Comment from Beth Ottman RN

Docket No. FDA-2026-P-6813 Comment Submitted by Beth Ottman, RN I am a Registered Nurse and am submitting this comment in support of FDA providing a substantive written response to the Citizen Petition regarding fluoride compounds distributed for community water fluoridation. Throughout my nursing career, I have been taught the importance of patient safety, informed decision-making, and clear regulatory accountability. Public confidence in health recommendations is strengthened when government agencies clearly explain the legal and scientific basis for their decisions. The Citizen Petition raises an important and reasonable question. FDA recently stated that ingestible fluoride products intended to prevent dental caries have not been approved through the New Drug Application process. The petition respectfully asks FDA to explain how that determination applies, or does not apply, to fluoride compounds distributed for community water fluoridation. One reason I believe FDA should answer this question is that organizations supporting community water fluoridation consistently describe its purpose as the prevention of tooth decay. The Centers for Disease Control and Prevention describes community water fluoridation as adjusting fluoride in drinking water to a level recommended to prevent tooth decay. The American Dental Association states that community water fluoridation helps prevent cavities and tooth decay. United States Surgeons General have endorsed community water fluoridation because of its role in preventing tooth decay and improving oral health. NSF International, an organization that certifies fluoridation chemicals used in public water systems, states: "Fluoride is added to water for the public health benefit of greatly reducing the incidence of tooth decay and therefore improving the health of the community." The Washington State Department of Health likewise discusses fluoridation as an oral health measure available to communities. Seattle Public Utilities has fluoridated its drinking water since 1970 and maintains fluoride levels consistent with recommendations from public health authorities. Like CDC, ADA, the Surgeon General, NSF International, and the Washington Department of Health, Seattle discusses fluoridation in the context of reducing tooth decay and improving oral health rather than improving the taste, appearance, or potability of water. Taken together, these organizations consistently identify the purpose of community water fluoridation as prevention of dental caries. FDA's own published guidance explains that intended use may be established not only through labeling and promotional claims, but also through consumer perception and through ingredients having a well-known therapeutic use. FDA specifically identifies fluoride in toothpaste as an example of an ingredient having a recognized therapeutic use. When federal agencies, state agencies, local governments, professional organizations, public water systems, and the public all describe community water fluoridation as a measure intended to prevent tooth decay, the intended purpose appears clear. NSF certification evaluates contaminants, manufacturing processes, impurities, and other drinking-water-treatment considerations. Those are important functions. However, NSF certification is not the same as FDA review under the Federal Food, Drug, and Cosmetic Act. NSF does not determine whether a product satisfies the statutory definition of a drug, conduct New Drug Application review, or establish FDA-approved indications, dosage instructions, contraindications, warnings, or conditions of use. The Citizen Petition does not ask FDA to regulate water systems or drinking water quality. It asks FDA to explain how the Federal Food, Drug, and Cosmetic Act applies to fluoride compounds distributed for community water fluoridation and intended for human ingestion to prevent dental caries. Regardless of one's views regarding fluoridation policy, I believe the public deserves a clear explanation regarding the regulatory framework that applies to products intended to prevent disease. I respectfully request that FDA provide a substantive written response to the questions presented in the petition, including a determination, the basis for that determination, and the regulatory consequences that follow from that determination. Respectfully submitted, Beth Ottman, RN Issaquah, Washington