This chapter focuses on the category of laws, regulations, and other public policies primarily designed to protect the public’s health or safety, especially by targeting individual or private sector behaviors that present health or safety hazards to the population. Examples include driving without a seatbelt, smoking in bars, creating exposures to toxic substances, and advertising tobacco products to minors. Chapter 4 continues the discussion by focusing on intersectoral policies that—without being designed primarily to protect health—affect health outcomes, and calls for incorporating consideration of health effects (both positive and negative) in policymaking in other sectors of government and in the private sector.
Below, the committee discusses the major ways in which laws enacted by federal, state, and local legislatures, regulations promulgated by the Executive Branch and its agencies, and to a lesser extent, litigation through the judicial system may be used as public health interventions. The committee provides examples of some prominent areas for policymaking, and explores the roles of public health agencies (and associated boards of health or other government executives) in making or shaping health policies. Government policy interventions work at a level far above the individual to transform the conditions for health and can achieve efficiencies and economies of scale that are not possible with one-on-one health education or clinical encounters.
Government has at its disposal a toolbox of law and public policy tools to improve population health (Gostin, 2010a; Gostin et al., 2008). Some
are in areas where the public health agency plays a critical or lead role and policies are designed explicitly to affect health. These are the focus of this chapter. Legal and public policy tools for the public’s health include
- taxation, incentives, and spending (e.g., cigarette and other “sin” taxes and allocation of the tax to combat the problem, may include pricing policies and financial incentives);
- altering the informational environment (e.g., food or drug labeling, and disclosure of health information);
- altering the built/physical environment (e.g., zoning, toxic waste);
- altering the natural environment (e.g., clean water, air, environmental justice);
- direct regulation (e.g., seat belts, helmets, drinking water fluoridation, folate fortification of grain-based products, iodized salt; licensure of medical care providers and facilities);
- indirect regulation (e.g., tort litigation in tobacco); and
- deregulation (e.g., distribution of sterile injection equipment or criminalization of HIV risk behaviors).
Most of the tools above refer largely to interventions aimed specifically at improving or protecting health, and some involve public health agencies directly. However, the distinctions between health-oriented and non-health policy are blurred in some areas, especially the built/physical environment, where zoning and land use have become increasingly focused on health. Box 3-1 provides examples of public policies in each of the categories above as applied to food and nutrition.
Using the Law to Achieve Population Health Objectives
The principles that form the basis for legal interventions by public health agencies and others in government to protect and improve the public’s health include discharging the statutory duty to protect from harm and promote health and safety. In many cases, this is done by intervening to attenuate externalities—negative side effects of individual actions such as speeding, addressed by imposing speed limits, and of business sector actions such as emitting air pollution, addressed by setting and enforcing air quality standards. Some legal interventions are more controversial than others and starkly illustrate the challenge of balancing public goods and individual freedoms due to varying norms/attitudes, expectations, and values that may inform both public opinion and decision-making by legislators in different jurisdictions.
The history of motorcycle helmet laws—using the tool of direct regulation—illustrates the arguments on both sides of a piece of legislation,
Actual and Hypothetical Examples of the Legal Models
of Intervention Applied to Food and Nutrition
a. Tax and spend: Subsidies for healthy school lunches
b. Informational environment: Laws requiring disclosure of calories on restaurant menus
c. Built/physical environment: Laws on fast-food or liquor store density
d. Natural environment: Food safety laws that order changes to the disposal of animal waste contamination of water sources
e. Direct regulation (of persons, professionals, businesses): Requiring fortification of cereal grains with folate to prevent birth defects
f. Indirect regulation: Tort liability lawsuit brought by overweight adults or children against fast-food chaina
g. Deregulation: End subsidies of agricultural products that contribute to unhealthy eating, including corn used to produce inexpensive sweeteners, and corn and soy used for feed, meat, and dairy
a See Mello et al., (2003). The case Pelman v. McDonald’s was initially dismissed “without prejudice” and with detailed guidance on how to refile. It was later refiled, [I.4] amended to reflect two more narrowly constructed claims of negligence, that is, failure to warn consumers about the “danger and hazard” created by the ingredients and additives in the food, and fraud (fraudulent and deceptive business practices). The refiled claim was dismissed because the plaintiffs failed to prove they had viewed the advertising they claimed was misleading and deceptive about the ingredients in the restaurant chain’s products (e.g., the claim that fries were cooked in zero-cholesterol oil, but failure to inform that they were cooked in even more unhealthy trans fats).
and the fact that empirical evidence is sometimes outweighed in the legislative arena by ideological or moral arguments. The Highway Safety Act of 1966 required that states enact and enforce motorcycle helmet laws to receive highway funding. By 1975, 47 states and the District of Columbia had done so. However, organized opposition by national- and state-based anti-helmet advocacy groups succeeded in overturning the federal sanctions, and a later effort to provide a financial incentive for such laws failed. In 2007, three decades after nearly universal enactment of state helmet laws, only 20 states and the District of Columbia required all riders to wear helmets (Moulton et al., 2007). Three states have no helmet laws, and in 27 of the remaining states, only young people under age 18 or 21, depending on the state, were required to wear helmets, and new riders were required to wear helmets for a year. Six of these states required that adult riders obtain $10,000 of medical insurance coverage, or that novice riders wear a helmet for the first year (Jones and Bayer, 2007).
The evidence base demonstrating the efficacy of helmet laws in reducing rates of death and serious head trauma is robust, and includes a Cochrane Collaboration review (Liu et al., 2009). Additional research indicates that the economic burden of hospital treatment for unhelmeted compared to helmeted motorcyclists is a considerable $250,231,734 (Eastridge et al., 2006). Rich natural experiments of the effects of the repeal of helmet laws showed dramatic increases in injuries and deaths. However, because the evidence of harm reduced or prevented by helmets has not persuaded antihelmet advocacy groups, a discussion of the ethical and conceptual dimensions of the debate is clearly needed (Cherry, 2010; Gostin and Gostin, 2009; Jones et al., 2006). Antihelmet activists argued that helmet laws infringed on their individual liberties and violated the due process clause under the 14th Amendment to the United States Constitution. They argued that their choice to ride without a helmet affected their personal well-being alone and had no effects on others. Proponents of helmet laws made three types of arguments: (1) an economic/utilitarian argument on the basis of direct and indirect costs incurred by society from motorcycle deaths and injuries; (2) an evidence-based argument about the proven effectiveness of helmets in preventing severe injuries and fatalities; and (3) a moral/paternalistic argument that civilized governments protect their citizens from inflicting great, but preventable, damage to themselves and burdening their families with wrenching grief and cost. Gostin and Gostin (2009) have shown that the debate about individual freedoms, especially in this particular context, may be one-sided, emphasizing the rights of individuals to freedom of actions that do not harm others—physically, at least. However, this argument shows little regard for the attendant freedom that accrues to the same individuals from avoiding disability, and the averted burden to society, by preventing crash-related permanent injuries and death.
As is the case with use of tobacco products (see Box 3-2), the consumption of unhealthy foods has serious implications not only for the individual, but for the common good. Smoking presents a threat to the health of others through environmental tobacco smoke, and an economic threat to businesses, which face higher medical care costs and losses in productivity, and to society in general (CDC, 2005; Musich et al., 200).1 Similarly, the consumption of unhealthy foods—whether containing trans fatty acids (shown to increase the risk factors for heart disease [Mensink et al., 2003], the leading cause of death in the United States), high in salt (known to increase blood pressure, a known risk factor for cardiovascular disease), or high in sugars (contributing to weight gain, which is related to a variety of chronic
1 The economic impact of smoking is complex. Data indicate that the societal costs of caring for ill smokers are in some ways offset by the savings incurred when smokers die, generally at younger ages than nonsmokers.
illnesses)—presents high costs to employers and society as a whole. The annual economic cost of obesity-related health conditions is an estimated $117 billion (Mello et al., 2003). Although some critics of policy interventions in the area of nutrition in general and trans fats in particular charge that such interventions interfere with consumer freedom to enjoy doughnuts, fried chicken, and other products prepared using partially hydrogenated vegetable oils, the reality is that consumer autonomy is overestimated for a number of reasons (Resnik, 2010; Wilson and Dawson, 2010). The belief in consumer autonomy is based on an assumption that people are entirely free agents in the marketplace. However, this overlooks what is known about human behavior (such as underestimating risk, optimism bias) and the fact that companies marketing products known to have deleterious health effects use highly sophisticated advertising and product labeling developed to exploit known consumer vulnerabilities (IOM, 2007; Wilson and Dawson, 2010). As is the case with smoking, people who are poor and less educated have higher levels of exposure to unhealthful foods, in part because they often live in neighborhoods where choosing less healthy options is facilitated by a high ratio of fast-food purveyors to fresh fruit and vegetable retailers.
Policy Interventions on the Informational Environment
Unhealthy foods and beverages may be targeted from different angles, including compelling or requiring manufacturers and retailers to take or avoid certain actions and modifying the informational environment. Industry packaging, labeling, and multimedia advertising of such products are based on market research, and the results are highly attractive products often accompanied by confusing or misleading information (Gostin, 2010b; Mello et al., 2006; Pomeranz, 2011). Several federal agencies have the authority to regulate businesses that produce some types of health-related information. For example, the Food and Drug Administration (FDA) has oversight of food labeling; the US Department of Agriculture has oversight of food safety; and the Federal Trade Commission (FTC) has oversight of food advertising. An industry policy to adopt a third-party certified “Smart Choices” labeling convention to identify certain foods as healthier garnered a warning letter from the FDA due to concerns about the potential of misleading consumers with labeling that suggested healthfulness (Layton, 2009; Taylor and Mande, 2009). Similarly, a food company’s claims about the benefits (i.e., increased child attentiveness) of its sugary breakfast cereal were challenged by and settled with the FTC for false advertising (FTC, 2009, 2010). The FTC’s authority allows it to intervene in the marketplace when a company makes deceptive claims. Although this authority is nar-
Lessons from the History of Tobacco Policy
The case of tobacco illustrates why a multi-faceted approach is needed to address some health threats (although, given the incomplete success of anti-tobacco campaigns, it also illustrates the enormous challenge of addressing complex health problems). The tobacco story also provides a rich example of a suite of public health interventions (including the power to tax and spend, indirect regulation through litigation, and intervening on the information environment), several of them public policies, to improve population health, specifically by reducing mortality and morbidity due to its use.
It is important to note that the anti-tobacco campaign illustrates that the laws enacted at the federal, state, and local levels include a variety of taxes on tobacco products, bans on indoor smoking (first in workplaces, and later in restaurants and bars), restrictions and enforcement on sales to minors, and a range of advertising regulations. The 58.2 percent decrease in the prevalence of smoking among adults since 1964 ranks among the 10 great public health achievements of the 20th century (CDC, 1999; IOM, 2007). Although the public health effort to lower tobacco use continues, many important lessons have been learned, some of which may be relevant to other areas where policy action is needed to change the conditions for health. Despite considerable gains, 2007 data show that approximately a fifth of U.S. adults smoke, resulting in 443,000 premature deaths yearly and annual costs of $193 billion in direct health-care expenditures and productivity losses each year (CDC, 2009). Only two states, California and Utah, reached the Healthy People 2010 objective of a 12 percent smoking rate. Although Utah’s rate is linked with the religious beliefs of a majority of state residents, California’s low rate has been shown to be associated with that state’s aggressive and multifaceted strategies against tobacco use (Graff and Ackerman, 2009).
Cigarette smoking is an individual behavior that affects both the health of the smoker and the health of others who are exposed to the secondhand smoke. For decades, a debate has occurred in multiple settings over the individual liberty of smokers, and the appropriateness of government interference with personal choices regarding tobacco
rowly drawn, the increase of evidence about nutrition-related television advertising and the proportion that is misleading or inaccurate may allow the Commission to take action in a wider range of cases. The primary challenge to public policy on the informational environment in which the public makes health-promoting or health-damaging choices lies in the protections afforded by the First Amendment to “commercial speech” to further both a business’s economic interests and the audience’s need for information (Mello et al., 2008).
Although FDA and other agencies—either explicitly mandated to protect population health or like FTC, indirectly responsible for overseeing and controlling certain market phenomena that may have some health consequences—have authority to take certain regulatory actions against
use. The 2007 Institute of Medicine report, Ending the Tobacco Problem: A Blueprint for the Nation, eloquently summarizes the key elements of the debate, including those that began to shift social norms:
For many years, a policy paradigm emphasizing consumer freedom of choice and decrying unwarranted “paternalism” dominated public opinion and policymaking on tobacco. In retrospect, however, the committee believes that predominant emphasis on consumer choice in public opinion during this period was largely shaped by the tobacco industry’s successful efforts to deny and obscure the addictiveness and health consequences of tobacco use, and on an array of resulting market failures, including information asymmetry between producers and users, distorted consumer choice due to information deficits, and product pricing that did not reflect the full social costs (especially the effects on nonsmokers). As the scientific evidence about addiction and the health effects of tobacco use has grown, and the industry’s deceptive strategies have been exposed in the course of state lawsuits and other tobacco-related litigation, public understanding of tobacco addiction has quickly deepened and the ethical and political context of tobacco policymaking has been transformed. (IOM, 2007, p. 33)
As public health practitioners have turned to the tobacco example for lessons that may be used to address other health threats that may be effectively targeted through legal or policy means, especially nutritional factors associated with the increasing prevalence of adult and child obesity, several things have become clear (Kline et al., 2006). Although food products, unlike tobacco, are generally not carcinogenic products, there are some parallels between the ethical and civil liberties arguments used in both cases, and in the “ecologic” aspects of unhealthy foods and those of tobacco. In the case of smoking, data indicate that most addicted adults began smoking in adolescence and before developing mature judgment, and that earlier life preferences tend to ignore long-term risks and are generally replaced by health-oriented preferences later in life (IOM, 2007). These factors indicate that smoking often begins at a vulnerable time of life, before autonomy or true independence can be said to emerge. Smoking behavior is associated with education level, parental occupation, and household poverty status, illustrating that factors beyond individual choice are highly influential in shaping smoking behavior.
industry, there are some statutory or resource-related gaps in their ability to enforce. For example, the Government Accountability Office recently concluded that unlike the FTC, which can require companies to provide evidence in support of their advertising claims, “FDA bears the burden of proving that a structure/function claim is false or misleading without having the authority to compel companies at the investigation stage to produce the evidence that the companies assert as support for their advertising claims” (GAO, 2011, p. 25). The FDA does possess this authority for drug and device regulation. Also, federal agencies sometimes lack the resources to enforce the law. Fines thus become simply the cost of doing business, and lack of agency authority to require removal of misleading information rather than requiring highly-publicized corrections of that information leave a con-
siderable gap in the application of agency authority. This is an area where the collaboration with state and local governments discussed in Chapter 2 may prove helpful, as they often have the capabilities to enforce federal law that federal agencies themselves may lack.
Direct and Indirect Regulation: Deregulation
In recent years, the model of direct regulation that has been used successfully in the context of smoking and other health challenges has been explored for its potential in addressing food-based threats to population health. Sugar-sweetened beverages represent one of many products that contribute to Americans’ intake of excess calories. However, efforts to legislate relative to this and other unhealthy food products will become politically feasible only when the proponents of regulation are able to “show that the industry is not behaving responsibly on its own—neither market forces nor the industry’s own professional codes of ethics lead it to conform to public expectations” (Mello et al., 2008, p. 4). Industry’s attempts at self-regulation have been limited primarily to collaborating with schools, communities, and local governments—a decision that allows companies to maintain greater flexibility—and avoiding more stringent attention from state governments. Relationships with schools and communities also meet the industry preference for statements of principles rather than binding commitments (Mello et al., 2008).
Other forms of regulation involve actions that build safety into a product or environment rather than attempting to modify human behavior. For example, setting standards (this may also be done through legislation, tool [c] in Box 2-1) to improve the safety of motor vehicles by changing certain features to reduce different types of risks has been more effective and efficient than teaching people to be better drivers (Vernick, 2011). That is also true of building safer roads and enforcing existing safety laws.
Indirect regulation through litigation has been successfully employed by tobacco control programs. The Master Settlement Agreement with 46 state attorneys general who had brought litigation against tobacco companies was the major event in the tobacco battles. The agreement required seven tobacco companies to change their strategies for marketing tobacco products, pay the states an estimated $206 billion, finance a $1.5 billion anti-smoking campaign, open previously secret industry documents, and disband industry trade groups believed to be concealing damaging research from the public (Office of the Attorney General, 2011).
Litigation has been contemplated or attempted in a range of areas, including firearm and motor vehicle safety. However, Congress can preempt litigation by enacting legislation that provides special protection for some types of products, rather than allowing the courts to make determinations
about a case’s worthiness (Vernick, 2011). This is the case with firearms litigation. Congress enacted the Protection of Lawful Commerce in Arms Act in 2005, which gives firearms manufacturers and retailers broad immunity from litigation (Vernick et al., 2007).
Capewell and Lloyd-Jones (2010) offer several powerful, recent examples of public policies that can facilitate the prevention of cardiovascular disease at the most upstream or distal level possible.2 These include deregulation, such as the public policies enacted in Poland, Finland, and the European Union, that have shifted government agricultural subsidies in ways that are designed to change national nutritional patterns or norms, such as away from an emphasis on meat and dairy and toward fruits and vegetables.
Incentives: A Step Down from Regulation, or in Combination with Regulation
Although there are numerous examples where industry is mandated by the government to bear the cost of harms created by its products (i.e., when harms cross a certain threshold, often based on evidence about dose-effect relationships [e.g., for toxic waste and cleanup, and chemical contamination of groundwater]), the notion of a less antagonistic way to engage industry bears greater consideration than it has received (EPA, 2004). Examples of incentives include labeling, such as obtaining an “organic” label, subsidies, government purchasing, and food policies, such as sale of food in government cafeterias, public parks, and beaches.
In addition to using the tool of direct and indirect regulation described above, requiring industry to make certain changes to their products or requiring consumers to operate within certain limits, the government may use the influence of its “bully pulpit” to motivate shifts in how private-sector entities operate with regard to products that are known to have the potential to harm health. One example comes from the United Kingdom, where the government has used a policy of collaboration and the incentive of public reporting to engage the food industry in taking voluntary steps to meet or exceed government-set guidelines for sodium levels in food. British and American analyses have shown that even small reductions in population risks, such as sodium intake, can lead to considerable improvements in population health and corresponding economic savings realized by governments and employers (see Box 3-3). Another example of setting voluntary guidelines and working with industry to adopt them comes from the FDA,
2 The term primordial prevention, used by Capewell and Lloyd-Jones (2010), has been defined as “intervention at the most distal point in the chain of causality” (Starfield, 2001, p. 454) and preventing the emergence of predisposing social and environmental conditions that can lead to causation of disease (Starfield et al., 2008).
Reducing Salt Intake: Examples of the Potential
of Laws to Affect Health Outcomes
Beginning in 2003, UK health authorities began a dialogue with the food industry about the levels of salt in food products and a collaborative effort to lower the salt intake in the population. In 2005, the UK’s Food Standards Agency Strategic Plan 2005–2010 established a target to reduce the average salt intake to 6g (approximately a teaspoon) per day by 2010. Voluntary salt reduction targets for the salt content of key food categories (e.g., breads, breakfast cereal, prepared cheeses and meat products, different types of snacks) were published in 2006, and revised in 2009. In 2008, the agency found that the nation’s average daily salt consumption fell from 9.5 g in its 2000–2001 national nutrition and diet survey to 8.6 g. The agency regularly reports on the progress of major food companies in meeting the voluntary targets. As examples, an update in March 2010 noted that a major brand of chips contained 55 percent less sodium, with several companies already meeting the 2012 targets for specific categories of foods. The agency estimates that meeting the target of 6 g daily intake of sodium will result in the prevention of 20,200 premature deaths per year (Food Standards Agency, 2008, 2009a,b, 2010).
The National Institute for Health and Clinical Excellence commissioned an economic model to measure the potential effects on cardiovascular disease risk factors of enacting legislation to eliminate trans fats or reduce dietary salt consumption by 3 grams per day. Modelers estimated that each of these proposed interventions could lead to discounted savings of more than $1 billion per year.
In 2008, the U.S. Congress asked the Institute of Medicine to make recommendations for reducing sodium intake of Americans. U.S. dietary guidelines call for no more than 2,300 mg per day for persons ages 2 or older. This is equivalent to approximately 6 g of salt per day. The average American consumes more than 3,400 mg of sodium per day. Decreasing salt intake could have dramatic effects on population health outcomes and medical expenditures.
In a modeling study, Palar and Sturm (2009, p. 49) found that reducing Americans’ sodium intake to the recommended level (2,300 mg) would “reduce cases of hypertension by 11 million, save $18 billion health care dollars, and gain 312,000 QALYs [quality-adjusted life years] that are worth $32 billion annually.” Danaei and colleagues (2009) estimated that high dietary sodium is responsible for more than 100,000 US deaths. This is clearly an area ripe for policy interventions.
which is developing a uniform system for front-of-package food labeling and will attempt to implement it through voluntary guidelines and then move on to a mandated approach if necessary (Pomeranz, 2011).
One legal scholar has proposed policy strategies for holding industry financially responsible for negative health effects related to the use of its products. Sugarman (2009) has described this approach as “performance-based regulation” that would offer an alternative to litigation or to mandat-
ing a certain way to operate. It would compel industries to act to lessen the externalities, or collateral damage, caused by different types of consumer products that are linked with a great proportion of morbidity and mortality and cause harm both to the individuals consuming or using them and to others (in some cases the harm is economic). This type of regulatory approach would seek to “harness private initiative in pursuit of the public good” by setting regulatory targets for the industry to reach (Sugarman, 2009, p. 1035). Companies would be allowed to employ existing methods or create new ones to decrease the harm of their products (or, in the case of tobacco, to lower the rates of consumers using their products). Companies reaching prescribed targets would receive public recognition (similar to the UK publishing the sodium-lowering efforts of specific food companies), and those failing to reach targets would be required to pay a fine.
An Example of the Cost-Effectiveness of Policy Approaches
The discussions leading up to and subsequent to the passage of the Affordable Care Act, and the political dialogue on other topics, made clear that getting value for major national investments is important to Americans and to their elected representatives. The committee believes that policy interventions can be effective and of high value in addressing major causes of death, disease, and disability at the population level. The committee’s belief is based on evidence reviews of the effectiveness of public policies aimed at injury prevention, tobacco control and prevention of environmental tobacco smoke, prevention of excessive alcohol consumption, and requirement of immunization for school entry (Elder et al., 2010; Hopkins et al., 2001; Task Force on Community Preventive Services, 2009; Task Force on Community Preventive Services et al., 2005). CDC has examined the effectiveness of state school-entry immunization requirements and found that they can be effective at achieving the high immunization rates needed to protect the population, but their effectiveness depends on the quality of enforcement (CDC, 2007).
The California Tobacco Control Program illustrates the powerful impact of that state’s tobacco taxation policy on adult and youth smoking rates and on medical care costs (Graff and Ackerman, 2009). In California, between 1989 and 2004, $1.8 billion was spent on the tobacco control program, and $86 billion was saved in personal health care expenditures alone (and 3.6 billion fewer packs of cigarettes were bought) (Lightwood et al., 2008). An additional example of the cost-effectiveness of legal interventions is found in alcohol taxation. Elder et al. (2010) conducted a systematic review of the literature on alcohol tax policy for the Guide to Community Preventive Services. The researchers found robust evidence (across countries, study designs and analyses, and time periods) that alcohol pricing and taxation
are inversely associated with excessive alcohol consumption and related harms. Two studies included in the review estimated the cost-effectiveness of alcohol tax interventions based on modeling. One study examined “costs and outcomes of 84 injury prevention interventions for the United States and found that an alcohol tax of 20 percent of the pretax retail price offered net cost savings (i.e., the savings outweigh the costs) even after taking into account the adverse economic impact of reduced alcohol sales,” and the other study examined the cost-effectiveness of alternative policies to address excessive alcohol use and “found that taxation was the most effective and cost-effective intervention in populations with a 5 percent or greater prevalence of heavy drinkers” (Elder et al., 2010, p. 223).
Evidence to Inform Policymaking
The committee’s discussion about the role of evidence in policymaking cuts across two distinct, but increasingly overlapping, categories of public policy: health policies and intersectoral policies with health effects. Chapter 4, which describes intersectoral or “health in all policies” approaches, also provides more extensive discussion of the process of assessing the evidence for and health impact of all policies that affect or could affect health.
Based on its review of the literature and information obtained at its information-gathering meetings with pertinent experts,
The committee concludes that an array of legal and policy tools is available to help local, state, and federal governments promote and protect the public’s health, and urges legislatures and government agencies to familiarize themselves with and to deploy such tools in addressing the leading causes of disease, injury, and early death in every community.
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