FDA restricts fluoride supplements for children under 3

The Food and Drug Administration on Friday moved to restrict the use of fluoride supplements for children, saying the pills, lozenges and drops should not be recommended for children younger than 3 and should be reserved for older children only if they face a serious risk of tooth decay. The agency said the change follows a new scientific analysis that found limited benefit for dental health and identified emerging safety concerns.

The FDA said it has sent letters to four companies warning them not to market fluoride supplements outside the new limits and has distributed a form letter to dentists and other health providers outlining potential risks. Until now, some supplements had been prescribed for infants as young as six months and are sometimes recommended for children and teens who live in areas with low levels of fluoride in drinking water. Manufacturers also sell drops intended for babies.

In a statement, the agency said its review found the supplements offer modest benefit for strengthening teeth but may be linked to gastrointestinal problems, weight gain and effects on cognition. The FDA also noted that extra fluoride intake can cause dental fluorosis, a spotting or...