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# Petition Seeks All Unapproved Fluoride Products Off Market
- URL: https://www.fdaweb.com/petition-seeks-all-unapproved-fluoride-products-off-market/
- Published: 2016-05-20T12:00:00.000Z
- Updated: 2026-09-14T21:04:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135725

The International Academy of Oral Medicine & Toxicology and the Fluoride Action Network have filed a [petition](http://fluoridealert.org/citizen%5Fpetition/?ref=fdaweb.com) urging FDA to take regulatory action to remove from the market all unapproved fluoride drugs, which are commonly known as fluoride supplements. Fluoride supplements are sodium fluoride-containing drops, tablets, and lozenges sold for preventing tooth decay. “Although prescribed to millions of children for decades, no manufacturer has ever submitted clinical evidence to the FDA to prove the safety and effectiveness of fluoride supplements,” the groups say.

A [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483224.htm?ref=fdaweb.com) earlier this year told Kirkman Laboratories to stop marketing its unapproved fluoride product new drugs. The petitioners seek similar actions against all other manufacturers marketing similar products.