Framing Processes - Commeentary Public of Tabaco PDF

Framing Processes in Public Commentary on US Federal Tobacco Control Regulation
Author(s): Andrew L. Roth, Joshua Dunsby, Lisa A. Bero

Source: Social Studies of Science, Vol. 33, No. 1 (Feb., 2003), pp. 7-44
Published by: Sage Publications, Ltd.
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ABSTRACT Governmental health policy officials increasinglyseek to promote public
participation in expert and technical decisions regarding health regulation. The issues
of what r6olethe public plays in regulatory processes, and how health policy officials
orient to public opinion, matter especially in the US context, where public
commentary is a requisite component of federal rule-making.This paper examines
written commentary as one specific, institutionalized form of public participation.To
understand the relationship between scientific evidence and public commentary in
public health regulation, we examine a US Food and Drug Administration(FDA)
regulation, proposed in 1995, to restrictthe promotion and sale of tobacco products
to minors.We use recent work on collective action frames to analyse how the FDA
framed the proposed regulation as a rational, science-based policy;the discursive
practicesemployed in the public commentary either to embrace or to contest the
FDA'sframing; and how the agency presented the final version of its rule as
responsive to that public commentary.Our content analyses reveal a significant
disparitybetween the FDA'semphasis on scientific evidence and the commentators'
emphases on political and ideological frames, which we analyse in terms of counter-
framing. An orientation to the dynamicsof framing and counter-framingcontributes
to an understanding of the relationship between scientific evidence and public
commentary in the formulation of controversialhealth policy regulations.
Keywords framing processes, public understanding of science, tobacco control

regulation
Framing Processes in Public Commentary on

US Federal Tobacco Control Regulation
Andrew L. Roth, Joshua Dunsby and Lisa A. Bero
In recent decades, many governments have sought appropriate ways to

involve the public in expert and technical decisions about public health
policy.' Such efforts entail the challenge of developing participation meth-
ods that generate useful input on expert matters from a lay public. A
variety of government-initiated participation methods - including opinion
surveys and focus groups, citizens' panels and advisory committees, and
public hearings - permit different types and degrees of public participation
in these regulatory processes.2
In the United States, public commentary constitutes one important,
institutionalized form of participation in the development of health-policy
regulation. Solicited by the governmental agency proposing a new regula-
tion, public commentary is typically open to anyone or any organization.
Social Studies of Science 33/1 (February 2003) 7-44

? SSS and SAGE Publications (London, Thousand Oaks CA, New Delhi)
[0306-3127(200302)33: 1;7-44;032038]
www.sagepublications. com
8 Social Studies of Science 33/1
US federal law requires the agency proposing the rule to read and give 'full
and serious' consideration to every submitted comment. These comments
are important for shaping the final version of the proposed regulation,
increasing its public acceptability, and for preventing the 'capture' of the
regulatory process by special interest groups.3
This paper examines the Food and Drug Administration's proposed
rule to restrict the promotion and sale of tobacco products to minors,4 the
public commentary submitted in response to the rule, and how the agency
presented revisions to the final version of the rule as responsive to this
public commentary. Employing current work on frame analysis (for exam-
ple, Benford & Snow, 2000), this case study investigates important aspects
of the relationships among science, health policy, and the public in
democratic societies such as the United States. An orientation to the
dynamics of framing and counter-framing is useful in understanding the
r6les that evidence and public commentary play in the formulation of
public health regulations.
We employ frame analysis to identify the discursive strategies em-
ployed by the US Food and Drug Administration (FDA) to present its
proposed regulation as a rational, science-based policy and those employed
in the public commentary to either embrace or contest this representation
of the proposed regulation. Content analysis of this commentary, based on
a sample of more than 500 individual comments, reveals a significant
disparity between the rule's emphasis on scientific evidence and the
commentators' emphases on political and ideological issues, which we
analyse in terms of counter-framing.
On 21 March 2000, the Supreme Court ruled narrowly (5-4) that
Congress had not given the FDA the authority to implement the final
version of its tobacco rule.5 However, the Court's decision hinged ex-
clusively on the FDA's jurisdiction;it specifically did not take into account
either the scientific evidence mobilized by the FDA, or the ideological,
economic and political arguments employed in the public commentary.
Nevertheless, an understanding of the relationship between the FDA's
framing of the proposed rule as a science-based policy and the types of
arguments submitted by the public remains important. Although the sites
of future contests over tobacco control in the USA are likely to shift - from
the FDA to Congress, and from federal- to state- and local-government-
the frames and counter-frames used to advocate and contest tobacco
control are likely to recur.6
The primary goal of this study is to analyse the FDA's proposed rule
and the public commentary on it as one historically-situated and institu-
tionally-specific instance of the relationship between (government) experts
and (public) laypersons. Although the FDA's proposed rule was unique in
a number of ways, the questions that we address have a relevance extend-
ing beyond the specifics of this particular case study:
How is the formulation of health regulations shaped by the expectation

(or requirement) of public commentary on it?
Roth, Dunsby & Bero: Framing Processes in Public Commentary 9
* If one purpose of public commentary is to increase public awareness of

and support for some policy, then how do regulatory agencies present
scientific evidence to the public?
* Under what conditions might the public treat scientific evidence as a
credible basis for supporting highly controversial health regulations?
To develop a basis for addressing these questions, we begin by reviewing
the concerns and methods of previous research on public response to
science-based policy, and then explicating our own method of inquiry.
Prior Research on Regulatory Processes and Public

Participation
In addressing public health risks, Jasanoff (1989: 152) observes: 'It is
difficult to formulate policy responses that strike divergent interest groups
as both technically and politically legitimate'. This difficulty is most
pronounced for instances in which the proposed policy seeks significant
restrictions based on disputable scientific evidence.7 However, even in
cases of widespread consensus on the credibility of the scientific evidence,
prior studies demonstrate that the role of science in the formulation of
health and environmental regulations cannot be understood as independ-
ent of politics, law, and the mass media.8
As Abraham & Sheppard (1997: 141) succinctly state, 'Experts do not
operate in a social vacuum'. Experts' perspectives may especially be
influenced by concerns for the public legitimation of regulatory science. In
the USA, this is almost necessarily the case because public accountability is
a formally institutionalized aspect of the regulatory process. As Sheila
Jasanoff (1990: 247) has described, federal laws leave US regulatory
agencies with 'little or no discretion to insulate the process ... from public
scrutiny'.9
These factors establish a basis for examining public attitudes toward
the use of science in health regulations. Empirical investigations of the
relationship in democratic societies between science-based regulatory pol-
icy and the public have tended to examine three sorts of empirical
evidence. First, studies such as Jasanoff's (1990) investigation of expert
science advisors to the Environmental Protection Agency and the FDA
have focused on official documentsas evidence.10 Such studies have been
crucial in developing a social scientific understanding of technical and
administrative rationality as institutionalized processes (see, for instance,
Jasanoff, 1989). A second area of social science research on expert-lay
relations relies on interviews (typically with experts) as evidence (see, for
example, Abraham & Sheppard, 1997, and Montini & Bero, 2001). These
studies offer useful insight into regulatory policy-makers' practices of
interpreting and evaluating public input. A third line of inquiry focuses on
investigating the perspectives of laypersons themselves, using a variety of
methods. For example, Abraham & Sheppard (1997) employed a combi-
nation of interviews with experts and 'non-expert' focus groups to identify
divergences between their perspectives on medicines regulation." This
research is especially important from a practical, policy-oriented per-

spective, because it provides an empirical basis for recommendations on
how to facilitate increased, efficacious public participation in regulatory
processes.
In cases where the gathering of public opinion is not part of the
regulatory process itself, social scientists interested in studying private
citizens' attitudes toward, and understandings of, science may have no
choice but to employ interviews and focus groups as methods to elicit
those attitudes and understandings. However, given our focus on public
participation in regulatory processes, US agencies such as the FDA offer
perspicuous investigation opportunities because these agencies solicit pub-
lic commentary as part of the regulatory process itself. More specifically,
the case of the FDA's proposed tobacco regulation is especially useful in
this regard because it generated an unusually large volume of public
commentary from private citizens.'2
Thus, in this paper, we examine not only the text of the FDA's
proposed regulation (in line with prior documentary studies of regulatory
decision-making), but also public commentary submitted to the FDA in
response to its proposed rule. By contrast with interviews, focus groups
and other methods in which researchers use a variety of techniques to elicit
subjects' attitudes and beliefs, the public commentary that we use is
naturally-occurring data. Naturally-occurring data are especially valuable
because they demonstrate people's actual actions, rather than relying on
their retrospective accounts of them.'3
Framing Processes
A second basic difference between this study and previous ones is our use
of frame analysis as a means of analysing the dynamic relationships, in the
case of the FDA's proposed tobacco regulation, between scientific evidence
and public commentary. Erving Goffman developed a sociological concep-
tion of 'framing' by examining the practices that social actors employ in
daily life 'to locate, perceive, identify, and label a seemingly infinite number
of concrete occurrences' (Goffman, 1986 [1974]: 21). In the past two
decades, scholars have adapted Goffman's concept of framing to examine
the dynamics of social movements.14 From this perspective, collective
action frames are 'action-oriented sets of beliefs and meanings that inspire
and legitimate the activities and campaigns of a social movement organiza-
tion' (Benford & Snow, 2000: 614; see also Gamson, 1992).
Examination of collective action frames entails analysis of how actors
mobilize and counter-mobilize ideas and meanings, in what Hall (1982)
has aptly characterized as 'the politics of signification'. More specifically,
Snow & Benford (1988) argue that collective action frames identify prob-
lematic conditions or situations in need of change ('diagnostic' framing),
articulate an alternative set of arrangements ('prognostic' framing), and
urge others to act in concert to affect change ('motivational' framing).
Framing processes are deliberative, utilitarian and goal-directed.
The development and elaboration of a frame do not ensure that all

actors will align with it, however. Through counter-framing,antagonists can
challenge a movement's diagnostic and/or prognostic framings, resulting in
framing contests (see, for example, Benford & Snow, 2000: 626). Scholars
have shown that, in framing contests, the resonance, and thus the strategic
efficacy, of competing frames depends on the cultural and political envi-
ronment (see, for example, Kane, 1997, and Gamson, 1992: 135-62).
In this paper, we use the concepts of framing and counter-framing to
analyse the text of the FDA's proposed rule and the public commentary. In
particular, we use the distinction between diagnostic and prognostic fram-
ing to analyse the patterns of support for, or opposition to, the FDA's
proposed rule in the public commentary.
As Brian Wynne (1995: 377) has observed, 'public "acceptance" or
"understanding" of science depends upon implicit trust in and identifica-
tion with the institutions controlling and deploying it'. Public trust in, and
identification with, institutions such as the FDA undoubtedly develop over
time. Examining the case of the FDA's tobacco regulation in terms of
framing and counter-framing allows us to show how regulatory agencies
attempt to establish public credibility for controversial policies, and how
the public responds to those attempts.
The FDA's Proposed Rule

On 10 August 1995, President Clinton announced the proposed Food and
Drug Administration (FDA) rule to reduce the youth appeal of tobacco
products and minors' access to them. Citing data indicating that one
million children and adolescents became regular smokers each year, and
that nearly one-third of these young people would die prematurely as a
result of smoking, the FDA's proposed rule declared the aim of reducing
youth use of tobacco by 50% within seven years (Department of Health &
Human Services, 1995: 41316).
The proposed rule that appeared in the FederalRegisteron 11 August
1995 consisted of two primary sections that, taken together, sought to
establish the FDA's scientific and legal authority. The first section ('Regu-
lations Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco Products to Protect Children and Adolescents': hereafter referred
to as 'Regulations') invoked scientific research on pharmacology, epide-
miology, and advertising effects as evidence in support of its aims. In these
'Regulations', the FDA cited a broad body of scientific research on the
influence of tobacco advertising on youth, the incidence of under-age
smoking, and nicotine addiction.
The second section ('Analysis Regarding the Food and Drug Admin-
istration's Jurisdiction Over Nicotine-Containing Cigarettes and Smoke-
less Tobacco Products') sought to establish that the proposed restrictions
on tobacco advertising and sales fell within the agency's jurisdiction. Here,
the FDA argued that cigarettes and smokeless tobacco 'affect the structure
or function of the body' within the meaning of the Federal Food, Drug and
Cosmetic Act that specifies the agency's jurisdiction. Though the FDA's
jurisdiction argument also invoked science, it was primarily a legal
argument.
In this paper, we focus on the FDA's identification of under-age
tobacco use as the problematic situation in need of change (diagnostic
framing) and the FDA's proposed remedy to that situation (prognostic
framing), as articulated in the 'Regulations'. Our interest in the role of
science in health regulations focuses our attention on this initial section of
the rule, where science and scientific evidence constitute the 'master
frame' (Snow & Benford, 1992; also Benford & Snow, 2000: 618-19) for
the FDA's claims. We do not address the FDA's arguments regarding
jurisdiction except to provide historical context, because that subject
entails analysis of primarily legal, rather than scientific, frames.
Historical Context
The FDA's proposed rule constituted a significant shift in the Agency's
historical approach to tobacco regulation (see Gostin, Arno & Brandt,
1997). In effect, the FDA sought to expand its authority into unprece-
dented areas.
In 1977, Action on Smoking & Health (ASH) submitted a citizen
petition urging the agency to assert regulatory authority over tobacco
products. The FDA declined to do so, arguing that it lacked jurisdiction
because cigarettes were not drugs, and there was no evidence of manu-
facturers' intent to 'affect the structure or function of the body'. In 1980, a
Court of Appeals judge upheld the FDA's position, but also allowed that,
in the future, the agency 'may depart from its prior interpretations', so long
as it 'provide[s] a reasoned explanation for its action'.15 Thus, Action on
Smoking & Health v. Harris allowed that, in the future, the FDA might
demonstrate tobacco product manufacturers' intent.
In 1991, FDA Commissioner David Kessler began to investigate
options for regulating cigarettes and other tobacco products. The agency
reviewed data on nicotine's effects on the structure and function of the
body. In June 1994, against the public backdrop of congressional hearings,
legal suits, and a Justice Department investigation related to revelations on
tobacco companies' manipulation of nicotine levels, the FDA argued that
nicotine was a drug, and that cigarettes and other tobacco products were
'drug delivery devices'. Prior to 1995, Kessler and the FDA might have
had the 'objective evidence' specified in Action on Smoking & Health v.
Harris to claim jurisdiction over tobacco, but the political support to make
good on the loophole from that significant case did not develop until
then.
An Orientationto Public Opinion

During this period, Kessler and the FDA sought to enlist the Clinton
Administration's support for the proposed regulation. In considering the
possibility of developing a Regulation, Kessler, the FDA, and the White
House all paid careful attention to public opinion, as indicated by polling

data, on tobacco control. In November 1994, Kessler and other key
members of the FDA made a presentation to Donna Shalala, Secretary of
the Department of Health & Human Services, hoping to enlist her support
for the Regulation. Among the evidence presented, Kessler recalls Sharon
Natanblut's presentation emphasizing public opinion:
Broad support from the American people was crucial in the highly
political environmentof the Department and the White House, and
Sharonrevieweda series of surveysthat showedwe had it. A GallupPoll
found that morethan threequartersof the populationfavoredrestrictions
on cigaretteadvertisingthat appealedto youth. Otherstudiesshowedthat
significantmajoritiesalso supportedbans on free product samples and
billboardsand favoredsuspendingthe tobacco licenses of retailerswho
sold cigarettes to minors. By the time Catherine [Lorraine], Judy
[Wilkenfield],and Sharonwerefinished,the key componentsof our draft
regulationhad been summarized.(Kessler,2001: 293)
This first meeting established the basis for Shalala and her Department's
involvement in promoting the FDA's draft Regulation to the White House.
Kessler relates a subsequent meeting in the White House with Leon
Panetta (the President's chief-of-staff) and Harold Ickes (the deputy chief-
of-staff) where Shalala cited poll results from a Robert Wood Johnson
Foundation survey indicating 'broad support for an approach that empha-
sized children' (Kessler, 2001: 324).
Inside the White House, one of President Clinton's strategic advisors,
Dick Morris, urged Clinton to take on the tobacco industry for strategic
political reasons. Polling data were also crucial for Morris in making his
case. His poll of voters in five key tobacco states (Georgia, Kentucky,
North Carolina, Tennessee and Virginia) indicated that whereas 50% of the
population would support regulation of adult smoking, the figure jumped
to 75% if it applied only to young people (Kessler, 2001: 322).16 The
conclusion to be drawn from Morris's poll was 'unmistakable,' according
to Kessler (2001: 323):
Regardlessof political affiliation,the American people did not want

tobacco sold to children.AlthoughI was not about to make decisionson
the basis of a poll, the figureswere reassuring.
As Kessler's accounts indicate, public opinion polls, suggesting voters'

support for restrictions that emphasized children, played a key role in the
development of political support in the White House for the FDA's
Regulation.
Thus, in August 1995, the FDA proposed its 'Regulations' with
confidence in the strength of both the scientific evidence and executive
support for the proposed Regulation. As such, the proposed Regulation
can be understood as characteristic of the 'pragmatic rationality' thatYaron
Ezrahi (1980) associates with science-based policymaking, in which 'prog-
ress from intellectual diagnosis to practical action is ... an unavoidable
mixture of scientific and non-scientific judgments' (Ezrahi, 1980: 114; see
also Ezrahi, 1984). Though the formulation of the FDA's rule may have
been guided by pragmatic rationality, in the Federal Register the FDA's
presentationof the rule to the public depicted it as technically and admin-
istratively rational, not as a product of pragmatic compromises between
'scientific and non-scientific judgments'.17
In August 1995, the FDA also believed, based on the previously
discussed opinion polls, that the proposed Regulation would be met with
public favour. Instead, the majority of the public commentary opposed the
rule. Our analysis of a representative sample of the commentary reveals a
disparity between the proposed rule's emphasis on scientific evidence (that
is, technical rationality) and the commentators' emphases on political and
ideological issues, which we analyse in terms of counter-framing. However,
before examining how the public commentary sought to reframe the
FDA's proposed rule, we first identify how the FDA attempted to frame its
rule as a matter of science-based regulatory policy. Throughout our analy-
sis of the FDA's proposed rule, our aim is not to determine whether the
FDA's diagnostic and prognostic claims are actually factual or valid, but
whether the scientific arguments and evidence presented by the FDA lent
themselves to being interpreted by the commentating public as a credible
basis for the agency's proposed rule (cf. Snow & Benford, 1992: 140-41,
esp. note 4).
Framing the Proposed Rule

Diagnostic Framing
Diagnostic frames identify the problematic conditions or situations in need
of change. The initial sections of the proposed rule identified the set of
related public health problems that it aimed to address by proposing its
'Regulations'. In 1995, whenever FDA Commissioner David Kessler ad-
dressed public forums, he regularly described tobacco-use as an 'epi-
demic', and under-age use of tobacco as a 'pediatric disease'. These two
themes figure prominently in the opening sections of the FDA's proposed
rule. The 'Introduction' identified the problem of tobacco-use in terms of
the general US population:
Approximately50 million Americans currently smoke cigarettes and

another6 million use smokelesstobacco products.These tobacco prod-
ucts are responsiblefor more than 400,000 deaths each year due to
cancer, respiratoryillnesses, heart disease, and other health problems.
Cigaretteskill more Americanseach year than acquiredimmune defi-
ciencysyndrome(AIDS), alcohol,car accidents,murders,suicides,illegal
drugs, and fires combined. On average,smokerswho die from a disease
causedby smokinglose 12 to 15 yearsof life becauseof tobaccouse.18
In subsequent sections, the text focused specifically on tobacco use among

children and adolescents, as evident in the following passages:
[T]he scientificevidencestronglysuggeststhat nicotine addictionbegins

when most tobaccousers areteenagersor youngerand, thus, is a pediatric
disease. ... Approximately3 millionchildrenunderthe age of 18 aredaily

smokers.One studyfound thatchildrenbetweenthe ages of 8 and 11 who
aredailysmokersconsumean averageof 4 cigarettesdaily,and those who
are betweenthe ages of 12 and 17 averagenearly 14 cigarettesdaily.The
study also estimatedthat adolescentsconsume an estimated947 million
packs of cigarettesand 26 million containersof smokelesstobacco an-
nuallyand accountfor annualtobaccosalesof $1.26 billion. (Department
of Health & Human Services, 1995: 41314 & 41317)
The text of the proposed rule focused from a broadly defined public-health
problem (the prevalence of tobacco-use among the general population) to
a specific problem (tobacco use by children under the age of 18). As we
noted earlier, the FDA and Clinton Administration undertook this narrow-
ing of scope partly due to pragmatic and political, rather than exclusively
scientific, reasons.
The diagnostic framing process includes what Benford & Snow (2000:
616) term an 'attributional component', which focuses on blame and
responsibility. The proposed rule attributed blame to two sources. First,
the text identified the inadequacy of existing state laws prohibiting under-
age tobacco use:
[A]11States prohibitthe sale of tobacco to persons under the age of 18
(withsome Statesprohibitingsalesto personsunderthe age of 19 and one
State,Pennsylvania,prohibitingcigarettesalesto personsunderthe age of
21). Unfortunately,few States successfullyenforce their laws restricting
tobacco sales to minors. (Department of Health & Human Services,
1995: 41317)
If, however, the FDA had limited the blame for under-age tobacco to
inadequate enforcement of existing state laws, the framing of the problem
might have suggested a less controversial solution. Rather than extending
the FDA's jurisdiction to include some regulation of tobacco products,
sceptics of the FDA's policy might simply have argued that each state
government ought to renew its commitment to enforcing the existing laws
restricting tobacco sales to minors. By contrast, the FDA argued that such
efforts would be inadequate in the face of the tobacco industry's persuasive
influence and economic interests.
To make the case for federal regulation of tobacco products under its
jurisdiction, the FDA identified the tobacco industry as a culpable agent,
as can be seen in this passage on the cigarette industry and its economic
interests:
Eachyear,the cigaretteindustryloses about 1.7 millioncustomersin the
United States;about 400,000 die from diseasescaused by their smoking
and another 1.3 million quit smoking.To offset the sales lost to smokers
who die or quit smoking,cigarettemanufacturersrelyon youngpeople as
the primarysource of new customers. Each day, approximately3,000
young people become regularsmokers, serving as the industry'smajor
domestic source of replacement smokers. (Department of Health &
Human Services, 1995: 41317)
The preceding passage brings together each of the key themes in the FDA's
diagnosis of the public-health problem to be addressed by its proposed
rule. Even though tobacco use is prevalent in the general US population,

the profit-oriented tobacco industry has an economic interest in recruiting
young people as tobacco users to replace those who have died of tobacco-
related disease. In brief, the FDA framed the problem of under-age
tobacco-use as a matter of preventableillness."9On this basis, the text of the
proposed rule began to describe the FDA's plan for solving the problem of
under-age tobacco use.
PrognosticFraming
Prognostic framing addresses the task of what is to be done about the
identified problem. The opening paragraph of the FDA's text stated the
proposed rule's intent and scope:
The proposedrule would reduce children'sand adolescents'easy access
to cigarettesand smokelesstobacco as well as significantlydecreasethe
amount of positive imagerythat makes these products so appealingto
them.The proposedrulewouldnot restrictthe use of tobaccoproductsby
adults. (Departmentof Health & Human Services, 1995: 41314)
The rule consisted of three basic components, targeting the issues of access,
appeal, and education.Table 1 summarizes the proposed rule's main fea-
tures, as presented by the FDA.
Each of these three components addresses the FDA's diagnosis of
under-age tobacco use as pediatric disease and preventable illness.
'Science'as a 'Master'Frame
Overarching both the identification of under-age tobacco use as a prevent-
able illness (the diagnostic frame) and the proposal to target access, appeal
TABLE1
The Proposed Rule's Prognostic Frame
1) Reducing Access
* Minimum age of 18 to buy tobacco products;
* Ban vending machines and self-service displays;
* Ban 'kiddie' packs, 'loosies', or free samples;
* Ban mail order sales.
2) Reducing Appeal
* Ban billboards within 1,000 feet of schools and playgrounds;
* Other billboards, outdoor and instore advertising limited to black-and-white text only;
* Advertising in publications with significant youth readership (more than 15% or 2
million) limited to black-and-white text only;
* Ban brand-name sponsorship of sporting or other events; only corporate-name sponsor-
ship permitted;
* Ban brand names on hats, t-shirts, gym bags, etc.
3) Educating Youth about Tobacco Health Risks

* $150 million national education campaign, funded by tobacco manufacturers, 'to counter
the pervasive imagery and reduce the appeal created by decades of pro-tobacco
messages'.
and education as a means of reducing youth tobacco use (the prognostic

frame) is the importance of science as the proposed rule's 'master frame'.
David Snow and Robert Benford differentiate master frames from col-
lective action frames (as we have considered so far) through a pair of
analogies:
Masterframesare to movement-specificcollectiveaction framesas para-
digms are to finely tuned theories. Master frames are generic; specific
collectiveactionframesarederivative.So conceived,masterframescan be
construedas functioningin a manneranalogousto linguisticcodes in that
they providea grammarthat punctuatesand syntacticallyconnects pat-
terns or happeningsin the world. (Snow & Benford, 1992: 138, note 30;
see also Benford& Snow, 2000: 618-19, note 5)
The FDA's prognostic and diagnostic frames were derivative (in Snow &
Benford's sense of the term) of science as a master frame; these frames
relied on science as the 'grammar' in terms of which they made sense.20
An exhaustive content analysis of the proposed rule - especially one
with a focus on the text's pervasive reliance on citations to existing
scientific literature and reports - goes beyond the scope of the present
paper. Consider, however, the following comparison as initial, anecdotal
evidence in support of the claim that science constituted the master frame
for the FDA's proposed Regulation. In the introduction to the FDA's
proposed rule, the text cites no fewer than 25 scientific reports as support-
ing evidence; by contrast, the equivalent section of the Occupational Safety
& Health Administration's (OSHA) 1994 proposed rule on indoor air
quality cited just one scientific study.21
Throughout the text of its proposed Regulation, the FDA identified
problems associated with under-age tobacco use and proposed solutions to
those problems as empiricallyverifiablematters, in terms of prior research
and supporting scientific findings. Moreover, by attributing these findings
to third parties, the text presented the findings as supporting evidence that
existedindependentlyof the FDA and whatever particular interests might be
attributed to it. Put another way, the FDA sought to assert that its
proposed Regulation was based on and supported by scientific evidence
generated outside the agency, rather than on the basis of the FDA's own
research. Had the FDA relied on the latter approach, the proposed
Regulation would have been vulnerable to the criticism that the FDA had
generated the evidence in order to rationalize its proposed Regulation, a
criticism that could have undercut the credibility of the evidence and the
legitimacy of the Regulation. The FDA sought to avoid such criticism by
presenting the scientific evidence for the Regulation as independent of, but
consistent with, the proposed Regulation.
Thus, in reporting scientific findings, the FDA sought to demonstrate
that its claims could be - and, indeed, had been - empirically verified. For
example, in documenting the bases for its proposed advertising restric-
tions, the FDA based its proposals on 'the recommendations of major US
and world health organizations and on current efforts by other countries to
reduce tobacco use', and went on to elaborate:
The proposed labeling and advertisingregulationsare also based upon

numerous studies and reports.The first and most compellingpiece of
evidencesupportingrestrictionson cigaretteand smokelesstobaccoprod-
uct labeling,advertising,and promotionis that these productsare among
the most heavilyadvertisedproductsin America.Between 1970 (1 year
before Federallaw prohibitedcigaretteadvertisementson televisionand
radio) and 1993, cigarette advertisingand promotional expenditures
increased from $361 million to $6 billion, a 1,562 percent increase.
(Departmentof Health & Human Services, 1995: 41328-29) 22
Over the following five pages, the FDA text described and discussed
additional findings on labelling and advertising, leading the agency to
conclude that ...
... the preponderanceof quantitativeand qualitativestudies of cigarette

advertisingsuggests: (1) A causal relationshipbetween advertisingand
youth smokingbehavior,and (2) a positiveeffect of stringentadvertising
measures on smoking rates and on youth smoking. (Department of
Health & Human Services, 1995: 41334)
Similarly, in presenting its claims that tobacco use is associated with

disease, the FDA introduced its summary of findings in terms of their
scientific authority:
Much of the followingbriefdiscussionis abstractedfrom severalSurgeon

General'sreports.The SurgeonGeneral'sreportssummarizethousandsof
peer-reviewedscientific studies and are themselves peer-reviewedand
subjected to significant scientific scrutiny. (Department of Health &
Human Services, 1995: 41318)
The subsequent two-page review included 67 references to studies, from

outside the FDA, documenting the health effects of tobacco use. In these
examples, and indeed throughout the proposed rule's text, the FDA sought
to demonstrate the objectivity of its claims and proposals by presenting
them as empirically verified. The numerous studies cited may be taken to
indicate consensus among the scientific community about tobacco's health
effects, as the FDA hoped to demonstrate. However, as claims to objectiv-
ity, they also indicate the FDA's orientation to the need to defend the
proposed rule against attack by opponents who would seek to portray it as
an arbitraryimposition by a bureaucratic agency, operating inappropriately
under the personal initiative of its leadership (cf. Porter, 1995, and
Jasanoff, 1991).
The use of scientific evidence and other research findings to demon-
strate objectivity is reinforced through a second, related aspect of the
FDA's reliance on science as a master frame. Throughout, the FDA cited
studies conducted independentlyof the agency, and its specific regulatory
agenda, as supporting evidence. The text's reporting of other studies
constitutes what Goffman (1981) and others have analysed as shifts in
footing. Examining spoken interaction, Goffman investigated how speakers
could report or otherwise 'animate' other, third parties' talk in their own
talk to accomplish a range of interactional projects (see also Goffman,
1986 [1974]: 496, 559). Subsequent analysts have examined how partici-
pants employ footing shifts in interactionally contentious situations (for
example, Goodwin, 1990; Clayman, 1992). Thus, Clayman (1992:
187-93) has shown how broadcast news interviewers attribute potentially
controversial topics to third parties, a practice that allows interviewers to
pose questions on these topics without being personally responsible for any
position(s) that these questions might be taken to embody.
In the FDA's proposed rule, the attribution of supporting evidence to
third parties also served as a means of adopting a (formally) neutral
stance.23 Like the news interviewers whose practices Clayman analysed,
the FDA's proposed rule employed third-party attribution to introduce a
controversial topic (a federal Regulation to restrict tobacco-related adver-
tising) and to defend against potential criticism (especially, that the agen-
cy's policy was a personal crusade by either FDA Commissioner David
Kessler or President Clinton). Not only did the proposed rule attribute
these findings to third parties, it also commented on the authoritativeness
of the sources it cited and the range of organizations endorsing the position
that it sought to advance (for example, 'thousands of peer-reviewed scien-
tific studies'), two practices for 'constituting credibility' that Clayman
(1992: 187-93) identified in news interviews.
In summary, the text of the FDA's proposed rule employed science as
a master frame. The FDA cited scientific evidence to document the
existence of a public-health problem (under-age tobacco use) and to
present the agency's proposed solution to it (restrictions on sales and
advertising, plus youth education). As analysts of framing processes ob-
serve, demonstrating empirical credibility - that is, the apparent fit
between framings and events in the world - is critical to the resonance of
any given frame (see, for example, Benford & Snow, 2000: 619-22).
Given the proposed rule's use of science as a master frame, one might
hypothesize that scientific arguments would figure frequently and promi-
nently in public commentary on the rule. For example, the rule's oppo-
nents might challenge the reliability and/or validity of the scientific evi-
dence cited by the FDA; and, alternatively, the rule's supporters might
embrace the scientific research cited by the FDA as incontrovertible
evidence derived from systematic research. Instead, we found that both
opponents and supporters of the rule overwhelmingly employed ideologi-
cal, economic and political frames, rather than scientific ones, to warrant
their position toward the proposed rule. Our subsequent analysis of the
public commentary investigates these patterns.
The publication of the proposed rule coincided with the opening of the
period for public commentary on the rule. The FDA accepted public
commentary on its proposed rule between 11 August 1995 and 19 April
1996.24 By the conclusion of the public commentary period, the FDA had
received more than 700,000 comments on the proposed rule, a massive
response without precedent in the Agency's history (Department of Health
& Human Services, 1996: 44418).25 In the following sections, we under-
take a quantitative and qualitative analysis of a representative sample of the
public commentary on the proposed rule to identify the types of arguments

mobilized by commentators, either for or against the rule. We begin by
explaining the methods we employed to select our sample and to code the
public commentary that comprised it.
Methods
Data Sourcesand Sampling
From the FDA, we obtained 96,755 submissions that the agency identified
as 'individual comments'. These individual comments excluded duplicates,
form letters and petitions, which comprised the great majority of the entire
700,000 comments received by the FDA. The FDA provided the complete
text of each individual comment in PDF-format on CD-ROM discs.
We randomly selected 572 comments for analysis, and determined the
commentators' affiliations and positions toward the proposed rule for each
comment (see below). We then selected every sampled comment from the
four most frequently occurring affiliation categories: private citizens, pri-
vate non-profits, the tobacco industry, and health-care service providers.
This selection gave us a working sample of 514 comments, which served as
the core data for our analysis of the arguments mobilized for and against
the proposed rule. We used QSR's N4 Classic software to facilitate data
management.
Coding
PositionTowardRegulation.We coded each of the sampled commentaries
as taking a position for or against the rule. We also had a 'neutral' coding
category, but none of the commentary in our sample fell into this
category.
Affiliation. We coded the affiliation of each commentary submitter into

mutually exclusive categories, including the following: State, local, and
federal government; labour organizations; business/merchant organiza-
tions; non-smokers' lay organizations; smokers' lay organizations; private
non-profit organizations; private practice/consulting; health-care service
provider/practitioner; health professionals' organizations; university/col-
lege; small business owner-manager; tobacco; and those with no affiliation
(that is, private citizens).26
Content Analysis of Frames and Counter-Frames.For commentary sub-

mitted by the four most prominent affiliation categories in our sample - the
tobacco industry, private non-profit organizations, health-care service pro-
viders, and private citizens - we coded the frames and/or counter-frames
employed in each commentary. The coding scheme for these consisted of
five basic frames types, based on recurrent themes in the data, and in terms
consistent with prior research on arguments for and against tobacco
control:27
* Scientificframes invoking research on tobacco use by minors, its health

effects, or advertising. This category included evaluations of the overall
quality of that research, and more specific arguments about study
design, measurement, and interpretation of results, including charges
of misinterpretation and fraud;
* Ideologicalframes invoking freedom of choice rights, and the necessity
for or threat of government intrusion;
* Economicframes focused on the proposed rule's costs (for example, to
government or the tobacco industry), its potential impact on the local,
state, and national economies, and the costs of tobacco-related
illnesses;
* Political frames invoking federal preemption of state and local laws,
enforcement of the proposed rule, and other strategic motivations for
it; and
* Proceduralframes invoking the adequacy, appropriateness, or fairness of
the rule-making process itself.
Commentators could mobilize any frame either for or against the proposed
rule. Using these categories we identified the types of arguments presented
in support of, or opposition to, the FDA's proposed rule, and determined
the frequency of their use.
In coding, we did not treat the five frames and their subcategories as
mutually exclusive categories because the commentators did not use them
that way. For example, a single letter might mobilize both scientific and
economic frames, or several different types of political frames. We designed
our coding to capture these possibilities. (See extracts [FDA06193] and
[FDA20532] below for two examples of this.)
For each commentary, we identified relevant passages and coded the
frames in those passages. For the quantitative analysis presented here, the
unit of analysis is the individual commentary. Using QSR's N4 Classic
software, our coding captures the specific array of frames invoked in each
sampled commentary. Thus the coding system emphasized validity without
sacrificing reliability: all categories presented in this paper have intercoder
reliability scores of at least 80%.
Results I: Position Toward Regulation and Affiliation

Sixty-four percent of the sampled commentary (328/514) opposed the
rule, and 36% (186/514) supported it. As Table 2 indicates, the great
majority of the sampled commentary (75%, N = 514) came from private
citizens.28
In our sample, commentary opposing the rule came almost exclusively
from private citizens (91%, N = 328) and the tobacco industry (9%, N =
328).29 Commentary supporting the rule (N = 186) came from private
citizens (48%), non-profit organizations (41%) such as the American Lung
Association, and health-care service providers (11 %).
TABLE2
Position Toward Rule, by Affiliation
Percentage of Commentaries
Total Against For
N = 514 N = 328 N = 186
Affiliation
Private Citizen 75% 91% 48%
Private Non-Profit 15% 0% 41%
Tobacco Industry/Corporation 6% 9% 0%
Health-Care Service Provider 4% < 1% 11%
Results II: Framing Support For and Opposition To the

Proposed Rule
This section describes the different types of frames presented in public
commentary for and against the FDA rule. Table 3 summarizes our
findings.
As Table 3 shows, 89% of the commentators opposing the rule invoked
ideological frames, whereas only 25% of the rule's supporters did so. The
sums of the columns for ideological, economic, political, scientific and
procedural frames are greater than 100% because any given commentary
could invoke multiple frames.
Notably, however, as indicated in the row titled 'Any Frame', whereas
every sampled comment opposing the rule (100%, N = 328) invoked at
least one frame to warrant opposition, just 55% of the sampled comments
supporting the rule (N = 186) made substantive arguments for it by
invoking one or more persuasive frames. Instead, in 45% of the supporting
commentary, the author simply assertedher/his support for the proposed
rule, without invoking any particular frame to warrant that support, as can
be seen in the following exemplars, which display the entire body of the
authors' letters:
TABLE3
Position Toward Rule, by Frame Type
Percentage of Commentaries
Total Against For
N = 514 N = 328 N = 186
Argument Type
Any Frame 84% 100% 55%
Ideological 66% 89% 25%
Economic 41% 35% 4%
Political 21% 23% 18%
Scientific 6% 5% 8%
Procedural 2% 3% 0%
Dear Sir or Madame,We would like to express our support for your
proposalto regulatetobacco as a drug, and to take strong measuresto
keep it awayfrom young people. [FDA02583: 1]
Dear Sirs: I support your proposed regulationsto curtail the sale on
marketingof tobacco products to young people. I hope that your pro-
posed rules on tobacco regulationswould be approvedin orderto curtail
access of individualsunder age 18 to tobaccoproducts.[FDA04224: 1]
Thus, not only did opponents of the proposed rule outnumber advocates
at a rate of nearly two-to-one, they were also more likely than advocates to
mobilize some type of persuasive framing in presenting a substantive
argument to support their stance.
ScientificFrames
Whereas the proposed rule cited an extensive, diverse body of scientific
evidence on the addictive effects of nicotine, the incidence of under-age
smoking, and the influence of advertising on youth, commentary on the
rule infrequently addressed this scientific evidence. Table 3 shows that, in
our sample, commentary for or against the rule mobilized scientific frames
less frequently than almost every other frame type.
When sampled commentary did mobilize a scientific frame, it most
often addressed the overallquality or significanceof the researchthat the FDA
presented in its proposed rule. The following pair of commentary extracts
represents arguments about overall research quality or significance, pre-
sented in supportof the proposed rule:
There is scientificevidencethat clearlydemonstratesthat more than 80%

of smokersstartby age 18. [The FDA's proposedrule] is an opportunity
to makea differencethatwill help saveanothergenerationfromaddiction!
[FDA01773:7-9]
There'senoughevidencethat nicotineis a drug in cigarettes,as well as in
gum and patches, and should therefore be regulated. [FDA02748:
13-15]
We also identified arguments regarding overall research quality or sig-

nificance in comments that opposedthe proposed rule. For example:
Study afterstudy shows that peer pressureand parentalinfluenceare the

two biggest factors that prompt teenagersto experimentwith smoking.
It's not 01'Joe or the MarlboroMan. [FDA01850: 19-22]
As further'evidence'the FDA cites the hypothesisset forth in the 1974
BehavioralResearchAnnualReportthat smokerscompensatefor changes
in the nicotineyields of cigarettesmoke. Once again,however,FDA edits
out the next paragraphin whichthe researchersstatethat despitesix years
of research, they were unable to prove that smokers 'compensate'.
[FDA59744:521]
Our coding of scientific frames also included instances in which com-

mentators - almost invariably private citizens - argued against the pro-
posed rule by offering accounts based in their own personal experience, as
counter-evidence to the scientific research that the FDA presented. For

example:
The statistics provided by the FDA and other agencies are incorrect. I live
in a tobacco belt, where a lot of people have smoked or still smoke. I
personally only know two people who have died from lung cancer or heart
trouble that were smokers. Most everyone that I know who died from
various diseases were nonsmokers. [FDA07972: 21-24]
Arguments about the interpretation of scientific evidence also figured

among scientific arguments in our sample. In our coding of scientific
frames, the interpretation subcategory included arguments about the mis-
representation or misappropriation of research findings and also claims of
fraud or misconduct, as exemplified in the following extracts:
Misrepresentation-Misappropriation
The additional Philip Morris documents FDA cites on this point likewise
do not conclude that nicotine or smoking is 'addictive'. Indeed, in a
number of instances the researchers explicitly state that their findings
cannot be equated with 'addiction'. Once again the Agency ignores the
conclusions in the very documents it cites, or omits critical sections which
refute the very innuendo FDA would like to draw. [FDA59744: 504]
Fraud-Misconduct
The so-called 'finding' [that tobacco manufacturers manipulate nicotine
delivery in smokeless tobacco] is, in fact, a theory that is unsupported by
any information in the administrative record. FDA's decision to announce
this theory as a proven fact is an act of gross intellectual dishonesty.
[FDA58211: 192]
In our sample, all 14 of the arguments about interpretation - including

claims of misinterpretation or fraud- appeared in commentary opposing the
rule. More specifically, all of the misrepresentation-misappropriation argu-
ments came from tobacco-industry affiliated commentators, as did eight of
nine fraud-misconduct arguments. The one additional fraud-misconduct
argument in our sample was from a private citizen.
In each of these representative examples, commentators expressed
support or opposition to the FDA's proposed rule in terms of science, the
FDA's master frame. As critical as some of the oppositional comments
were in accusing the FDA of 'gross intellectual dishonesty' and the like,
even those comments contested the proposed rule in terms of the 'gram-
mar' established by the FDA's master frame - that is to say, as a matter of
scientific evidence and its interpretation.
Despite the FDA's use of science as the rule's master frame, and the
preponderance of scientific evidence it mobilized in support of the rule, the
public rarely commented on the rule in these terms. Instead, the majority
of the commentary - whether for or against the rule - was framed in
ideological, political, or economic terms.
IdeologicalFrames
As Table 3 indicates, ideological frames appeared with the greatest fre-
quency in our sample: nearly two-thirds of the sampled commentary
included ideological arguments, either for or against the rule. Ideological
frames figured in 89% of the sampled commentary opposing the rule.
More specifically, nearly two-thirds of the opposing commentary argued
that the proposed rule constituted a form of governmentintrusionon privacy
(206/328, 63%). The following commentary extracts exemplify such
arguments:
The proposed FDA regulationof tobacco, the tobacco industry, and
ultimately,the regulationof free citizens' right to choice in the USA is
more evidence that the governmentis steppingup the intrusionof our
personaland economic lives. [FDA00143:9-11]
WeAmericansdo not need or want anyfurthergovernmentintrusioninto
our privatelives or where we do business, and we surelydo not want or
need them to act as our parents.[FDA00768:28-30]
Two other ideological frames frequently occurred in tandem with the

'government intrusion on privacy' frame. In the commentary expressing
opposition to the rule, frames invoking individual freedomof choiceand the
threat of prohibition often coincided with government intrusion frames.
More than two-fifths of the opposing commentary explained their opposi-
tion to the rule in terms of freedomof choice (140/328, 44%). The following
representative extracts exemplify such arguments:
Smokingand alcohol are adult choices. CommissionerKesslercan make
his own choices, and let citizensmaketheir own. [FDA01000: 10-13]
Whatupsets me the most is the ban on brandeditems such as t-shirts.It
bothersme becausethis is supposedto be a free country.Now, they want
to regulatewhat you wear.That is a directviolationof our constitutional
rightguaranteeingfreedomof speech. [FDA03548: 15-19]
Furthermore, nearly one-quarter of the sampled commentary opposing the

rule (76/328, 23%) expressed concern that the proposed rule was a step
toward an outright ban on all tobacco products. The following extract
exemplifies such prohibitionarguments.
I believe that Mr Kessler and the FDA intend to prohibitthe sale of
cigarettes.[FDA00171: 13-14]
Additional, related comments opposed the rule out of concern that the
proposed restrictions on tobacco foreshadowed more extensive govern-
ment restrictions of additional 'dangerous' products, as expressed in this
comment:
What is next? Red meat, alcohol, fats? They are all bad for you.
[FDA00396: 13-15]
In these representative extracts, commentators opposed the rule by fram-
ing it as a form of government intrusion that would encroach on individual
rights, and might constitute an initial step toward a complete ban on

tobacco products. As counter-frames to the FDA's proposed rule, these
arguments contest the FDA's diagnostic frame: none of the ideological
counter-frames call into question the FDA's analysis of under-age tobacco
use as a 'pediatric disease'. Instead, they attack the FDA's proposed
solution to the problem. In doing so, these ideological counter-frames do
not overtlycontest the FDA's use of science as a master frame. Instead, the
ideological frames tacitly contest the FDA's master frame of science, by
highlighting the consequences of the proposed rule for 'ideological' issues
such as freedom of choice, government intrusion into privacy, and
prohibition.
The rule's opponents were not alone in mobilizing ideological argu-
ments. As Table 3 shows, approximately one-in-four supporters of the
proposed rule invoked ideological arguments. Like the rule's opponents, its
supporters also addressed the issue of governmentintrusion, although less
frequently and from a significantly different perspective. Whereas oppo-
nents of the proposed rule argued that it constituted a form of government
intrusion, the rule's supporters argued that only through government
interventioncould the public-health problem of under-age tobacco use be
adequately addressed. The following extracts exemplify such framings:
There can be no question that federalleadershipand a comprehensive

programareneededif we aregoingto see a downwardturnin the number
of deathscausedby this deadlyaddiction.[FDA03395:27-31]
Whathigherpurposedoes governmenthave than to protectthe healthof
its citizensand especiallythe young?[FDA39332:14-15]
In addition to frames that identified (federal) government as the most

appropriate agent of intervention, supporting commentators (24/186,
13%) also framed the rule as necessary accommodations to protectpublic
health, with a special focus on children's health. The following extract
exemplifies this type of frame:
Whereasadultsshould be free to choose their smokingstatus,we have a

moral obligationto protect our nation's children.I support the FDA's
attemptsto reduce easy access by childrento tobacco products,and to
reduce the appealof tobacco productsto childrenby regulatingtobacco
advertisements.[FDA03201: 15-18]
Ideological arguments in support of the proposed rule, like those in

opposition to it, tended to focus on the FDA's prognostic, rather than
diagnostic, frames. However, whereas we interpreted the mobilization of
ideological arguments against the rule as attempts to contest the FDA's
framing of it as a rational, science-based policy, the ideological arguments
mobilized in supportof the rule reinforce, rather than contest, the master
frame of science.
Economic Frames
As Table 3 shows, more than two-fifths of the sampled commentary

invoked economic frames, either for or against the rule. Specifically, the
rule's opponents argued that the proposed rule would impose significant
negative economic impacts on the national economy in general (62/328,
19%), and for tobacco producers/marketers (44/328, 13%) and the federal
government (17/328, 5%) in particular:
National economy
The FDA plan is going to have a terrible economic impact. If this plan is
allowedto develop,millionsof jobs are at jeopardy.[FDA00652: 19-24]
Tobacco
Take your blindersoff and realizethat FDA control would have serious
economic consequences, not only for tobacco families, but for millions of
people related to the industry, such as suppliers, wholesalers, growers,
distributors, transportation companies and others. [FDA02790: 16-19]
Government
More importantly,however,will be the [proposedrule's] impact on the
cost of the FederalGovernment.As a taxpayer,I am not in favorof the
increasedcosts associatedwith additionalregulationsto an industrythat,
in my opinion, should not be regulated.[FDA02238:27-30]
As with ideological frames, the economic frames mobilized against the

proposed rule do not contest the FDA's identification of youth tobacco use
as a public health problem (prognostic framing), but instead focus on the
FDA's proposed solution to that problem (diagnostic framing). These
economic arguments against the proposed rule tacitly contest the FDA's
framing of the Regulation as a matter of science by arguing that the
proposed rule's economic consequences have been inadequately antici-
pated by the FDA and that they outweigh the rule's potential benefits.30
By contrast, only 4% of the rule's supporters mobilized economic
frames. The following extract exemplifies how supporting commentators
mobilized the 'cost to government' frame:
[The] FDA's measuresneed to be adoptedand enforced.If our country
choosesto do so, we can saveourselvesmillionsof dollarsin futurehealth
care costs, as well as save millions of lives. [FDA52333: 23-27]
In rare instances where supporters of the proposed rule framed it in

economic terms, they did so in terms that not only accepted, but also
reinforced, the FDA's framing of the proposed rule. For example, in the
instance displayed above, the reference to saving 'millions of dollars in
future health care costs' echoes (but actually underestimates) economic
arguments related to health concerns that the FDA itself considered.31
Political Frames
Approximately one in five comments mobilized political frames for or

against the rule; opponents and supporters of the proposed rule invoked
political frames at roughly equal rates. For instance, more than 10% of
those opposing the rule (43/328) argued that additional restrictions, as
proposed in the FDA rule, were unnecessary, and that the problem of
under-age smoking could be adequately addressed by enforcementof al-
ready existing laws:
The FDA restrictionsaren'teven necessary.Everysinglestate alreadyhas
a strictminimumage requirementfor the purchaseof tobaccoproducts.If
your goal is to reduce teen smoking, I think you should put more
emphasis on enforcing the laws that are on the books. [FDA00193:
15-18]
By contrast, the rule's supporters argued that existing restrictions, im-

plemented on state and local levels, were inadequate to address the
problem of under-age smoking, and that only federal regulation would be
adequate to that task (21/186, 11%), as in the following exemplar:
Althoughit is illegalto sell tobaccoproductsto personsunder 18 in all 50
states, the District of Columbia, and all US territories,these laws are
almost never enforced.Tobaccoproductsare readilyavailableto anyone
over the retailcounterand throughvendingmachines.As a result, 3000
Americanchildrenbecome addictedto tobacco every day. [FDA20532:
17-24]
Comparing comments mobilizing enforcement frames to oppose or sup-

port the rule reveals a recurrent familiar pattern in the commentary:
opponents contest the FDA's prognostic frame (for example, 'The FDA
restrictions aren't even necessary'), whereas supporters not only align with
the prognostic frame (for example, 'these [state] laws are almost never
enforced') but also relate that support back to the FDA's diagnostic frame
(for example, 'As a result, 3000 American children become addicted to
tobacco every day').32
In addition to enforcement frames, both opponents and supporters of
the proposed rule advocated their positions by identifying strategic or
personal motivationsfor the proposed rules. For example, opponents of the
rule depicted it as being motivated by political leaders' personal agendas:
PresidentClinton is merely posturinghimself for his 1996 presidential
campaignby utilizingexecutive authorityto dismantlea legal industry
which provides thousands of jobs and a legal product to millions of
Americans.[FDA00408: 18-20]
By framing the proposed regulation as a matter of personal motives and

political agendas, opposing comments such as this one rejected the FDA's
representation of the proposed rule as based on scientific considerations
and evidence.33
By contrast, those supporting the regulation expressed concern that it
might be defeated due to the influence of a powerful tobacco lobby:
It is abouttime our leadersput the healthof Americansand the futuresof
America'schildrenahead of the needs of lobbyistsand large campaign
donations.[FDA01739:39-42]
Finally, an elected official has the courage to stand up to the powerful

dollars that tobacco lobbyists use to pull their weight in Washington.
[FDA02746: 15-19]
Whereas opponents portrayed the individual initiative of government offi-

cials in negative terms (for example, as 'posturing'), supporters charac-
terized it in positive terms (for example, as evidence of 'courage'). In the
opposing commentary, the imputation of selfish motives served to under-
cut the credibility of the FDA's rule; by contrast, in the supporting
commentary, alternative characterizations of those motives served to un-
derscore the rule's credibility.
ProceduralFrames
Although just nine comments in our sample (2%) addressed the rule-
making procedure itself, these are worth noting, because they had a direct
impact on that process. All nine instances of procedural framing appeared
in commentary submitted by the tobacco industry in opposition to the
proposed rule. In these comments, the tobacco industry argued that the
original public commentary period - designated by the FDA as 11 August
to 9 November 1995 - was too short, and did not allow adequate time to
respond to the proposed rule. Subsequently, in response to these com-
plaints, the FDA extended the comment period until 2 January 1996. The
tobacco industry utilized this extension to its advantage: on the final day of
the extended comment period, the Tobacco Institute submitted a
45,000-page document in opposition to the proposed rule.34 On its own
initiative, the FDA extended the commentary period a second time, until
19 April 1996.
The FDA'S Response to the Public Commentary and after

At the conclusion of the public commentary period, three teams of FDA
staff members began to review, categorize and analyse each of the more
than 700,000 separate documents that constituted the public commentary
on the proposed rule.
In cases of rule-making involving the FDA, the US Code of Federal
Regulations requires the agency's Commissioner to (1) terminate the rule-
making process, (2) issue a new, revised rule, or (3) make a final rule,
exclusively on the basis of the administrative record, which includes the
public commentary.35The Code of Federal Regulations (CFR) also speci-
fies criteria for the Commissioner's decision to terminate, modify or
finalize a rule:
The qualityand persuasivenessof the commentswill be the basis for the

Commissioner'sdecision.The number or length of comments will not
ordinarilybe a significantfactor in the decision unless the number of
comments is materialwhere the degree of public interestis a legitimate
factorfor consideration.
Charged with giving each individual comment 'full and serious considera-
tion', FDA officials had to incorporate valid points into the revised rule
and explain why they rejected other points. A complete analysis of this
aspect of the rule-making process, and the specific practices employed by
the FDA to determine whether comments made valid points or not, goes
beyond the scope of this paper.36 However, it should be obvious that, as
worded, the CFR affords the Commissioner significant leeway in evaluat-
ing the 'quality' and 'persuasiveness' of the commentary, not to mention
the import of comments' quantity and length as indications of 'legitimate
public interest'.37
In the remainder of this section, we briefly summarize the changes
made by the FDA in the final version of the rule, and we discuss how the
FDA presented these changes as responsesto the public commentary. In
doing so, we are primarily interested in the FDA's public representation of
its orientation to the public commentary; consequently, we pay less atten-
tion to other factors, not publicly addressed by the FDA, that may have
shaped the final version of the rule. We also briefly consider the subsequent
legal battles, culminating in March 2000 with the Supreme Court's ruling,
over the FDA's jurisdiction to regulate tobacco.
Based on the evaluation of the public commentary, Commissioner
Kessler issued a final, somewhat revised rule, which appeared in the Federal
Registeron 28 August 1996 (Department of Health & Human Services,
1996). Table 4 compares the features of the proposed and final versions of
the FDA's rule. The most significant change involved the deletion of the
proposed $150 million dollar education programme, which the tobacco
industry was to have funded.
The final version of the FDA's rule presented itself as responsive to the
public commentary and incorporated aspects of the public commentary
into the revised rule. The final rule included a lengthy section summarizing
'the general issues reflected in the thousands of comments', including the
topics of the FDA's existing responsibilities, smoking as a free choice, and
the perceived threat of a total ban on all tobacco products (Department of
Health & Human Services, 1996: 44418-26).38 Throughout the rule's final
version, the FDA also incorporated frequent references to specific com-
ments (for example, 'One comment stated that ...'; 'Several comments
expressed concern that ...') and presented its responses to those com-
ments. Nearly every section of the final rule displays the extent to which
the FDA responded to public commentary on the proposed rule.
Perhaps the most noteworthy change, in light of the public commen-
tary, involved the final wording of the restrictions on brand-name sponsor-
ship of sporting or other events by tobacco companies. During the com-
mentary period, the FDA received copies of a form letter from 300,000
individuals, protesting the 'ban on tobacco sponsorship of events', an
understanding of the 1995 proposal that the FDA identified as inaccurate
(see Department of Health & Human Services, 1996: 44466).39 In line
with CFR guidelines emphasizing the quality and persuasiveness of com-
mentary, rather than its quantity or length, the FDA treated the 300,000
TABLE
4
Comparison of Proposed and Final Rules' Prognostic Frames
1) Reducing Access
ProposedRule Final Rule
Minimum age of 18 to buy tobacco Same
products
Ban vending machines and self-service Same exceptin certain nightclubs and
displays other 'adult only' facilities totally
inaccessible to persons under 18
Ban 'kiddie' packs, 'loosies', or free Same
samples
Ban mail order sales Mail order sales permitted
2) Reducing Appeal
Ban billboards within 1,000 feet of Same
schools and playgrounds
Other billboards, outdoor and in-store Same exceptcolour, imagery permitted
advertising limited to black-and-white in 'adults only' facilities if not visible
text only from outside and not removable
Advertising in publications with Same
significant youth readership (more than
15% or 2 million) limited to black-and-
white text only
Ban brand-name sponsorship of sporting Same, includingcars and teams
or other events; only corporate-name
sponsorship permitted
Ban brand names on hats, t-shirts, gym Same
bags, etc.
3) Educating Youth about Tobacco
Health Risks
$150 million national education Deleted, FDA subsequently sought to
campaign, funding by tobacco implement this under an alternate
manufacturers provision of the Federal Food, Drug,
and Cosmetic Act
form letters as a single comment (Department of Health & Human

Services, 1996: 44418). The final version of the rule upgraded the initially-
proposed restrictions by prohibiting 'all sponsored entries and teams using
the brand name in addition to the prohibitions that were proposed'
(Department of Health & Human Services, 1996: 44528).
However, the FDA did not simply ignore the number or length of
comments only when those comments expressed opposition to the pro-
posed rule. For instance, the FDA undertook the most significant revision
to the proposed rule - dropping the education programme from the final
version - even though, according to the text of the rule's final version,
nearly three-quarters of the 1,500 comments on this aspect of the pro-

posed rule supported the education programme. Despite this public sup-
port, the FDA re-examined its statutory authority and determined that a
'notification order', to be developed in consultation with tobacco manu-
facturers, would be the 'more appropriate and practicable' mode of ad-
dressing the harm that tobacco products posed to young people (Depart-
ment of Health & Human Services, 1996: 44538). The notification order
would be significantly less comprehensive than the initially proposed
education programme, and it would be developed jointly with the tobacco
industry, rather than under the principal direction of the FDA.
In retrospect, the FDA's decision to downgrade the proposed educa-
tional programme to a notification order might be understood as having
foreshadowed the Supreme Court's March 2000 decision. Before issuing
its final rule, the FDA deemed that it lacked the statutory authority to
impose the educational programme. And, on publication of the final rule
on 28 August 1996, representatives of the tobacco industry quickly initi-
ated multiple lawsuits challenging the proposed rule's legality. Ultimately,
on 21 March 2000, the Supreme Court ruled narrowly (5-4) that the FDA
lacked the necessary jurisdictionto implement its tobacco rule.40
Discussion
Prior research has indicated significant variation in institutional practices

for involving the public in decision-making on public health regulations
(Rowe & Frewer, 2000; Fiorino, 1990). By contrast with many European
democracies, in which regulatory processes prioritize the roles of techni-
cally trained experts and their specialized knowledge (see, for example,
Abraham & Sheppard, 1997: 139-40), the US regulatory process empha-
sizes the importance of both expert and public participation (Jasanoff,
1990). In this paper, we have examined the FDA's proposed tobacco
regulation and the public commentary on it, as one specific, institution-
alized form of public participation. Using frame analysis, we analysed
science as the 'master frame' of the FDA's proposed Regulation and
identified the Regulation's diagnostic and prognostic frames. We then
examined how public commentary responsive to the proposed rule either
embraced or contested the FDA's framing of it, and how the FDA
presented changes in the final version of the rule as responsive to that
commentary.
In this concluding discussion we address three themes suggested by
our findings that extend beyond the specifics of the FDA case. First, in the
course of summarizing our most significant findings, we consider why so
little of the commentary adopted the FDA's master frame of science, and,
second, why so little of the supportive commentary made any sort of
argument at all to warrant their position on the proposed Regulation.
Finally, we address how the particular form of public participation - in the
FDA case, public commentary - shapes rule-making processes. Together,
these three themes suggest important lines of inquiry for continued empiri-
cal research on the relationships among science, regulatory health policy,
and the public in democratic societies.
Despite the FDA's emphasis on science as the master frame for its
proposed rule, very little of the public commentary actually supported or
contested the rule in these terms. Specifically, anti-rule commentators
mobilized 'non-scientific' counter-frames to portray the proposed rule as
politically illegitimate and, to a lesser extent, economically irrational. This
pattern was especially pronounced for the commentary submitted by
private citizens, which constituted the great majority of the commentary
submitted to the FDA and in our representative sample. The most notable
exception to this pattern of opposition appeared in the 30 documents
submitted by representatives of the tobacco industry; these comments did
contest the FDA's proposed rule in terms of its master frame, scientific
evidence. Though the scientific counter-frames mobilized by the tobacco
industry suggest the importance of conceptualizing the 'public' as differ-
entiated publics (in plural form), whose responses will be informed by
varying interests, here we pursue the matter of private citizens' responses
in more detail.
The recurrent use of political, ideological, and, to a lesser extent,
economic counter-frames epitomizes what Gamson (1992) has identified
as the injusticecomponentof collective action frames: '[M]oral indignation'
expressed in the form of 'political consciousness' provides the emotional
motivation that is a catalyst for individuals' participation in a social
movement (Gamson, 1992: 7).41 Claims that the proposed rule would both
violate individual rights and constitute government intrusion oppose the
technical rationality of the proposed rule's scientific frame with frames that
emphasize the rule's (lack of) political legitimacy (cf. Jasanoff, 1989). As
we have seen, this opposition specifically targeted the FDA's prognostic
framing (that is, its proposed remedy for tobacco use as a 'pediatric
disease').
In the past, studies focused on public understanding of science reg-
ularly treated the public as passive and prone to misunderstanding sci-
ence.42 By contrast, our analysis of how public commentators contested
the FDA's proposed rule by reframing it suggests that the rule's opponents
were not 'misunderstanding' the FDA's scientific evidence; they simply
refused to grant it the privileged status as a master frame for debate that
the FDA sought to establish (cf. Trachtman & Perrucci, 2000). In an era
marked by increasing public scepticism toward the authority of elite
expertise,43 this type of counter-framing will probably continue to resonate
strongly in American political culture.
Stated differently, the mobilization of significant scientific evidence for
a regulation may actually serve as a motive for opponents of the regulation
to attempt to redefine the debate in other, non-scientific terms. More
generally, the greater the evidence in support of a given policy, the more
likely that the policy's opponents will attempt to reframe it, rather than
counter it in terms of the proponents' chosen frame(s): see, for example,

Murphy (2001) and Driedger & Eyles (2001).
However, this relatively straightforward explanation for the absence of
scientific counter-frames in the public commentary does not explain the
absence of scientific frames in the supportingcommentary. Despite the
preponderance of scientific evidence presented by the FDA, commentary
in support of the rule was only slightly more likely to invoke science as a
persuasive frame.44 Even more striking, we believe, is the discrepancy in
the rates at which supporters and opponents of the rule mobilized any type
of persuasive frame. As we have noted, in our sample, 100% of the
comments opposing the proposed rule mobilized persuasive frames to
warrant that opposition, whereas only 55% of the supporting comments
did so. What might account for this discrepancy, which is particularly
important owing to the Code of Federal Regulation's direction that the
Commissioner evaluate public commentary on the basis of its 'quality and
persuasiveness'?
Consider the challenges facing a potential supporter of the proposed
rule. Like opponents, a beginning point for a supporter is to assert one's
position. However, in turning to the next step - mobilizing persuasive
arguments to justify the asserted position - potential supporters may have
faced a practical problem. Because the FDA presented exhaustive scientific
evidence in support of its proposed rule, potential supporters may have
balked at the prospects of either presenting additional (scientific) evidence
in support of the FDA's frame or simply reiterating it. Providing additional
evidence would have required substantial scientific knowledge and re-
sources, which may have been available to private non-profit health organi-
zations and professional health-care providers, but not to private citizens;
both groups may have been hesitant to re-present studies and findings that
the agency had already cited.45
Ironically, then, the rule's complex, multiple components may have
made it easier to argue against than to support, because opponents could
criticize a single aspect of the rule, whereas supporting just one aspect of
the rule may have seemed less persuasive.46 Thus, nearly half of the
proposed rule's supporters may ultimately have chosen simply to assert
their support of the rule, without making a persuasive argument to warrant
it.
Earlier we noted that, in formulating and proposing its regulation, the
FDA (and the White House) paid attention to, and were encouraged by,
poll data indicating broad public support for tobacco regulation that
emphasized children (see Kessler, 2001: 293, 305, 324). What happened
to this anticipated public support when it came to public commentary on
the rule? An answer to this question is important for several reasons: it
shows that process matters, and reveals how public health regulations are
shaped by both agencies' expectations of public commentary and other
activist organizations' involvement in mobilizing members of the public to
submit commentary.
The institutional processes used to elicit public opinion shape the

resulting expression of public opinion. Whereas the FDA and the White
House relied on opinionsurveysto forecast public support for the proposed
Regulation, the proposed Regulation solicited writtencommentary.Scholars
of polling such as Benjamin Ginsburg have argued that ...
... [t]he assertionof an opinionthrougha poll requireslittle efforton the
part of the opinionholder. ... [P]olls,in effect submergeindividualswith
stronglyheld views in a more apatheticmass public. ... The matters
which appearsignificantto the agencies sponsoringpolls may be quite
differentfrom the concernsof the generalpublic. (Ginsburg,1989: 273;
see also Zaller, 1994)
Polls might be useful in anticipating public response that will take the form
of a referendum, in which private citizens would be asked to cast a vote for
or against a proposed regulation. By contrast, submitting written commen-
tary involves greater (individual and/or organizational) initiative. As a
method of soliciting public participation, written commentary is more
likely to lead to the most opinionated citizens responding.
The most opinionated responses are not necessarily the most in-
formed, of course, as our data and previous studies indicate. In our data,
we found numerous instances where opponents of the proposed rule
misinterpreted the rule's aims and scope, as in the following exemplar:
[A]s an adultI shouldbe entitledto consumeas much tobaccoas I want.
I should be allowed to consume when and where I want. [FDA02938:
19-21]
This commentator apparently (mis)understood the proposed rule as a
general ban on tobacco, rather than a targeted set of restrictions on the sale
and distribution of tobacco, aimed specifically at reducing the appeal or
availability of tobacco to children and adolescents.47 Prior research (for
example, Ziman, 1991) indicates that scepticism toward science often runs
highest among the least-informed members of public.48 This raises a
fundamental question about public commentary as a participation method
for health-policy regulation: what is the relationship between the public's
degree and sources of knowledge about a proposed regulation and their
assessment of its credibility?
In most instances, it seems unlikely that private citizens responding to
the FDA's proposed rule had read the text of it published in the Federal
Register.Instead, as our data and other accounts of the public commentary
indicate, the great majority of public citizens who submitted commentary
came to know about and understand the FDA's rule through accounts of it
circulated by activist organizations.49 Our findings indicate the need for
further analysis of activist organizations' impact on public commentary.
Here we simply observe that, insofar as the rule-making process offers
private citizens no structured access to resources that would enable them
to make good decisions, public commentary (as one specific form of public
participation) will remain vulnerable to 'capture' by special interest groups
(cf. Rowe & Frewer, 2000).50
However, 'good decisions' will depend on more than improved in-

formation, as our focus on the dynamics of framing and counter-framing
demonstrates. Clearly, providing the public with information (and espe-
cially scientific evidence) is important; however, the framing of that in-
formation is equally important. In the FDA case, despite a preponderance
of scientific evidence to support the proposed rule, public commentary -
whether pro or con - essentially ignored that evidence. Reframed by
opponents in political and ideological, rather than scientific terms, the
FDA's proposed rule failed to establish credibility with the segment of
private citizens that chose to respond to it with written commentary. More
generally, though scientists and regulatory experts may identify and pres-
ent scientific evidence to indicate proposed regulations' technical ration-
ality, the social problems that these regulations address may always be
reframed in moral terms that undermine the regulation's legitimacy. When
these moral values are understood by the public - or, more specifically, the
involved segment(s) of it - as more fundamental than the scientific evi-
dence, the proposed rule will lack public credibility.51
Notes
We are grateful to Katherine Bryan-Jones and Marieka Schotland for research assistance; to
Elizabeth Boyd, Ruth Malone and Nick Wolfinger for thoughtful feedback on this paper's
previous versions; and to the five anonymous reviewers whose constructive comments and
suggestions improved our work. This research was supported by grants from the American
Cancer Society (RPG9714301PBP) and the California Tobacco-Related Disease Research
Program (6RT0025).
1. For a recent attempt to review and theorize the problem of public participation in
technical decision-making, see Collins & Evans (2002). For historical accounts of the
problem of democratic participation in 20th-century industrial society, also see Fischer
(2000) and Gregory & Miller (1998).
2. For example, whereas governments can employ surveys and focus groups simply to
ascertain the public's attitudes, the use of advisory committees may afford the public
some degree of actual decision-making authority: see Rowe & Frewer (2000) and
Fiorino (1990).
Of course, 'grassroots' social movements, initiated by citizens rather than
government, constitute another potentially significant type of public participation in the
formulation of health policy. For an exemplary study of 'grassroots' activism directed at
the FDA, see Epstein (1996), which examines AIDS activists' criticisms of the FDA's
drug-approval policies. Epstein also reviews the relationship between science studies
and social movement research (1996: 19-22). For earlier examples of technical
controversies surrounding public health and safety regulations, also see the
contributions to Nelkin (1979).
3. Schotland & Bero (2002) make these points in their analysis of the r6olethat public
commentary plays in the development of risk assessments, which can serve as the basis
for regulatory policies. On the importance of public participation as a means of
increasing regulations' public acceptability, see, for example, Jasanoff (1987). On public
commentary as a means of preventing 'capture' by special interest groups, see, for
example, Wilson (1989).
4. Department of Health & Human Services (1995), available online at <http:l
/www.access.gpo.gov/sudocslfdal> .
5. FDA v. Brown & WilliamsonTobaccoCorp. (No. 98-1152) 153 F.3d 155, affirmed;
available online at < http://llsupct.
law.cornell.edu/supct/html/98-1152.ZS. html> .
6. Our focus in this paper is on regulatory, rather than legislative, policy development.
However, we expect that the frames and counter-frames we examine in the FDA case
will figure prominently in future debates over tobacco-control legislation as well. For a
concise review of the relevant distinctions between regulatory and legislative smoking
restrictions, see Bero et al. (2001).
7. See, for example, Gillespie, Eva & Johnston (1979) and, more recently, Abraham &
Sheppard (1999). The FDA case differs from these in that only representatives of the
tobacco industry treated the FDA's scientific evidence as disputable. Otherwise,
opponents disputed the political legitimacy and social benefits of the proposed
regulation, not the science that the FDA presented as its warrant for the regulation.
8. For political influences on medical research, see, for example, Chubin & Studer (1978),
Lynn (1986), Martin (1988) and Abraham & Lewis (2000). On the relationship
between science and the law, see the contributions in Smith & Wynne (1989).
Moreover, on the shaping of public understanding of science and technology by the
legal system, see Jasanoff (1995). On news media depictions of health-related social
problems, see Gamson & Modigliani (1989) and Malone, Boyd & Bero (2000).
9. Analysts of regulatory decision-making conventionally distinguish between
'technocratic' and 'democratic' approaches: see, for example, Abraham & Sheppard
(1997). The FDA, and US regulatory agencies more generally, follow a democratic
approach, emphasizing the importance of public participation in health policy
regulation.
10. Also see Abraham (1995). For an analysis of the US National Academy of Sciences'
expert advice on diet and health, using Erving Goffman's dramaturgical approach, see
Hilgartner (2000).
11. Also see Epstein (1996) for the use of expert and 'lay expert' interviews in creating a
historical narrative.
12. Bero et al. (2001), Schotland & Bero (2002) and Montini, Mangurian & Bero (2002)
have also examined written public commentary on US workplace smoking regulations
and risk assessments. Their methods and findings are similar to those reported here.
However, those studies differ from this one in that they focus on state, rather than
federal, tobacco regulation; and, more significantly, in the cases they examine, there
was relatively little participation by private citizens.
13. There are vast literatures on the merits of naturally-occurring data and, underlying
those merits, the importance of the distinction between action and accounts of it; on
actions and accounts, see, for example, Heritage (1984).
14. For a compact but thorough overview of these developments, see Benford & Snow
(2000).
15. Action on Smoking & Health v. Harris, 655F2d 236 (DC Cir 1980).
16. Kessler relates how an earlier poll by Morris, testing public attitudes toward the FDA
and government regulation, had been critical to Morris's initial success in persuading
President Clinton to confront the tobacco industry. In this poll, Morris's data showed
that Americans' enthusiasm for cutting government regulations focused on agencies like
the Internal Revenue Service, but weakened when those polled were asked about
reducing the FDA's ability to regulate drugs and food safety (Kessler, 2001: 305).
.17. We follow Jasanoff's (1989) distinction between technical and administrative rationality.
She shows how health policies aim to be (1) consistent with scientific knowledge and
modes of reasoning (technicalrationality), and (2) predictable, consistent with prior
agency practice, and free from bias or arbitrariness (administrativerationality).The
legitimacy of regulatory decision-making rests partly on constituents' orientations to
the policy as both technically and administratively rational. On rationality as a form of
legitimate authority, see Weber (1978). In discussing the 'limits of science' as a basis of
legitimacy, Weber (1946: esp. 150ff.) anticipated the tensions that Jasanoff and others
elaborate.
18. Department of Health & Human Services (1995: 41314, 41318-19). For brevity, in
this and subsequent quotations, we have omitted the FDA's footnotes and the
references to the studies cited in those notes. For example, this passage included four
footnotes with eight citations to supporting scientific research. Our argument that the
FDA framed its proposed rule in terms of scientific evidence is further supported by
the FDA's citation of these studies, but representing all of those citations would
overextend this paper's length.
19. We are indebted to an anonymous reviewer for this formulation.
20. On the r6oleof scientific evidence in the FDA's proposed rule, see Kessler et al. (1996)
and Kessler et al. (1997).
21. See Occupational Safety & Health Administration (1994), available online at < http:l
/www.osha.govlSLTClindoorairquality/index. html> .
22. The footnote for this passage cites a 1993 Federal Trade Commission report to
Congress on the Federal Cigarette Labeling and Advertising Act.
23. The position is 'formally' neutral; it does not guarantee substantive neutrality in any
absolute sense of the term, though it does give the appearance of neutrality: see
Clayman (1992: 197, note 1) for a discussion of'formal' neutrality.
24. Initially, the commentary period ended on 9 November 1995. However, in response to
protests by the tobacco industry that the commentary period was too short, the FDA
extended the deadline to 2 January 1996. (See the discussion of 'Procedural Frames',
below, for more on the tobacco industry's protests and the FDA's extension of the
commentary period.) On its own initiative, the FDA subsequently extended the
commentary period a second time, from 2 January 1996 until 19 April 1996.
25. The final version of the rule is availableonline at < http://
lwww.access.gpo.gov/su_docs/fdal> .
David Kessler, the FDA Commissioner at the time, reports that this response was
16 times greater than the previous agency record of 45,000 comments (see Kessler,
2001: 336).
26. The affiliation category for the tobacco industry was our most complex category: we
coded commentary as tobacco-industry-affiliated if it was submitted by (1) employees
of tobacco companies (for example, R.J. Reynolds) or industry-associated organizations
(for example, Council for Tobacco Research, The Tobacco Institute); (2) individuals
who made their livelihood in tobacco production (for example, tobacco farmers or
tobacconists), or (3) individuals who acknowledged that they had prepared their
commentary at the request of a tobacco company or organization. We are likely to have
underestimated the amount of tobacco-industry-affiliated commentary since industry
support is sometimes not disclosed (see Bero, Galbraith & Rennie, 1994).
27. See, inter alia, Bero & Glantz (1993), Schotland & Bero (2002) and Bero et al. (2001).
28. By contrast, for example, in their study of public commentary submitted to the State of
California's Environmental Protection Agency on its 1997 tobacco smoke risk
assessment in California, Schotland & Bero (2002: 135) report that 'private citizens'
constituted slightly less than 21 % of the written commentary.
29. Although the tobacco industry submitted a relatively small numberof contributions (a
total of 30 documents), the volume of their contribution is much greater than this figure
suggests, due to the length of each tobacco-industry submission. Whereas private
citizens' letters tended to range in length from several sentences to several pages, many
of the tobacco-industry submissions were more than 100 pages long.
30. As required by federal law, the FDA included analysis of the proposed rule's impacts,
including regulatory costs. See Department of Health & Human Services (1995:
41359-71), which includes the FDA's analysis of costs to the tobacco industry, tobacco
vendors, retail outlets and advertisers.
31. The following passage is extracted from the FDA's analysis of 'regulatory benefits':
The benefits of the proposed regulation include the costs that would be
avoided by eliminating the adverse health effects associated with the
consumption of tobacco products. ... In a recent statement, the US Office of
Technology Assessment (OTA) declared that 'the greatest "costs" of smoking
are immeasurable insofar as they are related to dying prematurely and living
with debilitating smoking-related chronic illness with attendant poor quality
of life'. Nonetheless, OTA calculated that in 1990 the national cost of
smoking-related illness and death amounted to $68 billion and included
$20.8 billion in direct health-care costs, $6.9 billion in indirect morbidity

costs, and $40.3 billion in lost future earnings from premature death.
(Department of Health & Human Services, 1995: 41361-62)
The text went on to explain why, compelling though such evidence was, the FDA
preferred 'incidence'-based research on the costs of tobacco use - which compares the
lifetime survival probabilities and expenditure patterns for smokers and nonsmokers -
over 'prevalence'-based research, such as the OTA studies cited in the quoted passage.
32. These two preceding extracts exemplify how single passages could simultaneously
invoke more than one persuasive frame. In addition to the legal frames analysed in the
main text, these two extracts [FDA00193: 15-18 and FDA20532: 17-24] also invoke
ideological frames regarding government intrusion and intervention, respectively.
33. In fact, as we previously noted, David Kessler's account of the proposed rule's
development repeatedly suggests that calculations by the Clinton Administration in
terms of its political agenda were important in eventually winning the White House's
support for the proposed regulation (see Kessler, 2001: 322-23). Kessler, however,
identifies Vice-President Al Gore and Clinton Advisor Mike Morris as the individuals
who championed the cause of 'taking on the tobacco industry' well before Bill Clinton
chose to do so.
34. Department of Health & Human Services (1996): 44418; see also Kessler (2001): 339:
'The industry saw the comment period as an opportunity to swamp us'.
35. See 21 CFR part 10.40 c(2), available online at <http://www.access.gpo.gov/nara/cfr/cfr-
table-search.html>.
36. But see Montini & Bero (2001) for insight, based on interviews with officials from
regulatory agencies, on such processes. Although Montini and Bero had a letter of
support from the FDA to conduct their study, only one former FDA official was able to
participate in their interviews because of a gag order on FDA officials. The gag order
resulted from the threat of tobacco industry lawsuits against the agency in response to
the proposed rule that we investigate here.
37. The evaluation of a comment's 'quality and persuasiveness' is an interpretiveenterprise,
which differs in character from treating the commentary as a referendum to be tallied
in terms of the numbers of comments for and against the proposed rule. By contrast
with a referendum approach, the agency's evaluation of commentary is unavoidablyan
interpretive enterprise, because it depends on the application of generalized criteria (for
example, 'quality and persuasiveness' of commentary) to an indefinite range of
contingent, concrete possibilities (for example, the language employed in the
commentary and the frames it mobilizes). In this regard, Hart (1961: 123) observes
that 'canons of interpretation' (for example, in this case, the criteria specified in the
Code of Federal Regulations) can only diminish, but not eliminateinterpretive
uncertainties, because 'these canons are themselves general rules for the use of
language, and make use of general terms which themselves require interpretation'.
38. Commissioner Kessler reveals that he 'underestimated' the extent to which tobacco
industry 'scare tactics' could present prohibition-type arguments to feed into a
'peculiarly American distrust of government' (Kessler, 2001: 335).
39. In fact, the agency proposed to permit tobacco company sponsorship of all events to
continue, 'as long as they are in the corporate name'.
40. FDA v. Brown &Williamson TobaccoCorp. (No. 98-1152) 153 F.3d 155 affirmed.
41. Benford & Snow (2000: 615-16) dispute Gamson's claim that all collective action
frames include an injustice component. However, in our analysis of the public
commentary opposed to the FDA's tobacco regulations, an injustice component is
clearly evident.
42. For an influential exception to this tendency, see the contributions to Irwin & Wynne
(1996); see also Dickson (2000).
43. On public scepticism toward expert claims-making, see, for example, Beck (1992),
Epstein (1995), Collins & Evans (2002) and Abraham & Sheppard (1997).
44. As Table 3 indicates, 8% of the supporting commentary invoked scientific frames,
compared with 5% of the opposing commentary.
45. For evidence of the social constraints on reporting something as 'news' when the
addressee already knows about it, see Harvey Sacks' (1992) work on 'recipient design'
in conversational storytelling.
46. We thank Brian Martin for this observation.
47. For another instance, see the first exemplar of a freedom-of-choice argument
[FDA01000: 10-13], quoted above (p. 23). Either of these comments can be compared
with the opening paragraph of the FDA's proposed rule (also quoted above, p. 14), for
how the commentator's opposition to the rule is premised on a misunderstanding of it.
48. Likewise, examining public opinion on US aid to the Contra rebels in Nicaragua,
Zaller (1994: 193) concludes that 'at least part of the reason that poorly informed
persons fail to embrace dominant elite ideologies ... is not that they are independent-
minded; it appears, rather, that they have paid too little attention to politics to know
what, exactly, they are being asked about'. By contrast, in their research on medicines
regulation in the UK, Abraham & Sheppard (1997) found that the least-informed focus
group in their study was the most supportive of science. For a discussion of some of
the circumstances for variable support, see Collins & Evans (2002).
49. See, for example, Kessler (2001: 336-37). Our data reflect the tobacco-industry
orchestrated letter-writing campaigns that Kessler describes. However, we also found
significant numbers of form letters from anti-smoking organizations. Perhaps most
notably, many school teachers organized their students to write letters in support of the
proposed rule. For example, in the final version of the rule, the FDA noted that 'tens
of thousands of school children wrote letters asking that vending machines be
eliminated' (Department of Health & Human Services, 1996: 44448).
50. Our findings are consistent with prior research showing that one special interest group,
the tobacco industry, has tended to dominate public commentary on tobacco control
regulation. Schotland & Bero (2002) and Bero et al. (2001), for example, indicate that
capture of public commentary by the tobacco industry is partly a result of significant
imbalances in the economic resources available to the tobacco industry and public-
health groups for mobilizing members of the public.
51. This possibility suggests a variation on the pattern that Malone, Boyd & Bero (2000)
identify in their research on journalists' construction of passive smoking as a social
problem. These authors argue that 'for a scientific issue to reach the "social problem"
stage in the news media, the science may require interpretation in moral (or human)
terms' (ibid.: 732). By contrast, in cases such as the FDA's proposed tobacco
regulation where the social problem (in this case, tobacco regulation) is already
understood by the public in moral and political terms, scientific evidence may be less
influential as a warrant for proposed restrictions.
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Andrew L. Roth, Visiting Assistant Professor, Department of Sociology,

Pomona College, is a sociologist with primary interests in the news media,
political discourse, and social interaction. He has published research articles
on social identity in news media discourse (in Media, Culture & Society
[1998] and Language in Society [2002]) and political ritual (in Sociological
Theory [1995]); email: andy.roth@pomona.edu
Joshua Dunsby, Postdoctoral Fellow at the University of California, San

Francisco, in the Institute for Health Policy Studies and the Center for
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Lisa A. Bero, Professor, Department of Clinical Pharmacy, School of

Pharmacy and Institute for Health Policy Studies, School of Medicine,
University of California, San Francisco, is a pharmacologist with primary
interests in how clinical and basic science is translated into clinical practice
and health policy. In addition to co-authoring The Cigarette Papers
(University of California Press, 1996), she has published research in the
Journal of the American Medical Association and the New England Journal
of Medicine.
Address: Lisa A. Bero, Institute for Health Policy Studies, University of
California, San Francisco, 3333 California Street, Suite 420, Box 0613, San
Francisco, California 94143, USA; fax: +1 415 519 9345; email:
bero@medicine.ucsf.edu

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Framing Processes in Public Commentary on US Federal Tobacco Control Regulation

Author(s): Andrew L. Roth, Joshua Dunsby, Lisa A. Bero

Keywords framing processes, public understanding of science, tobacco control

Framing Processes in Public Commentary on

In recent decades, many governments have sought appropriate ways to

Social Studies of Science 33/1 (February 2003) 7-44

How is the formulation of health regulations shaped by the expectation

* If one purpose of public commentary is to increase public awareness of

Prior Research on Regulatory Processes and Public

research is especially important from a practical, policy-oriented per-

The development and elaboration of a frame do not ensure that all

The FDA's Proposed Rule

An Orientationto Public Opinion

House all paid careful attention to public opinion, as indicated by polling

Regardlessof political affiliation,the American people did not want

As Kessler's accounts indicate, public opinion polls, suggesting voters'

Framing the Proposed Rule

Approximately50 million Americans currently smoke cigarettes and

In subsequent sections, the text focused specifically on tobacco use among

[T]he scientificevidencestronglysuggeststhat nicotine addictionbegins

disease. ... Approximately3 millionchildrenunderthe age of 18 aredaily

rule. Even though tobacco use is prevalent in the general US population,

3) Educating Youth about Tobacco Health Risks

and education as a means of reducing youth tobacco use (the prognostic

The proposed labeling and advertisingregulationsare also based upon

... the preponderanceof quantitativeand qualitativestudies of cigarette

Similarly, in presenting its claims that tobacco use is associated with

Much of the followingbriefdiscussionis abstractedfrom severalSurgeon

The subsequent two-page review included 67 references to studies, from

public commentary on the proposed rule to identify the types of arguments

Affiliation. We coded the affiliation of each commentary submitter into

Content Analysis of Frames and Counter-Frames.For commentary sub-

* Scientificframes invoking research on tobacco use by minors, its health

Results I: Position Toward Regulation and Affiliation

Results II: Framing Support For and Opposition To the

There is scientificevidencethat clearlydemonstratesthat more than 80%

We also identified arguments regarding overall research quality or sig-

Study afterstudy shows that peer pressureand parentalinfluenceare the

Our coding of scientific frames also included instances in which com-

counter-evidence to the scientific research that the FDA presented. For

Arguments about the interpretation of scientific evidence also figured

In our sample, all 14 of the arguments about interpretation - including

Two other ideological frames frequently occurred in tandem with the

Furthermore, nearly one-quarter of the sampled commentary opposing the

rights, and might constitute an initial step toward a complete ban on

There can be no question that federalleadershipand a comprehensive

In addition to frames that identified (federal) government as the most

Whereasadultsshould be free to choose their smokingstatus,we have a

Ideological arguments in support of the proposed rule, like those in

As Table 3 shows, more than two-fifths of the sampled commentary

As with ideological frames, the economic frames mobilized against the

In rare instances where supporters of the proposed rule framed it in

Approximately one in five comments mobilized political frames for or

By contrast, the rule's supporters argued that existing restrictions, im-

Comparing comments mobilizing enforcement frames to oppose or sup-

By framing the proposed regulation as a matter of personal motives and

Finally, an elected official has the courage to stand up to the powerful

Whereas opponents portrayed the individual initiative of government offi-

The FDA'S Response to the Public Commentary and after

The qualityand persuasivenessof the commentswill be the basis for the

form letters as a single comment (Department of Health & Human

nearly three-quarters of the 1,500 comments on this aspect of the pro-

Prior research has indicated significant variation in institutional practices