The federal agency is limiting fluoride supplements amid new safety concerns.
The Food and Drug Administration (FDA) announced a new policy restricting fluoride use for kids, marking a shift in how the agency approaches a chemical long seen as a cornerstone of dental health. Under the updated guidance, fluoride tablets, drops, and lozenges are no longer recommended for children under three years old or for older children who are not considered at high risk of tooth decay.
For decades, fluoride has been viewed as an important defense against cavities. Dentists have often prescribed supplements for children in areas without fluoridated water, particularly in rural communities. But the FDA now says new scientific findings suggest the benefits may not outweigh possible health concerns. Regulators cited growing evidence that fluoride could influence gut health, weight, and cognitive development—issues that have prompted the agency to reassess its decades-old endorsement.
The decision reflects ongoing scrutiny of fluoride by federal officials, including Health Secretary Robert F. Kennedy Jr., who has questioned the chemical’s safety. While Kennedy has called fluoride a potential neurotoxin, the FDA’s latest move stops short of banning the supplements altogether. Instead, the agency sent letters to several manufacturers warning them to comply with the new restrictions.
A scientific review released by the FDA concluded that fluoride supplements provide only modest protection against cavities for most children. The report noted that for the same reason fluoride can kill bacteria in the mouth, it may also alter healthy bacteria in the digestive system. Regulators emphasized that the changes were made out of caution, pending more research into long-term effects.
The decision immediately sparked pushback from the American Dental Association, which continues to support fluoride as a safe and effective cavity prevention tool. The group argues that the evidence linking fluoride to broader health problems remains weak, and that limiting access could increase rates of tooth decay—especially among children in small towns and low-income areas where dental care is harder to access. Dentists have also expressed concern that parents may misinterpret the FDA’s action as a signal to avoid fluoride altogether, including in toothpaste or treated water.
The Centers for Disease Control and Prevention continues to recommend fluoride as one of the most effective public health measures for preventing tooth decay. Fluoride works by strengthening enamel and restoring minerals lost during daily wear. The agency first set national fluoride guidelines for public water systems in 1962 and continues to monitor levels nationwide.
Still, debate over fluoride has intensified in recent years. Kennedy’s broader campaign to remove the chemical from drinking water has drawn attention from both health advocates and skeptics who view his position as part of a wider effort to reduce chemical exposure. Critics of the new policy warn that scaling back fluoride access could reverse decades of dental progress, particularly among children who do not have regular access to a dentist.
The FDA’s new rules do not affect fluoride in toothpaste, mouthwash, or treatments performed by dental professionals. Regulators said these products remain safe when used as directed and continue to offer protection against cavities for both children and adults. However, the agency’s decision signals a shift in thinking about how early—and how much—fluoride exposure is appropriate.
For now, the issue remains divided between those calling for stricter limits and those warning of higher rates of decay. As more research emerges, federal health officials may face growing pressure to decide whether fluoride’s protective benefits still outweigh its potential risks.
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