Corporate Misconduct Accountability Project
Chattem, Inc. · Class Action Lawsuit
ACT Kids Mouthwash Marketed to Preschoolers Despite FDA Warning
Chattem Inc. allegedly used candy flavors and cartoon packaging to sell fluoride mouthwash to children under 6, a group for whom the FDA says the product is too dangerous to use.
CRITICAL SEVERITY
TL;DR
Chattem marketed ACT anticavity fluoride rinse to preschoolers using bright colors, cartoon fruit imagery, and candy flavors like Groovy Grape and Bubble Gum Blowout. The FDA explicitly states fluoride mouthrinse is not safe for children under 6 because they swallow too much and lack developed swallowing reflexes. Parents bought the product believing it was specially formulated for young children, when it actually contains the same fluoride concentration as adult rinses and poses risks of poisoning, dental fluorosis, and potential neurological harm.
This case shows how corporate profit motives can put children’s health at risk through deceptive marketing that exploits busy parents and regulatory gaps.
2.3 mg
Fluoride in single 10mL dose, enough to cause toxicity in toddlers
112 mg
Total fluoride per bottle, potentially lethal if 54% consumed by 2-year-old
4,000+
Annual poison control reports for fluoride mouthrinse ingestion by children
68%
U.S. children with dental fluorosis by 2015-16, up from 23% in 1986-87
0.05%
Sodium fluoride concentration, identical to adult formulations
The Allegations: A Breakdown
Core Allegations
What Chattem allegedly did to mislead parents · 8 points
| 01 | Chattem marketed ACT Rinse with the word Kids in rainbow-colored crayon font on the front label alongside cartoon images of candy and fruit, creating the false impression the product is specially formulated to be safe for young children. | high |
| 02 | The company formulated ACT Kids Rinse with 0.05% sodium fluoride, the exact same concentration as adult fluoride rinses, despite marketing it specifically to preschoolers who face greater toxicity risks. | critical |
| 03 | Chattem created candy and juice flavors including Groovy Grape, Wild Watermelon, Pineapple Punch, and Bubble Gum Blowout that entice children to swallow the product, dramatically increasing fluoride ingestion and poisoning risk. | critical |
| 04 | The company failed to prominently display the FDA-required warning IMPORTANT: Read directions for proper use on the front label, instead burying it in the smallest font at the bottom while highlighting #1 DENTIST RECOMMENDED in bold at the top. | high |
| 05 | Chattem displayed the ADA seal of approval on the label without disclosing that the ADA only approves this product for children 6 years and older, not for the preschoolers the packaging clearly targets. | high |
| 06 | The company designed ACT Pineapple Punch packaging to closely resemble Hawaiian Punch children’s drink bottles, blurring the line between a dangerous drug and a harmless beverage in children’s minds. | high |
| 07 | Chattem knew or should have known that fluoride mouthrinses have been contraindicated for children below school age since at least 1960, yet continued targeting this exact demographic. | high |
| 08 | The company made no effort to reduce fluoride concentration or create a genuinely safer formulation for children, instead simply repackaging an adult product with child-targeted marketing. | medium |
Public Health and Safety Risks
How this product endangers children · 8 points
| 01 | The FDA states that fluoride mouthrinses are not indicated for use in children under 6 years of age on an over-the-counter basis because young children have not developed control of their swallowing reflex and cannot expectorate properly. | critical |
| 02 | A 2-year-old child of average weight who ingests just over half of a single 10mL dose of ACT Rinse will exceed 0.1 mg/kg of fluoride, the threshold at which nausea and gastrointestinal distress have been reported. | critical |
| 03 | A toddler who consumes just 54% of one ACT bottle reaches the Probable Toxic Dose of 5 mg/kg, the level that should trigger immediate therapeutic intervention and hospitalization due to likelihood of serious toxic consequences including death. | critical |
| 04 | Young children who swallow fluoride mouthrinse during tooth development face irreversible dental fluorosis, a permanent mottled discoloration that can cause brown, gray, or black patches and pits on teeth requiring expensive cosmetic treatment. | high |
| 05 | Studies show children aged 2-3 could not perform mouthrinsing with water and instead quickly swallowed the fluid, making any expectation that preschoolers will spit out candy-flavored rinse unrealistic. | high |
| 06 | The National Toxicology Program concluded in August 2024 that excess fluoride exposure is consistently associated with reduced IQ in children, and a federal court found fluoride in drinking water poses an unreasonable risk of reduced IQ. | high |
| 07 | Swallowing as little as 3 milligrams of fluoride in one sitting has caused widespread erosions of the gastric mucosa in adults’ stomachs, with children facing even lower toxic thresholds due to smaller body weight and stomach capacity. | high |
| 08 | The CDC, WHO, American Dental Association, American Academy of Pediatrics, and Colgate all state that fluoride mouthrinse should not be used by children under 6 without consultation with a healthcare provider. | medium |
Regulatory Failures and Legal Violations
How Chattem violated federal requirements · 6 points
| 01 | Chattem violated 21 C.F.R. Section 355.55 by failing to prominently place the required statement IMPORTANT: Read directions for proper use on the principal display panel, instead using the smallest font size on the label. | high |
| 02 | The company violated 21 U.S.C. Section 352(a) by using packaging that is false or misleading in any particular, specifically by conveying that ACT Rinse is specially formulated to be safe for young children when it is contraindicated for this age group. | high |
| 03 | The FDA stressed that safe use of fluoride mouthrinse requires proper labeling and that sellers must clearly instruct consumers to read the directions, requirements Chattem allegedly ignored. | high |
| 04 | The FDA did not require a fluorosis warning on mouthrinse packaging specifically because fluoride dental rinses are recommended only for use in adults and children 6 years of age and older, meaning Chattem’s targeting of younger children circumvents this safety assumption. | medium |
| 05 | Federal regulations require the poison warning Keep out of reach of children in bold type, yet Chattem’s child-targeted marketing directly contradicts this safety instruction by making the product maximally appealing to preschoolers. | medium |
| 06 | The FDA expressed concern that based upon familiarity with cosmetic mouthrinse use, a consumer might overuse and/or misuse an OTC fluoride rinse, a risk Chattem’s Kids branding dramatically amplifies. | medium |
Profit Over Children’s Safety
How Chattem prioritized revenue over health · 6 points
| 01 | Chattem deliberately targeted the preschool market to capture revenue from an untapped demographic, despite knowing this age group should not use fluoride mouthrinse according to every major health authority. | critical |
| 02 | The company chose to make the rinse taste and smell like candy and juice specifically to increase usage and encourage repeat purchases, even though sweet flavoring is known to increase the possibility that a child will ingest a toxic dose of fluoride. | high |
| 03 | Rather than create a lower-fluoride or genuinely safer formulation for children, Chattem simply repackaged an adult-strength product with child-friendly marketing to maximize profit while minimizing production costs. | high |
| 04 | The mouth rinse sector for children represents tens of millions in annual sales, giving Chattem strong financial incentive to overlook safety concerns and capture market share from parents seeking cavity prevention for toddlers. | medium |
| 05 | Chattem removed language from its website stating ADA accepted to reduce caries and protect enamel in kids aged 6+ only after receiving pre-suit notice of the claim, suggesting awareness of the deception. | medium |
| 06 | The company treats potential settlement or lawsuit costs as a mere cost of doing business, calculating that profits from misleading marketing outweigh legal risks. | medium |
Impact on Families and Communities
Real harm to parents and children · 7 points
| 01 | Parents reported using ACT Rinse for children as young as 1.5 years old based on the Kids label and cartoon packaging, with one parent stating their toddler absolutely loves the Wild Watermelon flavor. | high |
| 02 | Customer reviews show parents specifically bought ACT to introduce mouth wash to my toddlers and found it hard to convince them not to swallow it, exactly the dangerous scenario health authorities warn against. | high |
| 03 | One parent wrote that their 3-year-old granddaughter can’t brush her teeth enough during the day, she loves this stuff after tasting the bubble gum flavor herself, showing how the candy taste drives overconsumption. | high |
| 04 | Lower-income families who rely on prominent brand cues like Kids and ADA-Approved to guide purchasing decisions lack time or resources to research thoroughly, making them especially vulnerable to this deceptive marketing. | medium |
| 05 | Families whose children develop dental fluorosis face financial burden of medical care or expensive cosmetic fixes like veneers, worsening wealth disparity when a product marketed as protective actually causes permanent tooth damage. | medium |
| 06 | Parents may attribute symptoms of mild fluoride toxicity like nausea, vomiting, and diarrhea to colic or gastroenteritis, never realizing the mouthrinse caused the illness and continuing to use the product. | medium |
| 07 | Poison control centers receive thousands of calls annually about children ingesting fluoride mouthrinse, but this represents only a fraction of total incidents due to substantial underreporting. | medium |
Corporate Deception Tactics
How Chattem obscures the truth · 6 points
| 01 | Chattem prominently displays #1 DENTIST RECOMMENDED in bold font at the top center of the label while burying the FDA-required safety notice in the smallest font at the bottom, ensuring parents see marketing claims but miss warnings. | high |
| 02 | The company includes all FDA-required warnings and directions in fine print on the back label, then relies on the legal fiction that parents shopping with children in tow will carefully study complicated product packages. | high |
| 03 | By putting Children under 6 years of age: Consult a dentist or doctor only in back-label directions while the front screams Kids in cartoon font, Chattem ensures the warning never reaches parents at point of purchase. | high |
| 04 | The packaging design mimics children’s juice drinks like Hawaiian Punch so closely that kids cannot distinguish between safe beverages and a drug that should not be swallowed, exploiting children’s inability to read or follow instructions. | medium |
| 05 | Chattem displays the ADA seal without the age limitation, allowing parents to assume the prestigious endorsement applies to the young children the packaging targets rather than only to kids 6 and up. | medium |
| 06 | The company likely defends itself by claiming it clearly says do not swallow and that parents must supervise usage carefully, shifting blame onto consumers who supposedly ignore instructions that were deliberately obscured. | medium |
Corporate Accountability Failures
Systemic breakdown in oversight · 6 points
| 01 | Despite clear FDA regulations requiring prominent display of safety notices, Chattem sold ACT Kids Rinse with illegal labeling for years without enforcement action, demonstrating regulatory capture and underfunded oversight. | high |
| 02 | The FDA lacks resources and political will to police everyday labeling compliance, leaving private class action lawsuits as the only mechanism forcing companies to correct dangerous products. | high |
| 03 | Neoliberal deregulation has gutted the FDA’s authority over consumer products through funding constraints, intense lobbying, and cutbacks that hamper thorough oversight of labeling violations. | medium |
| 04 | Regulatory agencies often rely on data and internal documents from the very industries they regulate, creating conflicts of interest that enable companies like Chattem to skirt safety rules. | medium |
| 05 | Government enforcement budgets have shrunk to the point that agencies focus only on major crises while everyday policing of product labeling falls to harmed consumers who must sue to force compliance. | medium |
| 06 | The pattern of companies treating legal settlements as a cost of doing business means that without massive punitive damages, corporations have no incentive to prioritize safety over profit. | medium |
Wealth Disparity and Systemic Inequality
How corporate greed widens the gap · 5 points
| 01 | Chattem targets the most vulnerable populations including busy parents and small children who lack ability to read instructions or understand complex medical warnings, exploiting information asymmetry for profit. | high |
| 02 | The company engineers demand by making a dangerous product maximally appealing through candy flavors without changing its toxic fluoride concentration, ensuring frequent repurchase while externalizing health costs onto families. | high |
| 03 | Lower-income families bear disproportionate burden when children develop dental fluorosis or poisoning symptoms because they lack financial resources for medical care, cosmetic dental repairs, or time to research products thoroughly. | medium |
| 04 | The economic fallout of Chattem’s alleged misconduct flows upward to corporate shareholders while health costs, poison control resources, emergency room visits, and long-term dental damage flow downward to working families. | medium |
| 05 | Children who develop severe dental fluorosis may experience social stigma and require expensive veneers or other cosmetic treatments that insurance often does not cover, perpetuating cycles of disadvantage. | medium |
The Bottom Line
Why this matters beyond one product · 6 points
| 01 | The ACT Kids Rinse case exemplifies how neoliberal capitalism incentivizes corporations to prioritize quarterly earnings and market share over child safety, treating regulatory violations as acceptable business costs. | high |
| 02 | This lawsuit demonstrates that without robust government enforcement, private class actions become the only mechanism to protect public health from predatory marketing practices that target children. | high |
| 03 | Chattem’s alleged strategy of repackaging an adult-strength drug with cartoon imagery and candy flavors reveals how corporate greed exploits regulatory gaps and parental trust to capture profitable market niches regardless of harm. | high |
| 04 | The pattern of presenting dangerous drugs as food-like products increases poisoning risk for vulnerable children and exemplifies broader corporate corruption disguised as trusted brands. | medium |
| 05 | If successful, this class action could force Chattem to change its labeling or withdraw the product, showing that consumer litigation remains one of the few tools to challenge corporate misconduct when regulators fail. | medium |
| 06 | The case underscores the need for systemic reforms including stronger labeling requirements, age-restricted sales, elimination of candy flavoring in toxic products, and independent monitoring to protect children from profit-driven marketing. | medium |
Timeline of Events
1960
Scientific literature establishes fluoride mouthrinses should not be employed in children below school age due to swallowing risks.
October 1985
FDA proposes regulations stating fluoride dental rinses are recommended only for adults and children 6 years and older.
October 1995
FDA issues final monograph declaring fluoride mouthrinses are not indicated for use in children under 6 years of age on an OTC basis.
2001
CDC publishes recommendations stating children under 6 years should not use fluoride mouthrinse without consultation with healthcare provider.
2020
American Academy of Pediatrics states fluoride mouth rinses should not be used until a child turns 6 and only if child can reliably swish and spit.
2020-2024
Named plaintiffs purchase ACT Rinse for children aged 1.5 to 5 years old based on Kids labeling and cartoon packaging.
August 2024
National Toxicology Program concludes excess fluoride exposure is consistently associated with reduced IQ in children.
September 2024
Federal district court rules that adding fluoride to drinking water poses an unreasonable risk of reduced IQ in children.
January 2025
NTP scientists publish meta-analysis in JAMA Pediatrics finding inverse associations between fluoride and children’s IQ across 74 studies.
January 13, 2025
Class action lawsuit filed against Chattem, Inc. in U.S. District Court for Northern District of Illinois.
Direct Quotes from the Legal Record
QUOTE 1
FDA explicitly bars fluoride rinse for under-6 age group
health
“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.”
💡 This FDA statement proves young children cannot safely use the product Chattem markets directly to them.
QUOTE 2
FDA requires prominent warning that Chattem buried
regulatory
“the following statement shall be prominently placed on the principal display panel: ‘IMPORTANT: Read directions for proper use.'”
💡 This regulation is the basis for the unlawful business practices claim under California law.
QUOTE 3
FDA knew consumers would confuse fluoride with cosmetic rinse
regulatory
“based upon familiarity with cosmetic mouthrinse use, a consumer might overuse and/or misuse an OTC fluoride rinse.”
💡 The FDA foresaw exactly the confusion Chattem’s Kids branding creates.
QUOTE 4
FDA explains why prominence is legally required
regulatory
“the safe use of fluoride mouthrinse requires proper labeling. Towards this end, the FDA specifically commands that the labeling for fluoride mouthrinses clearly instructs consumers to read the directions.”
💡 This shows Chattem’s labeling failure is not a technicality but a core safety requirement.
QUOTE 5
Candy flavoring increases toxic dose risk
health
“The use of flavored consumer fluoride products increases the possibility that a child will ingest a toxic dose of fluoride.”
💡 Scientific literature directly contradicts Chattem’s decision to make rinse taste like candy.
QUOTE 6
Pictures of fruit signal product is food
profit
“pictures of fruit with flavoring to match on kids fluoride products is misleading because pictures of fruit send a common signal to a child that [the product] is intended to be consumed as if it were food.”
💡 Journal of Dental Hygiene explains exactly how Chattem’s fruit imagery deceives children.
QUOTE 7
2-3 year olds cannot rinse, they swallow immediately
health
“most 2 year old children and some 3 year old children could not perform mouthrinsing with water, but instead quickly swallowed the fluid.”
💡 FDA research proves preschoolers cannot use this product safely even with supervision.
QUOTE 8
American Dental Association age restriction
health
“Children younger than the age of 6 should not use mouthrinse, unless directed by a dentist, because they may swallow large amounts of the liquid inadvertently.”
💡 The ADA whose seal appears on the bottle explicitly says under-6 kids should not use it.
QUOTE 9
World Health Organization prohibition
health
“fluoride mouthrinses are not recommended for children below the age of 6 years.”
💡 Global health authorities agree this product should not be marketed to preschoolers.
QUOTE 10
Colgate warns against use by babies and toddlers
health
“babies and toddlers should not use [fluoride] mouthrinse because children under six may not have fully developed their swallowing reflexes and could swallow the mouthrinse, which can lead to side effects like vomiting, intoxication, and nausea.”
💡 Even Chattem’s competitor acknowledges the product category is unsafe for toddlers.
QUOTE 11
Parents describe using for children under 2
community
“I bought this product to introduce mouth wash to my toddlers! And the [bubble gum] flavor was perfect! Hard to convince them not to swallow it!”
💡 Real customer reviews prove Chattem’s marketing succeeds in reaching the exact age group that should never use it.
QUOTE 12
Parent used for 2.5 year old based on packaging
community
“Our son who is 5yrs old likes this one a lot. It’s easy for him to portion out with the control squeeze top. We are now teaching our 2 1/2yr old to use it as well.”
💡 Parents assume if it is easy to use it must be safe, exactly the deception the lawsuit challenges.
QUOTE 13
Child got it for 3 year old granddaughter
community
“Got it for my 3 yr old grandaughter and she can’t brush her teeth enough during the day, she loves this stuff”
💡 The candy taste creates overconsumption in preschoolers who should not use the product at all.
QUOTE 14
Chattem removed age restriction from website after notice
pr_machine
“Defendant appears to have removed this language from its website after Plaintiffs provided pre-suit notice of their claim. The language was previously located on the following webpage: https://www.actoralcareprofessional.com/kids-products/. On this page, Defendant had stated: ADA accepted to reduce caries and protect enamel in kids aged 6+”
💡 Chattem scrubbed evidence of the age restriction from its website after being notified of the lawsuit, suggesting consciousness of guilt.
QUOTE 15
Probable toxic dose defined
health
“The Probable Toxic Dose is defined as the dose of ingested fluoride that should trigger immediate therapeutic intervention and hospitalization because of the likelihood of serious toxic consequences.”
💡 This medical definition shows how close a toddler comes to lethal poisoning from this product.
Frequently Asked Questions
Why is ACT Kids mouthwash dangerous for children under 6?
Children under 6 have not developed swallowing reflexes and cannot spit properly, so they swallow large amounts of the rinse. ACT Kids contains the same high fluoride concentration as adult rinses (0.05% sodium fluoride). When swallowed, this fluoride can cause nausea, vomiting, stomach pain, and in severe cases, poisoning that requires hospitalization. Young children who repeatedly swallow fluoride also risk permanent dental fluorosis, which causes irreversible staining and damage to tooth enamel.
Does ACT Kids Rinse have less fluoride than regular mouthwash?
No. Despite being marketed with cartoon imagery and candy flavors for young children, ACT Kids Rinse contains exactly the same 0.05% sodium fluoride concentration as adult fluoride mouth rinses. Chattem did not create a gentler or safer formulation for children. The company simply repackaged an adult-strength product with child-friendly branding.
What health authorities say children should not use fluoride mouthrinse?
The FDA, CDC, World Health Organization, American Dental Association, American Academy of Pediatrics, and even Colgate (Chattem’s competitor) all state that fluoride mouthrinse should not be used by children under 6 years old. The FDA specifically says these products are not indicated for use in children under 6 years of age on an over-the-counter basis.
How much ACT Rinse would poison a toddler?
A 2-year-old child of average weight (12 kg) can experience nausea and vomiting from swallowing just over half of a single 10mL dose. The same child reaches the Probable Toxic Dose requiring immediate hospitalization after consuming about 54% of one bottle. Half a bottle contains enough fluoride to potentially kill a small child. One bottle of ACT Rinse contains 112 milligrams of fluoride total.
Why did Chattem market this product to preschoolers if it is unsafe?
The lawsuit alleges Chattem deliberately targeted the preschool market to capture revenue from an untapped demographic. By using bright colors, cartoon fruit imagery, candy flavors like Bubble Gum Blowout and Groovy Grape, and the word Kids in rainbow crayon font, Chattem could expand market share and build brand loyalty among families. The company prioritized profit over child safety.
Did Chattem break any laws with its labeling?
Yes. The lawsuit alleges Chattem violated federal regulation 21 C.F.R. Section 355.55, which requires fluoride mouthrinse labels to prominently display the warning IMPORTANT: Read directions for proper use on the front panel. Chattem used the smallest font on the label for this warning and buried it at the bottom, while prominently displaying marketing claims like #1 DENTIST RECOMMENDED in bold at the top. The company also violated 21 U.S.C. Section 352(a) by using false and misleading labeling.
How many children are poisoned by fluoride mouthrinse each year?
Over 4,000 calls to poison control centers occur annually for fluoride mouthrinse ingestion by young children. However, experts say this represents only a fraction of actual incidents due to substantial underreporting. Many parents attribute symptoms like nausea and vomiting to stomach flu and never realize the mouthrinse caused the poisoning.
What is dental fluorosis and can ACT Rinse cause it?
Dental fluorosis is permanent mottled discoloration of tooth enamel caused by ingesting too much fluoride while teeth are developing. It can cause white lines and streaks in mild cases, or brown, gray, and black patches and pits in severe cases. The damage is irreversible. The CDC explicitly states that if children repeatedly swallow mouth rinses, they may develop dental fluorosis. Rates of fluorosis in U.S. children tripled from 23% to 68% following introduction of candy-flavored fluoride products.
Why does the ADA seal appear on ACT Kids if the product is unsafe for young children?
The ADA specifically approves ACT Rinse only for children 6 years of age and older. However, Chattem displays the ADA seal on the label without disclosing this age limitation. Parents see the ADA seal, see the cartoon imagery and Kids branding, and assume the approval applies to the preschoolers the packaging clearly targets. The lawsuit calls this a material omission that misleads consumers.
What can parents do if they bought this product for a young child?
Parents who purchased ACT Rinse for children under 6 may be eligible to join the class action lawsuit seeking refunds and damages. Immediately stop using the product for young children. If your child has swallowed the rinse and shows symptoms like nausea, vomiting, or stomach pain, contact poison control or seek medical attention. Parents can also file complaints with the FDA about misleading labeling and support advocacy efforts for stronger regulation of fluoride products marketed to children.
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