Exploring Alternative In Vitro Models for Final Formulation Testing of OTC Antic

The OTC Monograph M021 Anticaries Drug Products for OTC Human Use, under which most fluoride toothpastes in the U.S. are marketed, requires an animal caries reduction test. Scientific advancements have developed new animal-free test methods such as pH cycling, which evaluate fluoride's effect on the mineral content of tooth enamel in vitro. These alternative methods rely on enamel evaluation techniques, such as microhardness, micro-computed tomography, spectroscopy, and microscopy.Our recent scoping review revealed the need for standardization of microhardness evaluation techniques to ensure suitability for incorporation into a regulatory test. This proposed study will examine and compare several evaluation techniques. This multifaceted approach will contribute to the test methods' development as valid alternatives to animal testing and increase our understanding of key experimental parameters. Together this work will help refine alternative testing for toothpastes marketed under M021

Estimated value

>= $250K and < $700K

Est. solicitation date

May 1, 2026

Anticipated award

Oct 1, 2026