Dentist files petition with FDA requesting regulation of dangerously acidic oral moisturizers

Washington State-based dentist Dr. Greg Grillo recently filed a petition with the Food and Drug Administration (FDA) requesting to regulate the manufacturing of dangerously acidic oral moisturizers currently sold over the counter in the US. Grillo, along with hundreds of dental professionals and consumers, want the agency to address this public health concern by requiring these products be safely formulated prior to distribution.

Dr. Grillo’s concern stemmed from an August 2017 study that reported, to be safe, oral moisturizers for dry mouth should contain a pH level of 6.7 or higher and that any oral moisturizer with a pH level below 5.5 is dangerous. Those findings were corroborated by a March 2018 University of Florida 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.

Read more: Testing pH levels in oral moisturizers

The research identified seven oral moisturizers for dry mouth sold in the U.S. that have a pH level below 5.5 and caused significant amounts of tooth 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 recent studies prompted Dr. Grillo to initiate the petition aimed at increasing awareness of the troubling issue. In addition to the FDA filing, Dr. 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're 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,” Dr. Grillo says. “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.”

The FDA filing, the letters sent to the seven manufacturer’s CEOs and the original petition can all be viewed at https://oralacidityawareness.wordpress.com.