Abstract Around the world, unhealthy diets are a leading cause of disease. Shifting population diets in a healthier direction will require downstream policy interventions. This means changing the composition of the processed food supply, particularly reducing salt, sugar and fat. Mandatory nutrient limits imposed by government are one way of achieving this. However, they have been criticized as a particularly intrusive regulatory option, interfering with both free markets and free choices. At the same time, voluntary industry reformulation has become an intervention favoured by national governments, the World Health Organization and the food industry. This article uses a comparison of the two interventions—which share a common public health goal, albeit achieved through different regulatory means—as a basis to evaluate the ethical charges against mandatory nutrient limits. It makes three main findings: (i) that both affect free dietary choice in very similar ways; (ii) that dominant public health ethics frameworks are not well equipped to compare mandatory and voluntary forms of regulation; and (iii) that food governance is inherently multisectoral, involving markets, governments and the public. Taking these findings into account, the article calls for a more nuanced ethical evaluation of food reformulation policies. Unhealthy Diets: A Policy Problem, and an Ethical Challenge Diet-related noncommunicable diseases (NCDs), including cardiovascular disease, stroke, type-2 diabetes and certain cancers, are now major contributors to morbidity and mortality in almost every jurisdiction on earth (Stuckler and Siegel, 2011; WHO, 2014). Accounting for more than 40 per cent of all NCD deaths, these share the underlying risk factor of unhealthy diets. As the prevalence and impact of diet-related NCDs has grown in recent decades, so has the list of preventive policy options available to governments. A key goal of prevention is to shift population diets in a healthier direction: less fat, sugar and salt, and fewer overall calories, as well as more fruits, vegetables and whole grains. However, this goal is in persistent tension with concerns about the potential for infringement on personal choice and dietary freedom (ten Have et al., 2011). One set of policy measures that have been described as particularly intrusive are mandatory nutrient limits. These are government regulations specifying upper permissible amounts of salt, fat or sugar in certain food products. In the public health law and ethics literature, they tend to be evaluated as an extreme and paternalistic state intervention, inappropriately interfering in both free markets and individuals’ right to their food choices. The essence of the critique is that removing consumers’ freedom to eat certain foods is too high a price to pay for what may only be incremental public health gains (Conly, 2014; Resnik, 2014). However, it seems that the critique does not apply when the food industry removes that same freedom. Voluntary food reformulation has become an intervention of choice for the World Health Organization (WHO), national governments and the food industry. The term tends to refer to actions of the food industry, with varying degrees of government involvement. Voluntary reformulation has the same public health goal as mandatory nutrient limits: to reduce over-consumed nutrients (salt, sugar or fat) in processed foods. And yet, it is rarely evaluated in terms of its ‘freedom’ impacts, whether on markets or individuals’ food choices. We are thus presented with two policy options that share a common goal of directly removing ingredients from the food supply, but which are assessed very differently in public health ethics terms. This provides a starting point for a critical reassessment of the ethical charges against mandatory nutrient limits. The article begins by explaining the concept of food reformulation, and why governments may seek to implement it as part of a prevention strategy on diet-related NCDs. It then sets out the two main policy approaches to reformulation, including the technical features, practical effects and ethical critiques of each. In the second half of the article, the comparison between these two approaches forms the basis for a close examination of the criticism that mandatory nutrient limits are a uniquely intrusive policy option. This leads to three key findings. First, that voluntary reformulation and mandatory nutrient limits in fact have very similar impacts on freedom of choice (the first limb of the critique). Secondly, that the dominant ethical frameworks for assessing public health policies, such as the Nuffield Ladder, are not well equipped to compare voluntary and mandatory forms of regulation. This is because they ignore the relationship between the food industry and the state. Finally, that the ‘free markets’ limb of the critique rests on a set of artificial binaries (voluntary/mandatory and market/state) that are not attuned to the context of food regulation. Drawing on the history of regulating diet-related NCDs, I argue that, as in all food governance, there is no such thing as strictly ‘government’ or strictly ‘market’ interventions. Ultimately, a meaningful comparison between mandatory and voluntary approaches to food reformulation must take place against a more nuanced understanding of the complex interactions between the state, the industry and the consuming public. Food Reformulation as Public Health Policy In the general context of food manufacturing, reformulation simply refers to changing the chemical or nutritional composition of processed foods for any reason (Garde, 2010). Manufacturers might reformulate a product to make it look or taste better (Moss, 2013) because of requirements related to the food’s ingredients, manufacture, storage or transportation (Golan and Unnevehr, 2008) or to keep up with consumer trends and demands (Watrous, 2016). However, in the context of diet-related disease, reformulation means changing the composition of processed food to achieve public health policy goals (Garde, 2010; EUFIC, 2010; National Heart Foundation of Australia, 2012). Specifically, it means removing trans fatty acids (TFAs; which have been shown to cause coronary heart disease) or limiting sodium (overconsumption of which is linked to high blood pressure and strokes) or sugar (linked to high blood sugar, diabetes and dental caries).1 While most policy approaches to diet-related NCDs focus on modifying our dietary choices and behaviours, reformulation instead aims to change the underlying food supply. This is because the determinants of unhealthy diets are environmental as well as individual: people select their diet from what is available (Hawkes et al., 2015; Roberto et al., 2015). Unlike educational or informational policies, reformulation involves a certain acceptance of the status quo of modern dietary habits. It accepts that people will continue to eat certain processed foods. Instead, it hopes that relatively minor changes to commonly consumed foods can have a major effect on population health (Swinburn, 2002). When a food is reformulated, ‘the consumer does not have to modify drastically his or her habitual dietary food pattern’ (van Raaij et al., 2009: 326), but nevertheless benefits from an improved diet. In this sense, it is an upstream intervention, modifying an environmental determinant of ill health (Rose, 1992)—or, more colourfully, ‘stealth health’ (Schwartz and Brownell, 2007: 80). Reformulation may be industry-led (voluntary reformulation) or may be government-led (mandatory nutrient limits). Mandatory Nutrient Limits What Are They? Mandatory nutrient limits are government regulations, currently in force in 25 jurisdictions worldwide. They are usually implemented as national food standards, but may also take the form of legislation or other rule types. They work by specifying permissible amounts of a given nutrient in a given food, and so force food manufacturers to reformulate if they want their food to remain on the market. Mandatory limits currently apply to fats (primarily trans fats) and salt. In 2004, Denmark was the first government to regulate an upper permissible limit, 2 per cent, on artificially produced TFAs. It has since been followed by nine other jurisdictions. The Netherlands introduced regulations in 2009 on the permissible amount of salt (sodium) in bread and flour. Eight jurisdictions followed, and in 2013 both South Africa and Argentina introduced mandatory sodium limits on a wide range of foodstuffs. Public health experts are now calling for mandatory limits on sugar (World Cancer Research Fund International, 2015), though so far no jurisdiction has implemented these. The Ethical Objection to Mandatory Nutrient Limits The literature on preventing diet-related NCDs tends to view government regulations in general as an extreme option, and mandatory nutrient limits as particularly intrusive. They are described as ‘highly paternalistic … heavy-handed, interfering with a person’s right to order what he or she wants’ (Gostin, 2008: 512), ‘the most far-reaching form of limiting choice’ (ten Have et al., 2011: 675) and ‘some of the most contentious public health laws’ (Taylor et al., 2015: 26). There are two limbs to the objection: the public is said to fear interference in free dietary choice, while the food industry fears interference in free markets, preferring non-regulatory approaches to public health (Cobiac et al., 2013). While the USA’s culture of ‘liberty of palate’ is well known (Linnekin, 2012; Semands, 2014; Wiseman, 2015), mandatory nutrient limits seem to be universally provocative. In Australia, the regulations have been described as ‘most unpopular’ (Commonwealth Department of the Parliamentary Library, 2001: 2) and ‘in the nature of a prohibition and [thus] controversial’ (Reynolds, 2011: 423). Similarly in Canada, Ries has noted that ‘regulatory interventions [on trans fats] are controversial’ and that critics view ‘food choices are fundamentally personal and an inappropriate arena for legal regulation’ (Ries, 2007: 17, 22). A European review found that mandatory nutrient limits would be effective but ‘intrusive’ (Brambila-Macias et al., 2011: 373). There is a small literature specifically addressing the ethics of mandatory nutrient limits. This has focused on trans fat limits, which have now been in the public consciousness for more than a decade (salt limits are a more recent development). Resnik’s (2010) article ‘Trans Fat Bans and Human Freedom’, and the resulting commentaries in the American Journal of Bioethics,2 is the best-known and most comprehensive treatment of the ethical charges against trans fat limits. Resnik does not dispute that TFA limits may improve health and save lives. Nonetheless, he finds their impact on freedom to be unacceptable because, first, there are other, less intrusive ways to reduce consumption of TFAs (for instance, through labelling and education, or through voluntary reformulation) and, secondly, trans fat limits are the first step on a slippery slope, which could ‘open the door to excessive government control’ over other food choices (Resnik, 2010: 29–30). For their part, defenders of TFA limits largely agree with Resnik. They agree that labelling and education are ‘softer’ alternatives to mandatory limits, but argue that these have been proved ineffective (Ries, 2007; Taylor et al., 2015). They also agree that TFA limits may pave the way for the ‘regulatory reconsideration of ingredients such as sugar, caffeine, and salt’, but they approve of this possibility (Brownell and Pomeranz, 2014: 1775). Most relevantly, they accept that TFA limits restrict our freedom to choose—but disagree on the importance of that freedom in this particular regulatory equation. They argue that other factors, core to the mission of public health, must also be considered: the very real social, physical and economic costs of NCDs to the community (Gostin, 2010; Wilson and Dawson, 2010). The Nature and Content of the Freedom Given that both critics and defenders agree that mandatory nutrient limits interfere with freedom, it is important to define the nature and content of that freedom. Questions of freedom (along with liberty and choice) lie at the heart of many debates in public health law and public health ethics (Childress et al., 2002, Dawson, 2011, Gostin and Wiley, 2016, and discussed further below). This is due to the focus of both disciplines on assessing the appropriate nature and reach of government action to protect public health. Core to this assessment is the extent to which such action might or should compromise liberty, autonomy, privacy ‘and other legally protected interests of individuals’ (Gostin and Wiley, 2016: 4). The relationship between the individual and the State—in public health or otherwise—can be described in terms of ‘freedoms’ that are broad and abstract. However, in the particular context of mandatory nutrient limits, the ‘freedom’ is quite narrow and specific. It is, as Resnik writes, ‘the freedom to choose what we eat’ (Resnik, 2010: 28). In the context of a modern, globalized, and—at least in wealthy countries—safe food supply, this freedom has become a feature of daily life, in a way that was possible at no other point in history. As Lang and colleagues write: ‘a family in Dublin, Paris, London or Berlin… can eat Italian, Japanese, Indian one moment, snack foods watching a Hollywood blockbuster film the next’ (Lang et al., 2009: 238). ‘The freedom to choose what we eat’ is a basic assumption of 21st-century capitalist culture, equally promulgated by food corporations and government health campaigns that emphasize consumer ‘choices’ (Mayes, 2014). As set out above, mandatory nutrient limits are government regulations on the amount of a particular nutrient in a particular food. They impact on the freedom to choose what we eat in the following ways: In Denmark, it is not possible to choose to eat a margarine containing more than 2 per cent artificially produced TFA (Danish Government, 2003); or In South Africa, it is not possible to choose to eat bread containing more than 380 mg of sodium per 100 g (Republic of South Africa, 2013); or In Ghana, it is not possible to choose to eat a cut of poultry with more than 15 per cent fat content (Thow et al., 2014), and so on. That is the practical effect of the regulations in each jurisdiction. The idea that food choices are fundamentally personal, and not a matter for government regulation, is at the heart of the ethical objection to mandatory nutrient limits. However, regulating food composition has been well within the scope of legitimate government activity for more than a century (French and Phillips, 2000). In jurisdictions around the world, and at the international level via the Codex Alimentarius Commission, governments already make rules about ‘what people may eat’, on food safety, consumer protection and other grounds. In the USA, for example, consumers may not purchase confectionery containing more than 0.5 per cent alcohol (Federal Food, Drug and Cosmetic Act 1938 §342(d)), or food containing the colouring additive amaranth (Federal Food, Drug and Cosmetic Act 1938 §348(a)). What makes mandatory nutrient limits controversial is not that they regulate food composition, or even that they limit certain nutrients in certain foodstuffs—but that they do so for the purpose of preventing chronic disease. Yet, even this purpose is not unique. As described below, voluntary reformulation—which has been endorsed by the WHO as an NCD-prevention strategy, and is becoming a favoured option of the food industry—has the same goal. As such, it provides a concrete comparison for examining the ethical objections to mandatory nutrient limits. Voluntary Reformulation International Policy Context: ‘All Could Become Partners’ Since the early 1990s, the WHO has encouraged the food industry to be responsible ‘partners’ in the prevention of diet-related NCDs, including by reformulating its products (WHO, 1990). By the turn of the century, public health experts were advising that ‘the food industry at all levels can be part of the solution’ (Yach et al., 2003: 276). This was formalized in 2004, with the publication of its Global Strategy on Diet, Physical Activity and Health (DPAS) (WHO, 2004). The DPAS emphasized the central role of governments, but noted that ‘all could become partners with governments and nongovernmental organizations in implementing measures … to encourage healthy eating’ (WHO, 2004: 61). The food industry was encouraged to produce products with lower levels of fats (trans and saturated), sugars and salt (WHO, 2004). The call to reformulate, and to encourage reformulation, has been consistent throughout later policy statements and guidance documents, including the United Nations (UN)’s Political Declaration on the Prevention and Control of Non-Communicable Diseases (United Nations General Assembly, 2011) and the WHO’s Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–2020 (WHO, 2013). National Reformulation Initiatives Member states have implemented the WHO’s guidance through a range of co-regulatory and quasi-regulatory arrangements. The UK’s salt reduction programme, 2003–2011—an early and successful example—is usually described as a government-led, voluntary scheme (Charlton et al., 2014), or as ‘voluntary with the threat of regulation/legislation’ (He et al., 2014: 351). Since then, a further 25 countries have implemented similar approaches to setting salt reduction targets across a range of foods (Webster et al., 2014). As documented by World Cancer Research Fund International (WCRF), most of these ‘voluntary’ industry initiatives involve the facilitation or guidance of at least one level of government (World Cancer Research Fund International, 2017). In addition, several countries and regions have implemented co- and quasi-regulatory policies to encourage reformulation across the food supply. Under the UK’s Responsibility Deal, for instance, companies are encouraged to make ‘pledges’ on reformulation ‘rather than resorting to regulation or top-down lectures’ (British Government Department of Health, 2010: 30). Similar partnership arrangements exist in the USA (New York City Health Department, 2012) and France (Sebillotte, 2013), while the European Union (EU) and Australia have established collaborative ‘platforms’ and ‘forums’, through which food companies can make voluntary commitments on food reformulation (European Commission DG Health and Food Safety, 2017; Australian Government Department of Health, 2017). In many of these cases, the state acts as little more than a facilitator—one partner among many—and official documents emphasize the voluntary nature of the reformulation. Yet, at the same time, all of these schemes are positioned as actions that the state is taking in relation to NCD prevention. If successful, reformulation is supposed to achieve improvements in the population’s diet and so reduce the modifiable risk factors of NCDs. Reformulation therefore appeals to two often-conflicting interests of 21st-century liberal democracies. On one hand, democratic governments have a duty to safeguard the health of the public (Gostin and Wiley, 2016). On the other, governments in capitalist, market-based economies face pressure to foster market freedom, and to limit their use of regulation (Cobiac et al. 2013, Lang and Heasman, 2015). Since the 1970s, government policy-making has been characterized by a preference for deregulation and market solutions, including voluntary or quasi-regulatory arrangements (Bartle and Vass, 2007). Policy-makers are encouraged to consider ‘whether an alternative approach to regulation may be a more efficient means of achieving a policy goal’ (OECD, 2009). As well as fitting in with philosophical preferences for a ‘smaller’ state, voluntary initiatives appeal to resource-constrained governments with an increasingly strong interest in containing public expenditure, including on monitoring and enforcement of industry regulation (Cobiac et al., 2013). Voluntary Reformulation and the Food Industry The other side of the ‘partnership’ equation is of course the food industry itself. Historically, reformulation has been a vexed proposition for the industry. The high levels of salt, sugar, fat and calories in processed food are closely related to the high profitability of that food (Moodie et al., 2013; Monteiro et al., 2013; Moss, 2013). However, in recent years, the contradiction between the profit motive and the epidemic of diet-related NCDs has become too glaring. With ‘business as usual’ no longer an option (Yach et al., 2010), the food industry has begun to advocate voluntary reformulation as a way to prevent diet-related disease. It has done so for several reasons. At one end of the spectrum is a profit incentive: the desire to tap into the lucrative market of consumer demand for ‘wellness’ and healthier foods (Michman and Mazze, 1998; Scrinis, 2013). At the other end of the spectrum is political pressure: the threat of governments introducing regulation, unless industry takes action of its own accord (Morris and Neering, 2008). Somewhere in the middle is corporate social responsibility—the desire of companies not only to be a ‘good corporate citizen’, but also to be seen as such (Lang and Heasman, 2015). Voluntary reformulation also involves a strong element of enlightened self-interest—recognition by companies that ‘long-term profits would be fatter if [the] customers were slimmer’ (Reingold, 2015) and that ‘cutting short the lives of your best customers isn’t much of a strategy for long-term success’ (Seabrook, 2011). In this regard, reformulation shares an important feature with another of the industry’s preferred responses to obesity, the focus on exercise and ‘energy balance’: neither implies eating, or selling, less food (Nestle, 2007; Seabrook, 2011). Indeed, far from slowing sales, there is evidence that marginal improvements to the healthiness of a product may confer a ‘halo’, ultimately assisting a company to sell more (Wansink and Chandon, 2006; Chandon and Wansink, 2007). Is There Any Ethical Criticism of Voluntary Reformulation? The constellation of factors set out above—from international health policy leadership to industry self-interest—helps to explain why reformulation has become ‘the default approach of many governments and the UN, and the preferred approach of industry’ on diet-related NCDs (Moodie et al., 2013: 675). However, it is not without its critics. The most frequent criticism of voluntary, co- or quasi-regulatory reformulation schemes is that they are not effective. In the absence of meaningful oversight mechanisms and sanctions for non-compliance, voluntary reformulation initiatives may (at best) advance slowly or (at worst) provide a smokescreen for inaction. A systematic review found that while mandatory trans fat limits ‘virtually eliminated TFAs from the food supply’, voluntary limits ‘were more variable and depended largely on the food category’ (Downs et al., 2013: 263). Further, an assessment of reformulation goals under the Australian Food and Health Dialogue (now called the Healthy Food Partnership) found that compliance on voluntary targets was patchy—likely due to the lack of accountability (Elliott et al., 2014). This effectiveness critique also has an ethical dimension: that the food industry has too great a conflict of interest to ever be a genuine ‘partner’ in public health (Norum, 2008; Monteiro et al., 2010; Moodie et al., 2013). Critics argue that voluntary food industry schemes are doomed to fail because there is ‘no evidence for an alignment of public health interest in curbing obesity with that of the food and beverage industry’ (Stuckler and Nestle, 2012: 2). Worse, handing responsibility to food companies ‘partners’ may actually provide them with access and opportunities to influence public health policy (Panjwani and Caraher, 2014). However, what is missing from such critiques of reformulation—a policy approach approvingly described as ‘stealth health’ by governments and industry (EUFIC, 2009; Jargon, 2014)—is any mention of its impact on ‘freedom to choose what to eat’. Whether reformulation is voluntary, quasi-regulatory, co-regulatory or mandatory, if it is effective, and covers all food products in a relevant category, then it must be presumed to affect consumers in the same way. That is, whether sodium in bread is reduced through voluntary reformulation or through mandatory nutrient limits, the net intended impact on consumers is that their bread is less salty. Yet, if the freedom to eat salty bread is so valuable as to override arguments for mandatory limits, it should also override arguments in favour of voluntary reformulation. Because the goal of a bona fide voluntary, co-regulatory or quasi-regulatory reformulation scheme should be the same as that of a mandatory scheme: to reduce the specified nutrient in the specified food. The intended effect of the UK’s voluntary salt reduction programme was to prevent consumers from buying bread that is saltier than 360 mg per 100 g (Charlton et al., 2014). Yet, neither academic nor popular debates tend to frame successful voluntary reformulation initiatives as an unacceptable intrusion on freedom of choice. Why, then, are mandatory limits seen as a controversial and intrusive, while voluntary reformulation is enthusiastically embraced by stakeholders at all levels? Evaluating Public Health Interventions: Ethical Frameworks Personal liberty and freedom of choice (including consumer choice) are ‘among the most firmly held desiderata of modern liberal society’ (Jackson, 2006: 109). However, they often come into conflict with the population focus and community orientation of public health (Kass, 2004; Dawson, 2011). As Geoffrey Rose noted, in public health: we are confronted by two irreconcilable opposites, yet both need to be accepted for both have authority. Personal freedom is paramount, yet every attempt to change our affairs for the better must of necessity impinge on that freedom because the aim is to influence what people do. (Rose, 1992: 114–`115) States therefore have a duty to consider whether public health interventions will be acceptable to their citizens. Accordingly, two ongoing themes in public health ethics are (i) the tension or balance between securing population health and protecting the rights of individuals, and (ii) defining the appropriate role and reach of the state. Both feed into an ongoing theoretical project of public health ethics, which is the development of frameworks or tools to evaluate the justifiability of different public health interventions (Childress et al., 2002; Gostin, 2002; Kass, 2004; Bayer et al., 2007; Nuffield Council on Bioethics, 2007; Dawson, 2011; Gostin and Wiley, 2016). Freedom (in various forms) has occupied a central role in most of these frameworks. In the policy-making context, the Nuffield Council on Bioethics’ ‘Ladder of Interventions’ (Nuffield Council on Bioethics, 2007) has been most influential. In its 2007 report ‘Public health: ethical issues’, the Nuffield Council (the Council) aimed to present ‘an ethical framework for the scrutiny of public health policies’. Its motivating question is ‘when and how the State should act’ to secure public health (Nuffield Council on Bioethics, 2007: v). Beginning with the foundation of classical liberalism, JS Mill’s harm principle, the Council adds a ‘social dimension’ to take account of the fact that individuals do not make decisions about their behaviours and choices in a vacuum, but within the context of community norms and collective goods. This produces a ‘revised liberal framework’, or ‘stewardship model’, which seeks to balance the competing interests described by Geoffrey Rose, above. Under the stewardship model, governments should assist people to live healthy lives, by giving ‘discouragement and assistance’ through ‘the provision of services through which risks are minimised and people are helped to change their behaviour’ (Nuffield Council on Bioethics, 2007: 25). However, they should stop short of coercing adults to live healthy lives, and should ‘seek to minimise interventions that are perceived as unduly intrusive and in conflict with important personal values’. The ‘Nuffield Ladder’, reproduced as Figure 1, below, gives a visual form to this guidance. The Ladder does not suggest specific kinds of interventions, but sets out broad approaches. These range from ‘do nothing and monitor the situation’ (which the Council emphasizes is still a policy choice) to ‘eliminate choice’. Importantly, the Ladder comes with guidance that ‘the higher the rung on the ladder at which the policy maker intervenes, the stronger the justification has to be’—because of the potential impact on freedom (Nuffield Council on Bioethics, 2007: 25). Figure 1. View largeDownload slide Nuffield Ladder of interventions. Figure 1. View largeDownload slide Nuffield Ladder of interventions. Where Does Voluntary Reformulation Sit on the Ladder? The Nuffield Ladder is a useful policy tool for public health because it allows different intervention options to be compared. In theory then, it should enable a comparative ethical evaluation of mandatory nutrient limits and voluntary reformulation, as illustrated by the following scenarios (Figure 2): Scenario 1 would sit right at the top of the Nuffield Ladder: ‘eliminate choice’. The state has eliminated consumers’ choice to buy foods containing more than 2% TFAs, by eliminating the food industry’s choice to sell such foods. However, the only way to describe Scenario 2 in Nuffield terms is that the state ‘does nothing and simply monitors the situation’—the lowest rung on the Ladder. And yet, the impact on consumers is the same as in Scenario 1: the choice to eat TFA-containing food has been eliminated. For a non-mandatory reformulation scheme to be taken seriously as an NCD-prevention strategy, it must be able to demonstrate effectiveness. But effectiveness, in this case, means effective at removing or reducing consumer choice. Why then are mandatory limits, but not voluntary reformulation, regarded as uniquely freedom-limiting? Figure 2. View largeDownload slide Examples of mandatory versus voluntary removal of TFA from food. (Shrapnel, 2012). Figure 2. View largeDownload slide Examples of mandatory versus voluntary removal of TFA from food. (Shrapnel, 2012). Reintroducing the Regulated Industry The reason for this disparity is that the standard bioethical models, as exemplified by the Nuffield Ladder, tend to be interested in the impact or intrusion of the state on individuals. They classify actions of the state according to the extent to which those actions will impinge on individual liberty. As such, they have been criticized by Dawson and others for retaining a Millean focus on the centrality of ‘non-interference’, inappropriately imported from medical ethics (Dawson, 2011). This, Dawson argues, is to miss the point of public health. Social justice, rather than liberty, is the core mission of public health. Only ‘someone who thinks that liberty is all that matters’ would use such a framework for public health policy decision-making (Dawson, 2016). Accordingly, ‘modified liberal’ frameworks, focused on preserving individual liberty, are not, by themselves, appropriate yardsticks for judging the merits of public health policies. To the ethicist’s critique, however, we must also add that of the regulatory theorist: that the modified liberal frameworks do not adequately reflect the range of actors and institutions involved in public health intervention, and especially in food governance. Modified liberal frameworks assume that counteracting public health risks always or usually involves regulating individuals. Yet, many threats to public health are not caused or carried by individuals (Egger and Swinburn, 1997; Swinburn and Egger, 2002), but by industries—and so, counteracting risk involves regulating those industries.3 However, the Nuffield Ladder tells us nothing about the form of the regulation, or the actors and institutions involved in its implementation and enforcement. In focusing attention on the relationship between governments and individuals, it ignores the relationship between industry and individuals, and the relationship between industry and the state—a triad crucial to understanding food governance (Lang, 2006; Lang et al., 2009). Further, classifying interventions solely according to their impact on individuals tells us nothing about the very different burdens and costs they might impose on businesses, which can often account for their very different political acceptability. Filling this gap, regulatory studies is the body of work that deals primarily with the actors and institutions involved in regulation—the state, but also non-state actors and the regulated industry itself (Freiberg, 2010). Along with the privatization of public assets and the fragmentation of traditional bureaucratic structures, the current deregulatory era has also brought about fundamental changes to the role of the state. This has been marked by decreased emphasis on traditional command-and-control apparatus, and an increased role for other, ‘softer’, ‘decentred’ or ‘networked’ forms of governance, involving a range of non-governmental and private sector actors (Moran, 2002; Bartle and Vass, 2007; Lang et al., 2009). This shift from ‘governing’ to ‘governance’ has been described as the rise of the neoliberal or regulatory state, or as the state ‘steering rather than rowing the ship of government’ (Osborne and Gaebler, 1992). In the regulatory state, power is decentralized and diffused, but the reach and number of different regulatory forms, such as guidelines, standards, codes of practice, proliferates (Bartle and Vass, 2007; Scott, 2010). Regulatory studies has closely observed these developments, analysing and classifying the new and emerging modes of regulation (Black, 2002; Drahos, 2017). It offers the language and tools to differentiate regulatory options in ways other than by focusing on freedom of (consumer) choice: for instance, by focusing on the relative costs and benefits imposed by different regulatory modes on different regulatory actors. However, only very recently have scholars begun to combine the analytical tools of regulatory studies with those of public health law and ethics (e.g. Reeve, 2011). Public health ethics frameworks are well equipped to differentiate between regulatory forms: for instance, between a labelling scheme versus taxation. However, they are poorly equipped to deal with regulatory modes, for instance, ‘a labelling scheme that is voluntary with government oversight’ versus ‘a labelling scheme that is a public-private partnership’. Once we understand this, the problem becomes clear: mandatory nutrient limits have been analysed under one lens, and voluntary reformulation under another. Mandatory nutrient limits have been understood as traditional state regulation, and thus assessed primarily for their ‘Nuffield’, or freedom-limiting, impacts. Meanwhile, voluntary reformulation has been understood as a new, decentred, ‘partnership’ mode of regulation, and evaluated accordingly. Both assessments have an ethical dimension, whether related to freedom of choice or to conflicts of interest. However, these have not, to date, permitted a true like-with-like comparison. Such a comparison would ask: What are the freedom-limiting impacts of voluntary reformulation? And, what are the relative benefits and burdens imposed on the actors involved in mandatory nutrient limits? As described above, the freedom-limiting impacts of voluntary reformulation should be very similar to those of mandatory nutrient limits. Indeed, the very definition of a successful voluntary reformulation scheme would be that it eliminated consumers’ choice to eat the specified quantity of the targeted nutrient. The freedom-of-choice argument against mandatory nutrient limits is then, if not quite a red herring, at least substantially neutralized by a comparison with voluntary reformulation. Clearly, food stakeholders—from the WHO to PepsiCo—are not unduly uncomfortable with the purpose of such regulation. If the purpose is not the real problem, we must next examine the form of the regulation. State Regulation and Free Markets in Food Regulation: A Spectrum Rather than a Binary ‘A Market Solution’ I now turn to the ‘free markets’ limb of the ethical critique of mandatory nutrient limits. While acknowledging the wide variance in free market economies around the world, I here use the term to summarize those appeals to market forces, the laws of supply and demand and a preference for less, or lighter, government regulation. The critique—often made by the food industry—is that, in addition to limiting freedom of choice, mandatory nutrient limits entail regulatory overreach by the state. Instead of government regulation, ‘market forces, driven by informed individual choice, [should] correct for negative results caused by high consumption of unhealthy commodities’ (Moodie et al., 2013: 675). Arguing against regulation, the food industry is optimistic that ‘if sufficiently many people demand food with a certain attribute, producers will respond and supply it’ (Deloitte Access Economics, 2013: 14)—all we need do is wait for ‘market readiness and business opportunity in a nation that values the healthfulness of its foods and beverages’ (Lavizzo-Mourey et al., 2014: e8). In this final section, I draw again on the comparison with voluntary reformulation to argue that such a strict state/market dichotomy is a fiction in food governance. Rather, both options—voluntary reformulation and mandatory nutrient limits—require a high degree of involvement from governments as well as the food industry. Whose Supply? Whose Demands? The ‘free market’ model assumes that companies respond only, or primarily, to consumer demand. This oversimplifies the complex entanglement of socio-economic, cultural and policy factors that shape dietary demand. Further, it ignores the influence in the opposite direction: the well-documented ways in which the industry, through marketing and through the products themselves, shapes consumer demand (Nestle, 2007; Monteiro et al., 2010; Stuckler et al., 2012; Moss, 2013). Importantly, it also ignores the extent to which, over the past half-century, government actions have shaped the dynamics of our consumption habits. Since the 1960s, for example, governments around the world have formulated and disseminated food-based dietary guidelines as a response to diet-related NCDs. In the wake of the Framingham study, which in the early 1950s provided evidence of the link between diet and cardiovascular disease, expert committees around the world began producing evidence on the link between diet and health (Truswell, 1987). To decrease the incidence of diabetes, cancer, heart disease, stroke and obesity, they recommended populations consume less fat (especially saturated fat), salt, sugar and overall dietary energy. By 1982, most high-income countries had published dietary guidelines (Truswell, 1987). Most of these did not aim to influence the food supply directly—rather, they were directed downstream, at consumers’ behaviour and ‘lifestyle’ choices (Nutrition Taskforce of the Better Health Commission, 1987; Hetzel and McMichael, 1989; Santich, 1995; Nestle, 2007). Nevertheless, these guidelines exerted a powerful, if indirect, effect on food producers, in the following way. On the basis of the scientific findings and government guidelines, ‘the low cholesterol, low fat diet [became] the cornerstone of public health nutrition’ for its supposed cardio-protective properties (Kromhout, 2015: 1). Consumers then began to seek out products that fitted in with this new, ‘low fat era’ (Santich, 2005). Skim or low-fat milk, previously considered an inferior food, was now in high demand, placing pressure on food producers to adjust the food supply. In Australia, milk processors responded by changing the system of farm-gate payments: instead of being paid for the percentage of dairy fat in their milk, as traditionally, farmers were now paid for the ratio of dairy fat to lean protein in milk (Santich, 1995). In Europe, low-fat dairy products had been considered special foods for diabetics in the 1980s; by the late 1990s, low-fat varieties made up 60 per cent of the yoghurt market and 70 per cent of the milk market (Sandrou and Arvanitoyannis, 2000). Similarly, the 2005 American Dietary Guidelines’ recommendation to consume more whole grains led to increased competition among firms to offer such products (Mancino et al., 2008). This led to increased consumption of whole grains—even in consumers who had not been demanding more grains, or were not even aware of the guidelines. After dietary guidelines, the next major policy response to diet-related NCDs was mandatory nutrition labelling: governments requiring food producers to present nutritional information, in a standardized format, on the packaging of eligible food and drink. This now applies in more than 20 national jurisdictions, as well as the European Union (Drichoutis et al., 2006; Campos et al., 2011; Kasapila and Shaarani, 2016). The primary purpose of such labels is to provide ‘the consumer with information about a food so that a wise choice of food can be made’ (FAO, 1985). But despite the language of consumer choices, here again the state has been an important actor shaping supply and demand. The first country to legislate mandatory nutrition labels was the USA, in 1990 (Federal Food, Drug and Cosmetic Act 1938 Part 101). In addition to educating consumers to make better choices, the legislation also aimed to give manufacturers an incentive to improve the nutritional profiles of their foods. A 2008 summary of the evidence found that nutrition labelling policies spur ‘competition in the food industry [which in turn] leads to fairly rapid reformulation of products’ (Golan and Unnevehr, 2008: 466). These examples illustrate that, in food governance, the concept of a ‘free market’ solution is more complicated than ‘consumers demand and producers supply’. In the cases of dietary guidelines and mandatory labelling, we observe the complex ways in which the state, the food industry and the public interact to create and respond to markets for healthier food products. In doing so they reveal that, even in ‘market’ solutions to diet-related NCDs, the state is already deeply implicated. Food Governance Is Inherently Multisectoral In its Global Action Plan for the Prevention and Control of NCDs, the WHO describes multisectoral action as involving multiple sectors of government, as well as—where appropriate—actors and institutions outside of government (WHO, 2013). When we compare voluntary reformulation and mandatory nutrient limits, both display characteristics of multisectoral action. As highlighted above, ‘voluntary’ reformulation in fact occupies a broad regulatory spectrum, from the commercial decisions of individual companies to the UK’s ‘government-led’ voluntary salt reduction. Scattered in between are the public–private partnerships and the co-regulatory and quasi-regulatory schemes. Beyond the fact of being ‘not mandatory’, these can have little in common. Governments are involved to different degrees and at different stages, and even the involvement of industry may differ, from policy-making to implementation. Their effectiveness is different, they may be ‘owned’ by different stakeholders (e.g. in the USA, the National Salt Reduction Initiative is hosted on a government website, while the Healthy Weight Commitment Foundation has a much more corporate image) (New York City Health Department, 2012; Healthy Weight Commitment Foundation, 2017). They may be supported to a greater or lesser degree by surrounding policies, such as a public awareness or education campaigns (van Raaij et al., 2009). In this context, the idea that mandatory limits are somehow unique—quite distinct from this spectrum of voluntary options—is unrealistic. Even command-and-control regulation leaves room for (and in some cases, even requires) a high degree of industry involvement. Denmark, for example, introduced its regulation on trans fats only after industry had demonstrated technical feasibility by implementing voluntary measures for some years (Katan, 1995, 2006). In the case of South Africa’s sodium regulations, the food industry was closely involved, through working groups, in setting timelines and targets that were eventually incorporated into the regulation (Charlton et al., 2014; Hofman and Tollman, 2013). In both Denmark and South Africa, there was evidence that industry members had lobbied for regulation, to ensure a level playing field among competitors. Finally, as discussed above, the common theme among suggestions for improving the effectiveness and robustness of voluntary reformulation schemes is more state involvement: adding in various ingredients of ‘mandatoriness’, such as tougher targets and timelines, and even sanctions for non-compliance (Brambila-Macias et al., 2011; Reeve and Magnusson, 2013; Réquillart and Soler, 2014; Magnusson and Reeve, 2015). Such that, when we compare a mandatory nutrient limit with an effective voluntary reformulation scheme, there is very little to separate them. As Charlton and colleagues found in their comparison of the (voluntary) UK and (mandatory) South African approaches to salt reduction, the programmes in fact had much in common in a substantive sense, including multisectoral involvement. The main difference was technical, i.e. the introduction of regulations in South Africa (Charlton et al., 2014). What this suggests is that mandatory nutrient limits belong on the same spectrum with the voluntary approaches, rather than distinct from it. The idea that one is a state intervention and the other a market solution is an artificial binary that does not reflect the evidence. Conclusion Evaluating public health interventions requires us to take multiple factors into account. As Gostin has set out, effectiveness and cost-effectiveness are relevant, but so are public acceptability and fairness (Gostin and Wiley, 2016). Faced with the ongoing, worldwide epidemic of diet-related NCDs, governments will increasingly be forced to consider measures that directly regulate over-consumed nutrients in the food supply—including mandatory and voluntary alternatives. As such, it is important to assess the criticism that mandatory nutrient limits are an unacceptably intrusive intervention. Policy-makers will need to consider how much weight to give this argument—sometimes alongside effectiveness evidence, but other times (as is often the case in public health regulation) in its absence. The objection to mandatory nutrient limits rests on two propositions: That mandatory limits interfere with freedom of (consumer) choice; and That mandatory nutrient limits interfere with free markets. As abstract philosophical propositions, these may be convincing. As policy debate, they are less so because the merits (ethical and otherwise) of mandatory nutrient limits must be assessed in the context of other policy alternatives. Voluntary reformulation, which shares the goal of preventing diet-related NCDs by limiting salt, sugar and fat in processed foods, provides an ideal comparator for this assessment. By comparing mandatory nutrient limits with reformulation, I have demonstrated that, in answer to the propositions above: If we compare like with like, the two interventions in fact have very similar impacts on freedom; and The relationship between the state and the market is complex and dynamic. As in all food regulation, the state is deeply implicated in constructing consumer ‘choice’, and even command-and-control measures involve a high degree of participation by the regulated industry. Neither of these findings overrides the ethical objection to mandatory nutrient limits. Instead, they enable a more nuanced consideration of the applicability of mandatory nutrient limits in any given setting. So, for instance, if the choice is between a voluntary and a mandatory scheme for improving the composition of food, the impact on freedom of choice can be considered moot. This paves the way for other, more decisive considerations—effectiveness, cost-effectiveness, cost to each stakeholder, potential for conflict of interest and ways to manage that conflict—to be taken into account. Reflecting free market ideals, governments’ preference for industry schemes is likely to persist. But, given the increasing evidence linking greater state involvement with more successful food reformulation outcomes, a default preference for the ‘voluntary’ may start to require a stronger justification. Acknowledgements Thanks to Prof Roger Magnusson and Dr Anne Marie Thow, who reviewed and gave valuable feedback on earlier drafts of the article. The anonymous reviewers also provided helpful and constructive comments. Funding This work was conducted as part of the author's PhD. The PhD is funded by an Australian Postgraduate Award from the Australian Government, and by supplementary scholarship funding from the Sydney Law School and the Charles Perkins Centre. Footnotes 1. In theory, reformulation can also involve adding nutrients associated with NCD prevention (fruit, vegetables, whole grains, fibre)—e.g. General Mills pledging to use whole grains in its cereals in 2004 (Schwartz and Brownell, 2007). But the more common understanding relates to removing or reducing trans fats, saturated fats, salt, sugar or energy density (van Raaij et al., 2009). 2. Note that Resnik’s article and the responses to it draw on evidence from local and state bans in the USA, as this literature predates the more recent move to regulate TFAs at the national or federal level. 3. This problem has been pointed out by the British House of Lords (HoL). 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Public Health Ethics – Oxford University Press
Published: Apr 1, 2018
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