I urge you to update—without delay—the FDA’s Anticaries Drug Products for Over-the-Counter Human Use Monograph to include the use of the pH cycling method as an accepted alternative to the animal caries test. This non-animal method is well established, extensively evaluated, and supported by a substantial body of data.
The pH cycling method offers greater reliability and human relevance than the currently used animal test, and it aligns with the direction that both the U.S. and global toothpaste industries have moved to over the past 25 years in favor of non-animal methods.
Requiring an animal test for efficacy of fluoridated over-the-counter products is inconsistent with modern science, ethical expectations, and international regulatory practice. It creates a barrier to the use of more human-relevant non-animal methods.