FDA issues new — and controversial — guidance on fluoride for young children Image By HPN Staff Key Points The FDA announced that children under age 3 should not receive ingestible fluoride products (tablets or drops), even in low-to-moderate-cavity-risk groups, marking a tightening of preventive-care guidelines. The American Dental Association (ADA) strongly disagrees, stating that fluoride tablets/drops are safe and effective when water supply lacks fluoride, and urging clinician discretion rather than blanket restriction. Public health implications are significant, because fluoride in water has long been credited with major reductions in cavities, and restricting supplements may increase decay risk—especially for children in low-fluoridation areas or those with higher risk of tooth decay. The Food and Drug Administration (FDA) has announced that children under age 3 should not receive ingestible fluoride products, including tablets and drops, marking a significant move in the ongoing national debate over fluoride use. The agency sent notices to four companies outlining enforcement intentions and notified health care professionals of the updated guidance for young children at low to moderate risk for tooth decay. The directive isn’t sitting well with the American Dental Association (ADA). ADA President Dr. Richard J. Rosato said daily fluoride tablets or drops are safe and effective for children at high risk for cavities whose water supply lacks fluoride. “A doctor’s clinical judgment, not a new warning label, should remain the guiding factor,” Rosato said, emphasizing both safety and access to care. The recommended level of fluoride in the water supply is 0.7 mg/L and the ADA only advises the prescription of 0.25 mg fluoride per day for children aged 6 - 36 months if the local water supply is less than 0.3 mg/L. Why it matters Fluoride is a mineral that has been used to prevent tooth decay by strengthening tooth enamel. Water fluoridation has been standard in the U.S. since the 1940s and is endorsed by the Centers for Disease Control and Prevention (CDC), the World Health Organization, and other major health organizations. As of 2020, about 63% of Americans receive fluoridated tap water, according to CDC data. Public health officials credit fluoridated drinking water with reducing cavities, particularly among children in low-income communities. But public skepticism is rising. Utah became the first state to ban fluoride in public water systems in 2025, and similar legislation is under consideration in North Dakota, Tennessee and Montana. Critics, including some parental rights groups and public figures, argue fluoride use is outdated and may carry risks. The big picture The FDA action follows months of public meetings, studies and evaluations under the White House’s “Make Our Children Healthy Again Strategy,” which lists fluoride as a priority for review. While some research raises questions about potential neurological risks in children, other experts, including the American Academy of Pediatric Dentistry (AAPD), say the evidence is weak or inconclusive. The AAPD warned that the FDA’s guidance could undermine preventive fluoride treatments in water, supplements, and toothpaste, potentially leading to higher rates of tooth decay. SUGGESTED STORIES FDA meeting reignites debate over fluoride in drinking water What has long been known as the “fight over fluoride” has gained new steam, and federal action could be forthcoming to reduce certain products containing it. A recent public meeting hosted by the Reagan-Udall Foundation and the U.S. Food and Dru Read more Fluoride in drinking water draws growing scrutiny A national re-examination of fluoridated water is well underway, with a number of localities and at least two states ending long-standing programs to add a bit of the mineral to their drinking water supplies. Legislatures in Florida and Utah Read more Momentum grows to modernize menopause care as FDA weighs new guidance The Food and Drug Administration (FDA) may soon make changes to what is known as the “black box warning” on hormone replacement therapy (HRT) for women in menopause. Commissioner Dr. Martin Makary recently said the FDA is having “serious discussions” about the warnin Read more
FDA meeting reignites debate over fluoride in drinking water What has long been known as the “fight over fluoride” has gained new steam, and federal action could be forthcoming to reduce certain products containing it. A recent public meeting hosted by the Reagan-Udall Foundation and the U.S. Food and Dru Read more
Fluoride in drinking water draws growing scrutiny A national re-examination of fluoridated water is well underway, with a number of localities and at least two states ending long-standing programs to add a bit of the mineral to their drinking water supplies. Legislatures in Florida and Utah Read more
Momentum grows to modernize menopause care as FDA weighs new guidance The Food and Drug Administration (FDA) may soon make changes to what is known as the “black box warning” on hormone replacement therapy (HRT) for women in menopause. Commissioner Dr. Martin Makary recently said the FDA is having “serious discussions” about the warnin Read more
