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# FDA Denies Petition on Oral Health Drug Monographs
- URL: https://www.fdaweb.com/fda-denies-petition-on-oral-health-drug-monographs/
- Published: 2019-01-23T12:00:00.000Z
- Updated: 2026-09-15T00:56:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143208

FDA has denied an 8/2/17 American Dental Association petition asking the agency to open the rulemaking process to review and update five over-the-counter oral health drug product monographs. The petition said many of the monographs had not kept pace with the latest science-based testing standards,

The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-4736-0004&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the petition failed to provide sufficient detail or supporting data to justify rulemaking action at this time. “We agree that the marketing and regulation of OTC oral health drug products should be informed by the best available scientific knowledge and testing methods,” the agency wrote. “However, your petition does not state specific regulatory changes or supply evidence regarding validated test methods that would advance this shared goal…. Additionally, we decline to initiate rulemaking to update the monographs described in your request at this time due to the evolving legislative landscape for reforming FDA’s system of regulating OTC drugs…. In light of the significant possibility that this transformative shift in our authorities will occur in the near future, and the absence of sufficient data in your petition, FDA believes that initiating notice and comment rulemaking to amend the oral health monograph described in your petition is not the appropriate course of action at this time.”