Children at Risk: Analyzing the 2025 Class Action Wave Against Major Fluoride Toothpaste Manufacturers
- Evan Howard
- Aug 17
- 5 min read
In January 2025, class action lawsuits were filed that shook the oral care industry to its core. Parents and advocates across the U.S. took a bold stand against iconic brands Crest, Colgate, Tom’s of Maine, Hello Products, Perrigo (Firefly), and Chattem (ACT), demanding answers and accountability for allegedly deceptive and hazardous marketing practices tied to fluoride-based toothpaste and mouthwash for children. Here, we'll dive into the legal battle, the science and health implications, regulatory concerns, and what it all means for families and future marketing.
Why Six Major Lawsuits and Why Now?
Fluoride is a cornerstone of modern cavity prevention, but its use in kids’ products has come under harsh scrutiny. Flavors, cartoon characters, and fun colors catch a child’s eye and, according to these lawsuits, make it all too easy for children to swallow toothpaste or mouthwash, risking health harm while parents are left in the dark. The 2025 cases were filed in federal courts in Illinois and California, targeting brands for failed warnings, marketing that entices overuse, and downplaying fluoride’s risks for children.
Who Was Sued and Why?
Defendants:
Crest (Procter & Gamble)
Colgate and Tom’s of Maine (Colgate-Palmolive)
Hello Products
Perrigo (Firefly)
Chattem (ACT Kids products)
Claims at a Glance:
Masquerading dental products as safe, fun treats through flavors, vibrant colors, and cartoon mascots;
Packaging and adverts that show generous amounts of toothpaste—far beyond guidelines for children; and
Implied “safe for kids” claims, even with high fluoride concentrations or trace heavy metals present.
Deceptive marketing practices that blur the line between health product and treat, inviting ingestion by kids too young to understand the difference;
Side-stepping or minimizing mandatory FDA warnings about quantity and age restrictions on packaging and advertising; and
Breach of warranty and misleading safety claims regarding child appropriateness and ingredient purity.
The Science of Risk: What’s Really at Stake for Children?
While fluoride protects teeth when used correctly, too much—often from unsupervised brushing with kid-friendly toothpaste—can spell trouble:
Health Risks:
Dental Fluorosis: Permanent visible discoloration and damage to developing teeth in kids, often from swallowing fluoride toothpaste during the crucial early years.
Acute Toxicity: High doses cause upset stomach, vomiting, and rarely, more severe effects like lowered IQ, highlighted in recent high-profile studies from 2024–2025. However, actual deaths are exceedingly rare due to medical interventions and labeling requirements.
The 2024–25 Evidence Surge
A major National Toxicology Program review and a September 2024 federal court decision both flagged a likely risk to child intelligence at fluoride exposures above 1.5 mg/L, paralleling what can occur with misuse of high-concentration kids’ dental products.
Legal Mechanics: False Advertising, FDA Violations, and Breach of Warranty
Misleading Marketing: Packaging and ads often show a thick stripe of toothpaste, suggesting that much should be used, despite official recommendations for only a rice-grain or pea-sized dab, depending on age.
Weak or Obscured Warnings: While FDA rules require prominent warnings like “Keep out of reach of children under 6” - toothpaste packaging often tucks them away in tiny print or behind promotional stickers.
Age-Inappropriate Marketing: Several brands advertised mouth rinses and high-fluoride pastes for children under six, directly opposed by FDA and ADA recommendations.
The Power of Marketing: Colors, Flavors, and Cartoons
Children’s oral care today is a retail playground. Bubblegum, watermelon, unicorn sparkle - these flavors and visuals are not just fun; they drive kids to use, and often swallow, more paste or rinse than is safe. Lawsuits argue such practices weaken parental oversight, making proper dosing less likely, while surveys reveal many parents load toothbrushes with six or seven times the safe amount.
Official Guidance: What the Experts Say
The CDC and American Dental Association both recommend:
Under 3 years: a rice-grain-sized smear
3 to 6 years: no more than a pea-sized amount
No fluoride rinses under age 6 (too risky for accidental swallowing)
Many class action claims rest on the manufacturers’ failure to reinforce these safe practices.
Just How Rare are Bad Outcomes? Poison Control and Real-World Risk
Poison control centers receive thousands of calls each year about accidental overuse, chiefly involving the under-six crowd. Most cases end harmlessly, but some kids experience vomiting or upset stomach; acute life-threatening cases are almost unheard of, and no U.S. child has died from toothpaste overdose in the modern era.
Lawsuit by Lawsuit: The Key 2025 Cases in Brief
Lawsuit | Defendants | Lead Allegations | Court/Jurisdiction |
Clayborne et al. v. Colgate-Palmolive, Tom’s of Maine | Colgate-Palmolive, Tom’s | Marketing misrepresentations and failure to warn | US District Court, Northern Illinois |
Multiple v. Crest (Procter & Gamble) | Crest | Enticement to overuse/ingest with kid-centric designs and ads | US District Courts, CA/IL |
Miller et al. v. Hello Products | Hello | Unsafe fluoride rinse labeling and promotion for young kids | US District Court, So. California |
Gibson et al. v. Perrigo (Firefly) | Perrigo | Deceptive, toy-like mouth rinse packaging with weak warnings | US District Court, Northern Illinois |
Gurrola et al. v. Chattem (ACT) | Chattem | Unsafe under-6 targeting, excessive fluoride risk | US District Court, Northern Illinois |
Cook v. Colgate-Palmolive (Hello Kids Rinse) | Colgate-Palmolive | Misleading “naturally friendly” safety claims | US District Court, Illinois |
Current Labeling Laws and Regulatory Scrutiny
FDA labeling mandates include:
Clear, visible warning to keep out of children’s reach under 6
Emergency advice for accidental ingestion
Age limits on mouth rinse
Encouragement of responsible dosing by parents
Still, state attorneys general—like in Texas—pursued their own probes in 2025, accusing lead manufacturers of prioritizing sales over clear risk communication.
The Money and Penalties: What Could Happen Next?
While settlements in these cases are pending, history hints at:
Cash refunds or capped per-product compensation (in past suits, up to about $4 per purchase)
Multi-million dollar totals in legal fees and penalties
Orders for clear corrective advertising and pledges to raise warning visibility
Long-term changes in labeling and restrictions on how toothpaste for kids is displayed and advertised in stores
Industry Reaction: Is Big Toothpaste Changing Tactics?
With lawsuits and investigations raining down, several brands revisited their practices:
Making warning labels more obvious
Dialing back the cartoon blast and candy flavors—especially for children under 6
Adding parent guidance on websites and stores
What Parents Need to Know Now
Whether lawsuits win or settle, the overarching message is: for parents, vigilance is everything. Always:
Supervise brushing
Use a tiny dab for little ones
Read every package warning—even the small print
Be wary of brightly-flavored, cartoon-laden products
Looking Forward: What Will 2025’s Class Actions Change?
Regulators, legal experts, and even manufacturers are nudging the industry toward greater responsibility. The likely outcome? Even stricter guidelines on child-targeted dental products, and a new baseline for honesty in advertising and labeling.
Six high-stakes cases in 2025 have raised the bar for child safety. That new accountability protects what matters most: the health and well-being of children, and the trust of every parent.
Howard Law is a business, regulatory and M&A law firm in the greater Charlotte, North Carolina area, with additional services in M&A advisory and business brokerage. Howard Law is a law firm based in the greater Charlotte, North Carolina area focused on business law, corporate law, regulatory law, mergers & acquisitions, M&A advisor and business brokerage. Handling all business matters from incorporation to acquisition as well as a comprehensive understanding in assisting through mergers and acquisition. The choice of a lawyer is an important decision and should not be based solely on advertisements. The information on this website is for general and informational purposes only and should not be interpreted to indicate a certain result will occur in your specific legal situation. Information on this website is not legal advice and does not create an attorney-client relationship. You should consult an attorney for advice regarding your individual situation. Contacting us does not create an attorney-client relationship. Please do not send any confidential information to us until such time as an attorney-client relationship has been established.
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