TL;DR: The FDA restricted prescription fluoride supplements (drops and tablets) for children under age 3 starting October 31, 2025. This action did NOT restrict fluoride toothpaste, which remains the primary and most effective tool for cavity prevention in young children according to the AAPD, ADA, and AAP.
Separately, new toothpaste packaging showing pea-sized amounts rolled out January 1, 2026, after settlements with Colgate and Procter & Gamble — addressing a real concern about overconsumption in young children.
Here is a complete breakdown of what changed, what did not change, and what you should do right now.
What Triggered These Changes?
Two separate government actions — one from the FDA, one from the Texas Attorney General — both took effect in late 2025 and early 2026, creating significant confusion among parents about what is and isn’t safe.
The FDA action stemmed from the National Toxicology Program’s January 2025 meta-analysis, which found associations between high fluoride exposure and reduced IQ scores in children.
As covered in detail in our breakdown of the JAMA fluoride research, those studies primarily involved fluoride levels 2–3 times higher than U.S. water fluoridation standards — but the FDA acted on the supplement question regardless, citing a precautionary approach for the youngest children.
The toothpaste packaging change came from a separate track entirely: Texas Attorney General Ken Paxton investigated Colgate-Palmolive and Procter & Gamble for toothpaste packaging that depicted large, full-brush amounts of toothpaste — far more than dentists recommend for young children.
Both companies settled, agreeing to update packaging to clearly depict pea-sized or smaller amounts appropriate for children’s ages, with the changes implemented January 1, 2026.
Change #1: FDA Restricts Fluoride Supplements for Children Under 3
Effective October 31, 2025, the FDA restricted prescription fluoride supplements — including fluoride drops and fluoride tablets — for children under the age of 3.
These supplements had previously been prescribed by pediatricians and pediatric dentists for infants and toddlers living in areas without fluoridated water, to help protect developing teeth from cavities.
The FDA’s stated concerns included potential effects on the gut microbiome, possible thyroid disruption, and the cognitive concerns raised by the NTP meta-analysis.
The restriction generated significant pushback from the dental and pediatric medical communities, with the AAPD, ADA, and American Academy of Pediatrics all issuing statements expressing concern that the action would increase cavity rates in children with limited access to fluoridated water.
More than 4,600 public comments were submitted to the FDA during the review period — one of the largest comment volumes for any pediatric oral health regulatory action in recent memory.
What this means for your child: If your child is under 3 and was previously prescribed fluoride drops or tablets — especially if your household uses well water, filtered water, or bottled water — contact your pediatric dentist to discuss alternative cavity-prevention options.
Your dentist may recommend more frequent fluoride varnish applications at checkups, adjusted toothpaste guidance, or dietary counseling as compensating strategies.
What the FDA Did NOT Restrict
This is the most important thing to understand about the October 2025 FDA action: it applied specifically and only to prescription fluoride supplements in drop and tablet form for children under 3.
Fluoride toothpaste remains fully available for all ages and continues to be recommended by every major U.S. pediatric and dental health organization.
Community water fluoridation (in states that still permit it) is not affected by the FDA supplement restriction.
Professional fluoride varnish treatments at dental offices remain available and recommended.
Fluoride mouthwash for older children (typically age 6 and older, when children can reliably spit) is not affected.
The restriction is narrow: prescription drops and tablets, for children under 3, only.
Change #2: New Toothpaste Packaging Showing Correct Amounts
Starting January 1, 2026, major toothpaste brands including Colgate and Crest began rolling out updated packaging following settlements with the Texas Attorney General’s office.
The core issue: previous packaging for children’s toothpaste often showed images of toothbrushes loaded with large, ribbon-style amounts of toothpaste — amounts that would significantly exceed what pediatric dentists recommend for young children.
- For children under 3, the AAPD recommends a rice-grain-sized smear of fluoride toothpaste — roughly 0.1 grams.
- For children ages 3 to 6, the recommendation is a pea-sized amount — roughly 0.25 grams.
The old packaging images were depicting amounts 3 to 5 times larger, effectively normalizing excessive fluoride ingestion for young children who have not yet mastered spitting.
The new packaging clearly illustrates age-appropriate amounts and in many cases includes printed guidance on the tube itself.
What this means for your child: Check your current toothpaste tube at home.
If it shows a large amount of toothpaste on the brush in the packaging images, you now know this does not reflect current dental guidance.
Use a rice-grain amount for children under 3 and a pea-sized amount for children ages 3 to 6, regardless of what the packaging shows.
Age-by-Age Fluoride Toothpaste Guide (Current AAPD Recommendations)
Under 12 months: No toothpaste needed yet. Wipe gums with a clean, damp cloth after feeding.
12 months to under 3 years: Use a rice-grain-sized smear of fluoride toothpaste (1,000 ppm minimum) twice daily. This is approximately 0.1 grams — far less than a typical pea. Supervise brushing and encourage spitting, but do not stress if some is swallowed; the amount is too small to cause harm.
3 to 6 years: Use a pea-sized amount of fluoride toothpaste twice daily. Continue supervising brushing and reinforce spitting after brushing. Children at this age are still learning — most do not spit reliably until age 4 to 5.
6 years and older: Standard adult fluoride toothpaste (1,000–1,450 ppm) is appropriate. Children can generally be trusted to spit reliably at this age, but spot checks are still worthwhile.
What If Your Child Uses Well Water or Bottled Water?
This question is more urgent than ever following the FDA supplement restriction.
Children who drink non-fluoridated water — including well water, most bottled water brands, and water filtered through reverse osmosis systems — do not receive the cavity-protective benefit of community water fluoridation.
Previously, pediatric dentists could address this gap with prescription fluoride supplements.
With supplements now restricted for children under 3, the primary compensating strategies are correct fluoride toothpaste use and professional fluoride varnish applied at dental checkups.
The AAPD recommends fluoride varnish applications at every well-child visit for children at elevated cavity risk — typically every 3 to 6 months rather than the standard 6-month schedule.
If your child drinks non-fluoridated water, bring this up explicitly at your next dental visit so your dentist can adjust their preventive care plan accordingly.
How to Talk to Your Child’s Dentist About This
You do not need to be an expert in FDA regulations to have this conversation — you just need to know what to ask.
- Ask your dentist: Does my child’s water supply contain fluoride? If not, what alternatives do you recommend now that supplements are restricted for children under 3?
- Ask: Based on my child’s cavity risk, how often should they be receiving fluoride varnish?
- Ask: Am I using the right amount of fluoride toothpaste for my child’s age?
- Ask: With the new toothpaste packaging coming out, is there a specific brand or formulation you recommend?
A good pediatric dentist will welcome these questions and use them as an opportunity to tailor a preventive care plan to your child’s specific needs.
Bottom Line
The FDA fluoride supplement restriction and the new toothpaste packaging changes are both real and worth understanding — but they do not mean fluoride is dangerous or that you should stop using fluoride toothpaste for your child.
Fluoride toothpaste in the right amount, used correctly and consistently, remains the most effective and accessible cavity-prevention tool available to the vast majority of children.
If your child was receiving prescription fluoride supplements and is under age 3, contact your pediatric dentist to discuss your options.
For every other family: check your toothpaste amount, keep up with regular dental visits, and let your dentist guide decisions based on your child’s individual risk — not social media headlines.
This article provides general information about recent FDA actions affecting fluoride products for children. It does not replace professional dental or medical advice. Always consult your child’s pediatric dentist or pediatrician before changing their oral care routine.
Frequently Asked Questions
Did the FDA ban fluoride toothpaste for children?
No. The FDA’s October 2025 action restricted prescription fluoride supplements (drops and tablets) for children under age 3 only. Fluoride toothpaste is not affected and continues to be recommended by the AAPD, ADA, and AAP for all children starting when their first tooth appears.
Why did the FDA restrict fluoride supplements for babies?
The FDA cited concerns including potential gut microbiome effects, possible thyroid disruption, and the neurodevelopmental concerns raised by the NTP meta-analysis published in January 2025. The restriction was a precautionary action specifically for the youngest children, not a broad condemnation of fluoride safety.
What should I use instead of fluoride supplements for my baby?
If your child was receiving fluoride supplements and is under age 3, consult your pediatric dentist. The primary alternatives include correct fluoride toothpaste use (rice-grain amount from first tooth), professional fluoride varnish at dental checkups, and — where possible — drinking fluoridated tap water rather than bottled or filtered water.
What toothpaste brands changed their packaging in 2026?
Colgate-Palmolive and Procter & Gamble (Crest) both agreed to update packaging as part of their settlements with the Texas AG’s office, with changes rolling out January 1, 2026. Other brands may follow suit. Look for packaging that clearly shows a pea-sized or smaller amount of toothpaste appropriate for children’s ages.
How much fluoride toothpaste should a 2-year-old use?
A rice-grain-sized smear — approximately 0.1 grams — is the current AAPD recommendation for children under age 3. This is a very small amount, much less than most packaging previously depicted. The new 2026 packaging updates are designed to make this clearer for parents.
Source List
- FDA. (October 31, 2025). Restriction of prescription fluoride supplement products for children under 3. Federal Register / FDA.gov.
- American Academy of Pediatric Dentistry. (2025). AAPD Statement on FDA Fluoride Supplement Restriction. https://www.aapd.org
- American Academy of Pediatrics. (2025). AAP Response to FDA Fluoride Supplement Action.
- American Dental Association. (2025). ADA Statement on Fluoride Supplements and Toothpaste Guidance.
- Texas Attorney General Ken Paxton. (2025). Settlements with Colgate-Palmolive and Procter & Gamble regarding toothpaste packaging. https://www.texasattorneygeneral.gov
- AAPD. (2023–2024). Fluoride Therapy Clinical Practice Guideline — Age-appropriate toothpaste amounts. https://www.aapd.org/research/oral-health-policies–recommendations/fluoride-therapy/
- National Toxicology Program. (2025). NTP Monograph on Fluoride and Neurodevelopment. Published in JAMA Pediatrics, January 2025.
- CDC. (2024). Fluoride Supplementation for Children: Recommendations. https://www.cdc.gov/fluoridation/
Mary – Queens Pediatric Dental Resource Manager. I’m a dental health researcher and parent advocate based in Queens, NY. After struggling to find reliable pediatric dental information during my own child’s dental emergency, I created this resource to help other Queens families navigate their children’s oral health needs.
I curate evidence-based information from leading pediatric dental organizations, peer-reviewed research, and trusted dental health experts. While I’m not a dentist, I’m committed to providing accurate, practical guidance that helps parents make informed decisions.
All content is thoroughly researched and includes proper medical disclaimers directing families to consult qualified pediatric dentists for their children’s specific needs.