Tom's of Maine petitions FDA for more time to complete fluoride bioavailability studies.
This article was originally published in The Tan Sheet
Executive Summary
TOM's OF MAINE SEEKING ADDITIONAL TIME TO COMPLETE FLUORIDE STUDIES for the anticaries ingredient's bioavailability in the company's Wintermint, Baking Soda and Children's toothpaste formulations. Tom's requests that FDA partially stay the effective date of the OTC anticaries final monograph in a Sept. 10 citizen petition to the agency drafted by the Washington, D.C. firm Buc & Beardsley. The final monograph, which goes into effect Oct. 7, requires animal testing to confirm fluoride bioavailability in dentifrice formulations. Because Tom's does not test products on animals, the company developed an alternate method for demonstrating fluoride bioavailability.
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