Exploring Alternative In Vitro Models for Final Formulation Testing of OTC Antic
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring research services to explore and standardize alternative in vitro testing methods for OTC anticaries drug products currently evaluated under the OTC Monograph M021, with a solicitation estimated to release on May 1, 2026 and award anticipated by October 1, 2026. The work focuses on replacing animal caries reduction tests with animal-free methods such as pH cycling that evaluate fluoride's effect on tooth enamel mineral content, with particular emphasis on standardizing microhardness evaluation techniques including microhardness, micro-computed tomography, spectroscopy, and microscopy to establish regulatory suitability.
The estimated award value ranges from $250,000 to $700,000. The contractor will examine and compare multiple enamel evaluation techniques to refine alternative testing methods for toothpastes marketed under M021 and develop understanding of key experimental parameters. Inquiries should be directed to the FDA Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
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
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