Safety

Safety

17. Harmful to humans?

18. More studies needed?

19. Recommended level?

20. EPA maximum?

21. EPA secondary level?

22. Total intake?

23. Daily intake?

24. Prenatal dietary fluoride supplements?

25. Body uptake?

26. Bone health?

27. Dental fluorosis?

28. Fluoridated water for infant formula?

29. Prevent fluorosis?

30. Warning Label?

31. Acute and chronic toxicity?

32. Cancer?

33. Osteosarcoma?

34. Enzyme effects?

35. Thyroid?

36. Pineal gland?

37. Allergies?

38. Genetic risk?

39. Fertility?

40. Down Syndrome?

41. Neurological impairment/IQ?

42. Lead poisoning?

43. Alzheimer’s disease?

44. Heart disease?

45. Kidney disease?

46. Erroneous health claims?

17. Does fluoride in the water supply, at the levels recommended for the prevention of tooth decay, adversely affect human health?

Answer.

The overwhelming weight of scientific evidence supports the safety of community water fluoridation.

Fact.

For generations, millions of people have lived in areas where fluoride is found naturally in drinking water in concentrations as high or higher than the optimal level recommended to prevent tooth decay. Research conducted among these persons confirms the safety of fluoride in the water supply.1-5

As with other nutrients, fluoride is safe and effective when used and consumed as recommended. No charge against the benefits and safety of fluoridation has ever been substantiated by generally accepted scientific knowledge. A number of reviews on fluoride in drinking water have been issued over the years. For example, in 19516 the National Research Council (NRC), of the National Academies, issued its first report stating fluoridation was safe and effective. Additional reviews by the NRC followed in 19777 and 19938 with the most recent NRC review completed in 2006.9 Additional reviews completed over the ten year period from 2007-2017 include:

2017 Australian Government. National Health and Medical Research Council (NHMRC). Information Paper — Water Fluoridation: Dental and Other Human Health Outcomes.10
2016 O’Mullane DM, Baez RJ, Jones S, Lennon MA, Petersen PE, Rugg-Gunn AJ, Whelton H, Whitford GM. Fluoride and Oral Health.11
2016 American Water Works Association. Water Fluoridation Principles and Practices. AWWA Manual M4. Sixth edition.12
2015 Water Research Foundation. State of the Science: Community Water Fluoridation.13
2015 The Network for Public Health Law. Issue Brief: Community Water Fluoridation.14
2015 Ireland Health Research Board. Health Effects of Water Fluoridation: An Evidence Review.15
2015 U.S. Department of Health and Human Services Federal Panel on Community Water Fluoridation U.S. Public Health Service Recommendation for Fluoride Concentration in Drinking Water for the Prevention of Dental Caries.16
2014 Public Health England. Water Fluoridation: Health Monitoring Report for England.17
2014 Royal Society of New Zealand and the Office of the Prime Minister’s Chief Science Advisor. Health Effects of Water Fluoridation: a Review of the Scientific Evidence.18
2013 U.S. Community Preventive Services Task Force. The Guide to Community Preventive Services. Preventing Dental Caries: Community Water Fluoridation.19
2011 European Commission of the European Union Scientific Committee on Health and Environmental Risks (SCHER). Fluoridation.20
2008 Health Canada. Findings and Recommendations of the Fluoride Expert Panel.21
2007 Australian Government National Health and Medical Research Council A Systematic Review of the Efficacy and Safety of Fluoridation; Part A: Review Methodology and Results.22

The overwhelming weight of scientific evidence supports the safety of community water fluoridation.

18. Are additional studies being conducted to determine the effects of fluorides in humans?

Answer.

Yes. Since its inception, fluoridation has undergone a nearly continuous process of re-evaluation. As with other areas of science, additional studies on the effects of fluorides in humans can provide insight as to how to make effective choices for the use of fluoride. The American Dental Association and the U.S. Public Health Service support this on-going research.

Fact.

For more than 70 years, detailed reports have been published on multiple aspects of fluoridation. The accumulated dental, medical and public health evidence concerning fluoridation has been reviewed and evaluated numerous times by academicians, committees of experts, special councils of governments and most of the world’s major national and international health organizations. The consensus of the scientific community is that water fluoridation, at the level recommended to prevent tooth decay, safely provides oral health benefits which in turn supports improved general health. The question of possible secondary health effects caused by fluorides consumed in optimal concentrations throughout life has been the object of thorough medical investigations which have failed to show any impairment of general health throughout life.10-22

The consensus of the scientific community is that water fluoridation, at the level recommended to prevent tooth decay, safely provides oral health benefits which in turn supports improved general health.

In scientific research, there is no such thing as “final knowledge.” New information is continuously emerging and being disseminated. Government agencies, such as the U.S. National Institutes of Health, National Institute of Dental and Craniofacial Research, and others continue to fund fluoride research. One example is the National Toxicology Program’s systematic review using animal studies to evaluate potential neurobehavioral effects from exposure to fluoride during development which began in 2015 and continues in 2017.23

In 2011, the U.S. Department of Health and Human Services and the U.S. Environmental Protection Agency (EPA) issued a joint press release24 outlining important steps the respective agencies were taking to ensure that standards and guidelines on fluoride in drinking water continue to ensure the safety of the public while supporting good dental health, especially in children. Those actions resulted in the 2015 report issued by the U.S. Public Health Service16 regarding the recommended level of fluoride in drinking water and the EPA activity was informational to the 2016 EPA Six-Year Review 325 in which the Agency completed a detailed review of drinking water regulations including the regulation for naturally occurring fluoride in water.

19. Why did the U.S. Public Health Service issue a report in 2015 recommending 0.7 milligrams per liter (mg/L) as the optimal level for fluoride in drinking water for all temperature zones in the U.S.?

Answer.

The U.S. Public Health Service (USPHS) updated and replaced its 1962 Drinking Water Standards related to community water fluoridation to establish a single value of 0.7 mg/L as the optimal concentration of fluoride in drinking water. This concentration provides the best balance of protection from tooth decay while limiting the risk of dental fluorosis.16

Fact.

The previous U.S. Public Health Service recommendations for optimal fluoride concentrations were based on average ambient air temperatures of geographic areas and ranged from 0.7-1.2 mg/L. In 2011, the U.S. Department of Health and Human Services (HHS) issued a notice of intent in the Federal Register26 proposing that community water systems adjust the amount of fluoride to 0.7 mg/L to achieve an optimal fluoride level.

The new guidance was based on several considerations that included:

Scientific evidence related to effectiveness of water fluoridation on caries prevention and control across all age groups.

Fluoride in drinking water as one of several available fluoride sources.

Trends in the prevalence and severity of dental fluorosis.

Current evidence on fluid intake in children across various ambient air temperatures.

As part of the process leading to the notice of intent, the U.S. Department of Health and Human Services (HHS) convened a federal interdepartmental, interagency panel of scientists to review the scientific evidence relevant to the 1962 USPHS Drinking Water Standards for fluoride concentrations in drinking water in the United States and to update these recommendations based on current science. Panelists included representatives from the Centers for Disease Control and Prevention, the National Institutes of Health, the U.S. Food and Drug Administration, the Agency for Healthcare Research and Quality, the Office of the Assistant Secretary for Health, U.S. Environmental Protection Agency, and the U.S. Department of Agriculture.16

A public comment period followed the publication of the notice of intent during which time more than 19,000 comments were received. The vast majority (more than 18,000) were variations on a letter submitted by an organization opposing community water fluoridation. Comments received were summarized and reported to the full federal panel. The panel then spent several years reviewing each comment in light of the best available science. After completing their extensive review, the panel did not alter the recommendation based on the following:

Community water fluoridation remains an effective public health strategy for delivering fluoride to prevent tooth decay and is the most feasible and cost-effective strategy for reaching entire communities.

In addition to drinking water, other sources of fluoride exposure have contributed to the prevention of dental caries and an increase in dental fluorosis prevalence.

Caries preventive benefits can be achieved and the risk of dental fluorosis reduced at 0.7 mg/L.

Recent data do not show a convincing relationship between water intake and outdoor air temperature. Thus, recommendations for water fluoride concentrations that differ based on outdoor temperature are unnecessary.16

In 2015 the USPHS published a final report establishing guidance for water systems that are actively fluoridating or those that may initiate fluoridation in the future.16 For community water systems that add fluoride to their water, the USPHS recommends a uniform fluoride concentration of 0.7 mg/L (parts per million [ppm]) for the entire United States to maintain caries (tooth decay) prevention benefits and reduce the risk of dental fluorosis.

The USPHS further noted that surveillance of dental caries (tooth decay), dental fluorosis, and fluoride intake through the National Health and Nutritional Examination Survey will be done to monitor changes that might occur following implementation of the recommendation.16

20. What is the recommendation for the maximum level of naturally occurring fluoride in drinking water contained in the 2016 EPA Six-Year Review 3?

Answer.

As established by the U.S. EPA, the maximum allowable level of naturally occurring fluoride in drinking water is 4 milligrams/liter (mg/L or ppm). Under the Maximum Contaminant Level (MCL) standard, if the naturally occurring level of fluoride in a public water supply exceeds the MCL, the water supplier is required to lower the level of fluoride below the MCL — a process called defluoridation. The MCL is a federally enforceable standard.27 (Additional details regarding the EPA maximum contaminant standards can be found in the Figure 3.)

Fact.

Under the Safe Drinking Water Act (SDWA),27 the EPA is required to periodically review the existing National Primary Drinking Water Regulations (NPDWRs) “not less often than every 6 years.” This review is a routine part of the EPA’s operations as dictated by the SDWA.

In April 2002, the EPA announced the results of its preliminary revise/not revise decisions for 68 chemical NPDWRs as part of its first Six-Year Review of drinking water standards.28 Fluoride was one of the 68 items reviewed. While the EPA determined that it fell under the “Not Appropriate for Revision at this Time” category, the agency asked the National Academies (NA) to update the risk assessment for fluoride. Prior to this time, the National Academies’ National Research Council (NRC) completed a review of fluoride for the EPA which was published as “Health Effects of Ingested Fluoride” in 1993.8

The National Research Council’s Committee on Toxicology created the Subcommittee on Fluoride in Drinking Water9 which reviewed toxicologic, epidemiologic, and clinical data published since 1993, and exposure data on orally ingested fluoride from drinking water and other sources (e.g., food, toothpaste, dental rinses). Based on these reviews, the Subcommittee evaluated independently the scientific and technical basis of the U.S. Environmental Protection Agency’s (EPA) maximum contaminant level goal (MCLG) of 4 milligram per liter (mg/L or ppm) and secondary maximum contaminant level (SMCL) of 2 mg/L in drinking water.

On March 22, 2006, almost three years after work began, the NRC issued a 500-page report titled Fluoride in Drinking Water — A Scientific Review of the EPA’s Standards9 to advise the EPA on the adequacy of its fluoride MCLG (maximum contaminant level goal) and SMCL (secondary maximum contaminant level) to protect children and others from adverse effects. (For additional information on the EPA maximum contaminant standards, please refer to Figure 3.) The report contained two major recommendations related to the MCLG:

In light of the collective evidence on various health end points and total exposure to fluoride, the committee concludes that EPA’s MCLG of 4 mg/L should be lowered. Lowering the MCLG will prevent children from developing severe enamel fluorosis and will reduce the lifetime accumulation of fluoride into bone that the majority of the committee concludes is likely to put individuals at increased risk of bone fracture and possibly skeletal fluorosis, which are particular concerns for subpopulations that are prone to accumulating fluoride in their bones.9

To develop an MCLG that is protective against severe enamel fluorosis, clinical stage II skeletal fluorosis, and bone fractures, EPA should update the risk assessment of fluoride to include new data on health risks and better estimates of total exposure (relative source contribution) for individuals. EPA should use current approaches for quantifying risk, considering susceptible subpopulations, and characterizing uncertainties and variability.9

The 2006 NRC report9 contained one major recommendation related to the Secondary Maximum Contaminant Level (SMCL):

The prevalence of severe enamel fluorosis is very low (near zero) at fluoride concentrations below 2 mg/L. From a cosmetic standpoint, the SMCL does not completely prevent the occurrence of moderate enamel fluorosis. EPA has indicated that the SMCL was intended to reduce the severity and occurrence of the condition to 15% or less of the exposed population. The available data indicate that fewer than 15% of children will experience moderate enamel fluorosis of aesthetic concern (discoloration of the front teeth) at that concentration. However, the degree to which moderate enamel fluorosis might go beyond a cosmetic effect to create an adverse psychological effect or an adverse effect on social functioning is not known.9

Additionally, the Subcommittee identified data gaps and made recommendations for future research relevant to future revisions of the MCLG and SMCL for fluoride.9

It should be emphasized that the 2006 NRC report was not a review of fluoride as used in community water fluoridation. In fact, the 2006 NRC Report in Brief29 states: “The committee did not evaluate the risks or benefits of the lower fluoride concentrations (0.7 to 1.2 mg/L) used in water fluoridation. Therefore, the committee’s conclusions regarding the potential for adverse effects from fluoride at 2 to 4 mg/L in drinking water do not apply at the lower water fluoride levels commonly experienced by most U.S. citizens.”29

In response to the recommendations noted above from the NRC report, in 2011, the EPA completed and peer-reviewed a quantitative dose-response assessment based on the available data for severe dental fluorosis as recommended by the NRC.30 Additionally, the EPA completed and peer-reviewed a document on the environmental exposure of children and adults to fluoride and the relative source contribution for water which is needed in order to derive the MCLG from the dose-response assessment.30 These efforts were being undertaken during Six-Year Review 2 and so no action on fluoride was taken during Six-Year Review 2.

In December 2016, the EPA announced the review results for the Agency’s third Six-Year Review (called Six-Year Review 3),25 in which the Agency completed a detailed review of 76 national primary drinking water regulations. The regulation for naturally occurring fluoride in water was examined as part of this review and is included among the list of regulated contaminants considered to be “Low priority and/or no meaningful opportunity” under “Not Appropriate for Revision at this Time.”25

The announcement of the results of the EPA’s Six-Year Review 3 in the Federal Register31 indicates that, with the reviews of fluoride conducted since the first Six-Year Review (including but not limited to the 2006 NRC report and the EPA Fluoride Risk Assessment and Relative Source Contribution) and noting that other contaminants are of much greater concern, the EPA is recommending that no further action be taken at this time to change the current MCL/MCLG of 4 mg/L (the maximum level of naturally occurring fluoride allowed in drinking water).31

21. What is the Secondary Maximum Contaminant Level (SMCL) for naturally occurring fluoride in drinking water established by the EPA?

Answer.

The Secondary Maximum Contaminant Level (SMCL) for naturally occurring fluoride in water is 2 mg/L (or ppm). This is a non-enforceable federal standard.

Fact.

In addition to the MCL, the EPA has established a Secondary Maximum Contaminant Level (SMCL) of 2.0 mg/L and requires consumer notification by the water supplier if the naturally occurring fluoride level exceeds 2.0 mg/L. The SMCL, while not federally enforceable, is intended to alert families that regular consumption of water with natural levels of fluoride greater than 2.0 mg/L by young children could cause moderate to severe dental fluorosis in the developing permanent teeth.32 The notice to be used by water systems that exceed the SMCL must contain the following points:

1. The notice is intended to alert families that children under nine years of age who are exposed to levels of fluoride greater than 2.0 mg/liter may develop dental fluorosis.

2. Adults are not affected because dental fluorosis occurs only when developing teeth are exposed to elevated fluoride levels.

3. The water supplier can be contacted for information on alternative sources or treatments that will insure the drinking water would meet all standards (including the SMCL).32

Figure 3. USEPA Standards and USPHS Recommendation for Fluoride in Drinking Water

image

image Additional information on these topics can be found in this Section, Questions 19, 20 and 21.

22. Does the total intake of fluoride from air, water and foods in a community in the United States with drinking water fluoridated at the recommended level pose significant health risks?

Answer.

The total intake of fluoride from air, water and foods in a community in the United States with drinking water fluoridated at the recommended level does not pose significant health risks.

Fact.

Fluoride from the Air

The atmosphere normally contains negligible concentrations of airborne fluorides. Studies reporting the levels of fluoride in air in the United States suggest that ambient fluoride contributes very little to a person’s overall fluoride intake.9,30

Fluoride from Water

For generations, millions of people have lived in areas where fluoride is found naturally in drinking water in concentrations as high as or higher than those recommended to prevent tooth decay. Research conducted among these people confirms the safety of fluoride in the water supply.1-5

A ten-year comparison study of long-time residents of Bartlett and Cameron, Texas, where the water supplies contained 8.0 and 0.4mg/L of fluoride, respectively, included examinations of organs, bones and tissues. Other than a higher prevalence of dental fluorosis in the Bartlett residents (8.0 mg/L fluoride), the study indicated that long-term consumption of fluoride from water and food sources (resident average length of fluoride exposure was 36.7 years), even at these levels more than 10 times higher than recommended for tooth decay prevention, resulted in no clinically significant physiological or functional effects.5

In the United States, the natural level of fluoride in ground water varies from very low levels to over 4 mg/L. Public water systems in the U.S. are monitored by the Environmental Protection Agency (EPA), which requires that public water systems not exceed a naturally occurring fluoride level of 4 mg/L.31 The recommended level for fluoride in drinking water in the United States has been established at 0.7 mg/L by the U.S. Public Health Service.16 This level has been established to reduce tooth decay while minimizing the occurrence of dental fluorosis.

Individuals living in a community with water fluoridation get a portion of their daily fluoride intake from fluoridated water and a portion from dietary sources which would include foods and other beverages. Water and water-based beverages are the chief source of dietary fluoride intake. Conventional estimates are that approximately 75% of dietary fluoride comes from water and water-based beverages.33,34 When considering water fluoridation, an individual consuming one liter of water fluoridated at 0.7 mg/L receives 0.7 milligram of fluoride.

Fluoride in Foods

In looking at the fluoride content of foods and beverages over time, it appears that fluoride intake from dietary sources has remained relatively constant.35 Except for products prepared (commercially or by the individual) or cooked with fluoridated water, the fluoride content of most foods and beverages is not significantly different between fluoridated and nonfluoridated communities. When fluoridated water is used to prepare or cook the samples, the fluoride content of foods and beverages is higher. This difference has remained relatively constant over time.33,35

Launched in 2004 and updated in 2005, the National Fluoride Database is a comprehensive, nationally representative database of the fluoride concentration in 427 foods across 27 food groups and beverages consumed in the United States.34 This database for fluoride was designed for use by epidemiologists and health researchers to estimate fluoride intake and to assist in the investigation of the relationships between fluoride intake and human health. The database contains fluoride values for beverages, water, and some lower priority foods.34

The fluoride content of fresh solid foods in the United States generally ranges from 0.01 to 1.0 part per million.35 The foods highest in fluoride are fish and shellfish, reflective of the fluoride found in ocean water, and the presence or absence of bone fragments such as those in sardines.35 (Fluoride has an affinity for calcified tissues such as bones.) Cereals, baked goods, breads, and other grain products were estimated to have fluoride concentrations between 0.06 and 0.72 ppm. The majority of vegetables (leafy, root, legumes, green or yellow) have a relatively low fluoride concentration (ranging from 0.01 to 0.5 ppm) with fruits generally having lower concentrations (ranging from 0.01 to 0.2 ppm) than in vegetables. Raisins are one exception in the fruit category with a higher fluoride concentration due to the use of certain pesticides and concentration through drying.35

Brewed teas can contain fluoride concentrations of 1 ppm to 6 ppm depending on the amount of dry tea used, the water fluoride concentration and the brewing time.36 The fluoride value for unsweetened instant tea powder appears very high when reported as a dry powder because this product is extremely concentrated. However, when one teaspoon of the unsweetened tea powder is added to an eight ounce cup of tap water, the value for prepared instant tea is similar to the values reported for regular brewed tea.34

Foods and beverages commercially processed (cooked or reconstituted) in cities fluoridated to the recommended level generally contain higher levels of fluoride than those processed in nonfluoridated communities. These foods and beverages are consumed not only in the city where processed, but also are often distributed to and consumed in nonfluoridated areas.37 This “halo” or “diffusion” effect results in increased fluoride intake by people in nonfluoridated communities, providing them increased protection against tooth decay.38,39 As a result of the widespread availability of these various sources of fluoride, the difference between tooth decay rates in fluoridated areas and nonfluoridated areas is somewhat less than several decades ago but this difference is still significant. Failure to account for the diffusion effect results in an underestimation of the total benefit of water fluoridation especially in areas where large amounts of fluoridated products are brought into nonfluoridated communities.38

The average daily dietary intake of fluoride (expressed on a body weight basis) by children residing in communities with water fluoridated at 1.0 mg/L is 0.05 mg/kg/day (milligram per kilogram of body weight per day).40 In communities without optimally fluoridated water, average intakes for children are about 50% lower.40 Dietary fluoride intake by adults in communities where water is fluoridated at 1.0 mg/L averages 1.4 to 3.4 mg/day, and in nonfluoridated areas averages 0.3 to 1.0 mg/day.40 With the 2015 recommendation that drinking water be fluoridated at 0.7 mg/L, average intakes would be 30% lower in fluoridated communities than when they were fluoridated at 1.0 mg/L.

23. How much fluoride is recommended to maximize the tooth decay prevention benefits of fluoride?

Answer.

As with all nutrients, the appropriate amount of daily fluoride intake varies with age and body weight. Fluoride is safe and effective when used and consumed properly.

Fact.

In 1997, the Food and Nutrition Board of the Institute of Medicine developed a comprehensive set of reference values for dietary nutrient intakes.40 These new reference values, the Dietary Reference Intakes (DRI), replace the Recommended Dietary Allowances (RDA) which had been set by the National Academy of Sciences since 1941. The new values present nutrient requirements to optimize health and, for the first time, set maximum-level guidelines to reduce the risk of adverse effects from excessive consumption of a nutrient. Along with calcium, phosphorous, magnesium and vitamin D, DRIs for fluoride were established because of its proven preventive effect on tooth decay. (See Table 2 in this Question.)

The Adequate Intake (AI) establishes a goal for intake to sustain a desired indicator of health without causing side effects. In the case of fluoride, the AI is the daily intake level required to reduce tooth decay without causing moderate dental fluorosis. The AI for fluoride intake from all sources (fluoridated water, foods, beverages, fluoride dental products and dietary fluoride supplements) is set at 0.05 mg/kg/day. Using the established AI of 0.05 mg/kg, the amount of fluoride for optimal health to be consumed each day has been calculated by sex and age group (expressed as average weight).40

The Tolerable Upper Intake Level (UL) establishes a maximum guideline. The UL is higher than the AI and is not the recommended level of intake. The UL is the estimated maximum intake level that should not produce unwanted effects on health. The UL for fluoride intake from all sources (fluoridated water, foods, beverages, fluoride dental products and dietary fluoride supplements) is set at 0.10 mg/kg/day (milligram per kilogram of body weight per day) for infants, toddlers, and children through eight years of age. For older children and adults, who are no longer at risk for dental fluorosis, the UL for fluoride is set at 10 mg/day regardless of weight. Using the established ULs for fluoride, the amount of fluoride that can be consumed each day to reduce the risk of moderate enamel fluorosis for children through age eight, has been calculated by sex and age group (expressed as average weight).40 (See Table 2.)

Table 2. Reference Intakes for Fluoride
Food and Nutrition Board of the Institute of Medicine 199740
Age Group Reference Weights kg (lbs)* Adequate Intake (mg/day) Tolerable Upper Intake (mg/day)
Infants 0-6 months 7 (16) 0.01 0.7
Infants 7-12 months 9 (20) 0.5 0.9
Children 1-3 years 13 (29) 0.7 1.3
Children 4-8 years 22 (48) 1.0 2.2
Children 9-13 years 40 (88) 2.0 10.0
Boys 14-18 years 64 (142) 3.0 10.0
Girls 14-18 years 57 (125) 3.0 10.0
Males 19 years and over 76 (166) 4.0 10.0
Females 19 years and over 61 (133) 3.0 10.0
* Value based on data collected during 1988-94 as part of the Third National Health and Nutrition Examination Survey (NHANES III) in the United States.40

As a practical example, daily intake of 2 mg of fluoride is adequate for a 9- to 13-year-old child weighing 88 pounds (40 kg). This was calculated by multiplying 0.05 mg/kg/day (AI) times 40 kg (weight) to equal 2 mg. At the same time, that 88 pound (40kg) child could consume 10 mg of fluoride a day as a tolerable upper intake level.

Children living in a community with water fluoridation get a portion of their daily fluoride intake from fluoridated water and a portion from dietary sources which would include foods and other beverages. When considering water fluoridation, an individual must consume one liter of water fluoridated at 0.7 mg/L to receive 0.7 milligrams (0.7 mg) of fluoride. Children under six years of age, on average, consume less than one-half liter of drinking water a day.35 Therefore, children under six years of age would consume, on average, less than 0.35 mg of fluoride a day from drinking optimally fluoridated water (at 0.7 mg/L).

If a child lives in a nonfluoridated area and is determined to be at high risk for tooth decay, the dentist or physician may prescribe dietary fluoride supplements.41 As shown in Table 1 “Dietary Fluoride Supplement Schedule” (See Benefits Section, Question 12.), the current dosage schedule recommends supplemental fluoride amounts that are below the AI for each age group.41 The dosage schedule was designed to offer the benefit of decay reduction with a margin of safety to prevent mild to moderate enamel fluorosis. For example, the AI for a child 3 years of age is 0.7 mg/day. The recommended dietary fluoride supplement dosage for a child 3 years of age in a nonfluoridated community is 0.5 mg/day. This provides leeway for some fluoride intake from processed foods and beverages, and other sources.

Tooth decay rates are declining in many population groups because children today are being exposed to fluoride from a wider variety of sources than decades ago.16 Many of these sources are intended for topical use only; however, some fluoride is ingested inadvertently by children.42,43 By reducing the inappropriate ingestion of fluoride from toothpaste, the risk of dental fluorosis can be reduced without jeopardizing the benefits to oral health.

For example, it has been reported in a number of studies that young children inadvertently swallow an average of 0.30 mg of fluoride from fluoride toothpaste at each brushing.44-48 If a child brushes twice a day, 0.60 mg of fluoride could be ingested inappropriately. This could slightly exceed the Adequate Intake (AI) values from Table 2. The 0.60 mg consumption is 0.10 mg higher than the AI value for children 6 to 12 months and is 0.10 mg lower than the AI for children from 1-3 years of age.40 Although toothpaste is not meant to be swallowed, children could consume the daily recommended Adequate Intake amount of fluoride from toothpaste alone. In order to decrease the risk of dental fluorosis, the American Dental Association (ADA) recommends:49

For children younger than 3 years, caregivers should begin brushing children’s teeth as soon as they begin to come into the mouth by using fluoride toothpaste in an amount no more than a smear or the size of a grain of rice (Figure 4). Brush teeth thoroughly twice per day (morning and night) or as directed by a dentist or physician. Supervise children’s brushing to ensure that they use the appropriate amount of toothpaste.

For children 3 to 6 years of age, caregivers should dispense no more than a pea-sized amount (Figure 4) of fluoride toothpaste. Brush teeth thoroughly twice per day (morning and night) or as directed by a dentist or physician. Supervise children’s brushing to minimize swallowing of toothpaste.49

image Additional information on this topic can be found in this Section, Question 29.

Figure 4. Examples of Toothpaste Amounts for Children49

It should be noted that the amounts of fluoride discussed here are intake, or ingested, amounts. When fluoride is ingested, a portion is retained in the body and a portion is excreted.

image Addition information on this topic can be found in this Section, Question 25.

24. Is there a need for prenatal dietary fluoride supplementation?

Answer.

There is no scientific basis to suggest any need to increase a woman’s daily fluoride intake during pregnancy or breastfeeding to protect her health. At this time, scientific evidence is insufficient to support the recommendation for prenatal fluoride supplementation for decay prevention for infants.

Fact.

The Institute of Medicine determined that, “No data from human studies document the metabolism of fluoride during lactation. Because fluoride concentrations in human milk are very low (0.007 to 0.011 ppm) and relatively insensitive to differences in the fluoride concentrations of the mother’s drinking water, fluoride supplementation during lactation would not be expected to significantly affect fluoride intake by the nursing infant or the fluoride requirement of the mother.”40

A 2005 a randomized, double blind study50 compared the amount of fluoride incorporated into primary teeth exposed to prenatal and post natal fluoride supplements to primary teeth that were exposed to only postnatal fluoride. The study concluded that teeth exposed to prenatal and postnatal fluoride supplements had no additional measurable fluoride other than that attributable to postnatal fluoride alone.50 This study confirmed the findings of a 1997 randomized, double blind study that evaluated the effectiveness of prenatal dietary supplementation which concluded that the data did not support the hypothesis that prenatal fluoride had a strong decay preventive effect on primary teeth.51

25. When fluoride is ingested, where does it go?

Answer.

Much of the ingested fluoride is excreted. Of the fluoride retained, almost all is found in calcified (hard) tissues, such as bones and teeth.

Fact.

After ingestion of fluoride, such as drinking a glass of fluoridated water, the majority of the fluoride is absorbed from the stomach and small intestine into the blood stream. This causes a short-term increase in fluoride levels in the blood. Fluoride is distributed through the body by plasma (a component of blood) to hard and soft tissues. Following ingestion, the fluoride plasma levels increase quickly and reach a peak concentration within 20-60 minutes. The concentration declines rapidly, usually approximating the baseline levels within three to six hours, due to the uptake of fluoride by calcified tissues and excretion in urine. In adults, approximately 50% of the fluoride absorbed each day becomes associated with calcified tissues within 24 hours while the remainder is excreted in the urine. Approximately 99% of the fluoride present in the body is in calcified tissues (mainly bone).52

Ingested or systemic fluoride becomes incorporated into forming tooth structures. Fluoride ingested regularly during the time when teeth are developing is deposited throughout the tooth structure and contributes to long lasting protection against tooth decay.53-57

image Additional information on this topic can be found in the Benefits Section, Question 2.

An individual’s age and stage of skeletal development will affect the rate of fluoride retention. The amount of fluoride taken up by bone and retained in the body is inversely related to age. A greater percentage of fluoride is absorbed in young bones than in the bones of older adults.52 However, once fluoride is absorbed into bones, it is released back into plasma (a component of blood) when fluoride levels in plasma fall. This absorption and release cycle continues throughout the life span.52

26. Will drinking water that is fluoridated at the recommended level adversely affect bone health?

Answer.

According to the best available science, drinking water that has been fluoridated at the recommended level does not have an adverse effect on bone health.

Fact.

Several systematic reviews have concluded that fluoride at the level used in community water fluoridation has no adverse effect on bone health. A systematic review published in 2000 concluded that there was no clear association between water fluoridation and hip fracture.59 Twenty-nine studies that looked at the association between bone fracture/bone development and water fluoridation were included in the review. The evidence regarding other types of bone fractures was similar.59 A systematic review published in 201710 concurred with the earlier review concluding that there is evidence that fluoridated water at recommended levels is not associated with bone fracture.10

In addition to the systematic reviews, a number of individual studies have investigated the bone health of individuals residing in communities with fluoride in drinking water at the recommended levels and higher than recommended levels. Most of these studies have focused on whether there exists a possible link between fluoride and bone fractures. Additionally, the possible association between fluoride and bone cancer has been studied. None of the studies provide a legitimate reason for altering public health policy regarding fluoridation and bone health concerns.

The following studies, listed in chronological order, add to the body of evidence indicating that there is no association between consumption of optimally fluoridated water and bone fracture.

The Iowa Fluoride Study/Iowa Bone Development Study60 looked at the association of fluoride intake with bone measures (bone mineral content and bone mineral density) in a cohort of Iowa children. Assessment of the participants’ dietary fluoride intake had been ongoing since birth with parents completing detailed fluoride questionnaires at numerous time periods through 15 years of age. These children had combined fluoride intake estimated from a number of sources including water, other beverages, selected foods, dietary fluoride supplements and fluoride toothpaste. Estimated fluoride intake was noted during different time periods and cumulatively from birth to 15 years of age. The findings indicate that fluoride exposures at typical levels for most U.S. adolescents in fluoridated areas do not have significant effects on bone mineral measures. These findings are generally comparable with those from the analyses of this cohort at age 11 years.61 During the intervening 4 years, cohort members generally experienced a substantial increase in bone mass accrual. For example, mean whole-body bone mineral content showed mean increases of approximately 61% in females and 96% in males. Despite the acceleration of bone growth near puberty, the associations between fluoride intake and bone outcome measures remained weak and none was significant after adjustment for other variables.60

In one of the largest studies of its kind with nearly half a million subjects, Swedish researchers looked at residents’ chronic consumption of various levels of fluoride and the risk of hip fracture. All individuals born in Sweden between January 1, 1900 and December 31, 1919, alive and living in their municipality of birth at the time of the start of follow-up, were eligible for the study. Information on the study population was linked to the Swedish health registers. Estimated individual drinking water fluoride exposure was stratified into 4 categories: very low, < 0.3 mg/L; low, 0.3 to 0.69 mg/L; medium, 0.7 to 1.49 mg/L; and high, ≥ 1.5 mg/L. Published in 2013, the researchers found Swedish residents chronically exposed to various levels of fluoride in drinking water did not show any differences in rates of either hip fracture or low-trauma osteoporotic hip fracture due to fluoride exposure.62

A study published in 2005 evaluated the bone mineral density levels and rate of bone fracture of 1,300 women living in three separate communities. To be included in the study, the women had to be ambulatory. The ages of the women ranged from 20 years to 92 years. The size and demographics of the three communities were similar. One part of the study looked at whether fluoride was associated with adverse bone-related outcomes. The study measured fluoride serum levels, fluoride exposure, and bone metabolism as related to fluoride exposure and fluoride’s interaction with other important bone factors including age, menopause status and medications. The study concluded that long-term exposure to fluoride was not associated with adverse effects on bone health.63

A study published in 200164 examined the risk of bone fractures, including hip fractures associated with long-term exposure to fluoridated water in six Chinese populations. The water fluoride concentrations ranged from 0.25 to 7.97 mg/L. A total of 8,266 male and female subjects, all of whom were 50 years old or older participated in the study. The results showed an interesting and potentially important finding regarding overall bone fractures. Whereas there appeared to be a trend for higher fracture rates from 1.00 to 4.00 mg/L, the fracture rate in the 1.00 to 1.06 mg/L category was lower than the rate in the category with the lowest fluoride intake (0.25 to 0.34 mg/L). The study concluded that long-term fluoride exposure from drinking water containing 4.32 mg/L or more increases the risk of overall bone fracture, as well as hip fracture, while water fluoride levels of 1.0 to 1.06 mg/L decreased the risk of overall fractures relative to negligible fluoride in water.64 (Note that 4.32 mg/L is more than six times the fluoride level currently recommended for community water fluoridation in the United States).

While a number of studies reported findings at a population level, both the Hillier and Phipps studies published in 2000, examined risk on an individual, rather than a community basis, taking into account other risk factors such as medications, age of menopause, alcohol consumption, smoking, dietary calcium intake and physical activity. Using these more rigorous study designs, these two studies reported no effect of the risk of hip fracture65 and no increase in the risk of hip fracture in those drinking fluoridated water,66 respectively.

According to the best available science, drinking water that has been fluoridated at the recommended level does not have an adverse effect on bone health.

27. What is dental fluorosis or enamel fluorosis?

Answer.

Dental fluorosis is a change in the appearance of the tooth enamel that only occurs when younger children consume too much fluoride, from all sources, over long periods when teeth are developing under the gums.36 In the United States, most commonly these changes are not readily apparent to the affected individual or casual observer and require a trained specialist to detect. This type of dental fluorosis found in the United States has no effect on tooth function and can make the teeth more resistant to decay.67 Photographs of mild dental fluorosis can be viewed at www.ADA.org/en/member-center/oral-health-topics/fluoride-topical-and-systemic-supplements. (Note that mild dental fluorosis is generally less evident than on these photographs. This is because the teeth were dried very well to improve the photography and this makes the mild dental fluorosis stand out, but if the tooth had saliva on it as it usually does, then it would be less noticeable.)

Fact.

The crown of the tooth (the part covered in enamel) is formed under the gums before the teeth erupt. Enamel formation of permanent teeth, other than third molars (wisdom teeth), occurs from about the time of birth until approximately eight years of age.68 Because dental fluorosis occurs only while teeth are forming under the gums, teeth that have erupted are not at risk for dental fluorosis; therefore, older children and adults are not at risk for the development of dental fluorosis.69 It should be noted that there are many other developmental changes that affect the appearance of tooth enamel which are not related to fluoride intake. In other words, not all opaque or white blemishes on teeth are caused by fluoride. Furthermore, dental fluorosis occurs among some people in all communities, even in communities that do not have community water fluoridation, or that have a low natural concentration of fluoride in their drinking water.70-72

Classification of Dental Fluorosis

Dental fluorosis has been classified in a number of ways. One of the most widely used classifications was developed by Dean in 1942.73 (See Table 3.)

In using Dean’s Fluorosis Index, each tooth in an individual’s mouth is rated according to the fluorosis index in Table 3. The individual’s dental fluorosis score is based upon the most severe form of fluorosis recorded for two or more teeth. Dean’s Fluorosis Index, which has been used since 1942, remains popular for prevalence studies in large part due to its simplicity and the ability to make comparisons with findings from a number of earlier studies.74

In 2010, a report by the U.S. National Center for Health Statistics described the prevalence and changes in prevalence and severity of dental fluorosis in the United States and among adolescents between 1986–1987 and 1999–2004.75 According to the report, in 1999 to 2004, 40.7% of adolescents had dental fluorosis. It should be noted that dental fluorosis can occur not only from fluoride intake from water but also from fluoride products, such as toothpaste, mouthrinses and excessive use of fluoride supplements during the ages when teeth are forming. A 1994 analysis of five studies showed that the amount of dental fluorosis attributable to water fluoridation at 1.0 mg/L was approximately 13%.76 In other words, at that time the amount of dental fluorosis would have been reduced by only 13% if water was not fluoridated. Now it would be less of a reduction, since fluoridation uses the lower level of 0.7 mg/L. The majority of dental fluorosis in the U.S. is caused by the inappropriate ingestion of fluoride products.76

The vast majority of dental fluorosis in the United States is the very mild or mild type. This type of dental fluorosis is not readily apparent to the affected individual or casual observer and often requires a trained specialist to detect. In contrast, the moderate and severe forms of dental fluorosis, characterized by esthetically (cosmetically) objectionable changes in tooth color and surface irregularities, respectively, are not common in the United States. Most investigators regard even the more advanced forms of dental fluorosis as a cosmetic effect rather than a functional adverse effect.40 In 1993, the U.S. Environmental Protection Agency, in a decision supported by the U.S. Surgeon General, determined that objectionable dental fluorosis is a cosmetic effect with no known health effects.77 However, in 2003, the EPA requested that the National Research Council (NRC) evaluate the adequacy of its MCLG for fluoride to protect public health. A committee was convened to review recent evidence and eventually developed the 2006 report titled, Fluoride in Drinking Water — A Scientific Review of the EPA’s Standards.9 As part of that report, a majority of the committee members found severe dental fluorosis to be an adverse health effect based on suggestive but inconclusive evidence that severe dental fluorosis (characterized by pitting of the enamel) increased the risk of tooth decay. All members of the committee agreed that the condition damages the tooth and that the EPA standard should prevent the occurrence of this unwanted condition. The prevalence of severe enamel fluorosis is very low below 2 mg/L of fluoride in drinking water in the U.S.9

image Additional information on this topic can be found in this Section, Questions 20 and 21.

The vast majority of dental fluorosis in the United States is the very mild or mild type. This type of dental fluorosis is not readily apparent to the affected individual or casual observer and often requires a trained specialist to detect.

Limited research on the psychological effects of dental fluorosis on children and adults has been conducted. However, a 2009 literature review that assessed the relationships between perceptions of dental appearance/oral health related quality of life (OHRQoL) and dental fluorosis concluded that very mild to mild dental fluorosis has little impact and in some cases evidence suggested enhanced quality of life with mild dental fluorosis.78 When evaluating the oral health related quality of life of children by tooth decay (cavities) and dental fluorosis experience, a 2007 study concluded that cavities were associated with a negative impact while mild dental fluorosis had a positive impact on children’s and parents’ quality of life.79

Very mild to mild dental fluorosis has no effect on tooth function and can make the tooth enamel more resistant to decay. A study published in 200967 investigated the relationship between dental fluorosis and tooth decay in U.S. schoolchildren. The study concluded that teeth with dental fluorosis were more resistant to tooth decay than were teeth without dental fluorosis. Not only should the cavity preventive benefits of fluoridation be considered when evaluating policy to introduce or retain water fluoridation, but the cavity preventive benefits of mild dental fluorosis should also be considered.67

Very mild to mild dental fluorosis has no effect on tooth function and can make the tooth enamel more resistant to decay.

A report published in 201075 described the prevalence (total percentage of cases in a population) of dental fluorosis in the United States and discussed the changes in the prevalence and severity of dental fluorosis among adolescents between 1986-1987 and 1999-2004. The report used data from the National Health and Nutrition Examination Survey (NHANES) 1999-2004 and the 1986-1987 National Survey of Oral Health in U.S. School Children. The data represented persons from 6 to 49-years of age and varied races and ethnicities including non-Hispanic black and Mexican-American persons. The oral exams for both surveys were conducted by trained dental examiners and included a dental fluorosis assessment of permanent teeth. The Dean’s Fluorosis Index was used to determine the prevalence and severity of dental fluorosis.

The data published in 201075 showed that less than one-quarter of persons aged 6-49 in the United States had some form of dental fluorosis. For the remaining three-quarters of persons in this age group, 60.6% were unaffected by dental fluorosis and 16.5% were classified as having questionable dental fluorosis. The percent distribution of the types of dental fluorosis in persons aged 6-49 years observed was:

Very mild fluorosis 16.0%
Mild fluorosis 4.8%
Moderate fluorosis 2.0%
Severe fluorosis less than 1%

While moderate and severe dental fluorosis comprise less than 3% of dental fluorosis in all persons aged 6-49, the prevalence of moderate or severe dental fluorosis in this age group comprised a very small portion (less than 10%) of the total number of all cases of dental fluorosis. In other words, approximately 90% of all dental fluorosis observed was very mild to mild form.75

In regards to dental fluorosis in adolescents, children aged 12-15 years in 1999-2004 had higher prevalence of dental fluorosis compared with the same aged children in 1986-1987.75

In reviewing this report,75 it should be noted that dental fluorosis was not assessed in NHANES 1988-1994 and so it was not possible to compare the NHANES 1999-2002 to the earlier NHANES report. The only other previously collected national data on dental fluorosis were the 1986-1987 National Institute of Dental Research (NIDR) National Survey of Oral Health in U.S. School Children. Differences in study design between NIDR 1986-1987 and NHANES 1999-2002 should be considered when drawing inferences about changes in prevalence and severity of enamel fluorosis.75 Examples of differences in these two surveys include but are not limited to:

NIDR survey is a school-based survey while the NHANES is a household survey.

NHANES did not collect residential histories; NIDR did gather residential histories but it is unknown if NIDR reported dental fluorosis data only for those with a single residence history.

NIDR collected water samples from schools for fluoride analysis; NHANES did not collect water samples for analysis until the 2013-14 survey cycle.

As defined in Table 3, very mild dental fluorosis is characterized by small opaque, paper-white areas covering less than 25% of the tooth surface. The risk of teeth forming with the very mildest form of dental fluorosis must be weighed against the benefit that the individual will have fewer cavities thus saving dental treatment costs, avoiding patient discomfort and reducing tooth loss.81,82 In addition, the risk of dental fluorosis can be viewed as an alternative to having tooth decay,83 which is a disease that causes cosmetic problems, pain, missed school and work, and can lead to infection and, in advanced cases, life-threatening health effects. This is in contrast to dental fluorosis which is not a disease and is not life-threatening.

The risk of teeth forming with the very mildest form of dental fluorosis must be weighed against the benefit that the individual will have fewer cavities thus saving dental treatment costs, avoiding patient discomfort and reducing tooth loss.

Table 3. Dental Fluorosis Classification by H.T. Dean – 194275
Classification Criteria-Description of Enamel
Normal Smooth, glossy, pale creamy-white translucent surface
Questionable A few white flecks or white spots
Very Mild Small opaque, paper-white areas covering less than 25% of the tooth surface
Mild Opaque white areas covering less than 50% of the tooth surface
Moderate All tooth surfaces affected; marked wear on biting surfaces; brown stain may be present
Severe All tooth surfaces affected; discrete or confluent pitting; brown stain prsent

28. Is it safe to use fluoridated water to reconstitute infant formula?

Answer.

It is safe to use fluoridated water to reconstitute infant formula.

Fact.

Fluoridated water can be used to prepare infant formula. However, if the child is exclusively consuming infant formula reconstituted with fluoridated water, there could be an increased chance of mild dental fluorosis.86 To lessen this chance, parents can use low-fluoride bottled water some of the time to mix infant formula. These bottled waters are labeled as deionized, purified, demineralized, or distilled. However, parents should be aware that using these types of waters exclusively means an infant does not receive the amount of fluoride the Institute of Medicine indicated is required to prevent tooth decay.40 On the other hand, the exclusive use of nonfluoridated water to reconstitute infant formula will not guarantee that an infant will not develop dental fluorosis. The chance of development of dental fluorosis exists through approximate eight years of age when the permanent teeth are still forming under the gums. Fluoride intake from other sources during this time such as toothpaste, mouthrinse and dietary fluoride supplements also contributes to the chance of dental fluorosis for children living in nonfluoridated and fluoridated communities.84

In response to the report of the National Research Council (NRC) Fluoride in Drinking Water: A Scientific Review of EPA’s Standards9 in November 2006, and with an abundance of caution, the ADA issued the Interim Guidance on Fluoride Intake for Infants and Young Children (Interim Guidance). The Interim Guidance is no longer current and has been replaced. Unfortunately, those opposed to fluoridation continue to publicize and use the Interim Guidance in efforts to halt fluoridation.

The Interim Guidance was replaced in January 2011 by the ADA Evidence-Based Clinical Recommendations Regarding Fluoride Intake From Reconstituted Infant Formula and Enamel Fluorosis A Report of the American Dental Association Council on Scientific Affairs.84 The report encourages clinicians to follow the American Academy of Pediatrics guidelines for infant nutrition which advocates exclusive breastfeeding until the child is aged 6 months and continued breastfeeding until the child is at least 12 months of age, unless specifically contraindicated. Additionally, the ADA report, designed for use by clinical practitioners, offers the following suggestions to practitioners to use in advising parents and caregivers of infants who consume powdered or liquid concentrate infant formula as the main source of nutrition:84

Suggest the continued use of powdered or liquid concentrate infant formulas reconstituted with optimally fluoridated drinking water while being cognizant of the potential risk of enamel fluorosis development.89

When the potential risk of enamel fluorosis development is a concern, suggest ready-to-feed formula or powdered or liquid concentrate formula reconstituted with water that either is fluoride free or has low concentrations of fluoride.84

It should be noted that the Centers for Disease Control and Prevention,85

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Feb 19, 2020 | Posted by in General Dentistry | Comments Off on Safety
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