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FDA Seeking Data on a Potential Non-Animal Method for Testing of Fluoride Toothpaste Products

Today, the U.S. Food and Drug Administration (FDA) published a Data Request asking for scientific data to help inform whether the pH cycling test model should be included as a testing procedure for fluoride toothpaste (dentifrice) products under OTC Monograph M021, which covers over-the-counter cavity-prevention drug products.

The pH cycling test model is a laboratory-based, non-animal test that mimics a specific aspect of the natural process of tooth decay and the role of fluoride toothpaste in its prevention. FDA is considering whether there is sufficient scientific justification to issue an order that, once final, would amend OTC Monograph M021 in accordance with section 505G(b) of the FD&C Act to add the pH cycling test model as a nonanimal testing procedure for fluoride dentifrice drug products. Therefore, FDA is seeking targeted, actionable data obtained through scientifically-rigorous investigations on the pH cycling test model.

FDA is requesting data related to:

• A standardized protocol for the pH cycling test model that addresses certain issues specified in the Data Request
• Results from at least one multi-site validation study using that standardized protocol
• A comparison of the multi-site validation study results to existing animal-based test results

How do I submit data?
The data request available on the OTC Monographs@FDA portal includes full submission instructions, including how to handle confidential information. Visit the OTC Monographs@FDA portal for more information about this data request and future OTC monograph activities.

Additional Information

• Learn more about OTC Monographs@FDA
• Read OTC Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use
• Federal Register Notice: Process for FDA Data Requests to Inform Certain Over-the-Counter Monograph Drug Activities

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