The Non-Financial Ledger

There is a mother in Chicago who bought her 2-year-old son a grape-flavored mouthwash because it said “Kids” on the bottle in rainbow crayon letters. She bought it at CVS. She bought it at Walgreens. She bought it again at Walmart. She was not directed by any doctor or dentist. She was directed by the packaging, and the packaging told her this was a product made for her child.

Her son, identified in court documents only as G.K., liked the candy flavor. That detail should sit with you for a moment. He liked it. The whole scheme depended on him liking it.

In Queens Village, New York, a mother named Sushmadavi Lakeram started giving ACT Kids to her son C.L. when he was approximately a year and a half old. Eighteen months. A child who could barely walk was being given a drug the FDA considers unsafe for children under 6, because the company that makes the drug designed its packaging to look like something you’d give a toddler without a second thought.

In Suisun City, California, Eileen Aviles’s daughter I.A.C. was 2 years old when her mother started using ACT Kids on her teeth. In Danvers, Illinois, Deena Johnson started giving the rinse to her daughter R.J. around age 2 as well, and continued until R.J. was 5.

None of these families were negligent. None of them were careless. They were parents trying to do the right thing for their children’s dental health, walking down the store aisle, reading a label that said the product was recommended by dentists, and seeing a seal from the American Dental Association. What they were not told was that the ADA’s approval only covers children 6 years and older. Chattem displayed that seal without that context. The company apparently even removed the age restriction language from its professional website after receiving pre-suit notice from the plaintiffs, though that language can still be found by searching Google for the exact quote.

The complaint describes what happens to a child’s developing teeth when they ingest too much fluoride. The enamel becomes more porous. White lines and streaks appear. In severe cases: brown, gray, or black patches and pits. It is a permanent condition. It cannot be undone. Studies in peer-reviewed dental journals describe children who are “reluctant to smile” because of the appearance of their teeth, children who have been subjected to “unkind remarks” from peers about what looks like poor hygiene. A child who did nothing wrong, whose parents did nothing wrong, carrying visible, permanent marks on their face because a corporation decided that candy-flavoring a drug approved only for older children and slapping a rainbow label on it was a viable business strategy.

When mild to moderate fluorosis appears on the upper front teeth, which are the most cosmetically significant teeth and the ones most affected by fluoride exposure in the first three years of life, the only options are expensive cosmetic procedures: abrasion in milder cases, dental veneers in severe ones. These are not accessible to every family. They are certainly not something anyone agreed to when they bought a $6 bottle of grape-flavored mouthwash at Walmart.

There is also the question of what nobody can yet quantify. The National Toxicology Program, part of the National Institutes of Health, concluded in August 2024 that excess fluoride is “consistently associated with reduced IQ in children.” A meta-analysis of 74 human studies, published in JAMA Pediatrics in January 2025, confirmed the dose-response relationship. No one is saying ACT Kids definitely lowered any particular child’s IQ. What we can say is that Chattem was selling a candy-flavored product that increases fluoride ingestion in children who are already getting fluoride from water, food, and toothpaste, in the exact age group science has flagged as most vulnerable to neurodevelopmental harm, while the front of the bottle said “#1 DENTIST RECOMMENDED” in bold letters and buried every caution in the smallest font on the label.

These four families are the named plaintiffs. The lawsuit estimates hundreds of thousands more people did the same thing they did. They all bought a product marketed at toddlers that the FDA, the World Health Organization, the American Academy of Pediatrics, the CDC, and Chattem’s own competitor Colgate all agree toddlers should not use.

Legal Receipts

Every quote below comes directly from the lawsuit filing, regulatory documents, or peer-reviewed sources cited within it. Nothing has been paraphrased or invented.

The FDA, in Its Own Words

“Children under 6 years of age . . . have not developed control of their swallowing reflex and are not able to hold the fluoride preparation in their mouth and then expectorate properly.”

“Based upon familiarity with cosmetic mouthrinse use, a consumer might overuse and/or misuse an OTC fluoride rinse . . . the ‘safe’ use of fluoride mouthrinse requires ‘proper labeling.'”

“The following statement shall be prominently placed on the principal display panel: ‘IMPORTANT: Read directions for proper use.'”

“We disagree with the district court that reasonable consumers should be expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box . . . We do not think that the FDA requires an ingredient list so that manufacturers can mislead consumers and then rely on the ingredient list to correct those misinterpretations and provide a shield for liability for the deception.”

“The use of flavored consumer fluoride products increases the possibility that a child will ingest a toxic dose of fluoride.”

“My toddler loves this product and even asks to use it after brushing.” / “Our son who is 5yrs old likes this one a lot . . . We are now teaching our 2 1/2yr old to use it as well. We will continue to buy.”

“If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.”

“A toddler who ingests just over half of the colorful candy-flavored liquid in the ACT bottle may suffer severe poisoning, including death.”

Societal Impact Mapping

Public Health

The documented public health consequences of Chattem’s marketing strategy fall into three categories: acute poisoning, permanent developmental damage, and emerging evidence of neurological harm.

• Over 4,000 calls per year are made to U.S. poison control centers related to fluoride mouthrinse ingestion by young children. Researchers and the FDA acknowledge this number is a significant undercount due to “substantial underreporting,” because parents often do not recognize mild fluoride toxicity symptoms, which mimic stomach flu.
• A 2-year-old of average weight (~12 kg) who swallows just over half of a single 10 mL dose of ACT Rinse ingests enough fluoride to cause nausea, vomiting, diarrhea, and gastrointestinal burning. Symptoms occur because fluoride combines with stomach acid to form hydrofluoric acid, which burns the gastric lining.
• A 1-year-old of average weight (~9 kg) exceeds the Probable Toxic Dose (5 mg/kg, the threshold requiring immediate hospitalization) by drinking just 40% of one ACT bottle. A 2-year-old hits that threshold at 54% of one bottle. ACT Rinse contains 112 mg of fluoride per bottle.
• Even sub-toxic ingestion causes risk: a 2-year-old who drinks one-sixth of a single dose ingests fluoride at levels credibly associated with impaired thyroid function in children with inadequate iodine intake, per the 2006 National Research Council review. A child who ingests one-third of a dose reaches blood fluoride levels associated with impaired glucose metabolism.
• The National Toxicology Program’s August 2024 systematic review found that excess fluoride is “consistently associated with reduced IQ in children,” based on a review of the global epidemiological literature. A January 2025 meta-analysis of 74 human studies in JAMA Pediatrics confirmed a dose-response relationship between fluoride exposure and children’s IQ scores. The NTP specifically flagged mouthwash as a source of fluoride exposure that may push children’s total intake above safe levels when combined with fluoridated water, toothpaste, food, and beverages.
• Dental fluorosis now affects 68.2% of U.S. schoolchildren, according to the most recent CDC national survey (2015–16). That number was 23% in 1986–87, before candy-flavored fluoride dental products became widespread. Children aged 0–3 are in the highest-risk window for fluorosis of the upper front teeth, the most cosmetically significant teeth.
• Fluorosis causes permanent hypomineralization of enamel, making it more porous. Mild fluorosis produces white streaks and lines. Severe fluorosis produces brown, gray, or black patches and pits on an irregular tooth surface. These effects are irreversible. There is no non-cosmetic cure.

“Children may be getting more fluoride than they need because they now get fluoride from many sources . . . and the combined total intake of fluoride may exceed safe amounts.”

Economic Inequality

The financial and social costs of this deception fall hardest on families who can least afford to absorb them.

• Parents who purchased ACT Kids for children under 6 paid the full retail price for a drug the FDA considers contraindicated for their child’s age group. The lawsuit argues the product’s true value to consumers in this context is zero, because no reasonable parent would knowingly purchase a drug FDA says should not be used by their child.
• Dental fluorosis requires costly cosmetic treatment. Mild cases may require professional abrasion of the tooth surface. Severe cases require veneers. Both procedures are expensive, often not covered by basic dental insurance, and entirely out of reach for low-income families. The permanent cosmetic damage falls disproportionately on children whose families cannot pay to fix it.
• The class action complaint notes that the product is sold at Walmart, Target, CVS, and Walgreens, mass-market retailers that serve price-conscious shoppers. These are not specialty shops where health-conscious, highly-researched consumers browse carefully. These are stores where a parent grabs a product off the shelf in a hurry because the label says “Kids” in a crayon font and the ADA seal is on the front.
• The named plaintiffs include working families from Chicago, Danvers (Illinois), Suisun City (California), and Queens Village (New York). Their injuries are economic: they paid money for a product they would never have bought if told the truth. They cannot recoup that loss without organized legal action, which is why a class action mechanism is essential and why Chattem’s individually small-dollar deception across hundreds of thousands of purchases represents a substantial aggregate injury.
• The psychosocial harm of dental fluorosis documented in peer-reviewed literature, including children being bullied by peers, refusing to smile, withdrawing socially, and suffering reduced confidence, creates secondary economic costs in the form of mental health support and social development consequences that disproportionately compound existing disadvantage.

What the Label Said vs. What Was True

Chattem made a series of specific claims and design choices on the ACT Kids label. Each one created a false impression the scientific and regulatory record directly contradicts.

The “Cost of a Life” Metric

The lawsuit estimates hundreds of thousands of class members purchased ACT Kids for children under 6. The case seeks compensatory damages, restitution, disgorgement, statutory damages, treble damages, and punitive damages in amounts to be determined at trial, with an aggregate controversy floor exceeding $5,000,000 under CAFA.

What Now?

The lawsuit is active in the Northern District of Illinois. Named corporate defendant is Chattem, Inc., a Tennessee corporation with its principal place of business in Bridgewater, New Jersey. Chattem is a subsidiary of Sanofi, one of the largest pharmaceutical corporations in the world.

Who to Pressure: The Watchlist

• Chattem, Inc. Corporate Leadership: The company’s registered principal place of business is Bridgewater, New Jersey. Chattem operates as a consumer healthcare division of Sanofi. Sanofi’s U.S. operations are a direct line of accountability for this product’s continued sale.
• U.S. Food and Drug Administration (FDA): The FDA already has a monograph requiring prominent front-label warnings on fluoride mouthrinse. The agency should investigate Chattem’s compliance with 21 C.F.R. § 355.55 and open an enforcement proceeding. FDA Consumer Complaint Coordinators accept reports at 1-800-FDA-1088.
• Federal Trade Commission (FTC): The FTC has jurisdiction over deceptive advertising and marketing practices. The candy-flavored, toddler-targeted marketing of a federally contraindicated drug is precisely the kind of consumer deception the FTC exists to stop. File a complaint at reportfraud.ftc.gov.
• American Dental Association (ADA): The ADA’s seal of approval is displayed on this product in a way that omits the age restriction. The ADA should issue a public clarification and consider whether its seal licensing agreement with Chattem adequately protects consumers from this type of misrepresentation.
• State Attorneys General: The lawsuit covers 15 jurisdictions. Attorneys General in Illinois, California, New York, Arizona, Connecticut, Florida, Hawaii, Idaho, Massachusetts, Minnesota, Missouri, New Jersey, Virginia, Washington State, and Washington D.C. all have standing consumer protection statutes that Chattem’s conduct allegedly violated.
• National Poison Control Center: If a child has ingested fluoride mouthrinse, call 1-800-222-1222 immediately. Document the incident and report it to the FDA’s MedWatch system at fda.gov/medwatch. Every report adds to the evidentiary record.

What You Can Do Right Now

• Check your home. If you have ACT Kids or any fluoride mouthrinse, verify the label says children under 6 should consult a dentist before use. Keep all fluoride products out of reach of any child under 6. This is also federal law under 21 C.F.R. § 355.50(c)(2).
• Talk to your pediatric dentist. If your child under 6 has been using fluoride mouthrinse, disclose the duration and frequency. Ask about monitoring for dental fluorosis, particularly on the upper front teeth.
• If you bought ACT Kids for a child under 6 without a dentist’s direction, you may be a class member. Contact the plaintiffs’ attorneys at Siri & Glimstad LLP: mconnett@sirillp.com or (888) 747-4529. Class membership is open to purchasers across the 15 covered jurisdictions and potentially nationwide.
• Share this investigation. The core deception here depends on parents not knowing the regulatory history of this product. Every parent who knows fluoride mouthrinse is contraindicated for children under 6 is a parent who cannot be misled by a rainbow crayon font. Spread the information directly, not through corporate platforms that algorithmically suppress consumer protection content.
• Organize locally. Parent groups, school PTAs, pediatric clinics, and community health centers are direct channels to reach caregivers who are still purchasing this product for toddlers. Print this article. Bring it to a meeting. The FDA’s consumer protection infrastructure depends on an informed public willing to engage it.
• Support mutual aid oral health networks in your area that provide dental screenings for children. Early fluorosis can be caught before it worsens. Low-income families who cannot afford cosmetic correction need community-based clinical support now.