Intersections of Dental Health and Food Law: The Conflict of Systemic Flouridation as a Public Health Instrument to Prevent Tooth Decay

Abstract

Prevention of tooth decay via administration of flourides in drinking water, milk, and salt has been performed by governments around the world over the last decades. The literature was scrutinized to validate benefits and disadvantages of systematic flouridation for the individual as well to identify the legal background.

Regulation of maximal dose and most beneficial application methodology were identified. A great number of countries have interrupted systematic use in favor of local application due to genera health hazards generated while others continue despite seriously breaching valid law.

The most important finding of this chapter is that local application of flouride best contributes to decay prevention in conformity with biomedical ethics best complimenting general health.

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

1 Introduction

Dental caries is an infectious disease, which constitutes a continuously growing and global public health threat—some even call it a pandemic.¹ In a textbook on international food law and policy including public health, the laws and policies encompassing dental and oral health must not be overlooked. Although several chapters in this book focus on food production, consumption and trade, food intake starting at the mouth plays, an integral role in a complete interdisciplinary analysis. Eating and drinking, after all, bridge the production and consumption of food aspects. On the most basic level of logic, one cannot eat well with decayed teeth, so that nutrient intake is impaired by diseased mouths.² Those laws affecting what consumers eat and drink, consequently, should be rooted in scientifically sound data and analysis. Notwithstanding the firmly-established place of public health and nutrition policy within the food law framework, dental health should figure into any comprehensive analysis, especially in light of regulatory frameworks affecting oral health. The laws addressing dental caries as an infectious disease, therefore, use the scientific data to promulgate guidelines and treat dental decay as a pandemic.

One of the instruments to treat the pandemic of dental decay is fluoridation, i.e. the artificial addition of fluoride to water, milk, salt, tablets, toothpastes and other topical agents. Within the scope of this book are, of course, the fluoridation of water, milk and salt, all of which are undeniably ubiquitous sources of nutrition and hydration in every country and for every person around the world. Governments around the world have added fluoride to tap water and monitored fluoride levels in milk and salt with dental health in mind for over 70 years. Essentially, the addition of fluoride to water, milk and salt is a governmental instrument of public health intended to strengthen tooth enamel and to halt the pandemic of rampant caries spread. The corresponding goal is oral health improvement combined with topical flouride application and the protection of socio-economic interests. However, medical and scientific publications document the conflicts and the dangers of systemic fluoridation, where local application prevents tooth decay but ingestion fails to accomplish the same goal.

After decades of systemic water, milk and salt fluoridation in various countries around the world, the question of the efficacy of systemic fluoridation remains highly controversial and its efficacy has not been conclusively proven. For the reason that scientific data has not conclusively proven the efficacy of systemic fluoridation, the fact that governments continue to support this practice begs the question of whether this long-standing practice is truly in the public’s best interest or whether it serves a different, possibly unintentional, purpose. This chapter analyzes and explains the conflict that permeates not dentists’ and dental organizations understanding of the problem but also demonstrates how lay people aid in making executive decisions that affect public health in various ways. As food and water are inextricably intertwined, this chapter sheds light on a marginalized issue that warrants more attention than popular knowledge suggests.

This chapter sheds light on the premise that fluoridation is an effective public health measure, instrumentizing legal recommendations and regulations world-wide, to reduce oral diseases. Notwithstanding the intentions behind the schemes of mass-medicating entire countries through fluoridation of water, milk and salt, it remains a systematic medication. The successes and dangers associated with systemic versus topical fluoridation and the globally deep-rooted policy framework will be weighed against governmental authority and consumers’ rights to chose not to be systematically medicated as part of a larger contagious pandemic.

1.1 Dental Caries and Systemic Fluoridation

The prevalence of dental caries as an omnipresent disease around the world validates its interdisciplinary relevance within public health, socio-economic concerns and food law. The US Surgeon General acknowledges dental caries as a severe national economic impact, thereby invoking aspects of food law because dental decay is a threat of substantial magnitude. Further statistical evidence supports the social and economic impact of tooth decay where a study published in the American Journal of Dentistry found that “[e]pidemiologic data from different countries show[s] an increase in dental caries prevalence affecting all ages.”³ As a result, the socio—economic impact of dental decay gave rise to the need of addressing caries disease as a high-priority national and international public health problem. Notably, a report of the US National Health Interview Survey in 1981, 4.87 million dental conditions caused 17.7 million days of restricted activity, 6.73 million days of bed disability, and 7.05 million days of work loss, according to the report.⁴ Moreover, dental caries in pre-school children has an impact on psychological and social aspects of the their lives⁵ while school children experienced dental pain, missed classes and performed poorly in coursework due to dental discomfort.⁶ In the US, in the year 2000 alone, the national annual cost of dental treatment exceeded $60 billion according to the Health Care Financing Administration. The figure has not really changed over the past 15 years and, therefore, dental treatment costs permeate both social and economic avenues. These avenues, in turn, implicate food law and policy because they affect the mouths and chewing processes of consumers in the first step of food digestion, the ultimate goal of the entire food production chain (Fig. 13.1).

Fig. 13.1

Extension of fluoride accumulation in the farm to fork (to teeth) chain. Following the path from food production to consumption, a.k.a. from farm to fork, the pathway can be extended to digestion and nutrition and, thereby, to teeth. Through this extension of the fluoride dissolution, administration and distribution pathway, oral health becomes an integral step in the public health and regulatory understanding of fluoride accumulation

Thus, in a discourse “from farm to fork,” as food law and policy often describe the food production chain, it is important to follow the path of food once it reaches the fork and, thereby, the mouth. This figurative speech is important but the connections have not been made until the writing of this chapter.

1.2 Tooth Decay and Predisposing Factors of Cavity Rates

The connections between food law, nutrition and dental decay lie in the food-related predispositions, such as a high-sugar and high-carbohydrate diet. Susceptibility to dental decay is directly related to an increased intake of carbohydrates. Although other factors also play important roles, such as the diminished salivary production associated with negligent oral hygiene and other major caries predisposing factors,⁷ they are beyond the scope of this chapter.

First and foremost, dental caries is “an oral infectious disease of the teeth in which organic acid metabolites produced by oral microorganisms lead to demineralization and destruction of the tooth structures.”⁸ Even though a variety of terms have emerged over the years, such as tooth decay and cavities, the disease is a bacterially-induced destruction of enamel and dentin, the hard tissue of the tooth. The consumption of carbohydrates and sugars, which bacteria break down into acids in a process called fermentation, generate a reduced pH level and facilitate the demineralization of protective healthy tooth tissue. The results are the common dental lesions, a.k.a. “holes in teeth.”

Predisposing factors of dental decay have been widely studied. Scientific literature describes the major etiologic and predisposing factors involved in caries as follows: (a) the availability of cariogenic bacteria, (b) the intake of fermentable carbohydrates, (c) a susceptible tooth and host, (d) time⁹ (e) individual, social, and community risk indicators.¹⁰ The resulting socio economic burden on oral health imposes substantial complications for individual suffering from tooth decay. Notably, the World Health organization (WHO) finds that “the major risk factors relate to unhealthy lifestyles (i.e. poor diet, nutrition and oral hygiene and [the] use of tobacco and alcohol), … limited availability and accessibility of oral health services” and “poor living conditions.”¹¹ Therefore, dental decay is preventable to a large degree and falls squarely within the realm of public health and socio-economic regulatory decision-making.

The wide array of factors, including diet and nutrition, affect the severity of an individual’s caries prevalence. In fact, the variables associated with dental caries are considered risk indicators, that likely predict the disease prevalence.¹² Figure 13.2 illustrates this Caries Balance and displays some of the most widely accepted factors. The scale tips toward caries rather easily. Public health and caries prevention measures, therefore, can directly impact the various factors by addressing the predictors listed in Fig. 13.2. Consequently, food policy can and should consider these factors in making dietary recommendations and setting nutrition goals.

Fig. 13.2

The caries balance. Protective and pathological factors shift the balance between re- and demineralization of tooth enamel off the baseline and, ultimately, caries. This balance is based on Adrian Lussi, Elmar Hellwig, Joachim Klimek, Fluorides—Mode of Action and Recommendations for Use, 122 Schweiz. Monatsschr. Zahnmed. (Nov. 2012) (citing Featherstone J D B: The science and practice of caries prevention. 131 JADA 887–889 (2000))

1.3 Prevalence of Tooth Decay

The prevalence of tooth decay has been increasing. Especially developing countries¹³ and lower-income populations have a higher prevalence of tooth decay but have limited, if any, dental care that can treat caries or halt the spread of infections.¹⁴ From any age groups, elderly populations are most affected by tooth decay and loss.¹⁵ The WHO estimates that, globally, about one third of people aged 65–74 have no natural teeth.¹⁶ Of course, tooth loss correlates with poor nutrition choices or availability because of their deteriorated capability to chew solid foods, such as whole grains, fresh fruits and vegetables. Therefore, the prevention of caries impacts whether nutritional goals are met.

All age groups, however, are affected by caries. If left untreated, caries and tooth aches can even be fatal.¹⁷ The WHO found that, globally, between 60 and 90 percent of school children and adults suffer from tooth decay.¹⁸ In the US, about one half of all children between the ages of five and nine have at least one cavity and one filling of a primary or permanent tooth.¹⁹ The caries prevalence increases to nearly 80 percent for teenagers and reaches almost 85 percent in adults.²⁰ Table 13.1 provides the caries prevalence in a selection of countries²¹ and illustrates the wide reach of this infectious disease.

Table 13.1 Selected rates of caries prevalence

Caries, as the data shows, is an infectious disease that can lead to severe health detriments and must be prevented and treated. As a logic and immediate consequence of tooth decay, the ability to eat and food choices work in conjunction with other factors to impact nutrition outcomes. The high prevalence of caries, therefore, justifies why governments all over the world address this public health threat—although it remains questionable whether aggressive water fluoridation is the best method to battle caries.

1.4 Fluoride: The Panacea

In 1901, Dr. Frederick S. McKay from Colorado Springs, identified the causal interrelation between water components (here fluorine)²² and anomalies in tooth structure for the first time.²³ He distinguished fluorosis, the ingestion of excessive amounts of fluorine, in his research.²⁴ Then, in 1930, H. V. Churchill identified Fluoride as originating cause for fluorosis through spectrographic analysis.²⁵ Several years later, in 1945, scientists agreed on acceptable levels of fluoride implementation in water and the first prospective field studies using water fluoridation to reduce dental caries were initiated. Since then, water fluoridation has come a long way and has reached the peak focus of international attention and public health programs. Despite its limitations, current research, ranking high in scientific evidence, proves that fluoride exposure reduces dental caries between 25 and 27 % in children and as well as in adolescents.²⁶ Nearly 100 years of research yielded conclusive results that fluoridation may aid in the reduction of dental decay. Over the decades, different patterns of fluoridation have been researched, systemic and topical ones. The crux consists in the proper selection of the best fluoridation approach with the highest decay prevention and the least adverse side effects for humans.

The American Academy of Pediatric Dentistry published guidelines on fluoride therapy. Through these guidelines, it is clear that fluoridation of water is a major strategy to address caries prevalence in children and adults. Thus, according to the American Academy of Pediatric Dentistry, the “[w]idespread use of fluoride has been a major factor in the decline in prevalence and severity of dental caries in the US and other economically developed countries. When used appropriately, fluoride is both safe and effective in preventing and controlling dental caries.”²⁷ This is not to say, however, that there are no downsides to fluoridation of drinking water, which is merely one of many methods to make fluoride available for caries prevention. Consequently, the guidelines acknowledge that “[f]luoridation of community drinking water is the most equitable and cost-effective method of delivering fluoride to all members of most communities”²⁸ but it is not necessarily the safest or most effective method to contain the caries panacea. Of interest for this chapter, therefore, is the effect of cookie-cutter fluoride treatment as a public health and food safety concern.

2 The Safety of Fluoridation and the Avenues of Systemic Fluoridation

Understanding the protective mechanism of action of fluoride is a prerequisite to select the best fluoridation approach for public health. Government agents making executive decisions and even dental professionals often lose sight of the basic mechanism of action: Teeth have a hard and a soft tissue structure. The hard tissue component is build by the highly mineralized enamel and the organic matrix rich dentin and cementum. Calcium deficient material with different ions is more abundant in the hard structure building a less resistant apatite when compared to hydroxyapatite. Thus, local and targeted application of fluoride can strengthen the tooth structure. However, systemic application fails to protect tooth structure because the fluoride does not dissolve as needed.

Enamel, the outermost hard and mineral-based shell of the tooth, is characterized by its content of 3 % carbonate versus 5 % in dentin. Enamel accounts for its availability of flourhydroxyapatite where around 5 % of the OH groups are replaced by flouride, stabilizing the apatite structure alongside calcium, phosphate, hydroxyl and fluoride ions. The flourhydroxyapatite concentration drops towards the inside of the tooth. Conversely, the presumed steady state of calcium ions made available by saliva, enamel, and fluoride ions are responsible for the barrier against acid attack. Any imbalance of these minerals favors the dissolution of phosphate and hydroxyl ions, which then leads to hard tissue dissolution.

Demineralization through high sugar intake and insufficient oral hygiene are the decisive factors in decay propagation. Systemic fluoridation approaches, like water, milk and salt fluoridation favor the incorporation of fluoride into the mineral components with a minimal ability to dissolution when compared to topical approaches. Topical or local approaches grant a higher level of fluoride saturation around the enamel inhibiting effective demineralization. This has been scientifically proven. Thus, fluoride, on the most basic level, helps to prevent demineralization.

On a larger scale, the intention to combat tooth decay has freed simultaneous fluoridation paths with little consideration for the cumulative levels of fluoride in the body, which can add up quite significantly and lead to toxicity. Therefore, several countries subscribe to the concept of systemic water fluoridation parallel to the availability of fluoridated milk, salt, tablets and topic products. All of these avenues of fluoridation have cumulative effects on the body, especially in countries with high population density, such as India and China, as is described in greater detail below. To simplify, some countries add fluoride to their tap water and others remove fluoride. How these regulations of water fluoride levels play out is explained as follows.

Various countries regulate fluoride levels based on differing scientific data. For example, for tap water in the European Union, the upper levels of fluoride have been set at 1 mg/l. The European Food Safety Authority (EFSA) recommends,

[a]n upper tolerable intake level (UL) of 0.1 mg/kg BW/day for fluoride has been derived by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) (EFSA 2005) based on a prevalence of less than 5% of moderate dental fluorosis in children up to the age of 8 years as the critical endpoint, i.e. 1.5 mg/day for children 1-3 years of age, and 2.5 mg/day for children aged 4-8 years. For adults, an UL of 0.12 mg/kg BW/day was based on a risk of bone fracture, which converts on a body weight basis into 7 mg/day for populations aged 15 years and older, and 5 mg/day for children 9-14 years of age.²⁹

In contrast, in the US, upper levels have been set by the US Department of Health and Human Services at 0.7 mg/l. The Australian The Health (Fluoridation) Act 1973 set the levels at 1.5 mg/l, while in UK it is the Water Act of 2003 with set value at 1 mg/l. Such variations illustrate the inconclusive bases for government-regulated fluoridation of water. It follows that the regulations are unlikely at ideal levels and commutations can quickly result in overdoses of fluoride. The dangers of systemic fluoridation, then, are evident from the high variability and likelihood of accumulation.

Notably, the safety data of fluoridation is of utmost importance for food safety and public health because regulatory measures are based on this data. When fluoride levels from water, milk and salt accumulate in the bodies of consumers, the upper tolerance levels can be quickly reached and lead to toxic levels with severe side-effects. Therefore, regulators must be aware of the safety data and upper tolerance levels of fluoride before systemic fluoridation passes safety thresholds. Sodium fluoride (SF), the fluoride form most commonly occurring in food, is classified as a “hazardous product for the human health and the aquatic environment.”³⁰ In its safety data sheet Solvay North America, a large salt producer, writes, “[s]odium fluoride is used for water fluoridation, as a metal surface treatment and cleaner, as a glass etchant, and for pH adjustment in industrial textile processing or laundries… Sodium fluoride is also used as a wood preservative and an insecticide.”³¹ This variety of fluoride uses, consequently, means that there are several ways for fluoride to come into the water supply, adding to the cumulative effects of water fluoride levels.

Three important interdisciplinary effects of fluoridation should be understood at the onset: the method of action, the dosage, and the safety data. These three considerations are important because the method of action determines the dosage and the dosage, in turn, determines the safety. The better the methodological application of fluoride, the lower the required dosage and the safer the fluoridation as a whole. It is, therefore, important to consider all three factors in determining the safety of fluoridation for public health and policy purposes.

First, the method of action of water fluoridation is directly on the tooth structure. Local replacement of the hydroxyl ion from the hydroxyapatite by Flouride generates the more stable and caries-resistant flour apatite of the tooth’s natural crown, which is surrounded by enamel. This is significant for dental health because the crystalline composition of enamel is hydroxyapatite, a component prone to acidic attack generated by bacterial fermentation. Fluoridation, as a caries prevention treatment, wards off acid attack directly to the tooth but it is not a measure to improve overall nutrition and protect teeth as shown on the caries balance in Fig. 13.1.

Second, the upper levels of fluoride, though varying nationally, is usually limited to one source and fails to recognize other sources of fluoride that also add to the cumulative levels of a population’s fluoride intake. Various countries regulate fluoride levels based on differing scientific data. Such variations illustrate the inconclusive bases for government-regulated fluoridation of water. It follows that the regulations are unlikely at ideal levels and accumulations can quickly result in overdoses of fluoride. The dangers of systemic fluoridation, then, are evident form the high variability and likelihood of accumulation.

Third, the safety data of fluoridation is of utmost importance for food safety and public health. When fluoride levels from water, milk and salt cumulate in the bodies of consumers, the upper tolerance levels can be quickly reached and lead to toxic levels. Therefore, regulators must be aware of the safety data and upper tolerance levels of fluoride before systemic fluoridation passes safety thresholds. Sodium fluoride (SF), the fluoride form most commonly occurring in food, is classified as a “hazardous product for the human health and the aquatic environment.”³² In its safety data sheet Solvay North America, writes³³: “Sodium fluoride is used for water fluoridation, as a metal surface treatment and cleaner, as a glass etchant, and for pH adjustment in industrial textile processing or laundries. … Sodium fluoride is also used as a wood preservative and an insecticide.” Multiple avenues and reasons of fluoride accumulation exist. Therefore, regulators and government agencies should exercise extreme caution in supporting mass-medication of entire states or regions through fluoridation of water.

2.1 Tablets

One way of administering fluoride is through tablets as nutrition supplements. Recently, an increased risk of mild fluorosis in anterior teeth has been identified as a result of fluoride tablets consumption.³⁴ The Cochrane systematic Review ³⁵ concluded that, “[t]he effect of fluoride supplements was unclear on deciduous teeth. When compared with the administration of topical fluorides, no differential effect was observed.” The WHO acknowledges the lack of scientific evidence in regards of the adequate quantity to be administrated.³⁶ In other words, taking fluoride supplements probably does little to prevent tooth decay.

2.2 Milk

It is widely—and erroneously—believed that milk is a source of fluoride for healthy teeth. In 1996, the WHO published a book entitled “Milk fluoridation for the prevention of dental caries” edited by Bánóczy et al.³⁷ based on studies performed in Bulgaria, Chile, China, Russia and the United Kingdom. Open questions conclude the publication and the authors could not reach a consensus, which illustrates the conflict of systemic fluoridation. Newer and higher level scientific research published in 2005³⁸ also failed to identify sufficient scientific support in favor of milk fluoridation. A request for labeling has been made by the WHO to label milk packages accordingly. Thus, there is no scientific support for the common belief that milk or fluoridation of milk contributes to dental health.

2.3 Salt

Another source of fluoride is table salt. In France and Germany, for example, 35–60 % of domestic salt is fluoridated.³⁹ However, to prevent undue accumulation of fluoride in the body, the WHO recommends utilization of either fluoridated water or fluoridated salt for caries prevention and warns of multiple concomitant sources of fluoridation.⁴⁰ The maximal dose should not exceed 200 mg F/kg salt. In response to these maximal dosages and warning levels, a request for regular homogeneity checks and concentration labeling on the package has been made by the WHO. This request further supports that mass-medication through fluoride addition to common food and drink items, such as water, milk and salt, remain doubtful in terms of safety and efficacy.

2.4 Ready-to-Feed (RTF) Infant Food and Drinks

An additional major source of fluoride are infant formulas and baby foods. A recently published study⁴¹ reviewed 122 infant foods and 25 drinks for F concentration manufactured by 12 companies. The identified F concentration ranged up to 1.200 μg/g. The American Dental Association’s Council on Scientific Affairs⁴² recommends utilization of F free water for the restitution of RTF infant formula milks.⁴³ A request for labeling has been made by the WHO because the safety of these high and fluctuating concentrations of fluoride in infant formulas and baby foods are not yet well-understood and regulated.

2.5 Other Food Sources of Fluoride

In addition to the aforementioned paths of fluoride accumulation in the body, there are several other avenues through water and food, but also through air, medicines, and cosmetics. Flouride is also naturally available in soil, even though it often does not leach into ground water reservoirs. Long-term applications of phosphorus fertilizers, however, accompanied by intensive irrigation likely raise the fluoride concentration in ground water⁴⁴ (see Fig. 13.1). Through fertilizer use and other farming practices, fluoride levels can also be higher in some foods and drinks than one may expect. In India, tea,⁴⁵ wheat,⁴⁶ spinach, cabbage, and carrots,⁴⁷for example, showed elevated fluoride levels.

Fluoride pollution of the environment, such as through fertilizer use, cigarette smoking⁴⁸ or aluminum production, may interfere with and add to water fluoridation, which result in higher total fluoride intakes through food and drinks which far exceed safe limits. Modern industrialization contributes to Fluoride pollution via manufacture of semiconductors and integrated circuits,⁴⁹ production of hydrofluoric acid, the activities of phosphate fertilizer plants, textile dyeing, from plastic factories⁵⁰ and the production of enamel, glass, brick and tile works and several others. All of these add to fluoride pollution of water and accumulate in water supplies that reach consumers directly, thereby causing widespread fluorosis.

2.6 Water Fluoridation

One of the largest sources of fluoride is fluoridated water, the main subject of this chapter. Global trends indicate that the more impurities and pollution exist in water, the higher the fluoride levels. These higher fluoride levels are, however, not a result of intentional public health measures against dental decay. Systematic water fluoridation is, nonetheless, societies’ response to the tremendous impact dental caries has put on national economies around the globe because it increases healthcare costs.⁵¹ In developing countries, for example, access to clean water is not guaranteed. Thus, it is estimated that out 200 million people from 25 nations are likely to be exposed to fluorosis, an excess of fluoride intake which likely correlates with high fluoride levels in drinking and tap water. In India alone 66 million people suffer from fluorosis although the fluoride levels are as low as 0.5 ppm,⁵² numbers similar to one tenth of the Chinese population. A systematic review revealed that despite lower than standard level concentrations of fluoride in water, Iran also has high levels of fluorosis.⁵³ In Kenia, in turn, a daily fluoride intake of less than 0.03 mg F/kg body weight produces dental fluorosis.⁵⁴ Scientific studies demonstrated that in midlatitude areas, such as China, the Middle East, Africa and southern Asia, fluorosis could be endemic.⁵⁵ Consequently, fluoridation and endemic fluorisis are indicative of areas with low water quality, high levels of impurities and pollution, and not—as many people erroneously believe—of progressive public health measures against dental caries. Once again, the distinction between local application of fluoride must be contrasted with the systemic mass-medication of populations, whether it is intentional or not.

2.7 Topical Fluoride Use for Caries Prevention

Topical fluoride use through gels, liquids or toothpastes are direct application on the enamel, i.e. the outermost hard shell of the teeth. The goal is a targeted and controlled application to strengthen and remineralize enamel. According to some of the highest evidentiary level dental research, topical fluoride use is beneficial to prevent tooth decay.⁵⁶ Dental professionals use, recommend and prescribe topical fluorides for individuals at risk of developing dental caries. The current maximal strength guidelines are set based on scientific data.⁵⁷ Although the fluoride concentrations used in dentistry are much lower than those accumulated through a variety of sources from foods and the environment, there has not been any research that succeeded to summarize the total concentrations and intakes of fluoride from different sources and considered the overall and accumulated side effects.

3 Side Effects of Systemic Fluoridation

Systemic Fluoridation can and often does lead to a variety of side effects, such as dental fluorosis, higher risks of hip fractures and other chronic effects.⁵⁸ Nonetheless, there remains some controversy through differing interpretation of data⁵⁹ in regard to fluoridation side effects.

3.1 Dental Fluorosis

Dental fluorosis⁶⁰ is a disturbance of tooth formation with aesthetic consequences that become visible as white stains on the teeth. The excess of fluoride leads to hypomineralization of the enamel and developmental disruptions in the natural mineralization and remineralization processes.⁶¹ Water fluoridation is a globally growing concern because of the raised fluoride levels that accumulate in the body. One of the consequences of these raised water fluoride levels is dental fluorosis.⁶² Although “the predominant cariostatic effect of fluoride is not due to its uptake by the enamel during tooth development,”⁶³ excess levels of fluoride still damage teeth. Therefore, water fluoridation is among the identified risk factors⁶⁴ of fluorosis. A 2006 review by the US National Research Council revealed the occurrence of moderate dental flourisis at water level fluoridation levels of 0.7–1.2 mg/l.⁶⁵ Governments should act according to the scientific data that clearly outlines the risks of water fluoridation. The fluoridation recommendations of the US Centers for Disease Control and Prevention (CDC), for example, contradict the actual research in the field of fluorosis as a risk and consequence of water fluoridation⁶⁶ but the data, as mentioned above, remains controversial. The WHO states that “there are some undesirable side-effects with excessive fluoride intake. Experience has shown that it may not be possible to achieve effective fluoride-based caries prevention without some degree of dental fluorosis, regardless of which methods are chosen to maintain a low level of fluoride in the mouth.”⁶⁷ Recent research, however, emphasizes the need to review the available data to avoid a further spread of fluorosis.⁶⁸

Flouride ingestion can result from any of the previously mentioned sources and government agencies as well as many public health professionals fail to act on the available data about the warning signs of fluoride overdoses. Based on the aforementioned, fluoride dietary supplements, such as those administered to small children, represent the most likely reason for the increased ingestion levels. Public health researchers acknowledge that it remains difficult to identify the exact amounts of fluoride that are ingested and to trace them back to their sources. Consequently, researchers have requested that public health authorities educate the public on fluoride sources and continuously revise the guidelines for fluoride supplementation based on the most scientifically sound data.⁶⁹

3.2 Bone Weakening Through Fluorosis and Other Fluorosis Induced Diseases and Degeneration

High fluoride levels negatively impact human health beyond dental fluorosis. Fluoride ions can alter the mineral structure of the bone by substituting hydroxyl groups in the carbonate-apatite, thereby, creating fluorohydroxyapatite, which can possibly weaken the bone. Studies support the weakening effects that excessive fluoridation may have on bone. For example, studies performed in the US in the early and mid-90s demonstrated a small but significant increase in hip fractures within an elderly population.⁷⁰ A study performed in China “concluded that long-term fluoride exposure from drinking water containing more or equal to 4.32 ppm increases the risk of overall bone fractures as well as hip fractures.”⁷¹ In the US, water fluoridation levels starting at 1.5 mg/l showed correlation with bone fractures. Notably, in those areas where the correlation was evident, a daily intake of 1.4 mg/day of fluoride could be a reason for stage I skeletal fluorosis.⁷² Additionally, data supports low risks of hip fractures in population exposed to fluoridated drinking water (concentrations around 1 ppm) in the UK.⁷³ Therefore, the risks associated with water fluoridation and its cumulative effects can be quite dangerous from a public health perspective.

Fluoride intake can also affect the heart, liver, kidneys, gastrointestinal tract,⁷⁴ lungs, brain, blood, and hormones in potentially health threatening ways. In fact, fluoride has a potential neurotoxic⁷⁵ effect as well as teratogenic actions,⁷⁶ which disturb embryologic development.⁷⁷ A systematic review that investigated the possible association between the occurrence of Down’s Syndrome and water fluoridation concluded that the available evidence was inconclusive⁷⁸ but did not rule the connection out.

3.3 Labeling Requirements

Due to its lack of efficacy and side effects fluoride supplements should not be prescribed or offered under the age of three, although the latest suggestions mark the age of six⁷⁹ unless prescribed by a dentist. The WHO, however, requests adequate labeling, child proof packaging, and indications of maximal doses per package not exceeding 120 mg.⁸⁰ For more information on nutrition and supplement labeling, see Chap. 16.

4 The Ethics of Water Fluoridation

At the core of the ethical controversy of water, salt, milk and other common types of fluoridation is the lack of consumers’ consent to mass-medication. When governments and public health agencies make the decision for the general public, whether in the public’s best interest or not, to fluoridate essential food and drink items, such as those mentioned in this chapter, ethical questions must be addressed. This is especially the case where these decisions to mass-medicate are not founded on sound data and science. Even worse, when such mass-medication as fluoridation occurs based on outdated sources or scientifically controverse principles, public health and environmental threats arise that can be difficult to control. As has been shown in this chapter, fluorosis and other negative health impacts arise from mass-medication with fluoride—a dangerous practice in the western world. In countries with already high fluoride levels in drinking water, such as China and India, fluoride is a rather threatening problem for public health that remain inadequately addressed. Organizations such as the FDA and EFSA, for example, must review the regulations that are in place and update them to bring fluoridation back to safe levels and must stop propagating the myth that the fluoridation of drinking water decreases dental decay—the cost is simply too high.

The key considerations in systemic fluoridation are the negative influence upon tooth formation in children up to the age of 3–6 years in addition to the already mentioned side effects. There are different preconditions in the different countries of the world that make general recommendations for fluoride intake obsolete because some countries have high fluoride levels in drinking and tab water and others have low levels. One example of this controversy occurred in Australia, where the respective government agencies evaluated the fluoridation versus fluorosis evidence. These evaluations gave rise to the recently escalated political debate.⁸¹ The goal of these evaluations was to investigate whether there is sufficient evidence to continue to support water fluoridation in the future. The researchers of the study suggested the application of proportionality “to resolve the conflict between the ethical principle of beneficence (prevention of dental caries) and … non-maleficence ([to] reduce an increased risk of fluorosis and possibly hypo-thyroidism and bone fractures) in the water fluoridation controversy.”⁸² Efficiency in caries prevention by water fluoridation has to be bigger than possible harm generation. Thus, the researchers juxtaposed caries reduction worldwide induced by water fluoridation and topical application of fluorides. They identified a higher efficiency in the latter and concluded that the evidence is not sufficient to support systemic fluoridation. Thus, in Australia, the evaluation of the data resulted in conclusions against mass-medication through water fluoridation.

Similar debates evolved in other parts of the world. In Canada, for example, the debate about water fluoridation raised questions of basic human rights and freedom of choice.⁸³ The mass-medication through water-fluoridation is so concerning to a number of Canadians, that these ethical considerations surface, as mentioned above. Correspondingly, in the EU, surveys of European citizens’ attitudes towards water fluoridation have been initiated in different population groups of 16 member countries.⁸⁴ The results of these surveys showed that a clear majority voted against systemic fluoridation. Therefore, pursuant to democratic principles, water fluoridation as mass-medication should not continue in the EU.

In the UK, a lawsuit shed further light on the ethics of water fluoridation. Where fluoride is used to prevent or to treat incipient disease, here dental caries, flouride has to be regarded as medicine under British law. Thus, the authority in charge, here the state, which mass-prescribes systematic water fluoridation has to obey to the same ethical rules applied to any health care worker. Therefore, the court in the aforementioned UK lawsuit⁸⁵ concluded that fluoridated water should be treated as medicine and falls squarely within the Medicines Act of 1968. Pursuant to this precedent, the state’s mass-prescriptions of fluoride to the public should follow the same laws that other drugs must follow under the Medicines Act even though this is currently not the case yet.

One of the fundamental principles underlying the UK precedent and the debates in the EU, Canada and in Australia involve biomedical ethics. The fathers of biomedical ethics, Beauchamp and Childress, introduced four principles that apply to health care workers: (a) respect of patient autonomy, (b) beneficience, (c) nonmaleficience, and (d) justice. According to these well-established principles, patient can refuse medical treatment under the principal of informed consent, which is also supported by the Council of Europe Convention on Human Rights and Biomedicine 1997.⁸⁶ The problem here is that the cookie-cutter mass-medication of the public through water fluoridation violates these basic biomedical ethics principles. From an ethical point of view, therefore, systematic water fluoridation could be considered to oppose the all philosophical principles,⁸⁷ and various ethical rules that strip the public and individual consumers of basic rights.

5 Regulation of Water Fluoridation Around the World

5.1 The WHO Approach to Water Fluoridation

Despite the vast amount of scientific data bemoaning water fluoridation as an ineffective and dangerous public health measure, the WHO has supported water fluoridation for several decades. In fact, the “WHO established a guidance value for naturally occurring fluoride in drinking water of 1.5 mg/L based on a consumption of 2 L water/day, and recommended that artificial fluoridation of water supplies should not exceed the optimal fluoride levels of 1.0 mg/L (WHO 2006).”⁸⁸In a coalition of large associations, “[t]he WHO Oral Health Programme, jointly with the FDI World Dental Federation (FDI) and the International Association for Dental Research (IADR), have embarked on an action plan for the promotion of using fluoride, particularly focusing on the disadvantaged and under-served population groups.” ⁸⁹Although this program may appear to be a public health measure, it fails to take high-value scientific evidence and geographical differences into account, thereby, promoting a one-size-fits-all approach to caries prevention that has been shown to backfire through dangerous fluorosis levels around the world.

Contradicting its own program, the WHO already found that systemic water fluoridation should not follow a global cookie-cutter uniform set of fluoridation recommendations because fluoride exposure differs greatly around the world. These differing local availabilities of fluoride have been well-documented and support the position against the aforementioned mass-medication:

[I]t is known that water is normally the major source of fluoride exposure, with exposure from diet and from burning high fluoride coal also major contributors in some settings. Fluoride occurs at elevated concentrations in many areas of the world including Africa, the Eastern Mediterranean and southern Asia. One of the best-known high fluoride areas extends from Turkey through Iraq, Iran, Afghanistan, India, northern Thailand and China. However, there are many other areas with water sources that contain high fluoride levels and which pose a risk to those drinking the water, notably parts of the rift valley in Africa. Many of these areas are arid and alternative sources of water are not available.⁹⁰

Therefore, it is important to use both sound science as a basis for fluoridation recommendations—if any—and to adapt these recommendations to the localities around the world. As long as this is not the case, overexposure and fluorosis will continue to be likely and dangerous consequences of uncontrolled fluoridation around the world. A more streamlined approach should be instituted to evaluate the scientifically relevant and to use sound data to help redirect caries prevention efforts and steer them away from mass-medication through water fluoridation.

5.2 Water Fluoridation in the USA

Several agencies regulate water fluoridation in the USA but there is no single streamlined approach to what a safe level of fluoridation may be, especially because the current regulatory framework is based on several decade old data that has long needed an overhaul. The Centers for Disease Control and Prevention (CDC), a government agency, declares that water fluoridation “has been a safe and healthy way to effectively prevent tooth decay” for over 65 years and also recognized water fluoridation as “one of 10 great public health achievements for the 20th century”⁹¹—a rather sad prospect by comparison, especially in light of the dangers that water fluoridation has proved to pose. Official recommendations by the US Department of Health and Human Services (DHHS) have set the level of fluoride level in water at 0.7 mg/l,⁹² which contrast other agency recommendations: “For values 0.1 mg/L above control range to 2.0 mg/L – Leave the fluoridation system on. For values 2.1 mg/L to 4.0 mg/L – Leave the fluoridation system on. For values 4.1 mg/L to 10.0 mg/L – Turn off the fluoridation system immediately.”⁹³ Thus, there is clearly no true consensus and this chapter has demonstrated that water fluoridation should not be a one-size-fits-all approach.

The Environmental Protection Agency is empowered to regulate flouride in drinking water under the Safe Drinking Water Act. Adverse effects of water fluoridation, however, are proven to be suspected world wide and the EPA failed to act on the science supporting the dangers of water fluoridation. For example, in a 1998 case filed by EPA scientists against the agency itself, the petitioners called the “process by which EPA Arrived at the [recommendations] for fluoride … irrational.”⁹⁴ On the same note, a report by the National Research Council released in 2006, performed by request of the EPA, confirmed the need to lower the maximum level of safe fluoride to zero.⁹⁵ Nonetheless, drinking water continues to be fluoridated in the US.

5.3 Water Fluoridation in the European Community

The EU has issued a Directive on the quality of water intended for human consumption, namely Council Directive 98/83/EC (1998). In this Directive, the European Commission has included a list of chemical parameters that are safe in drinking water, where a fluoride level (both natural and as a result of fluoridation) for water intended for human consumption of less than 1.5 mg/l was determined.⁹⁶ Although this level is still high, it is substantially lower than the levels determined to be safe in other parts of the world.

5.4 Water Fluoridation in Australia

In Australia, the Health (Fluoridation) Act of 1973 regulates the safe and effective addition of fluoride into drinking water supplies⁹⁷ and works in conjunction with the Australian drinking water guidelines and the Safe Drinking Water Act of 2003.⁹⁸ The dosage not allowed to be exceeded was set at 1.5 mg/l, the same level as in the EU.

5.5 Water Fluoridation in South Africa

Attributing water quality and health problems to water fluoridation, the South African Research Commission simply but most notably states that “fluoridation of groundwater is not advisable.”⁹⁹ Thus, some governments are firmly opposed to water fluoridation despite the aforementioned contradictions within the WHO’s recommendations.

5.6 Water Fluoridation in United Kingdom

Water fluoridation in the UK is regulated by paragraph 58 of the Water Act 2003. The Act limits the “the concentration of fluoride in the water supplied to premises in the specified area is maintained at the general target concentration of one milligram per litre.” Moreover, individual (health care) authorities are empowered to request water fluoridation from water suppliers to further ascertain whether water fluoride levels are safe.¹⁰⁰

5.7 Water Fluoridation in Israel

Similar to lawsuits in the US, UK and the EU, several lawsuits have been brought by concerned parties in an effort to update water fluoridation regulation. As a result of such litigation in Israel, the Supreme Court of Israel ruled against adding fluoride to drinking water in an opinion on July 29, 2013.¹⁰¹ In 2014, the Minister of Health decided to stop water fluoridation because “fluoridation can cause harm to the health of the chronically ill,” including “people who suffer from thyroid problems.”¹⁰² This breakthrough approach is evidence of progressive and scientifically-sound risk-benefit analysis, while simultaneously taking the ethics of water fluoridation into concern. Israel’s cessation of water fluoridation sets a positive example for regulators around the world.

6 Conclusion

Many reasons speak for the inclusion of caries in any well-rounded discussion on public health and food policy. This chapter shows that the socio-economic impacts of caries prevalence affect individuals, public health, economic systems and international policies. One of the major public health measures taken against caries is water fluoridation, a government-regulated mass-medication following a one-size-fits-all approach. The various health concerns arising from this mass-medication include fluorosis and other health complications resulting from the systemic fluoridation of drinking water. While the US Center for Disease Control called the decrease of caries prevalence by half through fluoridation of water one of the greatest achievements since 1980,¹⁰³ other data tie caries into discussions of public health and food policy as socio-economic aspects and reveal well-founded and strong objections to water fluoridation because it poses a number of health threats.

In essence, this chapter analyzes the role of law and regulations in addressing public health and food policy concerns in light of fluoride deficiencies or accumulation through water and food fluoridation. The three fold problems, therefore, are the questionable outcome of water and food fluoridation, the associated health hazards resulting from fluoride accumulation, and the ethical implications of mass-medicating the public based on scientifically ambiguous data. As a result, this chapter presents the various measures taken around the world to address these three problems and illustrates how an interdisciplinary approach to food law, policy and regulation can have broad global application.

This chapter identifies that caries causes socio-economic costs and that the regulatory remedy in response to these rising costs around the world is fluoridation. There are, however, two major approaches to fluoridation: (1) Systemic fluoridation and (2) topical fluoridation. Systemic fluoridation is regulated through governments and international entities, such as the WHO. These governmental measures have both ethical and medical problems as consequences of mass-medication of the public. By comparison, the topical fluoridation approach remains an individualized and more targeted preventive measure against caries because it can be applied either by the dental professional or the individual consumer. However, obstacles to proper topical fluoridation treatments for public health remain both consumer or patient education and individual healthcare costs. At the same time, those individuals choosing topical fluoridation have little avenues to avoid being mass-medicated and fluoride accumulation by the government as long as water fluoridation remains a public health practice.