February 5, 1996
The US Environmental Protection Agency, Food and Drug Administration, Public Health Service and Centers for Disease Control have a one size fits all policy regarding fluorides. They assume a pharmaceutical grade sodium fluoride is an appropriate clinical research surrogate for all fluorides. They also assume that naturally fluoridated areas are an appropriate surrogate when acquiring statistical research data regarding health problems arising from chronic fluoride toxicity. However, neither surrogate approaches the toxic reality of artificial water fluoridation agents nor does the assumption make for responsible science.
Present fluoridation research standards do not account for toxic interaction with water treatment chemicals or the types and grades of fluorides used as water fluoridation agents (recovered fluorine bound pollutants). For the past fifty years, it seems that all fluoride research projects have carefully avoided addressing the captured industrial fluoride pollutants used for fluoridation. These pollutants contain a variety of toxic fluoride compounds and complexes that would produce results quite different than the research performed with pharmaceutical grade sodium fluoride or statistical research data gathered in naturally fluoridated areas.
Fluorides seem to be one of the few drugs to have escaped the scrutiny of the US Food and Drug Administration. The FDA policy regarding fluorides is: They do not object to their use, however, fluorides are still classified as unapproved new prescription drugs.
The FDA requires manufacturers to list ingredients and post warnings on the packages regarding medicants made available for public use; however, water departments are not required to inform citizens of potential adverse health effects or the other toxic contents of fluoridation agents, which is their legal responsibility.
Unlike any other drug made available for public use, fluoridation agents have not been submitted to rigorous testing by the manufacturers or reviewed by the FDA. With any other medicant, prescription or non-prescription drug (even toothpaste), before the product can be made available to the public, the manufacturer is required to submit a New Drug Application with the FDA and proceed to perform a battery of safety and effectiveness tests costing millions of dollars. The manufacturers of industrial effluent fluoridation agents have never commissioned or performed any research to prove their product is either safe or effective. The fluorides used for water fluoridation are not the same chemical formulas as naturally occurring fluorides or the sodium fluoride used for clinical research.
After fifty years, the FDA has not defined or categorized the fluorides used for water fluoridation or medical purposes. As of 1988, the EPA no longer regulates the quality of fluorides used to fluoridate drinking or water treatment chemicals. The task of establishing water treatment chemical standards (including fluorides) was handed to the nonprofit, partially Government funded corporations, National Sanitation Foundation (NSF) and American Water Works Association (AWWA). The NSF relies on the AWWA to establish the recommended standards.
Members of the committee writing fluoridation standards, AWWA B703-94 for sodium fluoride (sodium fluorosilicate) and fluorosilicic acid include the Vice-Chairperson and the Secretary who represent the manufacturers and vendors of fluoridation agents.
In concert with the American Dental Association, US Public Health Service and US Centers for Disease Control, the AWWA promotes the use of untested, industrial effluent fluoridation agents. US Government agencies spend millions of dollars a year in block grants to defer fluoridation start-up costs, a two year supply of water fluoridation agents and engineers fees.
Tudor Davies, Office of Science and Technology, USEPA says in a 1993 letter that US Government Agencies could not require water fluoridation because the practice violated the Safe Drinking Water Act, yet there was no mention of a conflict of interest regarding the promotion, funding and recommending of fluoridation by Government agencies. US Government agencies are violating federal laws by promoting and funding fluoridation.
Fluorides were declassified as essential nutrients by the National Research Council in 1989. At that time, the manufacturers of fluoridation agents should have been required to apply for a new drug application. However, the FDA has not required the manufacturers to ever apply for a new drug application or prove their products are safe and effective.
The reclassification of fluorides would also require that the manufacturers comply with the Toxic Substances Control Act. The act requires that manufacturers of new chemical compounds are to determine what effects the compounds will have on the environment and people before they can be made available for public use.
The EPA policy regarding the use of toxic waste fluorides as stated by EPA attorney, Steve Speigle is: “The EPA encourages industry to find markets for their recovered pollutants.” Letters dating back to 1978 from EPA personnel state that industrial effluent fluorides are used because the use of food or pharmaceutical grades of fluorides would be prohibitive for water fluoridation because of cost factors. Another letter (1983) states that the use of industrial effluent fluorides is the ideal solution to a long standing problem.” The use of the toxic wastes reduces air and water pollution while offering a cheap source of fluoride to water departments.
Fluorosilicic acid and sodium fluorosilicate have been used extensively as water fluoridation agents for almost twenty-five years. During the twenty-five years, neither the EPA nor other responsible Government agencies have commissioned any clinical research using recovered fluorine based pollutants.
Out of over 3,700 peer reviewed studies, the responsible US Government agencies cannot produce one study that addresses the fluorides used for artificial fluoridation or enhanced toxicity of fluoride compounds and complexes created by the interaction of added fluorides and water treatment chemicals. The EPA has not offered any reason for not requiring the products to be proven safe and effective other than that they “assumed” that a pharmaceutical grade of sodium fluoride was an “appropriate surrogate.” It appears that water fluoridation as a public health issue is a facade for the cost-effective disposal of toxic fluoride pollutants which is supported and encouraged and encouraged by the EPA.
US Government agencies in collusion with the American Dental Association, American Water Works Association and the manufacturers of fluoridation agents are, by promoting and funding water fluoridation, blatantly violating the Safe Drinking Water Act, Drug and jCosmetic Act and Toxic Substances Control Act. There is absolutely no data even remotely suggesting that the water fluoridation agents being sold to the public are safe and effective.
In the past, fluoridation opponents approached the legality of water fluoridation as either a health or Constitutional issue (freedom of choice):
- As a health issue, most judges are ambivalent because the cases become a contest of who can produce the most studies and experts.
- The Constitutional approach (freedom of choice) has been successfully used at a state level; however, the US Supreme Court ruled that water fluoridation falls under the Police Powers Act and municipalities have the power to mandate fluoridation. The US Supreme Court now refuses to hear cases involving the constitutionality of fluoridation.
To date, no one has ever challenged the legality of fluoridation on the issues of product substitution, product liability and the violation of federal laws. Toxic fluoride pollutants are being sold to the public via drinking water with the implied warranty that the product will reduce cavities and, in some cases, promote strong bones. These claims are based on clinical research using pharmaceutical grade sodium fluoride or statistical data gathered from naturally fluoridated areas instead of the contaminated toxic waste used to fluoridate the water. The only common factor shared by the products used for research purposes and water fluoridation is the fluorine ion and maybe sodium. Otherwise, the molecular makeup, toxic volatility and reactivity of the fluoride compounds are vastly different.
The statement that the fluoridation agents sold for water fluoridation are safe and effective are not founded in science since neither the manufacturer, responsible government agencies nor municipalities and water departments can provide evidence that the products being sold to the public performs to the stated standards or the implied warranty. The Fitness for Particular Purpose concept of an implied warranty states that the buyer relies on the sellers expertise and judgement that the product will be suitable and conform to implied promises. This implied warranty applies to water fluoridation.
The use of federal funding to subsidize or promote water fluoridation is also illegal and can be contested in court. Water fluoridation violates the Safe Drinking Water Act and Toxic Substances Control Act.
Individuals, water departments, municipalities and states can also be held liable for damages or injury occurring from fluoridation. There is an assumption of risk involved with water fluoridation because fluorides are classified as:
- an “unapproved prescription drug by the USFDA.
- contaminates and they are regulated by the USEPA.
- hazardous waste; an uncontained spill of fluorides of on-hundred pounds is required to be reported to the USEPA.
- peer reviewed research regarding suspected and real adverse health effects from water fluoridation and fluorine based medicants are regularly published in dentistry, medical and government publications.
The present method of instituting water fluoridation is to avoid public referendum and to solicit elected officials, either state or local, to introduce and vote on the fluoridation measure. Consequently, the elected official assumes the liability for any damages or injuries incurred from mandated fluoridation. It is the elected officials duty to act in a reasonable and prudent manner regarding the safety and welfare of their constituents. Tort law supersedes the Police Powers Act. In cases where elected officials are made aware of the possible risks of fluoridation, the action becomes an intentional tort where it is foreseeable that injury could occur. This scenario also applies to water departments who should be aware of the dangers and the fact water fluoridation violates the Safe Drinking Water Act. It is conceivable that a party could sue a water department for damages and a refund of money for delivering nonconforming goods. The potential for fluoride tort litigation is almost endless and as a California attorney stated, “Fluoride tort litigation is a whole new area of law.”
Health Effects of Ingested Fluoride, NAS/NRC, 1993, National Academy Press, Washington, DC.
Correspondence from the US Environmental Protection Agency:
1978, Ervin Bellack to Col. G. Lindegren.
1983, R. Hanmer to Dr. L. Russel.
1993, T. Davies to Mrs. C. Cate.
1995, T. Davies to G. Glasser.
Correspondence from Florida Human Resources and Rehabilitative Services:
1990, S. Allen, Florida State Fluoridation Director to H. Tolsen, Director of Inner City Government Relations, St. Petersburg, Florida.
The Uniform Commercial Code.
CRC Handbook of Chemistry and Physics, College Edition, 1993, Chemical Rubber Company, Cleveland, Ohio.