Abstract
Adopting a place-based approach to categorization, we explore how and why institutional actors in the US and the UK have categorized e-cigarettes differently, namely as tobacco products in the US and as non-tobacco consumer products in the UK. Our inquiry identified the historical contingencies generating two different perspectives informing these differential categorizations—precautionary in the US and harm-reduction in the UK. Embedded in these two perspectives are different future imaginaries to address the harm from cigarettes and e-cigarettes to the different population groups at risk (i.e. smokers versus youth and non-smokers). Data also show institutional actors across the two countries offering justifications for or against e-cigarettes by deploying facts from different scientific research. We theorize these findings and conclude the article by discussing the importance of adopting a place-based approach to categorization.
Keep Calm and Vape on: UK Embraces E-Cigarettes, US Cautious
As the above quote highlights, e-cigarettes are regulated differently between the US and the UK. Specifically, regulators in the US and UK categorize e-cigarettes as tobacco products, and non-tobacco consumer products, respectively. As a result, manufacturers in the US must obtain pre-marketing authorization for their products (U.S. Department of Health and Human Services, 2016a), whereas companies in the UK need only notify regulators that their products conform to “minimum standards” for quality and safety (Medicines and Healthcare products Regulatory Agency (MHRA), 2016).
What explains the differential categorization of novel products by institutional actors across places? We define novel products as innovations characterized by equivocality that can serve as alternatives to established products (Weick, 1979, 2020), and places as institutionally demarcated spaces with distinct laws, norms, and shared meaning systems at the geographic country level (Wright et al., 2021). Accordingly, institutional actors operate with a “set of shared assumptions, categories, vocabularies, and frames” (Meyer et al., 2020: 194) to govern phenomena within places (see also Douglas, 1986; Jones and Svejenova, 2017).
In this study, we focused on the differential regulatory categorization of novel products by institutional actors across places (e.g. Ozcan and Gurses, 2018). Our perspective on categorization draws on recent work that departs from a prototypical view of categorization to a goal-based view encompassing the primary causal effects that institutional actors want to enhance or mitigate through their policies (e.g. Durand and Paolella, 2013; Glaser et al., 2020; Granqvist and Ritvala, 2016). In particular, we investigated the actions of regulators and public health organizations (PHOs) toward e-cigarettes, a novel product that has been promoted as an alternative to tobacco cigarettes, but with potential public health benefits and harms that remain contested among scientists (e.g. Abrams et al., 2018; Fairchild and Bayer, 2015; Glantz and Bareham, 2018).
We first review the literature on categories to establish our problematic on the categorization of novel products across places. After describing our methods used to gather and analyze data, we provide an in-depth account of our findings. We showcase how institutional actors in the US and the UK have categorized the same novel product (e-cigarettes) differently based on (a) the place-based historical contingencies shaping actors’ perspectives, (b) the goal-based future imaginaries embedded in them, and (c) the current justifications that actors offer in support of their policies. We theorize these findings, and close by discussing the limitations of our study and introducing topics for future research.
Background literature
We begin by summarizing the literature on categories, and then emphasize the role institutional actors play in categorizing phenomena across places (Cresswell, 2004; Jones and Svejenova, 2017; Lawrence and Dover, 2015; Wright et al., 2021). Subsequently, we discuss the importance of historical contingencies in shaping the perspectives of institutional actors who categorize phenomena to accomplish their goals. This leads us to our problematic on how institutional actors across places can categorize the same novel product in different ways.
Categorization and place
Categories are social constructions that actors use to group entities together, such as people, products, organizations, or practices (e.g. Delmestri et al., 2020; Douglas, 1986; Durand et al., 2017; Durand and Khaire, 2017; Granqvist and Siltaoja, 2020; Vergne and Wry, 2014). Organizational scholars initially adopted a prototypical view of categories (Durand and Paolella, 2013), in which entities are grouped together based on certain prototypical features defining the category. For example, chickens and robins are birds because they both have features that are considered typical of the category (Durand and Paolella, 2013).
While the prototypical view has played an important role in organizational scholarship, two additional approaches to categorization proposed by Durand and Paolella (2013) are useful. First, categorization can be based on entities meeting an actor’s particular goal. For example, a chicken and bread both provide food (Glaser et al., 2020; Granqvist and Ritvala, 2016). Second, categorization can be based on the primary effects that actors attribute to entities. For example, a robin and a drone can both fly. Combining these two approaches, we propose that categorization by actors is based on their goals encompassing the primary effects they wish to enhance or mitigate.
Such an approach to categorization is especially salient for gaining an understanding of how entities are categorized across places. Drawing from the work of multiple authors (e.g. Cresswell, 2004; Gieryn, 2000; Lawrence and Dover, 2015; Wright et al., 2021), places are institutionally demarcated spaces with shared “way[s] of seeing, knowing and understanding the world” (Cresswell, 2004: 11; see also Jones and Svejenova, 2017; Meyer et al., 2020). 1
Our interest is in the role of place-based institutional actors in categorizing phenomena. Functioning as “legitimated theorists,” institutional actors “analyze . . . and evaluate” (Jones and Svejenova, 2017: 206) phenomena, enacting rules and regulations in the process (Ozcan and Gurses, 2018). For example, whether it is deemed acceptable for people without housing to take shelter in parks is often determined by the legislative and judicial bodies governing the place (Cresswell, 2004). As institutional actors differ across places, what is considered acceptable (pure) in one place could be considered problematic (taboo) in another (Douglas, 1966).
Historical contingencies
Considering categorization across places raises questions as to how and why differences arise. Sensitized by prior work that has accounted for the role of history in categorization (e.g. Delmestri and Greenwood, 2016; Delmestri et al., 2020; Hsu and Grodal, 2021; Jones et al., 2012; Khaire and Wadhwani, 2010; Siltaoja et al., 2020), we suggest that historical contingencies play an important role in shaping how institutional actors across places categorize phenomena. 2 Indeed, the “[m]eanings that individuals and groups assign to places are more or less embedded in historically contingent . . . understandings of the terrain” (Gieryn, 2000: 473). Institutional actors are “carriers of [this] history” through the categorizations that they enact (David, 1994: 205). Below, we provide several examples to establish this point.
Our first example is the Indian Supreme Court extending social protections and equal rights to the transgender community by recognizing a distinct third gender category (Garud and Tharchen, 2016). In its judgment, the judiciary invoked the community’s significance in the country’s cultural and religious history. Absent this historical contingency, many other countries do not recognize transgender individuals, insisting that they be categorized within a binary gender classification scheme.
Our second example is how different societies considered lepers in the mid-twelfth century. While they were considered sinners in Western Christendom, no such categorization was applied by those in Jerusalem (Douglas, 1991). This difference has been attributed to historical contingencies in social structures between both places. In the Western kingdoms, which were more hierarchical, the charge of leprosy functioned as a tool to control and maintain social order. In Jerusalem, where social relations were egalitarian and cohesive, the disease was not used as a “political weapon for keeping down the system’s derelicts, nor . . . to remove unpopular incumbents of high office” (Douglas, 1991: 734).
Fourcade (2012) offered an example of how place-based categorization has been enacted to preserve commercial interests. She showed how the categories of wine quality institutionalized in France based on terroir, defined as a region’s physical features, arose out of the historic monopolistic practices of powerful landowners in high-status regions to protect their commercial interests. This is not the case in the US. Absent the contingencies present in France, the institutional actors in the US have not formally recognized terroir-based classifications (Fourcade, 2012).
In the case of architecture, Jones et al. (2012) showed how eminent architects across places have enacted different categorizations of “modern architecture” based on historical contingencies related to the composition of their client base. Architects in the US and Northern Europe formed the “modern organic” category in which they emphasized the Gothic ideals of nature. This was owing to their greater reliance on traditional religious and state clients. For another group of architects based in Germany and France, who served a larger percentage of business clients, the emphasis was on efficient and economical designs over traditional aesthetic considerations. This group of architects constituted the “modern functional” architecture category (Jones et al., 2012).
A contemporary example is Uber’s ride-sharing technology, which regulators have categorized differently across countries owing to place-based historical differences (e.g. Garud et al., 2022; Thelen, 2018; Uzunca et al., 2018). For example, while regulatory authorities in Germany saw Uber as a threat to their historically well-regulated transportation markets and effectively banned its presence, those in the US, in keeping with their liberal market policies, enacted the new category of Transportation Network Company (Garud et al., 2022; Thelen, 2018).
Overall, these examples show that historical contingencies, such as those related to cultural, sociopolitical, structural, occupational, and market spheres, shape how institutional actors differentially categorize phenomena across places. Such a view is consistent with a non-representational performative perspective that eschews essentialism, and instead highlights the role that history and contingency (i.e. the “contingent links among clusters of factors—links that happened to be formed in the course of time”) play in categorization (see Tsoukas, 1998: 799). Therefore, investigating these historical factors provides an analytical lens to explain how and why institutional actors across places categorize phenomena in different ways.
Differential categorization of equivocal novel products
While the possibility for differential categorizations to materialize across places exist for any phenomena, this is all the more so for novel products around which there exists equivocality, that is, the possibility of multiple meanings (Weick, 1979, 2020). Multiple meanings could arise from contradictory risk assessments related to the product’s benefits and harms (Beck, 1992a, 1992b) owing to the lack of “sufficient [scientific] authority to ‘fix’ the objects’ meaning” (Hardy and Maguire, 2020: 686). Under these circumstances and given the interpretive flexibility they are likely to generate, the categorization of novel products cannot be understood based on prototypical features.
Instead, investigating the goals of the institutional actors tasked with regulating such products (Durand and Paolella, 2013; Glaser et al., 2020) offers a more promising avenue to understand how place-based institutional actors categorize phenomena to constitute different “risk societies” (Beck, 1992a, 1992b; Hardy and Maguire, 2020). Accordingly, we explored the categorization of e-cigarettes, a novel product characterized by scientific contestation around its long-term public health benefits to tackle the harms of smoking (e.g. Abrams et al., 2018; Fairchild and Bayer, 2015; Glantz and Bareham, 2018). Differential categorization of e-cigarettes by regulators and PHOs in the US and the UK has generated different policy responses.
Before detailing the study’s methods, we preview our findings. Aside from historical contingencies that have shaped the differences in how regulators and PHOs in the US and the UK categorize e-cigarettes, our analysis highlights two additional factors that play roles: future imaginaries and current justifications. The term future imaginaries refers to the goals desired by the institutional actors (Jasanoff, 2015; Jasanoff and Kim, 2009). Current justifications refers to the use of specific scientific facts by institutional actors in support of their positions (Garud and Ahlstrom, 1997; Maguire and Hardy, 2013). By considering these temporal elements, we join with Hargadon and Wadhwani (2022) in accounting for situated microtemporal justificatory practices in time and a macrotemporal frame recognizing processes of continuity and change over time based on historical contingencies and future imaginaries.
Methods
We conducted a longitudinal comparative case study analysis to investigate the different e-cigarette categorizations in the US and the UK (Yin, 2003). These countries share similarities based on their Anglo-Saxon origins and highly developed market-based economies (Dore et al., 1999). Both countries have implemented tobacco-control policies, reducing smoking prevalence to similar levels. When the e-cigarette market was formed around 2006/2007 (British Medical Association, 2017; Etter, 2009), the smoking rates for adult and high school-aged youth were estimated at 20.8% and 23%, respectively, in the US (CDC, 2007), and 24% and 20%, respectively in the UK (ASH, 2007). In both countries, smoking rates were higher among lower socioeconomic groups (ASH, 2007; CDC, 2011). 3 Despite these similarities, however, the two countries have taken very different approaches to regulating e-cigarettes.
We used a contextualized inquiry approach to understand how and why differences have arisen across both places (Bothello et al., 2019: 1509), a point which Hsu and Grodal (2021) also noted in their study of e-cigarette category formation in the US. Accordingly, we collected and analyzed considerable archival data on e-cigarettes in the US and the UK between 2006/2007 and 2016 (Table 1). We chose 2016 as the end year, as regulators in both the US and the UK finalized their regulations for e-cigarettes in that year. To provide further evidence in support of our arguments, we have continued following developments after 2016.
Data sources.
PHO: public health organization; FDA: Food and Drug Administration; MHRA: Medicines and Healthcare products Regulatory Agency.
Our data collection and analysis employed several steps. Although we conducted these steps iteratively, we enumerate them sequentially for convenience in reporting them below.
(a) Proportion of media statements by institutional actors highlighting the potential benefits and harms from e-cigarettes. (b) Proportion of media statements by institutional actors highlighting their concerns for different population groups: Youth and Non-smokers, and Smokers.
Bruner (1986) argued that case narratives establish verisimilitude based on the trustworthiness of the flow of arguments (Lincoln and Guba, 1985). As such, verisimilitude is different from comprehensiveness, a criterion consistent with a logico-scientific approach (Bruner, 1986). Indeed, when it comes to analyzing historical data in combination with future projections and actors’ current justifications, Tsoukas and Hatch (2001) have argued for verisimilitude. To ascertain the verisimilitude of these findings through member checks (Lincoln and Guba, 1985), we shared our findings with a prominent historian of tobacco control, a tobacco policy consultant, and a tobacco control scientist. 4 They all corroborated our reported themes, thereby increasing our confidence in our analysis.
Our narrative was also informed by observational data including a 1-day regulatory workshop on pre-marketing tobacco product applications organized by the US FDA in October 2016, a 3-day scientific conference organized by the Society for Research on Nicotine and Tobacco (SRNT) in March 2016, and a 4-day workshop on nicotine and tobacco organized by the UK Centre for Tobacco & Alcohol Studies (UKCTAS) in May 2019. In addition, we have been following on an ongoing basis the presentations regulatory officials and scientists have made at the E-cigarette Summit, an annual conference first organized in 2013 with a focus on e-cigarette science, regulation, and public health policy (e-cigarette-summit.co.uk; e-cigarette-summit.us.com). Attendance at these events allowed us to observe firsthand the regulatory, public health policy and scientific thinking shaping the differential categorization of e-cigarettes across both places.
Findings
First, we offer details of the historical contingencies that have led to institutional actors’ different perspectives on e-cigarettes, namely precautionary in the US and harm-reduction in the UK. Second, we detail the future imaginaries embedded in these perspectives. Third, we provide evidence on the different scientific facts institutional actors use to justify their positions. Overall, we establish that there is heterogeneity in the categorization of novel products by institutional actors across places because of differences in historical contingencies, which implicate future imaginaries and current justifications (Table 2).
Historical contingencies, future imaginaries, and current justifications shaping categorization of e-cigarettes by institutional actors in the US and the UK. a .
FDA: Food and Drug Administration; MHRA: Medicines and Healthcare products Regulatory Agency.
We draw on several data sources, including tobacco control histories, scientific articles on e-cigarettes, and regulatory and PHO reports including the FDA’s 2016 deeming regulations for e-cigarettes in the US and the PHE’s 2015 evidence update report on e-cigarettes. The analyses of the historical contingencies, future imaginaries, and current justifications summarized here have been provided in greater detail in the Findings section of the article.
Historical contingencies shaping categorization across the US and the UK
Historical contingencies informing the precautionary perspective in the US
The precautionary perspective adopted by US institutional actors toward e-cigarettes must be viewed in the context of historical developments in US tobacco control. We emphasize two factors shaping this precautionary perspective: (a) a shift toward prevention-oriented policies focused on protecting youth and non-smokers, and (b) the revelations through litigation of the deceptive practices of tobacco companies in marketing “safer” cigarettes. Together, these developments have led institutional actors in the US to become wary of promoters of products such as e-cigarettes claiming they are reduced-risk alternatives to cigarettes.
Responding to smoking-related health concerns, US tobacco companies began developing “safer” filtered low tar and nicotine cigarettes during the 1950s and 1960s (Fairchild and Colgrove, 2004). These efforts were initially supported by government agencies and PHOs in the US. For instance, the National Cancer Institute (NCI) created the Less Hazardous Cigarette Working Group, which involved scientists from tobacco companies and spent millions of dollars in funding research to develop less harmful cigarettes (Parascandola, 2005). Influential PHOs such as the American Heart Association (AHA) and the American Cancer Society were on board with these initiatives, which were also endorsed by the US Surgeon General (Fairchild and Colgrove, 2004).
Support for “safer” cigarettes in the US however waned during the late 1970s and 1980s as policy emphasis shifted toward smoking cessation and prevention (Fairchild and Colgrove, 2004). This was on account of emerging scientific evidence on the addictiveness of nicotine and compensatory smoking (Parascandola, 2005). The research showed that addicted smokers of low tar and nicotine cigarettes modified their smoking behavior, such as smoking more intensely, to compensate for the reduced nicotine content, and hence potentially exposed themselves to dangerous levels of toxicity (Benowitz et al., 1983; Kozlowski et al., 1980). NCI funding for less hazardous cigarettes stopped completely by 1980, and the 1981 US Surgeon General’s Report warned that switching to lower-tar cigarettes yielded minimal benefits (Parascandola, 2005). The FDA’s approval of nicotine gum in 1984 for smokers to quit smoking was part of this “organized smoking cessation program” implemented by regulators and PHOs in the US (The New York Times, 1984).
Emerging scientific research on the health harms of secondhand smoke exposure during the early 1980s contributed to this shift (Fairchild and Colgrove, 2004). As the risks from smoking now extended to innocent non-smokers who involuntarily assumed them (Brandt, 1998), “the protection of nonsmoking bystanders, rather than smokers themselves, moved to the center of policy goals” in the US (Fairchild and Colgrove, 2004: 196). In response to concerns that tobacco company advertising targeted adolescents, prevention efforts in the 1990s were also directed at protecting youth from smoking. For instance, the 1994 US Surgeon General’s Report centered on preventing young people from starting to use tobacco (CDC, 1994). In the same year, the FDA announced it would regulate cigarettes as drug-delivery devices by characterizing smoking as a pediatric disease and in 1995 proposed regulations aimed at “breaking the cycle of addiction to nicotine” (Kessler et al., 1996: 991).
Numerous lawsuits against tobacco companies filed during the 1980s and 1990s accelerated this shift toward a dominant prevention-and-cessation-focused policy in US tobacco control (Fairchild and Colgrove, 2004). Liability litigation involving individual and class-action lawsuits filed on behalf of smokers and non-smokers alike, which involved regulators and PHOs in some instances, brought several incriminating internal documents to the surface (see Brandt, 2007: 319–445 for a detailed account). These documents provided evidence that, despite public denials, companies were aware of the harms of smoking and nicotine addictiveness and engaged in marketing practices to intentionally target youth (Brandt, 2007). Specific to “safer” cigarettes, they revealed that industry participants had “suppressed the evidence related to compensatory smoking” (Fairchild and Colgrove, 2004: 199), and continued marketing “light” low tar and nicotine cigarettes with implicit claims of harm-reduction (Brandt, 2007).
The idea of “safer” cigarettes soon became lost to most PHOs in the US, who began seeing them as efforts to further perpetuate smoking. The NCI described “safer” cigarettes as only “provid[ing] smokers with a false sense of reduced-risk” (National Cancer Institute, 2001: ii), and both the AHA and American Lung Association claimed that “there is no such thing as a safer cigarette” (Fairchild and Colgrove, 2004: 200). Meanwhile, a landmark 2006 judicial ruling, on a petition by the US Government and supported by some PHOs, indicted tobacco companies for selling a “lethal product with zeal . . . [and] deception,” and prohibited the “further use of deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health” (US District Court for the District of Columbia, 2006: 2, 4).
Within the US tobacco-control community, these historical developments have led to widespread precaution toward products claiming to be reduced-harm alternatives to cigarettes (Warner and Martin, 2003) to “avoid the mistakes made with ‘lights’ [cigarettes] decades ago” (Zeller et al., 2009: 325) and “prevent consumers from being similarly misled” (U.S. Department of Health and Human Services, 2016a: 29039). They argue that such products could potentially “weaken the impact of [ongoing] prevention and cessation efforts” (Zeller et al., 2009: 325). It is no wonder that as e-cigarettes entered the US market, regulators and PHOs recommended smokers only use medicinal nicotine replacement therapy (NRT) cessation products to quit smoking (American Academy of Pediatrics et al., 2010; FDA, 2009a) and expressed concerns that nicotine-based alternatives such as e-cigarettes could “risk deterring current smokers from quitting” (Campaign for Tobacco-Free Kids, 2009).
Historical contingencies informing the harm-reduction perspective in the UK
Continued policy support for risk-reduction through product modification alongside prevention strategies, and the subsequent endorsement of safer nicotine products as a reduced-risk alternative for smokers, has contributed to UK regulators and PHOs taking a harm-reduction approach toward e-cigarettes (Berridge, 2007). As in the US, initiatives to develop a “safer” cigarette were underway in the UK during the early 1970s as part of “voluntary regulation, of informal, non-statutory agreements between government and industry which became a norm in British smoking policy” (Berridge, 2003: 70). 5 As part of these initiatives, the Independent Scientific Committee on Smoking and Health (ISCSH) was established in 1973, and comprised scientists appointed by the Department of Health and Social Security (DHSS) to advise “both the government and the tobacco industry on the issue of . . . developing a ‘lower risk’ cigarette” (Berridge, 2003: 71). The idea of safer smoking initially found support from other PHOs in the UK, including the RCP and ASH (Berridge, 1999, 2003).
However, the “safer” cigarettes being developed found limited appeal among smokers and were commercially unsuccessful (Elias and Ling, 2018; Jarvis and Russell, 1980). Furthermore, paralleling developments in the US, an emphasis on risk-avoidance and prevention emerged in the UK during the 1970s. Voluntary agreements with the industry stipulated health risk warnings on cigarette packs, and the discontinuation of advertisements for cigarette brands containing high and middle-to-high tar levels (ASH, 2020). Cigarette taxation increased, and advertisement bans extended to include commercial radio (ASH, 2020). Moreover, anti-smoking PHOs such as ASH and the UK Health Education Council (HEC) called for a “new agenda which aimed at abstention . . . and an end to voluntary regulation in alliance with the [tobacco] industry” (Berridge, 2005: 103–104). For instance, ASH raised concerns that advertising substitutes to cigarettes could slow declines in smoking, and the HEC likened the use of smoking substitutes to “jumping off the thirty-sixth rather than the thirty-ninth floor of a tall building” (Berridge, 2003: 73). Scientific evidence regarding the risks of passive smoking also entered these arguments for complete cessation and distancing from the industry (Berridge, 2003, 2005).
However, unlike in the US, where regulators and PHOs engaged in litigation with tobacco companies, owing to the tradition of voluntary policymaking, “Britain deliberately avoided the route of legal regulation, with much less emphasis on law cases against tobacco companies” (Berridge, 2003: 77). 6 Instead, engagement with the industry continued through voluntary agreements during the 1980s. Industry funds led to the establishment of the Tobacco Products Research Trust (TPRT) in 1982, which funded research overseen by the ISCSH on the health effects of product modification through safer cigarettes, among other topics (Berridge, 2007). 7 Research from this initiative showed that “the toxicity of cigarettes might be reduced more if nicotine levels were reduced less than those for tar” (Berridge, 2003: 77). These findings contributed to “continu[ing] the risk-reduction strand within [UK] policy making” (Berridge, 2003: 77). In this regard, Berridge (2005: 119) observed how the UK Government was “involved in a complex balancing act which sought reduction of risk as well as elimination” by funding the activities of anti-smoking organizations such as ASH on one hand, while engaging with the industry through the TPRT on the other.
The pioneering scientific work of Dr Michael Russell at the Addiction Research Unit (ARU), Institute of Psychiatry, funded by the UK Medical Research Council, also contributed to interest in harm-reduction in UK smoking policy. Russell (1976: 1431), who famously observed that “people smoke for nicotine but they die from the tar,” led research that not only resulted in the development of NRT products for smoking cessation but also shaped scientific thinking around the use of cleaner nicotine delivery systems to substitute smoking for addicted smokers who could not or would not quit (McNeill and Robson, 2018). The latter was important in moving research away from safer cigarettes to developing purified nicotine products using non-combustible delivery systems for harm-reduction (Jarvis, 2018). Russell’s ideas on harm-reduction became influential in UK smoking policy, and many researchers who trained under him, such as Dr McNeill whose work we discuss later, are now central actors in the country’s policymaking on e-cigarettes (Berridge et al., 2021).
The above findings on nicotine’s role in establishing addiction and the “recognition of a group of smokers who would not, or could not, give up helped underpin policy interest in the concept of addiction” and “a revival of harm-reduction in the late 1980s” in UK smoking policy (Berridge, 2007: 275). While regulators and PHOs in the US also recognized nicotine addiction, an important distinction was that in “the United States, addiction was both a public health problem and an infectious disease, and nicotine shared in these developments” (Berridge, 2007: 273). Hence, scientific research on nicotine in the US argued “for an abstentionist model, for the reduction of nicotine, and for low tar–low nicotine cigarettes” (Berridge, 2007: 276) to primarily prevent nicotine addiction among young people (see Benowitz and Henningfield, 1994). 8
Meanwhile, in the UK, a focus on reducing the public health costs of smoking, 9 and its elevated prevalence among the more deprived sections of society despite taxation polices to make smoking more expensive, generated policy interventions to assist in smoking cessation using NRTs (Berridge, 2003, 2007; Department of Health, 1998). NRTs were only available by private prescription until the late 1980s, but made available by the National Health Services (NHS) by the mid-1990s (Berridge, 2007). While it was hoped that NRTs would aid in complete cessation, the UK Department of Health’s 1998 whitepaper “Smoking Kills” also identified as an important area for future research “the safety and effectiveness of NRTs . . . when used as an aid to smoking less (to reduce exposure to the harm caused by tobacco smoke)” (Department of Health, 1998).
Over time, other PHOs in the UK, including the UK HEA which had been skeptical of harm-reduction, began seriously considering it (Berridge, 2007). For instance, the UK HEA published a report on regulating nicotine delivery systems (Berridge, 2007), and the RCP argued in a series of reports for a regulatory framework promoting the development of less harmful nicotine products (RCP, 2000, 2002, 2007). Specifically, in a report titled “Harm-reduction in nicotine addiction: Helping people who can’t quit,” the RCP called for favorable policies that would enable the development of nicotine products that smokers could use as long-term substitutes to cigarettes (RCP, 2007). Subsequently, and following earlier approvals for the use of licensed NRTs to “cut down to quit” and achieve “temporary abstinence,” the MHRA in 2009 approved NRTs for the indication of “harm-reduction” “with no limit on the treatment duration” and “with the aim of quitting when . . . ready” (MHRA, 2009). This marked the implementation of harm-reduction through licensed nicotine products in UK tobacco control, in contrast to the US, where such products are primarily indicated for cessation (FDA, 2019a). Contrasting with the US, these historical developments led institutional actors in the UK to perceive nicotine-based alternatives such as e-cigarettes as promising alternatives for “smokers . . . to eliminate or reduce the harm from smoking” (MHRA, 2010: 4).
Comparative summary
Overall, our analysis indicates how historical contingencies shape institutional actors’ perspectives on novel products across places. The role of historical events in informing institutional thinking is unsurprising (Douglas, 1986); however, the specific perspectives adopted are revelatory. In the US, institutional actors adopted a precautionary perspective toward e-cigarettes. This aligned with their emphasis on protecting youth and non-smokers and safeguarding against any deceptive risk-reduction claims from manufacturers. In the UK, policy support to develop reduced-risk alternatives for smokers and the endorsement of safer nicotine products for such purposes led institutional actors to adopt a harm-reduction perspective on e-cigarettes. 10 Embedded in these two perspectives are institutional actors’ different future imaginaries concerning e-cigarettes, which we discuss in the next section.
Future imaginaries shaping categorization across the US and the UK
Future imaginaries in the US
In keeping with the precautionary perspective, our data analysis indicated that US institutional actors are mainly concerned about mitigating the potential negative effects of e-cigarettes on youth and non-smokers (Figures 1(a), (b) and 2). As early as 2009, the FDA initiated actions to detain imported e-cigarettes shipments as unauthorized drug-device combination products and expressed concerns that “e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products, including conventional cigarettes” (FDA, 2009b). The Campaign for Tobacco-Free Kids and other PHOs also warned about e-cigarettes providing a “pathway to nicotine addiction for children, leading them to smoke cigarettes and use other tobacco products to satisfy their addiction” (Campaign for Tobacco-Free Kids, 2009). Notably, these concerns regarding youth e-cigarette use were raised much in advance of any data that reported such use in the US. After the FDA’s attempt to regulate e-cigarettes as a drug-device combination product was rejected by the judiciary (US District Court for the District of Columbia, 2010), 11 the agency announced it would regulate e-cigarettes under tobacco control regulations (FDA, 2011).
Primary effects associated with e-cigarettes that institutional actors in the US and the UK address through their categorization and policies.
Tobacco companies’ entry into the e-cigarette marketplace in 2012 heightened concerns among regulators and PHOs that e-cigarettes were just a trojan horse to make a new generation of users addicted to nicotine (Esterl, 2013). PHOs raised concerns over e-cigarettes being sold in a wide variety of flavors that could appeal to youth and noted that companies marketed the product using themes from erstwhile cigarette advertisements (Campaign for Tobacco-Free Kids, 2013; see also Hsu and Grodal, 2021). Concerns that e-cigarettes could be a gateway to tobacco product use further intensified when the CDC published a report in 2013 on the number of middle and high school students who had used e-cigarette at least once in the past 30 days doubling during 2011–2012 (CDC, 2013). The CDC warned that, if it continued, this rising trend in e-cigarette use could re-normalize smoking and undermine years of tobacco-control efforts (Reinberg, 2013). Sixteen PHOs echoed the CDC’s concerns and urged the FDA to immediately regulate e-cigarettes as a tobacco product (American Academy of Pediatrics et al., 2013).
To address these concerns, the FDA proposed draft regulations for e-cigarettes in June 2014 (U.S. Department of Health and Human Services, 2014). Observing that the proposed regulations were a “foundational step . . . to promote and protect the health of the public” in the future, including “reducing sales to youth” (FDA, 2014), the draft regulations mandated e-cigarette companies undertake pre-marketing authorization for their products under standards similar for tobacco cigarettes (U.S. Department of Health and Human Services, 2014). Companies selling e-cigarettes would need to demonstrate that their product was less harmful than cigarettes, and that using e-cigarettes would not lead to new user initiation among non-smokers at the population level (U.S. Department of Health and Human Services, 2014).
Responding to the terms of the proposed regulations, PHOs called for even stronger measures to reduce the likelihood of youth and non-smokers trying these products, such as prohibiting online sales and banning “the use of sweet and fruity flavors in e-cigarettes . . . making a highly addictive product more appealing to youth” (American Academy of Family Physicians et al., 2014: 48). The CDC soon featured e-cigarettes as part of its “public health grand rounds” calling the product an “emerging public health challenge” (CDC, 2015). Again demonstrating the emphasis in the US on preventing e-cigarette use among youth, in his introductory address, CDC Director Thomas Frieden noted the increased risk of adolescents developing “a lifetime of addiction” to nicotine by using e-cigarettes (CDC, 2015).
Accounting for these concerns, the FDA concluded in 2016 that e-cigarettes “should be regulated due to their potential for public harm” and finalized regulations for them as a tobacco product that mandated pre-marketing authorization standards similar to tobacco cigarettes (U.S. Department of Health and Human Services, 2016a: 28983). Specifically, our analysis of the FDA’s regulatory text also reflects the regulatory agency’s overwhelming concern that “youth may initiate tobacco use with [e-cigarettes], become addicted, and then dual use or move on to traditional tobacco products” (U.S. Department of Health and Human Services, 2016a: 29040) despite some scientists pointing to decreased youth smoking rates being simultaneously observed in the US (Siegel, 2015). Reflecting the dominant future imaginary of US institutional actors involving the mitigation of risks to youth and non-smokers (Figure 2), the US Surgeon General also advocated precautionary strategies “to prevent and control the harms of e-cigarettes among youth and young adults” (U.S. Department of Health and Human Services, 2016b: 249). Smokers seeking to quit cigarettes were advised to continue using approved medicinal products for cessation and refrain from using e-cigarettes until such time that the product’s benefits were fully established (FDA, 2016).
The FDA’s stance on e-cigarettes was readily apparent in the agency’s public workshop on pre-marketing authorization that we attended in October 2016. There was little if any acknowledgment that the product could function as a reduced-risk alternative to cigarettes (Field notes). Officials mainly focused on the potential harms that could arise from e-cigarettes, including increased risk of nicotine addiction for non-smokers and potential harms from “aerosols contain[ing] [a] variety of respiratory toxicants and carcinogens” for all e-cigarette users (Yee, 2016).
Future imaginaries in the UK
In marked contrast to the US, the future imaginary of current smokers transitioning to less harmful alternatives such as e-cigarettes assumed greater predominance in the UK (Figures 1(a), (b) and 2). In this regard, following a public consultation process in 2010, the MHRA announced in June 2013 that all e-cigarettes containing nicotine would be regulated as medicine from 2016 onward. 12 Although the MHRA’s initial response was not unlike the FDA’s, the two organizations were guided by different objectives. The FDA’s effort to regulate e-cigarettes as a drug was in response to the smoking cessation claims made by e-cigarette companies, which the agency deemed to be unsubstantiated. Notably, unlike the MHRA, the FDA warned consumers about the health risks of e-cigarettes in its initial communiques, with little acknowledgment of any potential benefits related to harm-reduction (FDA, 2009b, 2009c).
The MHRA had already recognized the potential for alternate nicotine products to aid in cessation and reduce the harms from smoking, and viewed medicinal licensing as a step to realizing e-cigarettes’ “promise . . . in helping smokers quit tobacco” through the availability of safer and effective alternative products in the future (MHRA, 2013: 3). As alluded to above, this focus on smokers, particularly those from low-income groups, in the UK can be attributed to the greater involvement of the state in public health care (see Nicolini et al., 2016), and rising NHS expenditure for treating smoking-related diseases (Cabinet Office, 2011). 13
In line with the MHRA’s efforts, in 2013, the National Institute for Health and Care Excellence (NICE) published harm-reduction guidelines for health care workers engaged in smoking cessation interventions to advise patients. As no e-cigarettes were approved for medicinal licensing, the NICE report referenced e-cigarettes as unlicensed nicotine products that were “expected to be less harmful than tobacco,” while calling for more scientific evidence regarding their efficacy and safety (NICE, 2013: 11). Highlighting UK PHOs’ focus on the risks to smokers from the non-availability of harm-reduction alternatives, NICE would subsequently incorporate guidelines for e-cigarette use as being “substantially less harmful to health than smoking,” and additionally observe that “[p]eople who smoke should not be discouraged from switching to e-cigarettes” (NICE, 2018: 26).
NICE’s recommendations drew upon earlier publications by several other UK PHOs including PHE and the RCP, who had endorsed the use of e-cigarettes by smokers experiencing difficulties quitting. For instance, the PHE concluded in its August 2015 report that e-cigarettes were “95% safer than smoking” and noted that “Encouraging smokers who cannot or do not want to stop smoking, to switch to EC [electronic cigarettes] could be adopted as one of the key strategies to reduce smoking-related disease and death” (McNeill et al., 2015b: 13).
Addressing concerns raised by regulators and PHOs in the US regarding smoking renormalization through e-cigarettes, the PHE observed that while “newer smokers are experimenting with EC, the vast majority of youth who regularly use EC are smokers. Regular EC use in youth is rare” (McNeill et al., 2015b: 38). Furthermore, and in line with their future imaginary, the PHE report also provided a different interpretation than the CDC on the rising e-cigarette use among youth observed in the US. Noting the decreased cigarette smoking among youth also reported in US surveys, the PHE concluded that “[the survey] findings strongly suggest that EC use is not encouraging uptake of cigarette smoking” (McNeill et al., 2015b: 87).
In this regard, it should be noted that the Advertising Standards Authority (ASA) in the UK had implemented advertising rules for e-cigarettes in 2014. While permitting e-cigarette to be presented as an alternative to tobacco, e-cigarette advertising targeting youth and non-smokers was prohibited (ASA, 2014). As part of this ruling, the ASA started banning several e-cigarette advertisements perceived as glamorizing smoking (Neville, 2014). This situation in the UK pertaining to the regulations in place to prevent uptake among youth and non-smokers was different from that in the US, where no advertising rules had been implemented by the FDA, pending finalization of the FDA’s deeming regulations in May 2016.
The PHE’s “95% safer” claim was contested by some scientists in the UK, who questioned the quality of evidence and alluded to conflicts of interest in a significant number of research articles that the agency reviewed (McKee and Capewell, 2015). However, most PHOs in the UK were supportive of the PHE’s position (Berridge et al., 2021; The Week, 2015).
14
Leading scientists who co-authored the PHE report responded to conflict of interest charges by stating that they “have never taken any tobacco or EC industry funds,” and further affirmed that “[s]witching from smoking to vaping avoids most of the risks of smoking” (McNeill et al., 2015a: 1). A joint consensus statement published by 13 PHOs, including PHE, RCP, ASH, and Cancer Research UK, further confirmed the position of UK PHOs on e-cigarettes as a promising harm-reduction alternative for smokers:
We all agree that e-cigarettes are significantly less harmful than smoking. . . . The public health opportunity is in helping smokers to quit, so we may encourage smokers to try vaping but we certainly encourage vapers to stop smoking tobacco completely. . . . There is no circumstance in which it is better for a smoker to continue smoking. (PHE et al., 2016: 1–2)
Amid these developments, the MHRA announced regulations in February 2016 considering e-cigarettes to be consumer products (MHRA, 2016). 15 The MHRA adopted a “light-touch” regulatory approach to provide “minimum standards of safety and quality of e-cigarettes and e-liquids” (Keeley, 2015). The regulations limited the volume and nicotine concentration of the e-liquids used. To minimize the regulatory burden, obtaining pre-marketing authorization was not required; only information such as the product ingredients, nicotine dose, and toxicology data needed to be provided (Keeley, 2015; MHRA, 2016). Compared with the FDA’s regulations, the MHRA’s approach was clearly driven by concerns for smokers, in that “regulation that discourages or delays the development and use of non-tobacco nicotine is likely, in effect, to sustain tobacco smoking and hence perpetuate harm to smokers and wider society” (RCP, 2016: 151).
Comparative summary
Embedded in the institutional actors’ perspectives are different future imaginaries shaping e-cigarette categorization for regulatory purposes across both countries. Institutional actors in each place emphasized different goals to either mitigate or enhance the primary effects that they associated with the novel product: preventing nicotine addiction and smoking renormalization among youth and non-smokers in the US versus reducing the risk to smokers in the UK. In particular, they emphasized the risks to various population groups differently, and through their categorizations, implemented different policies (Jasanoff and Kim, 2009). These contrasting imaginaries related to the same novel product between the US and the UK constitute different risk societies (Beck, 1992a, 1992b; Hardy and Maguire, 2020). To support both imaginaries, institutional actors across the two places offered different scientific facts, on which we elaborate next.
Current justifications shaping categorization across the US and the UK
Current justifications in the US
In June 2014, a group of precaution-oriented scientists wrote to the World Health Organization (WHO), asking them not to exempt e-cigarettes from the Framework Convention on Tobacco Control (FCTC) provisions applied to tobacco cigarettes as suggested by harm-reduction-oriented scientists (Aktan et al., 2014). As part of the dueling letters offering competing inputs on e-cigarettes to WHO (Gartner and Malone, 2014), precaution-oriented scientists alluded to several reasons for advocating caution toward the product, including (a) the presence of toxic chemicals, (b) attractiveness to kids and young adults who might then begin smoking, and (c) the lack of evidence on long-term safety.
Many of these concerns are also evident in the scientific research of Dr Glantz, one of the signatories on the letter to WHO, and an influential tobacco control scientist in the US. Glantz, recipient of a FDA grant to investigate “current and emerging tobacco products” including e-cigarettes (FDA, 2019b) has highlighted how e-cigarettes contain toxic chemicals (Grana et al., 2014), may encourage the use of combustible cigarettes among youth (Dutra and Glantz, 2014), and is associated with “significantly less quitting among smokers” (Kalkhoran and Glantz, 2016) (Figure 3). It is this scientific base of precautionary research by Glantz and other scientists (see Glantz and Bareham, 2018) that US actors have emphasized to regulate e-cigarettes as a tobacco product.
Different science-based facts providing current justifications for precaution and harm-reduction.
Analysis of the FDA’s final deeming regulations provides compelling evidence of the agency drawing on several scientific studies on e-cigarettes highlighting the presence of toxicants, their lack of proven effectiveness as a smoking cessation aid, and the potential for youth to transition to combustible tobacco products. In this process, alternative findings and explanations from a harm-reduction perspective, although acknowledged, have been critiqued as not meeting the scientific standards necessary to shape the agency’s judgment. For instance, a study PHE referenced to substantiate its claim that e-cigarettes are 95% less harmful than cigarettes was challenged as lacking, among other things, a “derivation of the quantitative assessment of each harm criterion” and an “assessment of population effects such as a quantitative assessment of youth use prevalence” (U.S. Department of Health and Human Services, 2016a: 29030).
In another example refuting the science related to harm-reduction, several studies highlighting e-cigarettes’ potential to aid in smoking cessation, although acknowledged, have been collectively deemed as being insufficient to form a basis on which the FDA could recommend the use of e-cigarettes as a smoking-cessation aid. Instead, the requirement of “long-term population-level research that will help fill in current data gaps” is emphasized (U.S. Department of Health and Human Services, 2016a: 29037). Interestingly, and reflecting the FDA’s precautionary approach, the findings of a single study (Primack et al., 2015) with a low sample of baseline e-cigarette users has been taken as evidence that “youth e-cigarette users might transition to smoking traditional cigarettes” (U.S. Department of Health and Human Services, 2016a: 29040–29041).
Overall, given the FDA’s emphasis on long-term, population-level scientific studies to demonstrate any public health benefits from e-cigarettes, in its final regulations in 2016, the agency noted: “based on scientific data . . . the newly deemed products [including e-cigarettes] should be regulated due to their potential for public harm” (U.S. Department of Health and Human Services, 2016a: 28983). Reviewing the scientific literature on e-cigarettes, the US Surgeon General further noted: “long-term studies will be needed to identify the full health consequences of using e-cigarettes. . . . [W]hen there is inadequate or early knowledge, public health decisions should be made on the basis of precaution to prevent harm” (U.S. Department of Health and Human Services, 2016b: vii). Given the unsettled state of scientific knowledge on e-cigarettes, institutional actors in the US placed greater emphasis on scientific research from a precautionary perspective to categorize e-cigarettes as a tobacco product.
Current justifications in the UK
In contrast to the US, regulators and PHOs in the UK emphasized scientific findings highlighting e-cigarettes’ harm-reduction benefits. As noted above, scientists using a harm-reduction perspective wrote to WHO requesting the agency promote the use of low-risk, non-combustible nicotine products to reduce the “the toll of death and disease from tobacco” (Abrams et al., 2014: 1). These scientists argued that precaution-oriented policies that are “excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result” (Abrams et al., 2014: 2).
Dr McNeill, a leading tobacco control scientist in the UK and lead author of the PHE report, was among the letter’s signatories. McNeill has extensively studied issues related to reducing the health harms from tobacco use, especially within disadvantaged communities. Her research makes the case for using non-combustible nicotine products under appropriate regulatory oversight to reduce the public health morbidity and mortality from tobacco use (McNeill and Munafò, 2013). She has published several articles on e-cigarettes’ potential to enable smoking cessation or reduction (e.g. Britton et al., 2016; Brose et al., 2015) (Figure 3). Furthermore, she has shown how most regular e-cigarettes users are smokers, with youth and adult non-smokers in the UK experimenting with e-cigarettes but not becoming habitual users (Bauld et al., 2016; Dockrell et al., 2013). Such scientific work from a harm-reduction perspective (see Abrams et al., 2018) has informed UK institutional actors’ decisions to regulate e-cigarettes as a non-tobacco consumer product.
Our analysis of the 2015 PHE report (McNeill et al., 2015b) makes salient several justifications for promoting e-cigarette use that draw on scientific evidence highlighting (a) the presence of significantly lower levels of harmful chemicals than cigarettes and (b) e-cigarettes’ promising potential to aid smokers to quit cigarettes, and showing how (c) most youth e-cigarette use in the UK is mainly experimental. In doing so, the PHE report critiques the findings and interpretations of several scientific studies from a precautionary perspective. For instance, the report critiqued a widely reported study that found formaldehyde in e-cigarette aerosols and concluded e-cigarettes had a greater lifetime cancer risk than cigarettes as being performed under abnormal conditions of “higher power and longer puff duration than vapers normally use” (McNeill et al., 2015b: 77). The findings of another study reporting the harmful effects of e-cigarettes vapor on respiratory health have been similarly critiqued as being conducted at high stress levels, and as posing “little relevance for estimating human risk” (McNeill et al., 2015b: 79).
Aside from these critiques, the PHE report challenges US institutional actors’ concerns that e-cigarette use could lead to smoking renormalization and nicotine addiction among youth. Similar to the FDA lamenting the lack of long-term studies proving that e-cigarettes are an effective means of smoking cessation, the PHE report problematizes the gateway theory, asserting that such theories “requir[ing] randomising people to an environment with EC and one without, and then following them up over a number of years to assess uptake of EC and smoking” are “extremely difficult to test in humans” (McNeill et al., 2015b: 38). Instead, countering the gateway theory, the report points to the results of US and UK surveys showing declining rates of smoking among adults and youth, concluding “there is no evidence to date that EC are renormalising smoking, instead it’s possible that their presence has contributed to further declines in smoking, or denormalization of smoking” (McNeill et al., 2015b: 38).
Comparative summary
Our analysis shows institutional actors across the US and the UK have emphasized different purported scientific facts to justify their positions. By drawing on contrasting scientific evidence supporting precaution in the US and harm-reduction in the UK, institutional actors not only viewed the same entity, namely e-cigarettes, differently but also enacted different meanings and policies (Mol, 2002). Science has served not to reconcile but provide footholds for institutional actors to anchor their different categorizations. Implicit in these findings is also a consideration of what does and does not count as scientific evidence (Fairchild et al., 2019). For institutional actors in the US, evidence constituted studies using randomized controlled trials and long-term population-level data. In contrast, findings from other studies based on real-world settings and surveys were sufficient proof for actors in the UK (Fairchild, Bayer, and Lee, 2019). These differences speak to regulatory science, wherein policymakers adopt different assessment methods and standards depending on the goals and objectives they wish to pursue and realize (Jasanoff, 1995).
Discussion
The findings from this study problematize the prototypical view of categories in which essential features of an entity determine how it is categorized. Instead, they draw attention to institutional actors’ goals and the effects they wish to enhance or mitigate through their categorization of a novel product (Durand and Paolella, 2013; Glaser et al., 2020; Granqvist and Ritvala, 2016; Jones and Svejenova, 2017). These institutional actors operate within contexts, which are spaces that become meaningful places consisting of “laws, rules, and codes of conduct” (Wright et al., 2021: 44) arising from their historical contingencies (Cresswell, 2004; Gieryn, 2000). As demonstrated by the e-cigarettes case, institutional actors across places informed by their different histories will apply different perspectives to categorize and regulate novel products to pursue different desirable futures (Jasanoff, 2015; Jasanoff and Kim, 2009) based on their assessments of the potential benefits and risks to different groups (Beck, 1992a, 1992b). Categorization across places then becomes value-leaden, implicating the judgments of the institutional actors involved in each place (Arjaliès and Durand, 2019).
However, institutional actors’ categorization and policy enactment to further their future imaginaries is not straightforward. Actors must provide justifications for their decisions based on scientific evidence (Garud and Ahlstrom, 1997; Maguire and Hardy, 2013). When it comes to novel products characterized by equivocality (Weick, 1979, 2020) as with e-cigarettes, scientific evidence itself is equivocal (Garud and Ahlstrom, 1997). Hence, similar to the notion of the body multiple, 16 a situation of scientific multiplicity prevails for such products.
As our analysis highlights, scientific evidence on the potential benefits and harms from a product did not provide incontrovertible truths to the policymakers; rather, the availability of a multiplicity of scientific facts allowed institutional actors across places to utilize different pieces of evidence as justifications to shape their desired categorizations. Such engagement with science in which “[d]ecision makers are compelled [or have degrees of freedom] to choose between conflicting but well-articulated scientific claims” in support of their future imaginaries to enact their desired categorizations is characteristic of regulatory science (Jasanoff, 1995). Consequently, there is not one but multiple “truth-spots” (Gieryn, 2018), wherein different scientific facts are used to further institutional actors’ goals. This is particularly salient today, as many “hazards remain distorted objects . . . resembling modern mythological creatures, which now appear to be an earthworm, now again a dragon, depending on perspective and the state of interests [across places]” (Beck, 1992a: 105).
Contextualized categorization of phenomena across places
Highlighting the roles historical contingencies, future imaginaries, and current justifications play in shaping the differential categorization of novel products across places is a central contribution that we make to the literature on categorization, which we label the contextualized categorization of phenomena by institutional actors. At one level, this historically sensitive place-based account of categorization may appear to speak to the notion of path dependence, a concept David (1994) proposed to showcase how actions and decisions are shaped by historical contingencies. Such an account provides a contextualized understanding of categorization attending to the historical particulars of a location that shape actors’ efforts to categorize phenomena (Lawrence and Dover, 2015; Tsoukas, 1998; Wright et al., 2021).
However, our findings importantly depart from the strict notion of path dependence as applied to organizational phenomena (for details, see Sydow et al., 2009). As we have shown, institutional actors not only operate within contexts but also contextualize “by establishing [ongoing] links with the past, present and future to generate meaning” (Garud et al., 2014: 1183). Consequently, possibilities for change emerge as new circumstances arise in the present, such as changing priorities of the institutional actors themselves or the emergence of new scientific evidence that steers actors toward different imaginaries (Garud et al., 2014; Hargadon and Wadhwani, 2022; Jones and Svejenova, 2017).
In the e-cigarettes case, the US FDA launched a “new comprehensive plan for tobacco and nicotine regulation” in 2017 to strike “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes” (FDA, 2017). Under this plan, regulatory timelines for pre-marketing authorization of e-cigarettes were relaxed to encourage development of innovative tobacco products that are less harmful than cigarettes (FDA, 2017). This was a significant move by the FDA in acknowledging the harm-reduction potential of e-cigarettes, toward a future where “adults who still need or want nicotine could get it from alternative and less harmful sources” (FDA, 2017).
Although the FDA had to move up its compliance deadlines for pre-marketing authorization following a spike in youth e-cigarette use (FDA, 2020), the above mentioned developments suggest that institutional actors’ perspectives, while being shaped by history, remain open to “express a different future” given new priorities and a supporting set of contingencies (Jones and Svejenova, 2017: 229). It is for this reason that our perspective is not deterministic, which one might attribute to a process that is driven by a strict path-dependent ontology. Historical contingencies shape but do not determine actors’ perspectives, keeping open the possibility for actors to formulate new categorizations and pathways for product progression (see also Delmestri and Greenwood, 2016; Garud et al., 2010a, 2010b; Khaire and Wadhwani, 2010).
The implications of our findings go beyond the e-cigarette case that we studied, which in itself is significant. In particular, the findings show that “diffusion” is not necessarily the key mechanism driving the adoption of a novel product innovation across places (Rogers, 1995), but instead translation (see Callon, 1986; Czarniawska and Sevón, 2005; Law, 2009). By translation, we mean the emergence of meaning for a product through its contextualization by actors who associate it with other entities within settings (Garud et al., 2010a). Given historical contingencies shaping the associations that are likely to be forged by actors, the same product could ultimately be categorized differently across places, as our case shows. Moreover, such translations could result in a novel product being considered a “solution to a problem” in one place and a “problem to a solution” in another, as e-cigarettes demonstrate.
Limitations and future research
Our comparative analysis was limited to two countries. Future studies could extend the analysis to include other countries. For example, e-cigarettes are currently banned in many places worldwide, such as in India (Chakma et al., 2020). Other countries, such as Australia, have implemented restrictive prescription-based sales of e-cigarettes (Berridge et al., 2021; Norcia, 2021). It would be useful to investigate how historical contingencies have shaped institutional actors’ categorization of a novel product across these places and what future imaginaries and current justifications are implicated.
We focused on the institutional actors who were most visible and influential in shaping categorization: regulators and PHOs. Future research could examine the actions of other institutional and market actors, including legislators, judiciary, and entrepreneurs (e.g. Ozcan and Gurses, 2018; Uzunca et al., 2018). For example, studies could investigate how non-market strategies deployed by market actors, such as lobbying with regulators and even contesting their decisions in court, across places have shaped the observed categorization outcomes. Relatedly, it would be useful to investigate how regulations and policies enacted by institutional actors are translated by different stakeholders, such as consumers with different demographic profiles, with different religious beliefs, or from different social classes, and how these might play out over time to shape categorization across places. 17
A consideration of diverse stakeholders in the categorization of products highlights the socially constructed nature of categorization, in which heterogeneous actors with competing interests attempt to shape a product’s meaning. In the US context, Hsu and Grodal (2021) have studied such dynamics involving actors attempting to stigmatize or normalize e-cigarettes. Our study, which provides a comparative account of e-cigarette categorization by institutional actors in the US and the UK, showed how historical contingencies can shape categorization differences applied by regulators and PHOs. These observations open avenues for future comparative case studies on multi-stakeholder categorization of other novel products, such as insect-based food and drones, and existing contested products, such as firearms, alcohol, and gambling games (Galvin et al., 2004), across places. Such studies could better elucidate the translations conducted by various stakeholder groups, such as regulators, industry associations, and consumers, and how they interact to shape differential levels of acceptance for such products across places given historical contingencies.
Our findings also apply to existing products addressing grand challenges. Grand challenges, such as poverty, climate change, and food security, pose “wicked” problems (Rittel and Webber, 1973) that are characterized by “complexity, uncertainty, and evaluativity” (Ferraro et al., 2015: 368). These facets render the possibility for institutional actors across places to differentially interpret and categorize novel and existing products to address such problems, sometimes even when highly regarded scientists have reached a consensus regarding the benefits of a potential solution. For example, although Nobel laureates have endorsed genetically modified foods as a credible solution to meet global food shortage requirements (Roberts, 2018), regulators across places have adopted different regulations for such foods. While stringent regulations for genetically modified foods requiring pre-market approval processes have been implemented in the EU, a less stringent set of regulations prevails in the US (Lau, 2015).
Climate change is another challenge requiring different solutions across different places. Renewable energy sources offer an alternative to conventional fossil fuel-based energy, with low-carbon innovations having broad scientific support (Trancik, 2014). However, the adoption of renewable energy technology varies across countries, owing to the continued dependence of many developing economies on conventional fuel offering more cheaper sources of power. Aside from this historical contingency, developing countries offer different future imaginaries and current justifications related to prioritizing economic development before committing to Western nations’ emission reduction polices (France24, 2021). Future studies can investigate the different categorizations enacted for such products and technologies across places. Given that solutions to address grand global challenges such as climate change require the continuous participation and engagement of key stakeholders across places, such place-based inquiries can offer scholars, regulators, and practitioners a more contextualized understanding of different actors’ perspectives, which could, in turn, facilitate efforts to find common ground and generate robust action strategies (Ferraro et al., 2015).
Conclusion
Our central thesis is that place matters in the categorization of phenomena. Banal at one level yet profound at another, this thesis shifts the basis of scholarship on categorization from prototypicality to the goal-orientation of the institutional actors governing places. These actors operate within contextualized settings; therefore, they are informed by historical contingencies that bestow meaning on places. Accordingly, these institutional actors enact policies to accomplish certain goals, namely their future imaginaries, based on their categorization of phenomena in the present. In the process, these actors provide different justifications in support of their positions, thereby converting places into “truth-spots.”
Supplemental Material
sj-docx-1-soq-10.1177_14761270221124022 – Supplemental material for The differential categorization of novel products by institutional actors across places: The case of e-cigarettes in the US and the UK
Supplemental material, sj-docx-1-soq-10.1177_14761270221124022 for The differential categorization of novel products by institutional actors across places: The case of e-cigarettes in the US and the UK by Thinley Tharchen and Raghu Garud in Strategic Organization
Footnotes
Appendix 1
Acknowledgements
We thank Candace Jones for her invaluable editorial guidance throughout the review process, and Robert David and Grégoire Croidieu for the opportunity to be part of this special issue. We also thank three anonymous reviewers, Bernard Forgues, Filippo Wezel, Ruthanne Huising, Joel Gehman, Brice Dattée, Jeroen Struben, Tao Wang, Nevena Radoynovska, Jaekyung Ha, Laura Dupin, Olga Novoselova, Pedro Monteiro, Tao Han, Karthikeya Bajpai, Haitao Yu, Marjolaine Rostain, and other seminar participants at the STORM Research Center, Emlyon Business School. We acknowledge the inputs of seminar participants at the 2018 New Institutionalism Workshop and the 2018 EGOS Track on Institutions, Innovation, Impact: Grand Challenges held at Bocconi University and the Estonian Business School, respectively.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The author(s) gratefully acknowledge financial support received from the Strategy & Organization (STORM) Research Center, Emlyon Business School for this study.
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References
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