Benefits of Fluoride

 

Fluoride is a natural mineral recognized for its critical role in preventing tooth decay and strengthening enamel. Backed by over 75 years of research, fluoride is endorsed by leading health organizations like the CDC and WHO for its ability to reduce cavities and improve oral health. Public water fluoridation is a safe, cost-effective, and equitable solution that benefits everyone, especially underserved communities, while reducing overall dental costs. Good oral health is linked to better overall health, reducing the risks of systemic conditions such as diabetes and heart disease.

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FDA Launches Action to Eliminate Prescription Ingestible Fluoride Drug Products for Children

May 13, 2025

Per the notice below, the United States Food and Drug Administration (FDA) has launched action to remove ingestible prescription fluoride drug products for children from the market.

FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market

The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market.  Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers.  They have also never been approved by the FDA.  Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood.  Other studies have suggested and association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.

"The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome.  For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area.  When it comes to children, we should err on the side of safety."

The agency has set a goal date of October 31 for completing a safety review and public comment period and for taking appropriate action regarding removal of these products from the market.  In conjunction with this evaluation, the U.S. Department of Health and Human Services plans to disseminate best practices for dental hygiene in children that are feasible, effective, and do not alter gut health.

“Ending the use of ingestible fluoride is long overdue,” said HHS Secretary Robert F. Kennedy, Jr.  “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children.  This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”

Several states have taken action to stop fluoridation of drinking water, and fluoride is not added to drinking water in most of Europe or other countries of the world.  This action by the FDA is consistent with Secretary Kennedy’s Make American Healthy Again effort to ensure children grow up in a healthy environment.

Related Information

 

 

Fluoride FAQ

What is fluoride and how does it protect teeth?
Fluoride is a natural mineral found in water, food, and dental products like toothpaste. It helps protect teeth by strengthening the enamel, the hard outer layer of your teeth. Before teeth break through the gums, fluoride helps make enamel stronger, reducing the risk of decay. After teeth emerge, fluoride continues to help by remineralizing weakened enamel, reversing early signs of cavities.

Is fluoride safe?

Yes, fluoride is safe when used as directed. Scientific studies conducted over decades have consistently shown that fluoride, at recommended levels, is safe and effective in preventing tooth decay. The recommended fluoride level for public water supplies in the United States is 0.7 milligrams per liter (mg/L) or 0.7 parts per million (ppm). The Centers for Disease Control and Prevention (CDC) has recognized water fluoridation as one of the 10 greatest public health achievements of the 20th century.

What is water fluoridation?
Water fluoridation is the practice of adding fluoride to drinking water to bring the level up to a point that helps prevent tooth decay. It is a simple and cost-effective way to ensure everyone in a community, regardless of age or income, gets the cavity-fighting benefits of fluoride.

Should children use fluoride toothpaste?

Yes, fluoride toothpaste helps prevent cavities and makes teeth stronger. For children under 3, use just a small smear of toothpaste (about the size of a grain of rice). For children ages 3 to 6, use a pea-sized amount. Always supervise children while brushing to ensure they use the correct amount and don’t swallow toothpaste.

Does NYSDA support fluoride use?
Yes, the New York State Dental Association (NYSDA) strongly supports the use of fluoride as a safe, effective, and proven method to prevent tooth decay and improve oral health. NYSDA advocates for the use of fluoride in public water supplies and encourages the continued use of fluoride-containing dental products such as toothpaste and mouth rinses. NYSDA believes that access to fluoride helps promote better oral health for all New Yorkers, particularly underserved communities who may have limited access to dental care.

How can I find out if my water supply contains fluoride?
You can contact your local water utility to inquire whether your community’s water supply is fluoridated. Many local water suppliers provide this information in their annual Consumer Confidence Report (CCR), which is available to residents. The CDC’s My Water’s Fluoride tool also allows you to search for the fluoridation status of your community’s water supply. If your water is not fluoridated, you can still get the benefits of fluoride through toothpaste, mouth rinses, and professional treatments from your dentist.

Where can I learn more about fluoride?

For more information, we recommend visiting trusted sources such as:

For more detailed inquiries, please feel free to contact NYSDA directly.

 

 

Debunking Misinformation

Myth

Fluoride is harmful and toxic.

Fact

Fluoride is a naturally occurring mineral, and the levels used in community water fluoridation are strictly regulated for safety. At optimal levels (0.7 mg/L), fluoride is not harmful.

Fluoridation is unnecessary because people can just use toothpaste.
While toothpaste is important, water fluoridation provides continuous protection for everyone, especially those without access to dental care. It’s a proven, equitable solution that reaches all members of the community.
Fluoride causes developmental or neurological harm in children.
Decades of peer-reviewed studies, including research from the CDC and WHO, have found no reliable evidence linking fluoride at recommended levels to neurological harm or developmental issues in children.
Fluoride leads to fluorosis and discolored teeth.
Dental fluorosis occurs only when children ingest excessive fluoride during tooth development. Fluoridated water at recommended levels is safe and effective and doesn’t cause fluorosis when used as directed.

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