Tom’s Of Maine Original Formula’s Use As Reference Standard Urged
This article was originally published in The Tan Sheet
Tom's of Maine intends to market new dentifrice products formulated with sodium monofluoro-phosphate in a calcium-only abrasive system pending reference standard testing for fluoride bioavailability, according to the Kennebunk, Maine company
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TOM'S OF MAINE DENTIFRICE FORMULATIONS MUST BE INDIVIDUALLY TESTED for effectiveness, FDA told the Kennebunk, Maine-based company in a recent letter. Tom's had asked the agency in a Feb. 16 citizen petition to accept data from an intra-oral remineralization test in humans using the original Tom's Natural Toothpaste formula to show bioavailability of the fluoride ion in all of its fluoride toothpastes ("The Tan Sheet" March 4, p. 5). The company's corporate philosophy of not testing its products in animals conflicts with the OTC anticaries final monograph requirement that bioavailability be demonstrated through animal testing. Tom's is proceeding with testing its other toothpaste formulas.
ANTICARIES FLUORIDE BIOAVAILABILITY ALTERNATIVE TESTING PROCEDURE PROPOSED by Tom's of Maine to meet biological test requirements for fluoride dentifrice drug products in the OTC anticaries final monograph. In a Feb. 16 citizen petition, the natural toothpaste marketer asked that FDA accept data from an "intra-oral remineralization test in human subjects" as a replacement for the animal caries reduction test specified in the monograph.
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