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Expert Evaluation by Michael Waalkes, Ph.D. <br /> A concern has been expressed by some that fluoride is not "approved" by the U.S. Food and <br /> Drug Agency (FDA) and therefore, implicitly, its use as a public health measure via addition to a <br /> drinking water system is inappropriate. In point of fact, the U.S. Environmental Protection Agency (EPA) <br /> has Federal regulatory oversight of public drinking water (tap water) under the 1974 Safe Drinking <br /> Water Act (SDWA; FDA 20171). Thus, the FDA does not have Federal regulatory responsibility for <br /> drinking water quality or safety standards, including the use of fluoride in this specific fashion. <br /> Furthermore, the US EPA takes the view that fluoride is voluntarily added to drinking water systems by <br /> a State or local municipality as a safe public health measure in order to help reduce the incidence of <br /> cavities among the population drinking that water. <br /> Consistent with its responsibilities mandated in the SDWA, the US EPA has performed extensive <br /> assessment of available data on any toxic or adverse effects published in the scientific literature <br /> concerning fluoride in the drinking water. The EPA concludes (EPA 20192) there is no known or <br /> expected risk to health from drinking water fluoride levels drastically higher (4.0 mg/L) than the level of <br /> fluoride used at the recommended level for drinking water fluoridation (0.7 mg/L). Furthermore, when it <br /> comes to specific compounds of fluoride, sodium fluoride supplementation is considered by the United <br /> Nations World Health Organization to be both a highly safe and very effective agent in preventative <br /> dentistry and its use is considered critical to an effective health care system (WHO 20173). <br /> Conclusion: <br /> In conclusion, a decision to fluoridate a water supply is made by a State or local municipality. It is <br /> not approved or mandated by any Federal Agency including the FDA, EPA or any other US Federal <br /> Government entity. Thus, the absence of Federal approval for the use of fluoride in this fashion has no <br /> bearing on the regulatory validity of its use in this manner. <br /> 42 <br />