• Source: kashmirobserver.net-1

The Food and Drug Administration (FDA) announced Friday that it will restrict the use of fluoride supplements for children, citing new evidence of potential health risks. The agency said the products are no longer recommended for children under 3 years old or for older children who are not at high risk of tooth decay.

The updated guidance marks a shift from earlier recommendations, which allowed fluoride tablets, drops, and lozenges for children as young as six months. The FDA’s move follows a broader review of fluoride’s safety under Health Secretary Robert F. Kennedy Jr., who has been critical of the chemical’s widespread use in dental care.

The decision stops short of removing fluoride supplements from the market. Instead, the FDA issued warning letters to four manufacturers, directing them to stop promoting products for groups outside the new limits. The agency also sent notices to dentists and health providers outlining the updated recommendations.

New guidance narrows eligibility

Fluoride supplements are often prescribed to children and teenagers in areas where drinking water contains low fluoride levels. These products have been used for decades to help prevent cavities and strengthen tooth enamel.

The FDA’s revised analysis found that while fluoride can reduce tooth decay, its benefits in supplement form are limited and may be outweighed by emerging health concerns. The agency cited potential links between fluoride exposure and gastrointestinal problems, weight changes, and cognitive effects.

“For the same reason fluoride may work to kill bacteria on teeth, it may also alter the gut microbiome, which may have broader health implications,” the FDA said in a statement released Friday.

Agency cites emerging safety data

The new evaluation is part of a larger review of fluoride’s safety, which includes its use in drinking water. Kennedy has described fluoride as a “dangerous neurotoxin,” though major medical and dental organizations have disputed that characterization.

The American Dental Association (ADA) responded to the FDA’s announcement by reaffirming its position that fluoride is safe and effective when used at recommended levels. “There is no credible evidence linking fluoride supplements to serious health problems,” the association said, adding that mild tooth discoloration remains the primary known side effect.

Dentists warn of rural impact

Some dentists and public health experts expressed concern that restricting fluoride supplements could increase the risk of cavities, particularly in rural areas where water systems are not fluoridated. They noted that children in such communities already face barriers to dental care.

Fluoride remains a cornerstone of dental health policy in the United States. The Centers for Disease Control and Prevention (CDC) has long supported fluoridation, stating that fluoride strengthens enamel by restoring minerals lost through normal wear. In 1962, the U.S. Public Health Service set the first national standards for fluoride levels in drinking water.

The FDA clarified that its new policy does not affect fluoride-containing toothpastes, mouthwashes, or in-office dental treatments, which remain approved for both children and adults.

While the latest action represents a narrower approach to fluoride use, officials said the agency will continue to evaluate data as new research emerges. “Our goal is to ensure products marketed for children are both safe and beneficial,” the FDA said.

The review is part of a broader reassessment of chemicals and additives overseen by the Department of Health and Human Services, signaling ongoing scrutiny of long-standing public health practices.

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