Richard D. Sauerheber, Ph.D.
Palomar Community College
1140 W. Mission Rd., San Marcos, CA 92069
E-mail: email@example.com Phone: 760-402-1173
September 11, 2012
Dear Dr. Goldbaum,
By way of introduction, I should say that I serve as science advisor to Fluoride Class Action. I have published numerous peer reviewed articles in scholarly and scientific journals. Some of them are posted at:
I currently have a case open with the FDA regarding the safety, effectiveness, and legality of drinking water fluoridation. See my 21 letters to the FDA on this subject, including FDA’s responses at:
I respect your openness to engage with us on this important issue. I have read your letter to James Robert Deal dated June 1, 2012, and posted at:
I am writing to point out some errors which you made in that letter. I hope you will accept my criticism in the positive tone in which it is offered. I am confident that a person with your educational background will be able to come to a clearer understanding regarding these issues and ultimately switch sides.
You are not the only highly trained medical doctor who has believed in the safety and effectiveness of fluoridation. Feel free to call or email me at any time if you have questions. I will be glad to help you find your way out of the “fluoride maze”.
I will now review your statements one-by-one and comment on them. Your remarks are labeled “Snohomish Health District” and my remarks are labeled “Sauerheber”.
SNOHOMISH HEALTH DISTRICT: Yes, both the majority of the public and the majority of the health and scientific communities support water fluoridation.
SAUERHEBER: This is an idea or desire, not a fact. I have never seen a vote of all the scientific community that voted in favor of fluoridation. I have however seen the results of many public elections on fluoridation, and more often than not citizens vote against it. The entire State of Nebraska for example in a large majority of cities (49) voted overwhelmingly against adding fluoride compounds into water supplies (http://sci.tech-archive.net/Archive/sci.med.dentistry/2008-11/msg00098.html). This is partly because fluoride added without calcium is unnatural, and fluoride compounds are added to treat people, not to sanitize the water, a justifiable reason for adding a substance into otherwise-natural drinking water.
SNOHOMISH HEALTH DISTRICT: National organizations that review drinking water and fluoride quality include: The U.S. Environmental Protection Agency (EPA), responsible for the safety and quality of drinking water in the United States. The U.S. Food and Drug Administration (FDA), responsible for approving prescription and over-the-counter fluoride products marketed in the United States and for setting standards for labeling bottled water and over-the-counter fluoride products. The U.S. Centers for Disease Control and Prevention (CDC), the nation’s health protection agency, tasked with saving lives, protecting people from health threats, and saving money through prevention. NSF International, a not-for-profit, non-governmental organization, that is the world leader in standards development, product certification, education and risk management for public health and safety. American Water Works Association, an international non-profit scientific and education society dedicated to the improvement of drinking water quality and supply.
SAUERHEBER: The EPA regulates contaminants in water, not substances intentionally added to treat humans. EPA does not have access to controlled clinical trials data with human volunteers on fluorosilicic acid or sodium fluoride ingestion in either long or short term studies. Clinical trials in fact do not exist. Because of this, the FDA has not approved any fluoride compound for human ingestion. FDA ruled correctly that fluoride is not a mineral nutrient and in water is an uncontrolled use of an unapproved drug. FDA requires warning labels on all toothpastes containing synthetic fluorides, to avoid swallowing even a pea-sized amount and to prevent use in children under six who cannot control swallowing the material, because synthetic fluorides are toxic compounds when taken internally through ingestion.
Neither the EPA Office of Drinking Water nor the CDC require that water be treated with fluoride compounds. CDC recommends the practice but accepts no liability or responsibility for it and writes that cities themselves accept all liability and decide on their own accord whether to infuse fluoride compounds into water or not. The U.S. Safe Drinking Water Act prohibits any National requirement for a substance to be added to water to treat humans, or in fact any substance other than to sanitize the water. CDC recommends this water treatment with fluoridation it is prohibited from requiring. Yes the FDA reviews fluoride chemicals used by U.S. consumers. It must be emphasized that no fluoride containing material has ever been approved by the FDA to be taken internally through ingestion, and yet synthetic fluorides are mass injected into 70% of all U.S. public water supplies. Luride sodium fluoride tablets are unapproved drugs that are nevertheless allowed by the FDA by prescription only, and only in regions that have non-fluoridated water supplies, because synthetic fluorides when taken internally to affect tissue for any purpose may be considered unapproved drugs. For this reason sodium fluoride is listed in the U.S. Pharmacopeia and in Goodman and Gilman’s Pharmacologic Basis of Current Therapeutics. FDA allows bottled water that contains fluoride at 1 ppm or lower to be consumed by choice, but does not allow fluoride levels to be labeled on the bottle because fluoride is not considered a normal or necessary ingredient in fresh drinking water. Fluoride could be labeled as a contaminant but the FDA prefers the EPA to be in charge of contaminants, while the EPA recognizes that fluoride is routinely intentionally added, making it a substance used for a purpose other than an accidental contaminant or pollutant. EPA relinquished all authority to regulate water fluoridation in 1988. Many within the FDA cling to the notion that the EPA is in charge of water fluoridation, but EPA defers questions on safety and effectiveness (having no clinical trials data at hand) to the private organization the NSF, who defers such questions to the CDC, who accepts no liability for the infusions of synthetic fluorides that the “CDC” Oral Health Division consider a water supplement. All dietary supplements in the U.S. are under the control of the FDA, except the FDA considers fluoride in water to be an uncontrolled use of an unapproved drug that should be regulated by the EPA. In response to these facts, the FDA chief investigator on the fluoride water treatment ban petition (FDA2007-P-0346), accepted for review in 2007, announced that “some governmental agency has to regulate it.” Indeed, and the petition is still pending.
SNOHOMISH HEALTH DISTRICT: It is the fluoride ion, not the solid forms of fluoride, that provides the benefits of fluoridation. Fluoride is an element that binds to many other elements. Calcium fluoride does not dissolve in water, is not naturally found in significant quantities in solution in water, and is therefore not useful in water fluoridation. However, calcium fluoride crystals, formed when tooth enamel is repaired during the remineralization process, form a tooth structure that is more resistant to tooth decay. Fluorosilicic acid is a concentrated form of fluoride, is not to be consumed without first diluting with water, and is always diluted appropriately when used to provide its benefits to health.
SAUERHEBER: Fluoride is not an element. Fluorine is an element. Elemental fluorine does not exist in nature because of its extreme reactivity with virtually all other substances. Fluoride is a product ion that forms after the element fluorine (which can only be generated in a laboratory) reacts with other substances. Fluoride is reduced fluorine. Fluoride is permanent in nature because it cannot be either reduced or oxidized by other substances (Ebbing, General Chemistry). Fluoride can bind to many other elements in industrial synthetic reactions to form a variety of fluoride compounds, all of which are listed toxics on poisons registries because of extreme toxicity at minute concentrations that produce 5 ppm fluoride in blood.
Calcium fluoride is the natural compound that provides fluoride ion in some waters in the U.S. The claim that calcium fluoride does not dissolve in water is ludicrous. The solubility of calcium fluoride produces up to 8 ppm (Merck Index,1976, Rahway, N.J.) free fluoride ion at neutral pH, accompanied of course with dissolved protective calcium ion. Calcium fluoride is not a listed toxic because it is not possible to ingest sufficient quantities to be lethal, due indeed to its solubility maximum being 8 ppm. On the contrary, industrial synthetic fluoride compounds, including sodium fluoride and fluorosilicic acid, are extremely water soluble and contain no antidote calcium ion and are listed poisons, easily able to dissolve to lethal concentrations to provide lethal single oral doses of 125 mg/kg in mammals (Merck Index, 1976).
Calcium fluoride is not sufficiently soluble to be lethal by ingestion and is not recognized as a toxic and is correctly not listed on any poisons registry. Calcium fluoride was originally listed as a source chemical by the CDC for fluoridation because desired fluoride levels in water ranged from 0.7-1.2 ppm fluoride, within the solubility range for calcium fluoride.
Teeth are not re-mineralized with calcium fluoride from ingested fluoride because saliva fluoride levels average only 0.02 ppm (National Research Council, Report on Fluoride in Drinking Water, A Scientific Review of EPA’s Standards, Washington, D.C., 2006, p. 71). Saliva calcium is insufficient to precipitate fluoride at this level (i.e. the solubility product constant for calcium fluoride crystals to form is not exceeded by saliva calcium and 0.02 ppm fluoride). On the other hand, calcium fluoride globules do form temporarily on teeth surfaces treated with concentrated fluoride gels (thousands of ppm sodium fluoride), but provide little caries benefit since the formed calcium fluoride is fully soluble in even slightly acidic fluid as found during a typical meal. The calcium fluoride is then swallowed. Dental gels sadly are fully soluble sodium fluoride and that which is swallowed during treatment is fully assimilated into the bloodstream where fluoride does not belong, being not a mineral nutrient.
SNOHOMISH HEALTH DISTRICT: Water contains dozens of elements and compounds. Many of the contaminants Mr. Deal names are found in the source water from the Sultan Basin, including arsenic. Fluorosilicic acid is not an industrial grade compound. The processed compound shipped to Everett meets all federal and state requirements for safe treatment of drinking water. While the concentrated product (as do all concentrated additives) contain a variety of trace elements, these traces are either not detectable once diluted as recommended for the treatment of drinking water or occur in the finished drinking water at levels well below the safe limits set by the EPA. Everett meets the water quality standards for arsenic and lead by very wide margins. Snohomish County residents are mailed a water quality report annually.
SAUERHEBER: Contaminants present in most all drinking water supplies in the U.S. are regulated and monitored by the U.S. EPA under the Safe Drinking Water Act, and no law allows for the intentional addition into water of any contaminant at any level. Fluoride is an EPA contaminant that cannot exceed 4 ppm for water to be considered potable and to prevent skeletal fluorosis with increased bone fracture incidence (NRC, 2006, pp.151), and warnings must be provided for water with 2 ppm fluoride to minimize dental fluorosis during chronic consumption in children (NRC, 2006, pp.115-116), with abnormal enamel hypoplasia that costs thousands of dollars per tooth to restore. The EPA does not request cities fluoridate water, because fluoride is a recognized contaminant, but does not prohibit cities from choosing to do so as long as the above levels are not exceeded. EPA scientists involved in direct fluoride research oppose this allowance due to known discovered adverse serious health effects of chronic consumption of water at relatively low fluoride levels. The claim that fluorosilicic acid is not an industrial compound is disturbing. Fluorosilicic acid is not known to exist in nature, or in water in either concentrated or dilute form. Fluorosilicic acid is made synthetically, and when done so in large quantities, for industrial and other purported uses, it is indeed an industrial material compound. Fluorosilicic acid is not natural, while calcium fluoride is. In diluted, dissociated form, the fluoride ion from fluorosilicic acid is identical to fluoride ion from natural calcium fluoride, but only the latter solution has accompanying antidote calcium ion, which after ingestion minimizes assimilation of fluoride into the bloodstream. The fact that all contaminants in fluorosilicic acid, in addition to fluoride, are within EPA-allowed levels does not provide license to, or make legal, the intentional dumping of contaminants into public drinking water supplies in the United States. Point source exceptions have been often made for dumping certain contaminants into waterways by the EPA for various industries, but technically the SDWA prohibits dumping any contaminant at any level into water by intent. No exception to the SDWA has ever been officially granted to water districts by the EPA to infuse into public waters any or all of the contaminants known to be commonly present in industrial fluorosilicic acid preparations, such as arsenic and lead. No entity has legal rights to dump contaminants into a U.S. body of water simply because care is taken to ensure the final diluted level is below its EPA MCL. The NSF self-justifies certification of fluorosilicic acid by referring to fluoride as a water additive, but water additives sanitize water and are not added to treat people. Labeling fluoride as a water additive for dental benefit, as is found on some invoices for fluorosilicic acid, forces that fluoride be labeled a supplement, and alls supplements are under regulation by the FDA, not the EPA, NSF or CDC, as required by the Food Drug and Cosmetic Act.
SNOHOMISH HEALTH DISTRICT: The fluoride-rich by-products of the phosphate fertilizer industry are shipped to manufacturing plants for purification and recombination to create a variety of fluoride products for use in the treatment of drinking water. Sodium fluoride is manufactured from fluorosilicic acid. Sodium fluoride is utterly impractical for fluoridation by a large water system like the City of Everett. It is predominantly used by small water systems and in very small treatment plants.
SAUERHEBER: This statement contradicts the earlier claim that fluorosilicic acid is not an industrial chemical. Notice the admission that fluoride by-products of the fertilizer INDUSTRY are used to CREATE fluoride for use in drinking water, that is to be taken internally. No fluoridation chemical used today in the U.S. is found naturally– all are chemically synthesized. To be blunt, the claim that fluoridation is safe and natural is common and widespread but is completely false. Pure clean pristine fresh drinking water does not contain sodium or silicic acid or fluoride, as is found in waters for example in the Pacific NorthWest, that are the envy of the rest of the country. Fluoridation though produces 2-5 ppm sodium ion, 1 ppm silicic acid and 1 ppm fluoride ion, none of which belong in fresh drinking water, rendering claims that fluoridation is ‘natural’ to be incorrect. Calcium fluoride can be found dissolved in some waters but the fluoride is not considered a normal or necessary ingredient in fresh clean drinking water.
SNOHOMISH HEALTH DISTRICT:There is no measurable lead in the treated drinking water leaving the plant. Mr. Deal was provided the results of the monitoring that shows this. Numerous samples have been collected from the treated water each year since fluoridation began in 1992. Under the requirements of the EPA Lead and Copper rule which regulates corrosivity in drinking water to reduce the leaching of metals from consumer plumbing, Everett monitors for lead at consumer taps and using a “worst case” EPA sample collection protocol. The results from the past four rounds of samples collected over a dozen years show lead levels that are well below the standard set by the Lead and Copper regulation. Indeed, the levels are less than one-fifth the limits set by the standard. The raw water from Spada Lake Reservoir has low pH and low alkalinity and is corrosive without treatment. pH and alkalinity are two of the main drivers of water corrosivity and the rate at which leaching of metals from plumbing into water occurs. Regardless of the addition of the fluoride chemical, this source water requires corrosion treatment to reduce corrosivity. Reduced corrosivity is accomplished by increasing the water pH to reduce the solubility of the water and increasing alkalinity to deposit a protective alkaline film inside of the plumbing. pH and alkalinity are adjusted to optimal levels as required by the regulation. The fluoride chemical has no net effect on water corrosivity because soda ash (sodium carbonate) is added in sufficient quantity to produce the target pH and alkalinity. Keep in mind that this process reduces corrosivity and cannot eliminate it. There is no such thing as noncorrosive water. Water is the universal solvent.
SAUERHEBER: Mr. Deal has provided you with a recent Certificate of Analysis from Simplot showing that there is lead in the tanker trucks coming from Simplot. He has provided you with the 2008 NSF Fact Sheet on fluoridation, showing that fluorosilicic acid ordinarily contains lead. There is certainly lead going into the water as part of the fluoridation materials, although the typical level according to NSF is only .6 ppb to 1.6 ppb. This is too much lead to add to drinking water. There is no safe amount of lead to add to drinking water. However, this amount is small compared with the amount of lead which fluorosilicic acid leaches from pipes. Mr. Deal has provided Everett City Council with Everett Utilities test results which show up to 63 ppb lead at the tap in randomly selected Everett homes. Fluorosilcic acid leaches lead from pipes, and a lot of pipes in Everett contain lead.
Again, the levels of heavy metal contaminants after dilution not being significantly detectable is irrelevant. Their intentional infusion daily into public waters is not legal. Further, the leached lead being higher in fluorosilicic acid treated cities is due to lead leaching from lead-based plumbing (Masters and Coplan, http://www.dartmouth.edu/~news/releases/2001/mar01/flouride.html). Water districts are not in a position to measure lead levels at kitchen sinks in every treated home in any city. Measurement of undetectable lead in water leaving the plant has nothing to do with lead levels actually ingested by consumers down-line. Of course fluorosilicic acid acidity must be neutralized with alkaline chemicals. This is why sodium, which does not belong in fresh drinking water, rises in concentration in fluorosilicic acid or sodium fluoride treated water supplies. The fact that sodium carbonate is infused into water without fluoride is again irrelevant. Additional sodium chemicals must be added to neutralize the acidity of additional fluorosilicic acid when also added into water. The statement has little meaning, that water is the universal solvent and is always somewhat ‘corrosive’. Aqueous solutions are more corrosive when fluoride is present than water without fluoride at any particular fixed pH. This is because fluoride at any pH forms various trace amounts of hydrofluoric acid HF, the most corrosive substance known due to its extremely tiny size as an uncharged, non-dissociated molecule. HF is not a strong acid, since strong acids completely dissociate hydrogen ions in water. HF is a weak acid with a dissociation constant (approximately 10-5) but is comparable in size to the water molecule. Half of ingested industrial synthetic fluoride without added calcium is converted to HF in the acidic stomach which is freely permeable across cell membranes and is the form by which fluoride gains access to the bloodstream after ingestion. The fact that water corrosivity cannot ever be totally eliminated does not provide rights to add additional corrosives.
SNOHOMISH HEALTH DISTRICT: The “EPA Union” is the National Treasury Employees Union of the EPA, representing only 1,600 members out of the 18,000 EPA members nationwide. It does not represent the opinion or views of the EPA as an organization nor views of the majority of the professional employees of the agency.
SAUERHEBER: Opinions have no place in a scientific discussion. Statements made by EPA scientists are scientific and factual, not opinion. The views and opinions of any agency or its administrators, including those by the EPA as an organization, do not represent scientific facts presented by EPA scientists (or other fluoride toxicologists). Those instances when agencies or cities vote or state opinions in favor of fluorosilicic acid infusions are not armed with the whole truth prior to voting or stating such an opinion, as is evident in the points written here. It must be emphasized that the EPA, CDC and FDA are houses divided on fluoridation.
The CDC and EPA are the leading national authorities for the scientific basis for the safety and health effects of fluoride. Individuals may have different opinions, but they do not represent the views of the general scientific community.The vast majority of health professionals support and endorse community water fluoridation as stated on the American Dental Association Web site.
The CDC that purports to be a National authority on the toxicology of ingested fluoride compounds represents only a handful of dentists within the Oral Health Division, out of the vast number of professional employees of the CDC agency itself. Questions on fluoride ingestion safety or effectiveness sent to the CDC are always transferred within the agency to these few employees that represent the dental industry. The EPA Union of scientists who have conducted research on the toxicology of fluoride could reasonably be labeled a leading authority on safety of ingested fluorides, but the ”EPA” is not a leading authority on the scientific basis of the effects of fluoride ingestion because EPA administrators hold an opinion opposite that of EPA scientists who actually conduct fluoride ingestion research.
SNOHOMISH HEALTH DISTRICT: No European country has banned water fluoridation. Cuba and East Germany adopted salt fluoridation instead of water fluoridation. When piped water supplies are not available, salt or milk fluoridation is often substituted. Since the 1950’s fluoride has been made available in toothpastes, tablets, and in treatments at the dentist that also contribute to the declines in tooth decay for those that can afford them. They all have greater risks for fluorosis and toxicity than water fluoridation. Fluoride in drinking water is safest because of its low concentration and effectiveness.
SAUERHEBER: Many European countries have banned fluoride compound treatment of public water supplies, but may use language such as rejected, not permitted, or other phrases, including Austria, Belgium, Denmark, Norway, Sweden, as also have Japan and China. Some countries have not necessitated a ban because these countries do not infuse fluorides into water and have no plans to do so, including Finland, Germany and Hungary (http://fluoridation.com/c-country.htm). The only region in Europe with mandatory fluoridation is Southern Ireland, and that is soon likely to change. A detailed 348 page report of a Chartered Environmental Scientist exposed the results of long-standing fluoridation in Southern Ireland and requested to the European Union all water fluoridation be terminated immediately due to the adverse health effects that have accumulated in soft water regions of Southern Ireland because of fluoridation of water, (Waugh, D., Human Toxicity, Environmental Impact, and Legal Implications of Fluoridation, 2012; full 328 page report with 1,216 references:
Industrial fluoride ingestion from soft water lacking calcium antidote crosses the blood brain barrier where fluoride does not belong (NRC, 2006; Connett,2010), accumulates permanently in bone weakening bone at levels of 3,000 mg/kg or above (NRC, 2006), and systemic fluoride incorporates into atherosclerotic plaque in coronary arteries in cardiovascular disease patients (Yuxin, et.al., Nuclear Medicine Communications, 2012
Finally, tooth decay incidence has plummeted worldwide over many decades, in both Europe without water fluoridation and in the U.S. with widely practiced fluoridation (Connett, 2010; Waugh, 2012, p. 182).
SNOHOMISH HEALTH DISTRICT: Studies of fluorosis among people of color have found no associations with fluoride in drinking water, but they did find significant associations with fluoride in toothpastes or supplements. Toothpastes and supplements result in significantly higher ingestion of fluoride than fluoride in water supplies that adjust the level of fluoride to .7-1.2ppm. Fluoride is most effective combined with good daily home care and positive eating behaviors.
SAUERHEBER: Fluoride in toothpastes at 1,500 ppm and supplements of Luride (pure sodium fluoride) are more concentrated than fluoride in treated water supplies and of course can produce, after being taken internally, significant abnormal tooth fluorosis with enamel hypoplasia that is permanent. However, more than 50% of the fluoride concentration in the bloodstream of consumers in a fluoride treated city is that ingested from water (NRC, 2006, p. 62). As expected by fluoride toxicologists, the incidence of permanent abnormal tooth fluorosis always increases significantly in cities where water supplies are treated with fluoride, without exception. The fact that the remainder of blood fluoride is from supplements, dental gels, foods and other sources does not excuse the major contributor from fault. The reason Health and Human Services requested fluoride levels in water be lowered to 0.7 ppm is because of the endemic of this condition, in 41% of U.S. teens aged 12-15 as of 2004.
SNOHOMISH HEALTH DISTRICT: These studies were done in China and countries outside the United States. They had significant flaws in the research designs. For example, China, along with many countries, has fluoride levels in drinking water far in excess of the 4 ppm allowed in U.S. drinking water that were not accounted for in the analysis.
SAUERHEBER: All epidemiologic studies have flaws by design. There are no perfect studies among human populations that are not controlled clinical trials with human volunteers. Confounding variables are difficult to control perfectly, and some of the most egregious violations are those in which the idea of water fluoridation began, where alterations in teeth structure caused by extremely high calcium levels in water supplies in the Southwest were attributed instead to the presence of fluoride from natural calcium fluoride. There are studies correlating progressively decreasing IQ with progressively increasing blood fluoride levels, which eliminated the complication mentioned of the specific fluoride level in water being different than used in the U.S. The effects of systemic fluoride on brain function are widely published (Connett, 2010, pp. 148-156; NRC, 2006, pp. 205-223). It is the blood concentration that determines toxicity, not the actual level in water, but how much water is actually consumed and for how long.
SNOHOMISH HEALTH DISTRICT: Dental fluorosis occurs among some people in all communities, even in communities that do not fluoridate or have a low natural concentration of fluoride in their drinking water. Everyone is encouraged to know what steps can be taken to reduce the occurrence of dental fluorosis. Elimination of water fluoridation will not eliminate moderate or severe fluorosis. Severe fluorosis, which is cosmetically unsightly, is very rare in the U.S. provided fluoride levels are maintained less than 2ppm as recommended by the EPA.
SAUERHEBER: The claim that elimination of water fluoridation will not eliminate severe dental fluorosis is not referenced and is without merit. Notice in fact that it is contradicted in the very next statement, that severe fluorosis is rare as long as water levels are less than 2 ppm fluoride. What? Elimination of water fluoridation would certainly eliminate water concentrations in excess of 2 ppm in most all U.S. water supplies. Again, the EPA does not recommend any fluoride compound to be infused into water, or that water be treated with fluoride compounds at all (personal communication, Jill Korte, EPA, Office of Drinking Water, 2012). 2 ppm was set by EPA as a level at which cities must warn citizens, since it is known to the EPA (as a body agency) that this level can cause severe enamel fluorosis after continuous consumption long-term as a child when teeth are developing. The idea that the EPA recommends adding fluoride at less than 2 ppm does not respect the meaning of a secondary maximum contaminant level SMCL. The EPA has no authority to set the level of any substance designed to treat a human disease condition by being taken internally through ingestion. The EPA not only does not conduct controlled clinical trials with human volunteers but also has no Congressional authority to do so. EPA regulates contaminants and pollutants found in water either accidentally or naturally, such as arsenic in many U.S. water supplies that occurs naturally. But EPA cannot endorse the infusion of fluoride contaminants into water at any level, whether below the allowed maximum contaminant level MCL or not, where the EPA, as are all Americans, is constrained to abide by and uphold statues of the U.S. Safe Drinking Water Act. Furthermore, any use of a substance used for its biologic effects on humans taken internally by ingestion requires approval by the U.S. Food and Drug Administration according to Federal law embodied in the Food Drug and Cosmetic Act. As mentioned, the FDA has never approved any fluoride containing substance to be taken internally through oral ingestion in the U.S. (Waugh, 2012, p. 333) and has ruled that fluoride is not a mineral nutrient and its addition into water constitutes an uncontrolled use of an unapproved drug. In 1988 EPA published in the Federal Register that it terminated the agreement it made in 1979 (1979 MOU) with FDA to regulate water additives. This was effective in terminating the 1979 MOU (53 FR 25586-89). Finally, the FDA in 1996 published it would no longer avoid Food Drug and Cosmetic Act regulations for water additives in public water systems. Thus the FDA is in full charge of chemicals added to municipal drinking water as drugs for the purpose of altering tissue to treat or prevent diseases, including dental caries. Federal law prohibits marketing any drug without FDA pre-approval. According to statutory law (United States Code 21 U.S.C. 321(ff), for foods or water swallowed with ingredients to prevent disease, such ingredients are drugs. Public drinking waters are fluoridated to prevent dental caries disease and therefore are drugs (21 U.S.C. 321(g)(1)(B)).
SNOHOMISH HEALTH DISTRICT: All fluorides work systemically and topically. When fluoride is available at low levels in drinking water, it is absorbed in the blood stream, circulates in the saliva, and becomes available at the enamel level of the crevicular fluid. As the teeth go through the daily demineralization/remineralization cycles, the fluoride is available at a constant level to remineralize tooth enamel that results in stronger fluoride structure. During tooth development years, fluoride is also incorporated into the developing enamel of the permanent teeth as fluorapetite, which is also resistant to tooth decay.Topical fluorides, such as fluoride toothpastes and supplements are related to higher rates of fluorosis. Moreover, fluoride treatments, limited to the application to teeth, are the most expensive of fluoride methods, wear off fairly quickly, and must be repeated regularly to maintain the benefits.The question is not that fluoride is forced on everyone, but should the majority of Snohomish County residents be forced to pay the significant cost increase for alternatives. Other sources of drinking water are available for those that believe differently (e.g., home filtration or bottled water).
SAUERHEBER: Fluoride after ingestion exerts abnormal toxic effects systemically from the bloodstream, and fluoride applied in pastes and gels exerts effects topically. The topical effects of fluoride from saliva are insignificant at only 0.02 ppm fluoride that filters from the blood after swallowing. 0.7 ppm fluoride in water during a short swallowing residence time of course is also insignificant compared to 1,500 ppm fluoride in pastes. Calcium fluoride globules from topical fluoride applications can coat the surface of enamel, but do not incorporate into enamel hydroxyapatite itself. These globules do not form from fluoride at levels found in water supplies, but do so at fluoride levels in pastes and gels. Calcium fluoride globules are fully soluble at neutral or acidic pH and are quickly dissolved upon eating a meal or drinking and are then swallowed. At one time it was proposed that abnormal teeth enamel fluorosis that occurs in fluoridated cities was associated with incorporation of fluoride into enamel, but enamel deficiency is believed to be due to failure of enzymes to remove albumin from developing teeth. Moreover, X-ray studies in detail show that even soaking teeth in 10,000 ppm fluoride gel only forms calcium fluoride globules on the outer surface of teeth. The question at hand is most certainly whether citizens should be forced to have water supplied with added fluoride or not. If that is not the question, then why are we discussing the fluoridation of water? Cavities can be prevented without fluoride because absence of fluoride is not what causes caries. Caries are caused by sugary foods that are not washed from teeth for prolonged periods, allowing bacterial growth with acid secretions that cause enamel dissolution. Brushing teeth more often and eating less or no sugar or acidic sodas are safe methods than can eliminate caries. Natural normal drinking water does not cause caries. Treating people with industrial fluoride systemically in the bloodstream and all bodily organs, for those with caries, produces two problems, caries and fluoride where it does not belong, compared to caries and clean drinking water where one can choose to brush more and can choose to not eat or drink sodas and sugar. Home filtration and bottled water are not ‘answers’ for those who prefer not to drink water with added industrial fluoride. The fluoride ion is smaller than the length of the oblong water molecule (2.7 Angstroms) and cannot be filtered, even by typical reverse osmosis units. Ultra tiny pore sizes in various retail RO units now can eliminate fluoride but this also wastes several gallons of water for every gallon of product water. Distillation can separate clean water from fluoride, but this also removes valuable minerals, as does RO. Bottled water is often reverse osmosis treated municipal water and fluoride content can vary widely and must be tested. Bottled waters that are naturally devoid of fluoride can be found, but if water were left naturally fluoride free in the first place, the problem of freedom of choice would be eliminated. Those who believe in water fluoride consumption can obtain a prescription from a physician for fluoride tablets to add to glasses of water if desired, but such treatments are only allowed in cities that are not fluoridated, as per dosage instructions on Luride tablets allowed by the FDA as the unapproved drug it is.
SNOHOMISH HEALTH DISTRICT: Fluoride at the level of .7ppm to 1.2ppm does not cause harm. Fluoride at levels of 4 ppm or greater are not allowed in drinking water in the United States.Economists may disagree on the assumptions and ultimately on the economic benefits. However, the health benefits are clear. Given the low costs of fluoridation, the health benefits are cost-effective.
SAUERHEBER: Fluoride incorporates into bone irreversibly, typically in 1 ppm drinking water to 2-3,000 mg/kg in 24 months (NRC, 2006, p.94) which after lifetime consumption weakens bone making bone more subject to fracture (NRC, 2006, p. 158, lines 14-18). Consumption of 1 ppm fluoride water causes 0.21 ppm fluoride in blood which is sufficient to decrease IQ. In cardiovascular disease patients systemic fluoride incorporates into atherosclerotic plaque and hardens coronary arteries, the Nation’s number one disease incidence entity. There are no health benefits of ingested industrial fluoride. The CDC’s own published studies (Morbidity and Mortality Weekly Report, Aug., 2001) reported that fluoride does not act on teeth systemically from the bloodstream, and topical fluoride in saliva from ingestion is too low in concentration to affect teeth, as can 1,500 ppm fluoride in pastes. Since there is no benefit of ingested fluoride, the cost of fluoridation is not only excessive but is wasted.
SNOHOMISH HEALTH DISTRICT: You can find listings of the studies included by the Reviews conducted by CDC, EPA and ADA (and others) and they are available (for free or by purchase) through the U.S. Library of Congress (PubMed-Medline) listings of scientific peer-reviewed literature.
SAUERHEBER: Literature citing other literature and re-writing endorsements for fluoridation based on observations and anecdotal correlations, no matter how profusely such claims are made thousands of times, do not constitute proof of either safety or effectiveness. In fact, the largest taxpayer funded studies we have prove that fluoride in water does not decrease dental caries (Zeigelbecker as reviewed in Connett, 2010, pp. 50-51). The largest and longest study was international by Teotia (Fluoride 1994; 27(2): 59-66.) who concluded the same, that fluoride in water does not decrease dental caries which are lowest in those with calcium and vitamin D sufficient diets along with water that is not fluoridated. The highest caries incidence rate was found in those with calcium deficient diets and with fluoride in water.
SNOHOMISH HEALTH DISTRICT: The study you cite states that HHS recommends an optimal fluoride concentration of 0.7 mg/L for community water systems based on the following information: Community water fluoridation is the most cost-effective method of delivering fluoride for the prevention of tooth decay;• 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;• Significant caries preventive benefits can be achieved and risk of fluorosis reduced at 0.7 mg/L, the lowest concentration in the range of the U.S. Public Health Service recommendation.• Recent data do not show a convincing relationship between fluid intake and ambient air temperature. Thus, there is no need for different recommendations for water fluoride concentrations in different temperature zones.
SAUERHEBER: Risk of fluorosis is indeed reduced with water at 0.7 ppm fluoride compared to water with 1.2 ppm or higher, but fluorosis incidence nevertheless is higher in all cities treated with fluoride compared to that city without fluoride addition.
SNOHOMISH HEALTH DISTRICT: Everett Water District fluorosilicic acid compound meets the ANSI/NSF Standard required to create safe drinking water.
SAUERHEBER: NSF certification for fluorosilicic acid is conducted against its own regulations. This is why fluoride is properly termed a protected pollutant. NSF requires that levels of substances in water after dilution shall not exceed 10% of its EPA MCL. 10% of 4 ppm is 0.4 ppm, and even the new lowered amount requested by HHS of 0.7 ppm is in excess of NSF’s own requirement. Further, NSF shall not certify batches of fluorosilicic acid that contain more than1% HF. Everett fluorosilicic acid batches have been assayed at 2% HF and NSF ‘certification’ is improper.
SNOHOMISH HEALTH DISTRICT: The consumption of undiluted, concentrated fluoride materials would be toxic.
SAUERHEBER: This is a true statement, but does not address long-term toxicity of diluted fluorosilicic acid after lifetime consumption, particularly in the infirmed, those who consume more water than normal such as diabetics, and those with diseased, damaged or missing kidneys who do not eliminate fluoride well or at all. The statement also contradicts the often quoted claim that the listing of fluorosilicic acid on poisons registries is of ‘little concern, because even water can be toxic’. Consumption of pure undiluted water at 1,000,000 ppm (55 molar) is not toxic and in fact is a requirement at this concentration in all living systems. However, drinking fluorosilicic acid at only 125 mg/kg single oral dose is lethal, producing 5 ppm in blood that is sufficient to cause acute heart failure, as occurred with fluoridated water supplies during accidental overfeeds in Hooper Bay, Alaska and in Illinois and Maryland kidney dialysis centers (Gessner, New England Journal of Medicine, 1994, p.330). Water is an absolute requirement for life, but fluoride is not and is not a mineral nutrient.
SNOHOMISH HEALTH DISTRICT: The statement that fluoridation is illegal suggests a failure to understand the process by which NSF standards are set. The toxicology work needed to establish the standard was done by the EPA and others and was obtained by NSF as part of the standard development process. This information is available online. Toxicology studies are only required if no existing studies and data are available for the contaminant in question. This was not the case for fluoride, lead or arsenic, all of which were considered in the standard setting process and for which robust studies were available from the EPA.
SAUERHEBER: EPA toxicology research on pollutants is largely based on animal testing (as reviewed by the CDC in Agency for Toxic Substances and Disease Registry, Fluorine, Hydrogen Fluoride, and Fluorides, U.S. CDC, 2003). Since industrial fluoride (not natural calcium fluoride) was found to increase incidence of bone cancer in mammals, EPA scientists have become convinced to oppose treatment of public water supplies with synthetic fluorides. It is illegal however to conduct studies with contaminants or pollutants on humans without oversight by the National Institutes of Health or controlled clinical trials for substances proposed to be used as drugs for FDA approval. Clinical trials on human fluorosilicic acid ingestion have never been done and have never been authorized. All other human studies citing effectiveness and safety of fluoride ingestion are merely either observational (such as the original correlation proposed relating natural fluoride levels in water to dental decay incidence in 1939) or anecdotal correlations, including the original sodium fluoride treatment of public water supplies in Grand Rapids, MI and Newburgh, N.Y., neither of which were conducted with people who volunteered to be controlled for dietary and other variables. Epidemiologic studies best controlled for confounding variables were reviewed in Yiamouyiannis, Fluoride the Aging Factor and in Connett, 2010) finding a 10-15% increased incidence of various cancers in U.S. cities treated with synthetic fluoride over chronic time periods. Thorough critical analysis of these data led to rulings in three separate U.S. courts that synthetic fluoride treatment of drinking water causes increased incidence of deaths due to cancers.
A false belief is wide spread, that any fluoride may be used to treat water supplies without being tested since natural calcium fluoride and sodium fluoride has been ‘tested.’ Toxicity of fluoride is determined by the environment in which fluoride resides. In hard calcium-rich water, assimilation of fluoride is inhibited and for this reason calcium fluoride is not a listed poison, as are all synthetic fluorides; and calcium is the antidote for poisoning from synthetic fluorides. Moreover, arsenic fluoride and fluorosilicic acid fluoride have different toxic properties than sodium fluoride due to the particular material with which fluoride must associate when infused into water. Long-term chronic toxicity of water treated with fluorosilicic acid fluoride (most commonly used in the U.S.), arsenic fluoride (not used in water fluoridation), sodium fluoride (used in 10% of U.S. fluoridated cities) or calcium fluoride (not used for fluoride infusions in U.S. waters) all differ in chemical behavior and require separate clinical trials testing for effectiveness and safety. No human clinical trials required by the Food Drug and Cosmetic Act for any purported ingestible have been conducted or authorized to be conducted for any of these substances. EPA has not considered modern published findings on synthetic fluoride toxicology in man or animals that requires a re-assessment of allowed MCLs for synthetic fluoride as requested by the National Research Council in 2006. EPA has not considered the serendipitous finding published January 2012 by the Veterans Administration Health Care Center, Los Angeles (Yuxin, 2012), that systemic fluoride incorporates into atherosclerotic plaque in coronary arteries of cardiovascular disease patients, contributing to the Nation’s leading lethal disease. This fact is introduced to help explain why there are no data for synthetic fluoride ingestion that could ever constitute being ‘robust studies.’ Robust is a relative term and thus useless in this discussion.
SNOHOMISH HEALTH DISTRICT: Everett supports community water fluoridation as a safe, effective, low cost and equitable means to reduce tooth decay. We defer to our elected officials to determine the need for hearings. If hearings are held, we will certainly participate.
SAUERHEBER: Many residents in Everett do not support water fluoridation and understand full well that it is not safe for all, it is ineffective and it is not low cost.
SNOHOMISH HEALTH DISTRICT: The $300,000 treatment cost of fluoridation equals approximately 54 cents per person per year for the 560,000 persons benefiting from fluoride in drinking water. Elimination of fluoridation would save the average Snohomish County resident less than a penny a gallon.
SAUERHEBER: This does not include the costs to construct fluoridation equipment, tanks, meters, plumbing alterations that is millions of dollars for cities the size of Everett. Nor does it factor in the costs of tooth restorations for those who do not wish to have permanent abnormal fluorotic teeth enamel. Nor does it include costs associated with treating those with bone disease for whom fluoride consumption is contraindicated. Nor does it include costs associated with treatment of bone replacement surgeries now common in the U.S. or convalescent care for those with bone fractures after lifetime consumption of industrial fluoride with bone loading above 3,000 mg/kg, a level expected to be exceeded by lifetime residents in soft water fluoridated Everett. The U.S. now has an epidemic of hip fractures in the elderly with 1/3 million cases annually. The continued, intentional incorporation of fluoride lifetime into bone through industrial fluoride infusion into public drinking water under these conditions is inexcusable.
SNOHOMISH HEALTH DISTRICT: The ADA, EPA and especially the CDC have valuable sources of information.
SAUERHEBER: The ADA is a professional dental association whose advice regarding drinking fluoridated water is inconsistent, especially when it comes to infants. The EPA and CDC are agencies within which supporters of fluoride infusion can be found, but within which also strict opposition to fluoride treatment of water is also present. These agencies are divided. Regardless, no Federal agency can require the infusion of any chemical substance into water other than to sanitize the water. Specifically, 42 U.S.C. §300g-1(b)(11) states “No national primary drinking water regulation may require the addition of any substance for preventative health care purposes unrelated to contamination of drinking water.” As published by Graham and Morin (Highlights in North American Litigation during the Twentieth Century of Artificial Fluoridation of Public Water Supplies, J. R. Graham and P. Morin), this provision was intended by Congress to prohibit the use of the Safe Drinking Water Act as a means of imposing artificial fluoridation of public water supplies throughout the United States.
Note that unscrupulous individuals have attempted to evade this Statute by inserting amendments providing for exceptions, to allow the intentional injection of synthetic industrial fluorides into public water supplies, but the original Congressionally approved Statute and its intent remain un-repealed at this time.
SNOHOMISH HEALTH DISTRICT: Recognizing that “fluoridation is the single most effective public health measure to prevent tooth decay,” the Snohomish Health District’s Board of Health formally endorsed fluoridation by unanimous vote of Resolution Number 89-27 at its May 9, 1989 meeting.
SAUERHEBER: The result of an election, no matter how fair and Democratic it may or may not be, is not always the correct one. More often than not citizens vote against fluoridation, and this is likely to be the case when voters are actually fully informed on what the toxic hazardous waste material actually is and that it introduces three materials into water that are not ingredients found in normal pristine clean fresh drinking water.
Again, feel free to email me or call me if you need clarification or additional information. I look forward to you coming over to our side of this issue.