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The Food and Drug Administration (FDA), the United States food and drug regulatory agency, announced new measures to limit the use of ingestible medications and supplements with fluoride in children.
The decision, published last Friday (10/31), follows a scientific review that highlighted potential health risks and limited benefits in the fight against tooth decay/Photo: Reproduction
The decision, published last Friday (10/31), follows a scientific review that highlighted potential health risks and limited benefits in combating tooth decay.
The agency said it sent notifications to four companies that market these unapproved products labeled for use in children under three years of age or in older children at low risk of cavities. The FDA also released notices to health professionals with guidance on precautions when using these substances.
“There are better ways to protect children’s teeth than ingesting unapproved fluoride, which is now known to alter the gut microbiome,” agency Commissioner Marty Makary said in a statement.
Risks of excess
- Although fluoride is essential for oral health, excessive use can cause dental fluorosis, a condition that causes white spots on the enamel of developing teeth.
- In most cases, it is just an aesthetic problem, but in more serious situations it can cause tooth fragility and wear.
- In Brazil, the ideal concentration of fluoride in water varies between 0.6 and 0.8 mg/L, which is considered safe and effective for preventing cavities, according to the WHO.
Fluoride supplements, offered in drops, tablets or tablets, were recommended for children who lived in areas with low concentrations of the mineral in the water. Now, the FDA recommends that use be limited to specific situations, as unnecessary ingestion can cause unwanted effects.
Among the concerns highlighted by the agency are changes in the intestinal microbiome, weight gain and possible cognitive impacts. These effects are still being studied, but they reinforce the need for caution.
The FDA reinforces that the recent measures do not affect topical products, such as toothpastes and mouthwashes, nor fluoride treatments carried out in dental offices. The focus is to protect young children from ingestible substances without scientific evidence and promote safer, evidence-based prevention practices.
