The U.S. Food and Drug Administration (FDA) has issued a significant advisory, urging parents and medical professionals to refrain from administering ingestible fluoride tablets to children under three years old. This announcement, released on a Friday, follows a scientific evaluation and concerns regarding the safety and efficacy of these unapproved products. While doctors have historically prescribed these tablets to young children in areas lacking fluoride in their drinking water to mitigate tooth decay risks, the FDA asserts that these products have never received official approval and differ from topical fluoride applications like toothpaste and mouthwash because they are swallowed.

The agency revealed its intention to take action against four unnamed companies producing these tablets, instructing them to apply labels that restrict their use to children at high risk of tooth decay or those with poor dental hygiene. The FDA’s conclusion, based on a scientific evaluation, explicitly states that ingestible fluoride tablets should not be used for children under three or for older children not deemed to be at high risk of tooth decay. This decision aligns with a broader initiative by the administration to reassess fluoride use.

Health and Human Services Secretary Robert F Kennedy Jr (RFK Jr) publicly supported the FDA's action, stating that it drives "a stake through the heart of outdated science" and protects children from associated risks, lamenting that these products have been used for decades without safety approval. He emphasized that this action raises public awareness, informs medical professionals, and supports President Trump's commitment to the 'Make Our Children Healthy Again' agenda.

The FDA's decision is rooted in a review of scientific evidence suggesting that fluoride, while beneficial for killing bacteria on teeth, may also harm the gut microbiome, or the bacterial community in the gut, which could have "broader implications" for health. The agency referenced a Cochrane Review, recognized as a gold standard for scientific evidence, which found no clear evidence that these supplements effectively reduced the risk of tooth decay in primary, or baby, teeth. Furthermore, a bombshell federal report from the previous year, which suggested a potential link between fluoride exposure in drinking water and a reduction in IQ by up to five points, was also referenced.

Fluoride has been a mainstay in U.S. drinking water since the 1950s, widely considered a significant 20th-century public health achievement due to its proven ability to strengthen teeth and reduce cavities. Estimates from the CDC suggest that water fluoridation saves approximately $6.5 billion annually in dental treatment costs and can reduce cavity occurrences by up to 25 percent.

However, RFK Jr has vocally criticized fluoride, labeling it an "industrial waste" and linking it to various health issues including arthritis, bone fractures, bone cancer, IQ loss, thyroid disease, and neurodevelopmental disorders. As a former environmental lawyer, he has made ending the use of ingestible fluoride a cornerstone of his 'Make America Healthy Again' agenda, stating in May that such a move was "long overdue."

FDA Commissioner Dr. Marty Makary echoed these concerns, stating, "There are better ways to protect children's teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome. The microbiome is increasingly recognized to be central to a child's health and development." The agency had commenced the process of banning prescription fluoride tablets for children in May and formalized its decision in October after months of evaluating scientific studies and consulting stakeholders.

Despite the FDA's stance, the American Dental Association (ADA) has staunchly opposed plans to ban the tablets, asserting a lack of evidence that they cause harm and maintaining their effectiveness in reducing tooth decay. In a May release, the ADA dismissed research linking fluoride to microbiome changes as "limited" and expressed concerns that reducing the availability of these tablets could lead to increased rates of dental cavities. Dr. Brett Kessler, the ADA's president, warned that such proposals could harm rural America, where fluoride supplements often provide the only access to appropriate fluoride levels for preventing tooth decay in non-fluoridated communities. He urged a cautious approach to fully study the implications of such actions on national health.

Beyond the debate on fluoride supplements, general dental hygiene remains critical. Dentists recommend brushing teeth at least twice daily, ideally in the morning and evening, to remove plaque and bacteria that contribute to cavities and gum disease. Despite this, an estimated 30 percent of Americans do not follow this recommendation, increasing their risk of dental complications and bad breath. Reinforcing proper tooth brushing habits from a young age is considered essential for lifelong oral health.