Xylitol for Caries Prevention: A Petition for FDA Recognition


Xylitol for Caries Prevention: A Petition for FDA Recognition
The Issue
A Better Standard for Oral Health: Xylitol
Support the petition for FDA recognition of xylitol as an anticaries agent in dental hygiene products.
Petition Summary
Dental caries (tooth decay) remains one of the most common and costly diseases in the United States. Despite decades of widespread fluoride use, nearly 90% of U.S. adults still suffer from tooth decay during their lifetimes. Fluoride helps strengthen enamel, but it does little to target the real problem: the bacteria that cause cavities.
Xylitol, a naturally occurring compound derived from plants, directly inhibits the growth and transmission of these bacteria. Backed by nearly 20,000 studies and decades of international use, xylitol has been shown to reduce dental caries by up to 80%—a protective factor far greater than fluoride alone. Unlike fluoride, xylitol is safe, well-tolerated, and effective in multiple delivery forms, including toothpaste, rinses, chewing gum, lozenges, and dental “candies.”
This petition calls on the FDA to:
- Recognize xylitol as an active anticaries ingredient under federal regulations.
- Amend or issue a new OTC drug monograph so that xylitol can be used broadly in over-the-counter dental hygiene products.
Recognizing xylitol as an FDA-approved active ingredient will:
- Give dental professionals a proven, science-backed tool to fight cavities.
- Provide safer alternatives for children and adults concerned about fluoride ingestion.
- Help reduce the staggering $136 billion in annual costs associated with oral disease in the U.S.
- Improve patient outcomes and expand access to effective prevention.
It is time for the FDA to take action. By formally recognizing xylitol as an active ingredient in dental hygiene products, we can protect more smiles, support dental professionals, and strengthen public health.
Click here to see the full petition and learn more.
1,724
The Issue
A Better Standard for Oral Health: Xylitol
Support the petition for FDA recognition of xylitol as an anticaries agent in dental hygiene products.
Petition Summary
Dental caries (tooth decay) remains one of the most common and costly diseases in the United States. Despite decades of widespread fluoride use, nearly 90% of U.S. adults still suffer from tooth decay during their lifetimes. Fluoride helps strengthen enamel, but it does little to target the real problem: the bacteria that cause cavities.
Xylitol, a naturally occurring compound derived from plants, directly inhibits the growth and transmission of these bacteria. Backed by nearly 20,000 studies and decades of international use, xylitol has been shown to reduce dental caries by up to 80%—a protective factor far greater than fluoride alone. Unlike fluoride, xylitol is safe, well-tolerated, and effective in multiple delivery forms, including toothpaste, rinses, chewing gum, lozenges, and dental “candies.”
This petition calls on the FDA to:
- Recognize xylitol as an active anticaries ingredient under federal regulations.
- Amend or issue a new OTC drug monograph so that xylitol can be used broadly in over-the-counter dental hygiene products.
Recognizing xylitol as an FDA-approved active ingredient will:
- Give dental professionals a proven, science-backed tool to fight cavities.
- Provide safer alternatives for children and adults concerned about fluoride ingestion.
- Help reduce the staggering $136 billion in annual costs associated with oral disease in the U.S.
- Improve patient outcomes and expand access to effective prevention.
It is time for the FDA to take action. By formally recognizing xylitol as an active ingredient in dental hygiene products, we can protect more smiles, support dental professionals, and strengthen public health.
Click here to see the full petition and learn more.
1,724
The Decision Makers
Supporter Voices
Petition created on September 25, 2025
