Sauerheber – Letter 49 to the FDA

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April 22, 2014

From: Richard Sauerheber, Ph.D.

To the FDA:

This information supports the petition to ban the addition of industrial synthetic fluoride compounds, sodium fluoride, fluorosilicic acid, and sodium fluorosilicate, into U.S. public drinking water supplies that are added for the purpose of whole body fluoridation to treat dental caries (petition #FDA2007-P-0346). Of course no request is made to remove natural calcium fluoride from public water supplies at levels below the EPA MCL/SMCL of 2-4 ppm.  Unfortunately, the EPA and the CDC are unable to understand the vastly higher toxicity of industrial fluorides in calcium deficient water, for which there is no MCL. Attached please find information taken from the recent review article on fluoride infusions into public water supplies by Dr. Stephen Peckham, the London School of Hygiene and Tropical Medicine and Dr. Awofeso, the School of Health and Environmental Studies, Dubai, UAE.  The review was published this week in The Scientific World JournalThe conclusion of the review is that the infusion of industrial fluoride compounds into public water supplies must be abolished since ingested fluoride is ineffective in affecting dental caries and instead ingested fluoride causes adverse health effects on organ systems and ironically on teeth even at prescribed levels. The review includes a paragraph discussing my study in the J Env and Pub Health. A statement made is that the U.S.FDA deleted key passages from the Federal Register regarding fluoride in 1979 that had argued that fluoride might be a possible mineral “nutrient.” Based on detailed information this of course was overruled. Fluoride has no nutritive value of any kind. The authors emphatically conclude that although fluoride is a recognized pollutant, it is being used as though it is a medicament under the recommendations of the U.S. CDC. Since no regulations for its use as a medicament are in place (see article), and this is misbranding of a chemical substance as though it is an ingestible decay preventive treatment, it is necessary for the FDA to halt fluoride infusions into all U.S. public water supplies. Thank you,

Richard Sauerheber, Ph.D.
(B.A. Biology, Ph.D. Chemistry, University of California, San Diego)
Palomar College, San Marcos, CA
April 22, 2014

  *** The Scientific World Journal Volume 2014 (2014), Article ID 293019, 10 pages   Review Article Water Fluoridation: A Critical Review of the Physiological Effects of Ingested Fluoride as a Public Health Intervention Stephen Peckham1,2 and Niyi Awofeso3   1Centre for Health Services Studies, University of Kent, Canterbury CT2 7NF, UK 2Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK 3e-School of Health and Environmental Studies, Hamdan Bin Mohammed e-University, P.O. Box 71400, Dubai, UAE   Multisite studies commenced in 1945 to determine impacts of fluoridated water on dental caries prevention and health appeared to demonstrate a positive effect of water fluoridation—with claims of a reduction of dental caries by up to 60% among almost 30,000 schoolchildren in Grand Rapids, MI, USA [1]. However, these findings have been criticized for major methodological flaws, including data cherry-picking and selection bias [2,3]. Notwithstanding this and before the final results of these studies were known, the US Public Health Service adopted the 1 ppm level and supported widespread introduction of community water fluoridation schemes in 1950.   The United States’ lead in instituting artificial water fluoridation led to its acceptance by the World Health Organization as an effective oral health intervention. At least 30 nations instituted artificial water fluoridation policies. However, a number of countries including Sweden, The Netherlands, Germany, and Switzerland stopped fluoridating their water supplies due to concerns about safety and effectiveness [4,5]. Currently, only about 5% of the world’s population—350 million people—(including 200 million Americans) consume artificially fluoridated water globally. Only eight countries—Malaysia, Australia, USA, New Zealand, Singapore, and Ireland, more than 50% of the water supply artificially fluoridate. Over the past two decades many communities in Canada, the USA, Australia, and New Zealand have stopped fluoridating their water supplies and in Israel the Minister for Health announced in April 2013 the end of mandatory water fluoridation. However, public health authorities continue to try and develop new community water fluoridation schemes.   On 16 March, 1979, the United States Food and Drug Administration deleted Paragraphs 105.3(c) and 105.85(d)(4) of Federal Register which had classified fluorine, among other substances, as essential or probably essential. In an extensive review of fluoride and human health published in 2011, the European Commission’s Scientific Committee on Health and Environmental Risks concluded that fluoride is not essential for human growth and development [6].   Although fluoride, used in artificial water fluoridation, is promoted as a medicine for preventing tooth decay, it is not subject to the strict guidelines of medicines statutes in the nations that implement artificial water fluoridation. The practice of water fluoridation is recommended as a means of preventing dental caries. Despite this very clear definition of purpose, no fluoridating country defines fluoridation of water supplies as a medicine. As Shaw has recently argued, this classification of fluoridation appears to be based on a legal fiction and argues that artificial water fluoridation is indeed a mass medication and should be subject to strict provisions of Medicines Act in the United Kingdom and similar legislation elsewhere where the practice of artificial water fluoridation occurs [7]. Within the European Union, the only regulation in force for hexafluorosilicic acid—commonly used for community water fluoridation—is as an industrial product.   Given that most of the toxic effects of fluoride are due to ingestion, whereas its predominant beneficial effect is obtained via topical application, ingestion or inhalation of fluoride predominantly in any form constitutes an unacceptable risk with virtually no proven benefit. Improvements in occupational health and safety practices and safer disposal of fluoride waste would help to reduce occupational and environmental exposures to fluoride. Artificial or natural fluoridation of water represents a public health hazard—significantly damaging health where fluoride levels are high but are clearly demonstrated as having harmful effects at lower levels found where water has been artificially fluoridated. In addition, ingested water is a very inefficient way of delivering fluoride to teeth given its topical effect but is an important cause of fluoride’s adverse effects on human health. Of all sources of fluoride, artificially fluoridated water is the most practical source to eliminate in order to reduce its human hazards at population levels. Indeed, the abundance of fluoride sources ingested by humans, from tea to cereals and condiments [8,9], suggest that the prime public health priority in relation to fluoride is how to reduce ingestion from multiple sources, rather than adding this abundant and toxic chemical to water or food. all nutrient values for fluoride need to be withdrawn, not least because it is irrational to have daily nutrient intakes for a hazardous substance whose mode of action is topical on teeth enamel. Third, coordinated global efforts to reduce adverse human health effects on fluoride need to start with ensuring that its introduction into water supplies is prohibited, occupational and industrial fluoride exposures and injuries are reduced to the minimum possible, While the only uncontroversial clinical complication of (severe) dental fluorosis is adverse psychological impact on well-being, self-esteem, and negative community perception of affected individuals’ oral health, established clinical complications of skeletal fluorosis include arthritis, radiculomyelopathy, quadriparesis, and pathological bone fractures [7]. Since the initially proposed optimum fluoride intake of 1 mg/day (from one litre of 1 ppm fluoridated water), new sources of fluoride have been introduced through dental care products, processed foods, and commercial beverages. These sources have increased average cumulative fluoride intake to more than 2 mg/day. With these higher levels of fluoride intake, dental fluorosis and other toxic effects noted above have also increased.   Currently, about 41% of children in the United States, where water has been fluoridated at an average level of 1 ppm, have varying degrees of dental fluorosis—levels of over 50% in some fluoridated areas [10]. Fluoride exposure has a complex relationship in relation to dental caries and may increase dental caries risk in malnourished children due to calcium depletion and enamel hypoplasia, while offering modest caries prevention in otherwise well-nourished children. It has been demonstrated that at low friction loads, enamel hydroxyapatite and fluoroapatite appear to wear in the same way. However, at high friction loads, fluoroapatite enamel flakes and wears catastrophically, leaving severely fractured enamel, whereas hydroxyapetite enamel does not as it is more adaptable to remodeling. This may be due to fluoride’s disruption of cycles of demineralization and mineralization which take place throughout the lifecycle of teeth enamel [11–13]. The adverse impact of fluoride in producing brittle teeth has been recognized in laboratory animals since 1933, and fluoride-induced brittle teeth were demonstrated to be worse with industrial fluorides such as sodium fluoride compared with naturally occurring calcium fluoride [14].   Sauerheber has analyzed the physiologic conditions (such as calcium and pH levels) and systemic effects of ingested fluoride as well as the efficacy of ingested artificially fluoridated water on dental caries prevention [15]. He highlights the important distinction that should be made between naturally occurring fluoride (calcium fluoride CaF2) found in water supplies and added fluoride compounds (sodium fluoride NaF and fluorosilicic acid H2SiF6). His analysis is based on a detailed review of the effect of fluorides on physiological functions and concludes that there are harmful effects from adding artificial fluoride compounds to water supplies. He observes that most analyses of fluoridation rarely focus on detailed physiological analysis but rely on observational epidemiological data to demonstrate effectiveness which are rarely sensitive enough or examine potential issues of harm. One key exception to this was the review by the National Research Council in the USA for the Environmental Protection Agency which took a weight of evidence approach to examining toxicological and physiological effects of fluoride on water [8]. This review identified a number of potential and established adverse effects including cognitive impairment, hypothyroidism, dental and skeletal fluorosis, enzyme and electrolyte derangement, and cancer [8].   The classification of fluoride as a pollutant rather than as a nutrient or medicine is a useful starting point for analyzing the adverse effect of fluoride. No fluoride deficiency disease has ever been documented for humans. Indeed, the basis for setting an “adequate intake” of fluoride rests on the alleged ability of ingested fluoride to prevent tooth decay. However, since it is now known that the effect of fluoride is topical, the notion of an “adequate daily intake” is flawed. One of the key concerns about water fluoridation is the inability to control an individual’s dose of ingested fluoride which brings into question the concept of the “optimal dose.” Since the 1980s numerous studies have identified that adults and children are exceeding these agreed limits, contributing to a rapid rise in dental fluorosis—the first sign of fluoride toxicity [16–18]. In 1991, the Centers for Disease Control (CDC) in the USA measured fluoride levels and found that where water is fluoridated between 0.7 and 1.2 ppm overall fluoride, total fluoride intake for adults was between 1.58 and 6.6 mg per day while for children it was between 0.9 and 3.6 mg per day and that there was at least a sixfold variation just from water consumption alone [19]. Early support was based on an assumed systemic role of fluoride in reducing decay. However, later studies have shown that the differences in fluoride concentration in surface enamel between permanent teeth from areas with no fluoride or low levels and fluoridated areas were minimal and support the fact that effect of fluoride is almost exclusively posteruptive and topical rather than systemic challenging claims made for water fluoridation’s efficacy [20–22]. A number of recent studies have questioned whether water fluoridation is effective with studies suggesting no difference in the level of dental caries between children who drink fluoridated water as compared to those who drink nonfluoridated water [23]. Despite this community water fluoridation is endorsed by the World Health Authority, the US Public Health Agency, and most dental and public health organizations as a safe and effective method of reducing dental decay.   Given the questionable evidence of benefit and increasing evidence of harm the policy of water fluoridation for the prevention of dental caries should be abandoned in favor of more effective interventions combining communitywide and targeted oral health interventions.   1. F. A. Arnold, LikensRC, A. L. Russell, and D. B. Scott, “Fifteenth year of the grand Rapids fluoridation study,” Journal of the American Dental Association, vol. 65, pp. 780–785, 1962. 2. R. Ziegelbecker and R. C. Ziegelbecker, “WHO data on dental caries and natural water fluoride levels,” Fluoride—Quarterly Reports, vol. 26, no. 4, pp. 263–266, 1993. View at Scopus 3. P. R. N. Sutton, Fluoridation: Errors and Omissions in Experimental Trials, Melbourne University Press, Melbourne, Australia, 1959. 4. G. Pizzo, M. R. Piscopo, I. Pizzo, and G. Giuliana, “Community water fluoridation and caries prevention: a critical review,” Clinical Oral Investigations, vol. 11, no. 3, pp. 189–193, 2007. View at Publisher · View at Google Scholar · View at Scopus 5. National Health and Medical Research Council, Public Statement: The Efficacy of Fluoridation, NHMRC, Canberra, 2007. 6. European Commission, “Critical review of any new evidence on the hazard profile, health effects, and human exposure to fluoride and the fluoridating agents of drinking water,” Scientific Committee on Health and Environmental Risks (SCHER), 2011. 7. D. Shaw, “Weeping and wailing and gnashing of teeth: the legal fiction of water fluoridation,” Medical Law International, vol. 12, no. 1, pp. 11–27, 2012. 8. National Research Council (NRC), Fluoride in Drinking Water: A Scientific Review of EPA’s Standards, National Academies Press, Washington, DC, USA, 2006. 9. P. Grandjean and J. H. Olsen, “Extended follow-up of cancer incidence in fluoride-exposed workers,” Journal of the National Cancer Institute, vol. 96, no. 10, pp. 802–803, 2004. View at Scopus 10. E. Beltran and L. Barker, Prevalence of Enamel Fluorosis among 12–19 Year-Olds, U.S., 1999–2004, Centers for Disease Control and Prevention, Atlanta, Ga, USA, 2007. 11. J. O. Alvarez, “Nutrition, tooth development, and dental caries,” The American Journal of Clinical Nutrition, vol. 61, no. 2, pp. 410S–416S, 1995. View at Scopus 12. J. M. Powers, R. G. Craig, and K. C. Ludema, “Wear of dental enamel,” Wear, vol. 23, no. 2, pp. 141–152, 1973. View at Scopus 13. D. J. White and G. H. Nancollas, “Physical and chemical considerations of the role of firmly and loosely bound fluoride in caries prevention,” Journal of Dental Research, vol. 69, pp. 587–594, 1990. View at Scopus 14. W. H. Serell and H. T. Dean, “Changes in the teeth of white rats given water from a mottled enamel area compared with those produced by water containing sodium fluoride,” Public Health Reports, vol. 48, pp. 437–470, 1933. 15. R. Sauerheber, “Physiologic conditions affect toxicity of ingested industrial fluoride,” Journal of Environmental and Public Health, vol. 2013, Article ID 439490, 13 pages, 2013. View at Publisher · View at Google Scholar 16. S. Erdal and S. N. Buchanan, “A quantitative look at fluorosis, fluoride exposure, and intake in children using a health risk assessment approach,” Environmental Health Perspectives, vol. 113, no. 1, pp. 111–117, 2005. View at Publisher · View at Google Scholar · View at Scopus 17. S. M. Levy, F. J. Kohout, M. C. Kiritsy, J. R. Heilman, and J. S. 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