FDA Reviews Ingestible Fluoride Supplements Amid Health Concerns
U.S. health regulators are taking significant steps to phase out ingestible fluoride supplements, which have traditionally been used to strengthen children’s teeth. The initiative was announced by the Food and Drug Administration (FDA) on Tuesday as part of a broader public health review.
FDA’s Planned Actions
The FDA is scheduled to conduct a scientific evaluation of these products by late October, aiming to remove them from the marketplace. Instead of a lengthy rulemaking process that can span several years, the agency will encourage manufacturers to withdraw these products voluntarily.
Usage and Recommendations for Fluoride Supplements
Fluoride tablets and lozenges have been prescribed for children and adolescents at an increased risk of dental decay, especially in areas where local water supplies have low fluoride levels. Additionally, fluoride drops are available for infants.
Health Risks Associated with Ingestible Fluoride
FDA Commissioner Marty Makary highlighted concerns that ingestible fluoride might disrupt beneficial gut bacteria, which play essential roles in digestion and immunity. He referenced studies indicating that excessive fluoride intake could correlate with various health issues, including reduced IQ levels in children.
Although previous public health assessments by dental professionals have generally found no substantial health risks associated with fluoride supplements, the growing scrutiny around these products suggests a shift in perspective.
Changes in State Policies
As local and state governments, like Utah—the first state to ban fluoride from drinking water—begin to remove fluoride from municipal supplies, the demand for fluoride supplements is expected to increase. In fact, Utah recently made fluoride supplements available without the need for a prescription.
Historical Context and Current Recommendations
Fluoride is known for its ability to fortify dental enamel and diminish cavities by replenishing minerals lost through daily wear. The Centers for Disease Control and Prevention (CDC) set fluoride level guidelines for municipal water systems as far back as 1962.
Health Secretary Robert F. Kennedy Jr. has been vocal about his concerns regarding fluoride, labeling it a “dangerous neurotoxin” and asserting that its use warrants thorough investigation. Recently, he also advocated for the CDC to cease recommending fluoride in drinking water.
Scientific Studies and Expert Opinions
A federal report from the National Toxicology Program last year established a connection between high fluoride concentrations in drinking water and lowered IQ scores in children, based on research spanning multiple countries, including Canada and China.
Notably, the U.S. Preventative Services Task Force recommends fluoride supplements for children aged six months to five years residing in low-fluoride areas, a stance affirmed by a 2010 American Dental Association paper suggesting these supplements for children up to 16 years who are at high risk of cavities.
Potential Side Effects
The most commonly observed side effect related to fluoride supplements is the discoloration of teeth, which occurs due to excess fluoride exposure.
Legal Scrutiny and Industry Implications
The FDA also made it clear that ingestible fluoride products have never received formal approval. This new initiative follows a wave of recent legal actions against fluoride-containing products, including investigations into the marketing practices of Colgate-Palmolive and Procter & Gamble by Texas Attorney General Ken Paxton, who has called their promotions “misleading, deceptive and dangerous.”
This evolving situation around fluoride supplements reflects a complex interplay of public health policy, scientific inquiry, and regulatory action, with significant implications for children’s dental health across the nation.