The American Fluoridation Society has spoken out against the FDA’s decision to restrict the use of ingestible fluoride products.
Four notes:
1. The FDA announced Oct. 31 that it sent letters to four companies notifying them of its intent to take enforcement action against those marketing unapproved fluoride drug products. It also sent letters to healthcare professionals warning about the risks associated with products.
2. The enforcement applies to fluoride-containing ingestible drug products labeled for use in children under three years of age, or with labeling that does not limit use to children at high risk for dental caries.
3. Johnny Johnson, DMD, called the limitations a “big mistake,” and pointed out the FDA’s new guidance goes against previous recommendations for clinicians to prescribe fluoride supplements to children between the ages of 6 months and 16 years, and who live in communities with low levels of fluoride in their water supply.
“Cavities can start forming in a child’s mouth very soon after the teeth appear. Tooth decay is a disease process that often starts before age 3. For this reason, the FDA guidelines mean that many children won’t get the topical benefits of fluoride that supplements can provide to their erupted baby teeth,” Dr. Johnson said.
4. The American Dental Association and the CareQuest Institute for Oral Health also recently opposed the FDA’s decision.
