigarettes and smokeless tobacco products
(F~J0tf 1717rf nIX&' .,~il~lli,li~tr'iltic,r, ;`. RULi'Ii & 1t'i//i,7,775clIl
Td'ilii0 Corp., 53Y U.S. [20001, 120 s. c-t. I31 1.
,J.s a result, the FDA no longer has regulator\. author-
itv to enforce the final rule it issued in 1 YYh.
  Justice Sandra Da\' O'C onnor \\.rotc the majorit\.
opinion for the Court. In ruling h
                  acrainst the FDA, she
noted that "The agencv has ampI\, demonstrated that
tobacco use, particularl\, among childi-en and adoles-
cents, poses perhaps thi single most significant threat
to public health in the United States" (p. 1315). Ne\ -
ertheless, the majoritv ruled that Congress had pre-
cluded the FDA from asserting jurisdiction o\.er
tobacco products as customarilv marketed because
"5uch authoritv is inconsistent \vi;h the intent that Con-
gress has expressed" (p. 1297) in the Federal Food, Dmg,
and Cosmetic Act and other tobacco-specific statutes.
  Justice O'Connor noted the unusual nature of
both the case the Court \j.as deciding and the role of
tobacco in the United States. She tvrote:

Otving to its unique place in American historv and
society, tobacco has its o\vn unique political historv.
Congress, for better or for \vorse, has created a dik-
tinct regulatorv scheme for tobacco products,
squarelv rejected proposals to gi\pe the FDA juris-
diction o\-er tobacco, and repeatedly acted to pre-
clude anv agencv from exercising significant
policymaking autllorit!. in the area (p. 1315).

  Justice Stephen Breyer wrote the dissenting opin-
ion. He disagreed lvith the majority view that Con-
gress never intended the FDA to have the authority to
assert jurisdiction over tobacco products. In summa-
rizing \vhy the four justices in the dissent believed the
FDA had acted la\vfully, Justice Breyer tvrote:

The upshot is that the Court today holds that a regu-
latory statute aimed at unsafe drugs and devices
does not authorize regulation of a drug (nicotine)
and a de\.ice (a cigarette) that the Court itself finds
unsafe. Far more than most, this particular drug
and de\,ice risks the life-threatening harms that
administrati\,e regulation seeks to rectify (p. 1331).

Legislative Developments

In an effort to claiify the public health perspec-
ti\.e on potential legislation, on September 17, 1997,
President Clinton outlined the principles he believed
must be at the heart of any national tobacco legisla-
tion (1 lohler lYY7):

.A comprehensi\.e plan to reduce youth smoking,
includin;: tough penalties if targets are not met.
Full authority for the FDA to regulate tobacco
products.

An end to the tobacco industrv's practice of
marketing and promoting tobacco-to children.
Broad document disclosure (especially of those
documents relating to marketing tobacco to
children).

Progress to\zard other public health goals, such as
reducing environmental tobacco smoke (ETS), ex-
panding smoking cessation programs, strengthen-
ing international efforts to control tobacco, and
pro\,iding funds for health research.

Protection for tobacco farmers and their communities.

   A number of bills intended to enable the enact-
ment of the June 20,1997, multistate settlement agree-
ment Tvere introduced into the U.S. Senate in late 1997
and earlv 1998. In March 1998, the Senate Commerce
Cornmit;ee bill introduced bv Senator John McCain
(R-AZ) became the focus oi all settlement-related
legis1atiL.e activity in the Senate. The Commerce
Committee endorsed a preliminary version of a sub-
stitute bill, S. 1415, on March 30, 1998, bv a wrote of 19
to 1. On Ma\ 1, 1998, the Commerce Committee's \`el--
sion of the bill-S. 1115.IiS (the "McCain Committee


Bill")--Mas reported by Senator McCain to the full
Senate. Among other things, the McCain Committee
Bill would have done the follo\ving:

o Required the tobacco industry to pay $516 billion
($147.5 billion more than was specified in the June
20th multistate settlement agreement) over 25 years
to help states and the federal government bear the
medical costs of smoking-related illness.

o Raised cigarette taxes by $1.10 per pack over five
years.

. Preserved the FDA's ability to regulate the
tobacco industry in ways that the June 20th agree-
ment did not.

o Drastically reduced cigarette marketing, advertis-
ing, and promotion (Kelder 199X).

  In addition, the Floor Manager's Amendment to
the bill would have established a detailed regulatory
scheme to be administered by the FDA (S. 1415.RS
[Floor Manager's Amendment of May 18, 1998, 105th
Cong., 2nd Sess.]). First, the FDA could designate de-
monstrablv safer products as "reduced risk tobacco
products"<sec. 913[a][2][A]). Second, the FDA would
have the authority to promulgate performance stan-
dards, including "the reduction or elimination of nico-
tine yields" (sec. 907[a1(2][Al[l]) and "the reduction
or elimination of other constituents or harmful com-
ponents of the product " (sec. 907[a][2][A][ii]). The
agency \vould follo\~ normal administrati\se proce-
dures, unless it sought to eliminate "all cigarettes, all
smokeless tobacco products, or anv similar class of
tobacco products" (sec. 907[b][3][A]j or to require "the
reduction of nicotine yields of a tobacco product to
zero" (sec. 907[b][3][8]). In that tl'ent, the amendment
stipulated, "the standard may not take effect before a
date that is 2 vears after the President notifies the Con-
gress that a iinal regulation imposing the restriction
has been issued" (sec. 907[b][3][B]). Third, the Floor
Manager's Amendment \1rould ha\re required that the
FDA be given the additive information specified in the
settlement agreement Mithin six months of enactment
(sec. 904[a1[31).

The amendment would also ha\:e required that
manufacturers share \yith the FDA "all documents.
relating to research activities, and research findings,
conducted, supported, or possessed by the manufac-
turer (or agents thereof) to the health, behavioral,
or phvsiologic effects of tobacco products, their con-
stituents, ingredients, and components, and tobacco
additives" (sec. 904(a][l]) or "to marketing research

involving the use of tobacco products" (sec. 904Ia1[51).
Tobacco product advertising would be required to in-
clude a "brief statement of the uses of the tobacco prod-
uct and relevant warnings, precautions, side effects,
and contraindications" (sec. 903[a1[81[Bl[i]). Further-
more, the FDA would be given explicit power to im-
pose "restrictions on the access to, and the advertising
and promotion of, the tobacco product" (sec. 906[d][ll).

  Senate bill 1415 was vehemently opposed by the
tobacco industry. On April 8, 1998-nine days after
the Commerce Committee endorsed the preliminary
version of the McCain Committee Bill-Steven F. Gold-
stone, RJR Nabisco's chief executive officer, announced
that his company was pulling out of the congressional
process for developing comprehensive tobacco legis-
lation. Blaming Congress for failing to stick to the
terms of the June 20th agreement, Mr. Goldstone,
speaking to the National Press Club in Washington,
DC, declared his company's intention not to sign the
consent decrees to voluntarily limit advertising that
were part of the McCain Committee Bill. Philip Mor-
ris, Brown & Williamson, United States Tobacco, and
Lorillard made similar announcements shortly after
Mr. Goldstone's speech.

In retrospect, one can conclude that this tobacco
company brinkmanship-when paired with a widely
disseminated, industry-sponsored advertising cam-
paign that portrayed the McCain Committee Bill as a
vast "tax-and-spend" proposal-was a major force in
scuttling the proposed legislation. Emboldened by the
effect that the industry-sponsored advertising campaign
had on public opinion, the tobacco industry's Senate
allies greatly altered the McCain Committee Bill, cul-
minating in the Floor Manager's Amendment on May
18, 1998. Some of these amendments would have in-
creased the bill's potential harmful impact on public
health. For example, in this final form, the bill had been
shorn of almost all of its funds for initiatives to fund
tobacco use redtiction, and the tobacco industry had
been given a potential means of immunity in the form
of caps on plaintiffs' attorneys' fees (Kelder 1998).

  On June 17,1998, the McCain Committee Bill died
after four weeks of intense debate and political ma-
neuvering. In the absence of congressional action to
enact the proposed settlement, individual state law-
suits proceeded. Four states-Mississippi, Florida,
Texas, and Minnesota-have settled their suits with
the tobacco industry. Because these settlements in-
volve the recovery of Medicaid payments made by the
states, they are discussed with other such litigation
approaches, later in this chapter (see "Recovery Claims
bv Third-Party Health Care Payers").


Master Settlement Agreement

  On November 23, 1998, 11 tobacco companies
executed a legal settlement \\ith 16 states, the District
of Columbia, and fi1.e cnnimonrvealths and territories.
The plaintiffs had sued the tobacco industrv to recoup
I\edicaid costs for the care of persons injured b\,
tobacco use. The suit alleged that the companies had
\?olated antitrust and consumer protection la\vs, had
conspired to lvithhold information about acl\-erse
health effects of tobacco, had manipulated nicotine It\.-
els to maintain smoking addiction, and had conspired
to \vithhold lolver-risk products tram the market.

  In the settlement, the companies agreed to pa!.
states 5216 billion o\.er 25 vears. But in addition, the
settlement agreement contained a number of impor-
tant public health pro\-isions (see the test box). The
agreement placed significant marketin, 0 restrictions on
the industry bv prohibiting direct ad\.ertising and pro-
motion aimed at \roung people, LX. limiting brand nanit`
sponsorship at &.ents that might be frequenttyl LX
vouth, bv requiring the renio\.al of street ad\-c,rtisin;:
lvithout restrictions on cnunterdcl\.ei-tisin~, L~J. plaiins
substantial restrictions on lobbvin;: and on the suppres-
sion of research findings, and bir requiring major coon-
tributions from the industrv to cessation and pre\.twtion

Clean Indoor Air Regulation

activities (Wilson 1YYY). In addition, the agreement dealt
I\-ith such issues as legal fees, court supervision, civil
liabilities restrictions, and public disclosure. Unlike the
1997 settlement, the 1998 settlement contained no pro-
visions regarding FDA authority.

  The agreement raised a number of issues for
states, but foremost among these has been the compe-
tition bettreen tobacco control efforts and other state
spending priorities. The National Governors Associa-
tion issued a policv statement that reaffirmed states'
entitlement and asserted that the federal go\rernment
had no legitimate claim to settlement funds. The asso-
ciation committed to spending "a significant portion of
the settlement funds on smoking cessation programs,
health care, education, and programs benefitting chil-
dren" but reser\.ed the right to make funding decisions
tailored to states' indi\?dual needs (National Governors
Asvwiation IYYY). Bv micl-lC)Y9, 37 states had allocated
their first and second settlement payments. Of these,
2.3 had specified some portion of the monev for public
health activities, and 16 had specifically -designated
sptwding for tobacco control and prevention efforts.
Specific issues related to the allocation of Master Settle-
ment Agreement funds to tobacco control efforts in
states are discussed in Chapter 7.

Introduction

  If the regulation of tobacco products themsel\.es
has been characterized bv ~10~. and incremental ad-
vances, the regulation of where and ho\v tobacco prod-
ucts are used-that is, the regulation of exposure,
particularly of nonsmokers, to ETS-has encountered
comparatively little resistance. Public and private
steps to regulate ETS have become both more com-
mon and more restrictive o\ser the past se\.eral decades.

  There arc various reasons for this broad and rapid
implementation. One reason is that the public health
necessity of regulating ETS exposure is manifest: ETS
is known to cause acute and chronic diseases in non-
smokers (National Academv of Sciences 1986;
USDHHS 1986; National Institute for Occupational
Safety and Health 1991; EPA 1992; California EPA
lQY7): Moreover, this demonstrated health threat is
unentangled with legal or ethical issues ot "informccl

choice" or "informed consent" (see "Product Regula-
tion," earlier in this chapter)-hence a popular name
for this exposure, fwssiw smoking. Regulating ETS
exposure also has important implications for reduc-
in;: smoking: studies have shown that restricting
smoking in public settings increases the likelihood that
smokers in these settings smoke fewer cigarettes or
quit smoking entirely (Petersen et al. 1988; Borland et
al. 1990a; Stillman et al. 1990; Sorensen et al. 1991a;
Woodruff et al. 1993). It has been estimated that the
combined effect of general smoking cessation and
smoking reduction in public settings could decrease
total cigarette consumption by as much as 40 percent
(Woodruff et al. 19931, although this conclusion may
be questioned based on assessment of worksite inter-
ventions (see "Worksite Programs" in Chapter 4). A
second reason for the expansion of ETS regulations is
that their public support, a kev marker for successful


Major Provisions of the Master Settlement Agreement

I n addition to the monetar\, pavments from the
                       _ .
tobacco industry to states, the settlement pro-
vided for other requirements and restrictions:

Youth Access

No free samples except in an enclosed area
where operator ensures that no underage
persons are present.

No gifts to youth in exchange for buying tobacco
products.

No gifts through the mail without proof of age.
Prohibits sale, manufacture, or distribution of
cigarettes in packages of felver than 20 until
December 31, 3001.

Marketing

o  No brand name sponsorship of concerts, team
sporting el.ents, or e\.ents l\.ith a .significant
irouth audience.

o  No sponsorship of e\ ents in \vhich paid partici-
pants are underage.

o Bans use of tobacco brand names in stadiums
  and arenas.

.  Bans use of cartoon characters in tobacco ad\-t,r-
tising, packaging, and promotions.

o  Bans payments to promote tobacco products in
entertainment settings, such as mo\ies.

o  Bans distribution and sale of merchandise \\ith
brand name tobacco logos.

Lobbying

o  Prohibits industr!, from supporting di\wsion of
settlement funds to nonhealth LISTS.

o  Restricts industr!- from lobbying against restric-
tions of advertising on or in school grounds.

o  Prohibits ne\z challenges by the industry to state
and local tobacco control 1arl.s enacted before
June 1, 19%.

Outdoor Advertising

o  Bans transit and outdoor advertising, including
billboards.

o Tobacco billboards and transit ads to be
removed.

o At industry expense, states could substitute
advertising discouraging youth smoking.

Cessation and Prevention

o  The tobacco industry will contribute $25 million
annually for 10 years to support a charitable
foundation established by the National Associa-
tion of Attorneys General to study programs to
reduce teen smoking and to prevent diseases
associated lvith tobacco use. The foundation,
since named the American Legacy Foundation,
is governed by a board and will carry out a sus-
tained national advertising and education pro-
gram to counter tobacco use by young people
and educate consumers about the health hazards
of tobacco use. It w?ll also evaluate the effec-
ti\,eness of counteradvertising campaigns,
model classroom educational programs, and ces-
sation programs and Lvill disseminate the results.
Other actit?ties include commissioning and
funding studies on the factors that influence
vouth smoking, developing training programs
ior parents, and monitoring youth smoking to
determine the reasons for increases or failures
to decrease tobacco use rates.

o  The industry Mill contribute $1.15 billion over
five years to support the National Public Edu-
cation Fund, which will carry out a national sus-
tained advertising and education program to
counter youth tobacco use and to educate con-
sumers about tobacco-related diseases. The to-
bacco industry will continue to contribute $300
million annually to the fund as long as the par-
ticipating tobacco companies hold 99.05 percent
of the market.


implementation, is implicit: national studies suggest
that most of the U.S. public experiences discomfort and
annoyance from ETS exposure (CDC 1988,1992b), and
smaller-scale surveys have found that the great ma-
jority of both nonsmokers and smokers favors smok-
ing restrictions in various public locations, including
the workplace, restaurants, and bars (CDC 1991). A
third reason is that employers might be expected to
support ETS regulations, because prohibiting smok-
ing in the workplace can help employers realize lower
maintenance and repair costs of buildings and prop-
erty, lower insurance costs, and higher productivitv
among nonsmokers (Mudarri 1994). Employer sup-
port, however, may be influenced by other factors (see
"Effectiveness of Clean Indoor Air Restrictions," later
in this chapter).

  Not surprisingly, during the 1980s the tobacco
industry identified ETS regulation as the single most
important issue confronting the industrv's economic
future (Chapman et al. 19901. The industry is con-
cerned that the increasing focus on ETS mav cause the
public and policymakers to view smoking as an envi-
ronmental issue rz-ith broad social consequences in-
stead of as a personal beha\+or in\,olving indi\-idual
choice. The tobacco industrv is also concerned about
legal backlash from possib-le ETS-related litigation
against employers and about revenue losses from pos-
sible decreased cigarette consumption due to smok-
ing restrictions (Chapman et al. 1990). An example of
the latter concern may be found in California, M-here
Tvorkplace restrictions extant in 1990 have reduced
consumption by an estimated 148 million packs per
year, at a value of 5203 million in pretax sales (Wood-
ruff et al. 1993).

Health Consequences of Exposure to ETS

  The detrimental health effects of exposure to ETS
are well established (National Research Council 1986;
USDHHS 1986,200Ob; EPA 1992; California EPA 1997).
The most comprehensive revierv of the respiratory ef-
fects of ETS to date is the 1992 report of the EPA, which
states that ETS is a human lung carcinogen that annu-
ally accounts for approximately 3,000 lung cancer
deaths among adult nonsmokers in the United States.
Autopsy reviews (Trichopoulos et al. 1992) and stud-
ies of ETS metabolites in body fluids (Hecht et al. 1993)
provide biologic support for epidemiologic studies
linking ETS and lung cancer. ETS also has subtle but
significant effects on the respiratory health (including
cough, phlegm production, and reduced lung function)
of adult nonsmokers.

  Among children, ETS has far-reaching health ef-
fects. ETS causes bronchitis and pneumonia, account-
ing for an estimated 150,000-300,000 annual cases in
infants and young children, and causes middle ear
diseases (infections and effusions). ETS causes addi-
tional episodes of asthma and increases its severity,
worsening an estimated 400,000-l,OOO,OOO cases
annually. As a risk factor for new cases of asthma,
ETS may account for 8,000-26,000 annual cases (EPA
1992; California EPA 1997).

  In an important ruling, Judge Osteen of the U.S.
District Court annulled Chapters l-6 and the Appen-
dices to the EPA's 1992 report (EPA 1992; F~~IL'-CUY~~
TO~WCCCI COO/JL'~l7tii'l' Sf~bili;~ti~t? CO~,LJ. iI. United SfflfPs
El7i~irorlr77r7ltnl Protccfion A~E~IcJ/, 4 F. S~pp. 2d 435
[M.D.N.C. 19981). The decision was a mix of proce-
dural and scientific concerns. Judge Osteen found that
the EPA had not complied with the procedural require-
ments of the Radon Gas and Indoor Air Quality Re-
search Act of 1986, had acted bevond congressional
intent, and had violated administrative law procedure
by dra\ving conclusions about ETS prior to conclud-
ing a scientifically sound risk-assessment study. The
judge \vas also concerned with the amount of evidence
in the record supporting EPA's final basis for its plau-
sibility hypothesis, \vith some of the animal labora-
tory tests that he felt were inconclusive but were cited
as compelling evidence of the dangers of ETS, and with
the EPA's choice of epidemiologic studies to support
its findings.

  Considerable information appeared after the
EPA's 1992 report that supported its general conclu-
sions (Brownson et al. 1992a; Stockwell et al. 1992;
Fontham et al. 1994; Cardenas et al. 1997). A recent
meta-analysis of workplace ETS exposure and increased
risk of lung cancer also provided needed epidemiologic
support (Wells 1998). The ninth EPA report on carcino-
gens was released in the year 2000 and lists ETS as a
known carcinogen for the first time (USDHHS 2000).

  Since the 1992 EPA report, further evidence link-
ing ETS and heart disease has been assembled as well.
(Glantz and Parmley 1995; Steenland et al. 1996; Cali-
fornia EPA 1997; Kawachi et al. 1997; Law et al. 1997;
Howard et al. 1998; Valkonen and Kuusi 1998; Wells
1998). If ETS is a causal risk factor for coronary heart
disease, it likely accounts for many more deaths from
heart disease than from lung cancer (EPA 1992; Wells
1994). A review of 12 epidemiologic studies has esti-
mated that ETS accounts for as many as 62,000 annual
deaths from coronary heart disease in the United States
(Wells 1994). However, because smoking is but one of
the manv risk factors in the etiology of heart disease,


quantifving the precise relationship betlz-een ETS and
this diskase is difficult.

  Strong evidence is also accumulating that ETS is a
risk factor for sudden infant death syndrome (Jinot and
Bayard 19%; DiFranza and Lew lYY5; Klonoff-Cohen
et al. 1995; Anderson and Cook 1997; California EPA
1997; Alm et al. 1998; Dybing and Sanner 1999). In a
large U.S. study, maternal exposure during pregnancy
and postnatal exposure of the netvborn to ETS increased
the risk of this syndrome (Schoendorf and Kiely 1992).

Other Consequences of ETS

  Separate from their concerns about direct health
effects, most nonsmokers are annoyed by ETS expo-
sure (CDC 1988; Bro\vnson et al. 1992b). U.S. survey
data have suggested that 71 percent of all respondents,
including 43 percent of current smokers, are annoyed
by ETS (CDC 1988). Similarly, data from urban St.
Louis and Kansas City, Missouri, have sholvn that 66
percent of all respondents and nearly 40 percent of
current smokers lvere annoyed bv ETS exposure
(Brownson et al. 1992b). The term "annoyance," a
seemingly minor attribute, has some nontrivial rami-
fications. Public attitudes tolrard smoking, an amal-
gam of concerns about health and social interactions,
have changed in the past decade, as is discussed in
greater detail in the section "Effectiveness of Clean
Indoor Air Restrictions," later in this chapter. The find-
ings from one survev suggested that the proportion of
Americans ~.ho fa\,&ed a total ban on smoking in res-
taurants and Lvorkplaces increased from less than one-
fifth in 1983 to almost one-third in 1992 (Gallup
Organization, Inc. 1992). The proportion fa\.oring no
restrictions fell from as high as 13 percent in 1983 to 5
percent in 1992. Similarly, by 1992, more than 90 per-
cent of respondents favored restrictions or a total ban
on smoking in trains and buses as rvell as in hotels
and motels. More than 90 percent "agreed" or
"strongly agreed" that ETS is injurious to children,
pregnant \\-omen, and older adults. Thus, an impor-
tant consequence of information on ET'S has been a
changing social norm regarding smoking and an evol\--
ing foundation for clean indoor air regulations.

  Because of the consequences of ETS, employers
are likely to save costs by implementing policies for
smoke-free \vorkplaces. Savings include those associ-
ated with fire risk, damage to property and furnish-
ings, cleaning costs, workers compensation, disability,
retirement, injuries, life insurance, absenteeism, pro-
ducti\ritv losses, and svnergistic occupational risks
such as asbestos exposure (Kristein 1989). Such costs
\vere estimated at 51,000 per smoking employee in 1488

clollars. In a recent report on the savings associated
with a nationwide, comprehensive policy on clean in-
door air, the EPA estimated that such a law would save
$4 billion to $8 billion per year in operational and
maintenance costs of buildings (Mudarri 1994).

Prevalence of Exposure to ETS

  Exposure to ambient tobacco smoke is wide-
spread. The 1988 National Health Interview Survey
reported that an estimated 37 percent of the 79.2 mil-
lion U.S. nonsmoking workers worked in places that
permitted smoking in designated and other areas and
that 59 percent of these experienced moderate or great
discomfort from ETS exposure in the workplace
(National Center for Health Statistics 1989). Since the
advent of urinary cotinine screening, firmer documen-
tation of ETS has become available. In a study of 663
nonsmokers attending a cancer screening, Cummings
and colleagues (1990) found that 76 percent of partici-
pants were exposed to ETS in the four days preceding
the interview. The authors concluded that the work-
place and the home \vere the primary sources of ETS
exposure among these nonsmokers. The best single
predictor of urinary cotinine was the number of smok-
ers among friends and family members seen regularl)
by the study participant. In a study of 881 nonsmok-
ing \,olunteers, Marcus and colleagues (1992) found
that employees in workplaces that were "least restric-
tive" (i.e., allo\,ved smoking in numerous locations)
\vere more than four times more likely to have detect-
able salilra cotinine concentrations than employees
from smoke-free workplaces were (p. 45).

  The largest study of population exposure to ETS
!1-ith biochemical markers is the CDC's Third National
Health and Nutrition Examination Survey, conducted
from 1988 to 1991 on a nationally representative sample
of 16,818 persons aged 2 months and older (Pirkle
lYY6). Serum cotinine was measured in 10,642 partici-
pants aged 4 years and older. The data indicate high
concordance between reported ETS exposure and se-
rum cotinine le\,el. Among nontobacco users, 87.9
percent had detectable levels of serum cotinine, and
the le\,el M'as significantly and independently associ-
ated \vith both the number of smokers in the house-
hold and the number of hours of work exposure. The
authors concluded that both the work and the house-
hold environments make important contributions to
the lvidespread exposure to ETS experienced by chil-
dren and adults.

  Some improvement in ETS exposure has been
noted. A shady from California found that nonsmokers'
self-reported exposure to ETS at work declined from


2Y percent in 1990 to 22 percent in lYY3 (Patten et al.
lYY?b). This decline w-as not as pronounced, holz,e\-er,
among some sociodemographic subgroups, such as
Xfrican Americans, Asian Americans, and persons
\vith less than a high school education. During the
same period, the percentage of employees reporting
that they I\-orked in smoke-free \vorkplaces greatl\
increased (from 35 to 65 percent). Sur\-ev data from
Missouri in 1993 indicated that 11 percent of the poppy-
lation lvere exposed to ETS in the \\.orkplace and 1X
percent in the home en\.ironnient (Bro\\.nson et al.
lYY5a). Among subgroups, \-oungcr persons, men,
Hispanics, and persons \\,ith -less than a high school
education had more 1%.orkplace exposure to ETS. Simi-
larly, data from rural Missouri sho\vcd higher pre\a-
Icnce of kvorkplace ETS exposure among 1 ounger
persons, men, African Americans, and persons l\.ith
less than a high school education (Bro\z.nson et al.
IYY5a). Emmons and colleagues (lYY2) analvzed en-
tries in diaries recording ETS esposure among 186
persons \vho rvere former smokers or had ne\ el
smoked. Approximatelv 50 percent of the dail\, ETS
exposure \\.as attributed to the \vorkplacc, and 10 per-
cent I\.as attributed to the home en\?ronment. Ho\?.-
c\-er, for persons \vho lived \vith a smoker, more
exposure occurred in the home than in the \vorkplace.

  Relatilrely felt population-based data that spe-
cificallv examine the levels of ETS exposure in the
rcorkplace have been collected. Such data ma\' be
important, because exposure levels likely \.ary griatl\
b\r Lvorkplace, and recent studies ha1.e indicated that
higher levels of ETS (measured by intensity or dura-
tion of ETS exposure) increase the risk of lung cancer
in nonsmokers (Brownson et al. 1992~1; Stocklvell et al.
lY92; Fontham et al. 199-l). In a re\,ie\v of existing stud-
ies, Siegel (1993) found that ETS concentrations var-
ied widely b\r location; mean le\rels of nicotine
measured in the ambient air lvere 4.1 ,ug/m' for of-
fices overall, 4.3 pg/m' for residences tvith at least one
smoker, 6.5 ,ug/m' for restaurants, and 19.7 p'g/m' for
bars. In a sur\rey of 25 Massachusetts bvorksites,
Hammond and colleagues (1995) found that the type
of lvorksite smoking policy had a great effect on nico-
tine concentrations. Levels of nicotine ranged from
8.6 pg/m' in open offices that allolved smoking to 0.3
Jig/m' in worksites that banned smoking.

Legal Foundation for Regulation
of Public Smoking

  The legal foundation for regulating public
smoking is based on case la\v pertaining mainlv to the

protection of the health of workers. Under common
la\2- (the body of law based on court decisions rather
than jio\,ernment laws or regulations), employers must
pro\-ide a lvork environment that is reasonably free of
recognized hazards. Courts have ruled that common-
lax\, duty requires employers to provide nonsmoking
emplovees protection from the proven health hazards
of ETS.exposure (Skveda 1994).

  Three pioneering cases have demonstrated the
basis for this protection. In Shimp 7'. Ntw ]evsq Bell
Ttd~~~~l~orr~~ Co. (368 A.2d 408, 115 N.J. Super. 516 [19761),
a secretay, \vho \vas allergic to cigarette smoke sought
an injunction requiring a smoking ban. The court or-
dered the emplover to provide a safe Lvorking envi-
ronment bv restricting smoking to a nonwork area.
Similarly, in the case of S\llil/l 7'. Wcstcrr~ Elccfric Co.
(613 S.\Y.2d 10 [Mo. App. 198231, the Missouri Court
of Appeals o\-erturned a lolver court and forced the
emplo\,er to "assume its responsibility to eliminate the
hazarc~ous conditions caused by tobacco smoke" (p.
13). Finall!; in L~,cI 7'. Dqwrf?!w~!~ of Pfltl/ic \Vc/,fflrc (No.
15385 [Mass. Mar. 31, 191131, c'ifcd irl 1.2 TPLR 2.82
[19X6]), a social xvorker sued her employer, seeking
relief from ETS exposure at tvork. The Massachusetts
Superior Court ruled in favor of the plaintiff and re-
quired a smoke-free workplace. Additional protections
to employees are extended bv federal statute, such as
the Americans lvith Disabilities Act of 1990 (ADA)
(Public Larz. 101-336), and by rulings in workers com-
pensation claims.

Status of Restrictions to Limit Smoking in
Public Places

  Although the health risks of ETS exposure be-
gan to be publicized in the early 1970s (NC1 1991),
momentum to regulate public smoking increased only
in 1986, M-hen reports by the Surgeon General
(USDHHS 1986) and the National Academy of Sciences
(1986) concluded that ETS is a cause of lung cancer in
nonsmokers. Since then, government and private busi-
ness policies that limit smoking in public places have
become increasingly common and restrictive (Rigotti
and Pashos 1991). The designation of ETS as a class A
(kno$t.n human) carcinogen by the EPA (1992) stimu-
lated further restrictions on smoking in public places
(Brownson et al. 1995a), but a recent court ruling set
aside that report (see "Health Consequences of Expo-
sure to ETS," earlier in the chapter),

  Although many of the regulatory efforts discussed
herein focus on go\,ernment's passage of a law or an
ordinance, other regulations can be implemented by


Table 5.1. Summary of landmark events in the development of U.S. policies for clean indoor air

Year                                   Event

1971

1972

The Surgeon General proposes a federal smoking ban in public places.
The first report of the Surgeon General to identify environmental tobacco smoke (ETS) as a health risk
is released.

1973

Arizona becomes the first state to restrict smoking in several public places and to reduce ETS exposure
because it is a health risk.

The Civil Aeronautics Board requires no-smoking sections on all commercial airline flights.

1974

1975

1977

Connecticut passes the first state law to apply smoking restrictions to restaurants.

Minnesota passes a comprehensive statewide law for clean indoor air.
Berkeley, California, becomes the first community to limit smoking in restaurants and other public
places.

1983

1986

San Francisco passes a law to place pri\,ate workplaces under smoking restrictions.

A report of the Surgeon General focuses entirely on the health consequences of involuntary smoking;
ETS is proclaimed a cause of lung cancer in healthy nonsmokers.
The National Academy of Sciences issues a report on the health consequences of involuntary smoking.

Americans for Nonsmokers Rights becomes a national group; it had originally formed as California
GASP (Group to Alleviate Smoking Pollution).

1987

The U.S. Department of Health and Human Services establishes a smoke-free environment in all of its
buildings, affecting 120,000 employees nationvvide.

Minnesota passes a law requiring all hospitals in the state to ban smoking by 1990.
A Gallup poll finds, for the first time, that a majority (55 percent) of all U.S. adults favor a complete
ban on smoking in all public places.

1988   A congressionally mandated smoking ban takes effect on all domestic airline flights of two hours or less.

New York City's ordinance for clean indoor air takes effect, banning or severely limiting smoking in
various public places and affecting 7 million people.

California implements a statewide ban on smoking aboard all intrastate airplane, train, and bus trips.

1990

A congressionally mandated smoking ban takes effect on all domestic airline flights of six hours or
less.

The U.S. Environmental Protection Agency (EPA) issues a draft risk-assessment on ETS.

1991

CDC's National Institute for Occupational Safety and Health issues a bulletin recommending that
secondhand smoke be reduced to the lowest feasible concentration in the workplace.

1992

Hospitals applying for accreditation by the Joint Commission on the Accreditation of Healthcare
Organizations are required to develop a policy to prohibit smoking by patients, visitors, employees,
volunteers, and medical staff.

The EPA releases its report classifying ETS as a group A (known human) carcinogen, placing ETS in the
same category as asbestos, benzene, and radon.


Table 5.1. Continued

Year                                   Event

1993

1994

1995

1996

1997

1998

Los Angeles passes a ban on smoking in all restaurants.

The U.S. Postal Ser\.ice eliminates smoking in all facilities.

Congress enacts a smoke-free policy for WIC (Special Supplemental Food Program for Women,
Infants, and Children) clinics.

A w-orking group of 16 state attorneys general releases recommendations for establishing smoke-free
policies in fast-food restaurants.

Vermont bans smoking in all public buildings and many pri\,ate buildings open to the public.

The U.S. Department of Defense prohibits smoking in all indoor military facilities.

The Occupational Safety and Health Administration proposes a rule that would ban smoking in most
U.S. \vorkplaces.

San Francisco passes a ban on smoking in all restaurants and \1-orkplaces.

The Pro-Children's Act requires persons proI,iding iederallv funded children's services to prohibit
smoking in those facilities.

Next York City passes a comprehensi\-e ordinance eifecti~~rly banning smoking in most workplaces.

Maryland enacts a smoke-free policy for all lvorkplaces except hotels, bars, restaurants, and private
clubs.

California passes comprehensive legislation that prohibits smoking in most enclosed workplaces.

Vermont's smoking ban is extended to include restaurants, bars, hotels, and motels, except those
holding a cabaret license.

The C.S. Department of Transportation reports that about 80 percent of nonstop scheduled U.S. airline
flights between the United States and foreign points will be smoke free by June 1, 1996.

President Clinton signs an executive order establishing a smoke-free environment for federal
employees and all members of the public visiting federally owned facilities.

The California EPA issues a report determining that ETS is a toxic air contaminant.

Settlement is reached in the class action lawsuit brought by flight attendants exposed to ETS.

The U.S. Senate bans smoking in the Senate's public spaces.
California law takes effect banning smoking in bars unless a bar has a separately ventilated smoking
area.

agencies with special authoritv. An example of a non-
government regulatory; action'is the recent adoption of
an accrediting standard that prohibits smoking in hos-
pita1 buildings (Joint Commission on Accreditation of
Healthcare Organizations 1992; Longo et al. 1995).

Government Restrictions

  Selreral of the noteworthy events in clean indoor
air regulation are shown in Table 5.1. These events
include federal, state, and local activities.


Federal Laws artd Regulatiom

  The most notable federal regulation of ETS is the
requirement that domestic airline flights be smoke free.
The regulation ~`as first enacted in 1988 for domestic
flights lasting two hours or less and M'as renewed in
1989 for domestic flights lasting six hours or less (Table
5.1). Since the earlv 197Os, the Interstate Commerce
Commission (ICCj has required that smoking on
interstate buses be confined to the rear of the bus
and that smoking sections constitute no more than 10
percent of total seating capacity. Similar ICC regula-
tion for trains was repealed in 1979. In 1987, congres-
sional legislation that threatened to withhold federal
funds influenced the State of Nelv York's Metropoli-
tan Transportation Authority to ban smoking on
the MTA Long Island Rail Road (USDHHS 1989).
Currently, the Occupational Safety and Health Admin-
istration is considering regulations that should either
prohibit smoking in all workplaces or limit it to sepa-
rately ventilated areas (Fc[lr~l~l Rqistcr 1994). Further-
more, the federal gol.ernment has instituted
increasinglv stringent regulations on smoking in its
oM'n facilities, and the Pro-Children's Act of 1994 (Pub-
lic Law 103-227, sets. 1041-1041) prohibits smoking in
facilities in which federally funded children's services
are provided on a regular or routine basis.

State Lazes ad Regulatiom

  As of December 31,1999, smoke-free indoor air
to some degree or in some public places was required
by 45 states and the District of Columbia. These re-
strictions vary widely, from limited restrictions on
public transportation to comprehensive restrictions in
worksites and public places (CDC, Office on Smoking
and Health, State Tobacco Activities Tracking and
Evaluation System, unpublished data). In 1973, Ari-
zona became the first state in which public smoking
was regulated in recognition of ETS as a public health
hazard (Table 5.1). Five states (Alabama, Kentucky,
New Mexico, North Carolina, and Wyoming) have ei-
ther no legislation or legislation that preempts locali-
ties from enacting any law to restrict smoking in public
places (see also Figure 5.2).

  As of December 31, 1999, laws restricting smok-
ing in government worksites were present in 43 states
and the District of Columbia: 29 limit smoking to des-
ignated areas, 2 require either no smoking or desig-
nated smoking areas with separate ventilation, and 11
prohibit smoking entirely. Twenty-one states have
1aLys restricting smoking in private worksites: 20 limit
smoking to designated areas, and 1 (California) re-
quires either no smoking or separate ventilation for
smoking areas.  Thirty-one states have laws that

Figure 5.2. Cumulative number of state laws and amendments enacted for clean indoor air, 1963-1998

1963  1965  1Y67  1969  lY71  1973  1975  lY77  lY7Y  1981  lYX3  lY85  1987  1YHY  1991  1993  1995  1997

                                  Year

IV&>: The category "state" includes the District of Columbia.
Source: National Cancer Institute, State Cancer Legislative Database, unpublished data, August 31, 1998.


regulate smoking in restaurants; ot these, onlv Utah
and Vermont completely prohibit smoking in restau-
rants, and California requires either no smoking or
separate \.entiIation for smoking areas (CDC, Office
on Smoking and Health, State Tobacco Acti\,ities
EL-aluation System, unpublished data).

  In 1991, Maryland proposed a regulation that
lvould prohibit smoking in most \vorkpIaces in the state,
including restaurants and bars (M~7ryl17111l Rqi~fcr 1991).
Despite strong support among both nonsmohers and
smokers for restrictions on public smoking in the state
(Shopland et al. lYY5), this proposal bias aggressi\.ely
challenged bv the tobacco industrv (Spavd lY94), \vhich
questioned the state's legal authoi-it! to.regulate smok-
ing through administrati\.e rule rather than la!\. [n earl\,
1995, the original regulation It-as modified by Iegisld-
tive action to permit some esceptions for the hospital-
itv industry, and the rules ivent into effect. In October
1491, the state of Washington also enacted an ektensi\.c
indoor Ivorkplace ban. In this instance, a temporar>,
injunction \vas dismissed b\, the state court, and the ban
event into effect \vithout litigation (CSH lYY4b).

  In North Carolina, legislation Ivas enacted on Jul\
15, lYY3 (HB 9571, that required that smoking be per-
mitted in at least 20 percent of space in state-controlled
buildings but also formally required nonsmoking
areas. An important preemption clause prohibited
local regulatory boards from enacting more restrictive
regulations for public or pri\,ate buildings after Octo-
ber 15,1993. During that three-month "ivindn\v of op-
portunity," 89 local agencies passed nei2' measures
providing some increased protection from ETS. De-
spite the rush to ne\v restrictions, researchers estimated
that bv the year 2000, the preemption \~ould prevent
39 percent of priorate emplovees in North Carolina from
being protected from ETS iConlisk et al. 1995).

Local Ordillaiices

  The modern era of local ordinances for clean in-
door air began in the early 1970s (Pertschuk 1993). In
1977, Berkeley, California, became the first community
to limit smoking in restaurants and other public places
(Table 5.1). After the release of the 1986 Surgeon
General's report on the health consequences of ETS, the
rate of passage of local ordinances accelerated (Figure
3.3). Bv 1988, nearlv 400 local ordinances to restrict
smokini had been enacted throughout the United States
(Pertschuk and Shopland 1989). The trend toward
smoke-free local ordinances has accelerated since 1989
(Rigotti and Pashos 1991; Pertschuk 1993). As of June
30, 1998, public smoking \vas restricted or banned in
820 local ordinances. Of those that specified \vhich

agency was responsible for enforcement, 44 percent cited
health departments or boards of health, 19 percent
named city managers, 3 percent said police departments,
and 6 percent identified other agencies (Americans for
Nonsmokers' Rights, unpublished data, June 30, 1998).
The effectiveness of various enforcement mechanisms
and the Ie\rel of compliance achieved are not known.
Data from Wisconsin suggest that implementation may
be just as important as legislation in achieving policy
goals (Nordstrom and DeStefano 1995).

  One study examined the impact a local ordinance
had on restaurant receipts (CDC 1995a). Contrary to
some prior claims, an analysis of restaurant sales after
a ban on smoking in this community (a small suburb
of Austin, Texas) showed no ad\,erse economic effect.
In a series of ecologic analyses, Glantz and Smith (1994,
1997) analyzed the effect of smoke-free restaurant and
bar ordinances on sales tax receipts. Over time, such
ordinances had no effect on the fraction of total retail
sales that [Vent to eatin g and drinking places. The
authors asserted that claims of economic hardship for
restaurants and bars that establish smoke-free policies
ha\.e not been substantiated.

Private Sector Restrictions on Smoking
in Workplaces

  T\VO national data sets are available to ascertain
the level of workplace smoking restrictions among pri-
vate firms in the United States. A survey conducted
by the Bureau of National Affairs, Inc. (19911, estimated
that 85 percent of large workplaces had policies
restricting smoking. The percentage of smoke-free
\vorkplaces has increased dramatically, from 2 percent
in 1986 to 7 percent in 1987 and to 34 percent in 1991.
Similarly, data from the 1992 National Survey of
Worksite Health Promotion Activities indicated that 87
percent of workplaces with 50 or more employees regu-
lated smoking in some manner and that 34 percent were
smoke free (USDHHS 1993). The 1995 Update of the
Business Responds to AIDS Benchmark Survey con-
ducted by CDC also found that 87 percent of worksites
with 50 or more employees had a smoking policy of
some kind (National Center for Health Statistics 1997).

  The prevalence of smoking policies in small
\vorkplaces, tvhere the majority of Americans work,
is less \velI studied. A comprehensive examination
of workplace smoking policies from the NCI's tobacco
use supplement to the Current Population Survey
(n = 100,561) indicated that most indoor workers sur-
vexed (81.6 percent) reported that an official policy
go;,erned smoking at their \vorkplaces, and nearly
half reported that the policy could be classified as


"smoke-free"-that is, that smoking XVL?S not permit-
ted either in ivorkplace areas or in common public-
use areas (Gerlach 1997). This proportion \.aried by
sex, age, ethnicity, and occupation: blue-collar and
service occupations had significantly less access to
smoke-free environments. Though data Ivere not spe-
cifically reported by wrorkplace size, the range of occu-
pations suggests that the survey included a substantial
proportion of persons who M'ork in smaller workplace
environments. But for all workplace sizes, the data
suggest that access to smoke-free environments could
be substantially improved.

Effectiveness of Clean Indoor
Air Restrictions

  Although it is generally accepted that regulatory
changes influence nonsmokers' exposure to ETS and
smokers' behavior, relativelv felt eifaluation studies
quantify these effects o\,er- time. Evaluating such
changes is hampered bv the complex interaction of
social forces that shape behavior, bv the decline in

smoking and smoke exposure in the overall popula-
tion, and by the overlapping effects of concomitant
regulatorv policies (e.g., a new law for clean indoor
air passed at or around the time of an increase in the
cigarette excise tax). Controlling for such potential
confounding factors in studies is difficult.

Population-Based Studies

Efiects 011 Nonsmokers' Exposure to ETS

  Despite the widespread implementation of re-
strictions against public smoking, few population-
based studies have examined whether these
restrictions have reduced nonsmokers' exposure to
ETS. One such study from California used data col-
lected in 1YYO and 1991 to examine the association be-
tween the strength of local ordinances for clean indoor
air and cross-sectional data on nonsmokers' exposure
to ETS in the workplace (Pierce et al. lY94b). Expo-
sure to ETS in the workplace ranged from 25 percent
of workplaces in areas with a strong local ordinance
to 35 percent in areas with no local ordinance.

Figure 5.3. Cumulative number of local laws and amendments enacted for clean indoor air, 1979-1998

1487      1989      19Yl      lY93      1995     1997

     Year

IV&c: Ordinances must specifically mention these locations to be counted. Therefore, other ordinances may cover
these areas without being included in these figures.
*Before 1983, there were four lvorkplace ordinances: one passed in 1975, one in 1979, and two in 1980. These are
not included in this chart, because data for consecutive years only became available beginning in 1983 for
workplaces.
Source: American Nonsmokers' Rights Foundation, unpublished data, June 30, 1998.