Petition Asks FDA to Regulate Oral Moisturizers

Dentistry Today


Greg Grillo, DDS, has filed a petition with the Food and Drug Administration (FDA) asking it to regulate the manufacture of acidic over-the-counter oral moisturizers and require them to be safely formulated prior to distribution. Grillo’s concern stems from an August 2017 study reporting that oral moisturizers for dry mouth require a pH level of 6.7 or higher to be safe for teeth, while pH levels below 5.5 are dangerous.

Those findings were corroborated by a March 2018 study that measured dentin tooth erosion when exposed to acidic dry mouth lozenges and concluded that a correlation exists between high acidity and dentin tooth loss. The objective of the study was to measure the pH levels, titratable acidity, and erosive effect of commercially distributed dry mouth lozenges on dentin. The study identified seven moisturizers that have a pH below 5.5 and cause significant erosion: 

  • OraMoist by DenTek (2.9 pH)
  • Mouth Kote by Parnell Pharmaceuticals (3.0 pH)
  • Cotton Mouth Lozenges by Cotton Mouth Candy Company (3.1 pH)
  • MedActive Oral Relief Lozenges (3.2 pH)
  • Hager Pharma Dry Mouth Drops (4.4 pH)
  • Rite Aid Dry Mouth Discs (5.1 pH)
  • CVS Pharmacy Dry Mouth Discs (5.3 pH)

The studies prompted Grillo to initiate the petition aimed at increasing awareness of the troubling issue. In addition to the FDA filing, Grillo sent a certified letter to the CEOs of each of the seven companies urging them to remove said products from their shelves until they are reformulated to meet safety standards.

“It’s critical that these products be removed for the long-term oral health of the thousands of people who use these products on a daily basis,” said Grillo.

“With the strong backing of hundreds of fellow concerned dental professionals, we’re confident that the FDA will do the right thing and call for the safe manufacturing of all oral moisturizers sold in America. I’m also personally confident that the chief executives of each of these companies will put public safety first and remove their dangerously acidic products at once,” Grillo said. 

The FDA filing, the letters sent to the CEOs, and the original petition all can be viewed at

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