Comment from Richard Hudon

Docket No.FDA-2026-P-6813 Comment in Support of Citizen Petition I respectfully submit my comment in support of the Citizen Petition requesting a determination regarding the regulatory status of fluoride compounds distributed for community water fluoridation and intended for human ingestion to prevent dental caries, aka tooth decay. A response frequently given in discussions concerning fluoridation is that the FDA does not regulate public water systems. I understand and agree that public water systems are regulated under other authorities and that FDA is not responsible for operating or regulating municipal water utilities. However, that is not the question presented in this petition. The petition does not ask FDA to regulate water systems, water utilities, drinking water quality, or local fluoridation decisions. Instead, the petition asks FDA to address a different question: how the Federal Food, Drug, and Cosmetic Act applies to manufacturers and distributors of fluoridation chemicals that are produced, marketed, and distributed for community water fluoridation and intended for human ingestion to prevent dental caries. My comment is simple, in the form of a 4 part question. How can the FDA support the use of an industrial, toxic waste chemical that somehow magically becomes therapeutic between its production and its transportation to a water treatment facility to be dripped into drinking water without there being any statutory framework considerations as to 1. its toxicology, 2. its innocuous nature, 3. not being manufactured in GMP facilities, 4. not being certified or regulated as a drug by any agency for its intended use. The Citizen Petition does not ask EPA to regulate fluoridation chemicals. It does not ask FDA to regulate water utilities. Rather, it asks FDA to explain how the Federal Food, Drug, and Cosmetic Act applies to fluoride compounds distributed for community water fluoridation and intended to prevent dental caries. If the FDA concludes that such fluoridation chemicals are not subject to the same statutory framework applicable to other fluoride products intended to prevent dental caries, the public deserves a clear explanation of the basis for that distinction. Regardless of one's views concerning fluoridation policy, the questions presented are reasonable and deserve a substantive response. I respectfully request that FDA provide a written determination, explain the basis for that determination, and identify the regulatory consequences that follow. I contend that the FDA's determination will impact other jurisdictions, in my case, Canada, therefore, this intervention. Respectfully submitted, Richard Hudon, Co-founder & board member: Fluoride Free Canada - Canada sans fluorure https://www.fluoridefreecanada.ca/ BEng, MSc Astronomy Certified Systems Analyst Independent Health Researcher 3755 Loch Garry Rd Apple Hill, ON K0C 1B0 613-861-6510