Comment from Karen Spencer

Attached please find my comment in support of the Citizen Petition requesting that FDA provide a determination regarding the regulatory status of fluoride compounds distributed for community water fluoridation and intended for human ingestion to prevent dental caries. The comment includes supporting references. In summary, significant scientific, legal, and ethical questions remain regarding the use of fluoridation chemicals in public water supplies for the purpose of preventing dental caries. Water is regulated as a food when bottled, and fluoridated water is consumed directly and used in the preparation of foods and beverages. Because fluoride is intentionally delivered to consumers for a disease-prevention purpose, there is a substantial question as to whether its use falls within FDA's responsibility to evaluate safety, efficacy, dosage, and conditions of use. I believe the FDA should formally address the regulatory status of fluoridation chemicals and provide clear guidance regarding their use for community water fluoridation. Regards, Karen Favazza Spencer Regards, Karen Favazza Spencer