FDA restricts use of kids' fluoride supplements citing emerging health risks


WASHINGTON (AP) — On Friday, the Food and Drug Administration announced new restrictions on the use of fluoride supplements intended to fortify children’s dental health. This decision, spearheaded by Health Secretary Robert F. Kennedy Jr. and his team, targets a chemical long considered vital in dental care.

The FDA now advises against using these supplements for children under three years old, as well as for older children who are not at significant risk of developing dental cavities. Previously, even infants as young as six months were eligible for these prescriptions.

Although earlier discussions in May hinted at a possible market withdrawal of these products, the FDA opted for a different route. The agency issued warning letters to four companies, instructing them to comply with the newly established guidelines.

Fluoride tablets and lozenges are often prescribed to children and teenagers vulnerable to tooth decay, especially in regions where local water supplies contain insufficient fluoride. Additionally, some companies offer fluoride drops for infants.

In their latest scientific assessment released Friday, the FDA noted that fluoride supplements provide minimal dental benefits for children and could potentially pose safety issues. Concerns were raised about possible links to digestive problems, weight gain, and cognitive effects.

“Fluoride’s role in eliminating oral bacteria may similarly impact the gut microbiome, potentially leading to wider health consequences,” stated the agency.

The agency also sent a form letter to dentists and other health providers warning about the risks of the products.

Those claims have been disputed by the American Dental Association, which has said there are no significant health problems associated with fluoride when used at the levels prescribed by dentists. The supplements can cause spotting or discoloration of teeth due to the extra fluoride, a downside the FDA also noted.

Dentists have warned that restricting fluoride supplements may result in more cavities and dental problems in rural communities, which are less likely to have fluoridated water. Kennedy is also seeking to end the practice of adding fluoride to drinking water throughout the U.S.

Fluoride strengthens teeth and reduces cavities by replacing minerals lost during normal wear and tear, according to the Centers for Disease Control and Prevention. In 1962, the agency set guidelines for how much should be added to water.

Kennedy, a former environmental lawyer, has called fluoride a “dangerous neurotoxin” tied to a range of health dangers.

The FDA regulates most dental products, including fluoride-containing toothpastes, supplements, mouthwashes and rinses. The agency’s actions don’t affect toothpastes, mouthwash or fluoride treatments used by adults or those offered in dentists’ offices.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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