LOS ANGELES, – The U.S. Food & Drug Administration has issued a “Warning Letter” that orders a manufacturer of fluoride drops and tablets to “immediately” discontinue marketing these products because FDA has never approved them as safe and effective.
On Wednesday, the Fluoride Action Network joined with The International Academy of Oral Medicine & Toxicology to petition the FDA to take similar action against all other companies producing unapproved fluoride “supplements.”
According to FAN, fluoride supplements are sodium fluoride-containing drops, tablets and lozenges sold for the purpose of preventing tooth decay. Despite being labeled “supplements,” the FDA’s Warning Letter states that these products are “drugs” which are “not generally recognized as safe and effective” for cavity prevention.
The FDA issued the Warning Letter in January to Kirkman Industries, one of the manufacturers of fluoride supplements.
“Each and every one of the issues that FDA identified with Kirkman’s fluoride supplements is equally applicable to the fluoride supplements being manufactured by other companies,” stated Michael Connett, executive director of FAN.
FAN argues that fluoride supplements were launched in the 1940s on the premise that fluoride needs to be ingested during early childhood to provide a meaningful role in cavity prevention.
FAN cited the body of evidence that today shows that fluoride’s predominant effect on cavities comes from topical application, such as from toothpaste, not ingestion.