The American Dental Hygienists’ Association (ADHA), in collaboration with Xlear, has filed a citizen petition with the U.S. Food and Drug Administration (FDA) requesting that xylitol be formally approved as an over-the-counter (OTC) active ingredient in dental hygiene products. If approved, the ingredient could be included in a range of products such as toothpaste, rinses, gels, mouthwashes, gums, and lozenges.
Xlear, based in American Fork, Utah, manufactures hygiene products that include xylitol. According to the company, xylitol-based dental hygiene products are already widely available in the United States, but current regulations do not classify xylitol as an approved active ingredient for anti-caries use. The petition asks the FDA to either amend its existing Anti-caries Monograph or issue a new monograph under Section 505G of the Federal Food, Drug, and Cosmetic Act.
According to Xlear, the petition cites decades of scientific research indicating that xylitol reduces the presence of Streptococcus mutans, the bacteria responsible for cavities, and decreases its ability to produce acid that erodes tooth enamel. The company states that while fluoride strengthens enamel, it does not significantly reduce this cavity-causing bacteria. Xlear claims that studies have shown xylitol has a higher “protection factor” against cavities than fluoride.
“Dental decay is the single most common communicable, chronic disease inflicting Americans today. Moreover, dental decay is also closely associated with driving other serious health risks, ranging from heart disease to diabetes,” says Trisha O'Hehir, MS, RDH.
“For nearly a century, fluoride has been the singular solution for cavities, yet 90% of American adults still experience dental decay,” says Nate Jones, CEO of Xlear. “Xylitol doesn’t replace fluoride, but it offers something different: a safe, evidence-based way to target the bacteria that actually cause cavities. Together, enamel strengthening compounds and xylitol can provide a more complete approach to oral health.”
According to Xlear, studies have shown that xylitol can reduce cavities by up to 80 percent. The company also notes that xylitol is safe if swallowed, which may offer an added benefit for children. Xylitol is already in use internationally and is commonly found in chewing gum and other oral hygiene products.
If approved, the petition would expand the FDA’s recognition of xylitol as an active anti-caries agent, allowing broader consumer access to oral care products formulated with it.
The full petition can be viewed here. The petition can be signed by clicking here.
ADHA represents approximately 220,000 registered dental hygienists across the United States.
Xlear produces xylitol-based hygiene products that are available in pharmacies, major retail stores, natural food outlets, and online.
