UPDATE (May 2016): FAN has filed a Citizen Petition to FDA calling on the Agency to remove all fluoride supplements from the market. Read the Petition here, and show your support by signing this online letter to FDA!

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Fluoride Supplements Have Never Been Approved

Fluoride supplements were designed to provide children living in non-fluoridated areas the daily equivalent of drinking an average amount of fluoridated water (up to 1 mg/day). For over 50 years, millions of children have been prescribed fluoride supplements by their dentist or pediatrician. As these documents demonstrate, the FDA has never approved any fluoride supplement as either safe or effective.

“To date, FDA has approved no fluoride-containing supplements as prescription or over-the-counter drugs.”
SOURCE: Robert Moore, Food & Drug Administration, November 17, 2005. [See document]

“No NDAs [New Drug Applications] have been approved or rejected for fluoride drugs meant for ingestion.”
SOURCE: Melinda Plaisier, Food & Drug Administration, December 21, 2000. [See document]

“At this time there are no approved new drug applications on file with the Agency for these products.”
SOURCE: Frank Fazzari, Food & Drug Administration, February 21, 1997. [See document]

“At the present time, there are no approved new drug applications or abbreviated new drug applications on file with FDA for children’s fluoride supplements.”
SOURCE: Frank Fazzari, Food & Drug Administration, June 8, 1993. [See document]

“There are no NDAs [New Drug Applications] on file with FDA covering fluoride supplements for infants.”
SOURCE: Frank Fazzari, Food & Drug Administration, January 28, 1993. [See document]

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