AGD Urges FDA to Support Access to Pediatric Fluoride Prescription Products Amid Declining Water Fluoridation

The Academy of General Dentistry (AGD), representing more than 40,000 general dentists across North America, recently submitted formal comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s request for input on the use of orally ingestible prescription drug products containing fluoride for the pediatric population.

In its letter to FDA Commissioner Marty Makary, MD, MPH, AGD reaffirmed its strong support for the continued availability of fluoride drops and tablets for children, especially in communities where public water fluoridation is limited or absent.

“Preventive oral health care begins in childhood,” said Chethan Chetty, DDS, MAGD, president of AGD. “With water fluoridation in decline in some regions, it is critical that families have safe and effective alternatives to protect their children from dental caries, a highly preventable disease.”

Although fluoride prescription products have been in use since the 1940s, none have been formally approved by the FDA for safety, efficacy, or manufacturing quality. AGD emphasized that scientific concerns over fluoride toxicity often involve levels far higher than those present in standard pediatric prescription fluoride products.

The AGD urged the FDA to swiftly assess and determine the safety and effectiveness of these products to ensure continued access for families and providers.

Why It Matters:

• The Centers for Disease Control and Prevention (CDC) has declared water fluoridation one of the top 10 public health achievements of the 20th century.
• A modeling simulation showed that eliminating fluoride could increase dental caries prevalence by 7.5 percentage points, costing an estimated $9.8 billion over five years in added treatment expenses.
• Prescription fluoride serves as a critical alternative where water fluoridation is unavailable.

“As healthcare providers dedicated to improving the oral health of our communities, we believe that access to fluoride treatment, whether through topical products, community water or safe prescription alternatives, should remain a public health priority,” said Chetty.

AGD welcomes continued dialogue with federal health agencies to protect access to evidence-based preventive care for America’s youngest and most vulnerable patients.