Petition with the Food and Drug Administration Requesting Regulation of Dangerously Acidic Oral Moisturizers
Washington State-Based Doctor Urges
the FDA to Regulate the Manufacturing of Dry Mouth Products that Can Have a
Detrimental Effect on Teeth While Also Requesting Removal of Dangerous Products
from Shelves
Omak,
WA (October 2, 2018) – 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.
The research identified seven oral moisturizers
for dry mouth sold in the US 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)
- 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 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,” remarked Dr. 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.”
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.
About Dr. Greg Grillo
Dr. Greg Grillo is
a 1995 University of Washington School of Dentistry graduate practicing in
North Central Washington. He balances clinical practice with his role as
Content Director for Legwork, a rapidly growing dental software company. Dr.
Grillo purchased his current practice in 2001, after serving four years as a US
Navy Dental Officer. He’s now the senior partner of Grillo Robeck Dental, an
innovative practice blending technology with exceptional staffing to provide
relationship-based healthcare. For more information, visit http://www.grillorobeckdds.com.
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