Colgate must face lawsuits over safety of mouth rinse for young children
Reuters - March 27, 2026
By Jonathan Stempel
A federal judge on Friday said Colgate-Palmolive must face two lawsuits claiming its packaging for mouth rinse misleads parents into believing children under 6 can use the products safely. The judge dismissed a similar lawsuit concerning Colgate toothpaste.
Consumers in the proposed class actions said U.S. health authorities warned that children under 6 should not use fluoride rinses, and recommended that children between 2 and 6 use only "pea-sized" amounts of fluoride toothpaste.
They said Colgate's packaging, featuring bright colors and flavors such as Bubble Fruit and Silly Strawberry, made it seem safe for young children to use rinses, and to use as much toothpaste as older children and adults. Fluoride can be harmful if swallowed.
U.S. District Judge Andrea Wood in Chicago said reasonable consumers might not know where to draw the line for rinses, given how most Colgate labels prominently featured the words "kids" or "children's."
She said she was unpersuaded by Colgate's insistence that consumers would know rinses are over-the-counter drugs and check the back labels, which contain required U.S. Food and Drug Administration warnings for young children.
Toothpaste was different, the judge said, because the labels expressly instructed that children between 2 and 6 use pea-sized amounts.
"Viewed in context, the toothbrush with a full strip of toothpaste is there only to represent the act of toothbrushing," Wood wrote.
Colgate, based in New York, and its lawyers did not immediately respond to requests for comment.
Michael Connett, a lawyer for the plaintiffs, said courts have been receptive to deceptive labeling claims. "These rulings will hopefully send a wake-up call to manufacturers to stop promoting unsafe use of fluoride products," he said.
Procter & Gamble, which makes Crest, as well as Perrigo and Sanofi have also been sued over their packaging of fluoride products for children.
Colgate agreed last September to introduce new packaging for its Colgate, Tom's of Maine and hello brands of toothpaste to resolve, opens new tab an investigation by Texas Attorney General Ken Paxton. Procter & Gamble reached a similar resolution in January.
SOURCE:
https://www.reuters.com/legal/governmen ... 026-03-27/
USA: Colgate must face lawsuits over safety of mouth rinse for young children
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Fluoride mouthrinse deception claims survive Colgate and Tom’s of Maine motions to dismiss
MORE INFO:
ADVERTISING—N.D. Ill.: Fluoride mouthrinse deception claims survive Colgate and Tom’s of Maine motions to dismiss, (Mar 31, 2026)
Law Firms Mentioned:Kirkland & Ellis LLP | Nagel Rice, LLP
Organizations Mentioned:Colgate-Palmolive Co. | Kirkland & Ellis, LLP
By Justin Marcus Smith, J.D.
It was not unreasonable to think that child-friendly labeling meant that mouthrinse products would be appropriate for all ages of children, whereas toothpaste deception claims pertained to proper use, and back labeling provided specific use instructions for small children.
Parents who sued the Colgate-Palmolive Company (Colgate) and Tom’s of Maine, Inc. (Tom’s) pleaded sufficient state statutory consumer deception claims in connection with the child-friendly labeling of certain fluoride mouthrinses, held the federal district court in Chicago, in denying the defendants’ motions to dismiss class actions. The court explained it was not unreasonable for consumers to conclude that a product labeled as being for children would be appropriate for all ages of children. In addition, the Food, Drug, and Cosmetic Act (FDCA) did not preempt the mouthrinse deceptive labeling claims because the labeling was fully consistent with FDCA regulations for mouthrinses, and the plaintiff parents were only challenging voluntarily added deceptive labeling statements. However, the court dismissed deception claims in connection with certain toothpastes because the parents read too much into the front labels. The toothpaste deception claims pertained to proper use, but the manufacturers provided instructions on the back labels that distinguished how children between ages two and six should only use a small amount of fluoride (Harden v. Colgate-Palmolive Co., No. 1:25-cv-00362 (N.D. Ill. Mar. 27, 2026)).
Background. Parents in three related cases alleged they bought oral hygiene products containing fluoride for their children because the labeling and packaging misled them about whether they could be safely used by children under the age of six. The Food and Drug Administration has determined that fluoride poses unique safety risks to children under age six because they might swallow toxic amounts. The parents brought putative class actions asserting claims for violations of Consumer Fraud and Deceptive Business Practices Act (ICFA), 815 ILCS 505/1 et seq., and other substantially similar state consumer-protection laws.
On discrete motions to dismiss, the defendants argued first that the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 379r(a)(2), expressly preempted all three actions. And in the event that preemption did not apply, the defendants contended the mouthrinse actions and toothpaste action all failed to plead that the defendants made any false or misleading representations on the disputed product labeling.
The court denied the defendants’ discrete Fed. R. Civ. P. 12(b)(6) motions to dismiss the actions involving mouthrinse products (mouthrinse action), but it granted dismissal of the action involving toothpaste (toothpaste action).
Mouthrinse action. The court found at relevant times Colgate variously sold mouthrinse with disputed front labels featuring characters from popular children’s movies, labeled as “kids” or “kids fluoride rinse,” or labeled with whimsical names or having flavors like bubble gum. The disputed Tom’s mouthrinse label said “children’s anticavity.” Various aspects of the mouthrinse packaging and labeling appeared to appeal to parents buying for their young children, but excessive fluoride ingestion can lead to mottled teeth coloring, diarrhea, vomiting, and even death in extreme cases. The defendants appeared to be aware of the safety risks and the FDA regulations inasmuch as all of the disputed mouthrinse products had warnings to keep out of reach of children, advice about poison control, and various related instructions.
The plaintiffs in the mouthrinse actions contended the FDA-required warnings and labels were minimized on the back label, concealed, and outweighed by other attributes of the product packaging and labeling that explicitly represented the mouthrinses as being for children. They claimed deception and that they would not have bought the mouthrinses but-for deception.
Toothpaste action. The same contraindications for children under age six did not apply to toothpastes containing fluoride. However, they did apply to children under age two. Even so, the FDA required labeling instructs to keep fluoride toothpastes out of the reach of children under age 6 with related warnings about accidental swallowing.
Despite the apparent consensus that children ages two through six should brush with only small amounts of fluoride toothpaste, the plaintiffs in the toothpaste action alleged that the defendants aggressively marketed their fluoride toothpastes in a way that encouraged children to use the typical amount of toothpaste for people over age six. In other words, the plaintiffs said the defendants were encouraging overconsumption. The disputed toothpaste packaging, like the mouthrinse packaging, involved whimsical flavors and sometimes other attributes that would tend to appeal to kids. Each of the plaintiffs said they allowed their children under six to use the disputed toothpaste products without limiting them to only a smear or pea-sized amount. The plaintiffs said the packaging misled them into believing a full strip of toothpaste was an appropriate amount for their young children.
Mouthrinse deception. The mouthrinse actions pleaded a plausible ICFA claim. The court said it could not conclude, at the pleading stage, that a reasonable consumer would know to draw a line at the age of six when shopping for the disputed mouthrinse products.
All but one mouthrinse product front label involved the word “kids” or “children’s,” and the back label of the remaining product made it clear it was meant for “little brushers.” In this context, it did not strike the court as unreasonable for a consumer to see a product labeled as being for kids or children and believe it to be appropriate for all ages of children. Other aspects of the labeling, like the use of cartoon or movie characters, as well as the whimsical flavors, reinforced the impression of an appeal to young children.
The court rejected the defendants’ contention that consumers would have checked back labels before buying insofar as the consumers would have understood the products to be over-the-counter drugs. The court noted the Seventh Circuit has held that “accurate fine-print” on a grocery product’s back label “does not foreclose as a matter of law a claim that an ambiguous front label deceives reasonable consumers.” The court continued that there was not much to distinguish the mouthrinses from low-cost groceries. The court cited another court in the district as having explained, in denying a motion to dismiss a substantially similar ICFA claim, that reasonable consumers are not likely to check the back label to ensure that a “candy-flavored mouthwash depicting cartoon characters” is safe for preschool children.
Considering the labeling as a whole, consumers could reasonably interpret the explicit and implicit labeling to mean the mouthrinses were children’s products suitable for use by children under six. The ICFA claim was plausible.
Toothpaste deception. Turning to the toothpaste action, the court drew a different conclusion. The consumers failed to state an ICFA claim because the alleged deception pertained to product instructions, which consumers could find on the back labels. The toothpaste action did not object simply to the defendants’ representing their products as being for children, in a context where the FDA has approved use by children as young as two. Instead, the plaintiffs asserted that labeling attributes intended to appeal to children also misleadingly induced parents of children under six to let their children use more than the recommended amount of toothpaste.
The court distinguished that, with one exception, the challenged aspects of the toothpastes’ labels did not make any representation about instructions for proper use, whereas the back labels did include instruction to use only a pea -sized amount for children between age two and six. The FDA did not require this. The defendants apparently added it voluntarily.
Where the back label was the only actual instruction on proper use, it would be unreasonable for a consumer to ignore it and take guidance instead from front label words and images that did not make a representation about the proper quantity for use.
The plaintiffs did not claim there was anything misleading about the instructions on the one Colgate front label that was the exception here. In the view of the court, the graphic depicting a full strip of toothpaste was only meant to represent the act of brushing teeth. It remained that the consumers failed to state an ICFA claim about the toothpaste because they read too much into the toothpaste packaging.
Express preemption. The court held the FDCA did not preempt the mouthrinse actions because the mouthrinse claims were fully consistent with FDCA regulations for fluoride mouthrinses.
The defendants argued that the FDCA preempted the mouthrinse actions because the Anticaries Monograph did not prohibit the attributes of the mouthrinse labels that held them out as a children’s product. Moreover, they asserted the FDA carefully considered the risk of child ingestion and determined the Anticaries Monograph was enough to mitigate the risk. The court acknowledged that some courts in other circuits have interpreted FDCA express preemption as having the expansive scope the defendants claimed. However, the Seventh Circuit has distinguished that preemption will not apply when a plaintiff’s complaint concerns a requirement already imposed by the FDCA or an aspect of labeling that the FDCA does not address. The plaintiffs said there was no preemption because they were not seeking to compel the addition of language, they were only challenging voluntarily added deceptive labeling statements about the suitability of the mouthrinses for children under six.
The court agreed with the plaintiffs. The mouthrinse actions asserted it was deceptive to package and label the mouthrinses as a product for children generally when the Anticaries Monograph requires that those products instruct children under six to consult a dentist or doctor before use. Those directions embody FDA judgment that fluoride rinses are not indicated for children under six on an over-the-counter basis. The court said its conclusion here was in accord with another court in the district that considered substantially similar deception claims about the labeling of children’s mouthrinses.
The Case is No. 1:25-cv-00362.
Judge: Wood, A.
Attorneys: Lisa R. Considine (Nagel Rice, LLP) for Jason Harden. Donna M. Welch (Kirkland & Ellis LLP) for Colgate-Palmolive Co.
Companies: Colgate-Palmolive Co.
SOURCE:
https://www.vitallaw.com/news/advertisi ... 21193dc410
ADVERTISING—N.D. Ill.: Fluoride mouthrinse deception claims survive Colgate and Tom’s of Maine motions to dismiss, (Mar 31, 2026)
Law Firms Mentioned:Kirkland & Ellis LLP | Nagel Rice, LLP
Organizations Mentioned:Colgate-Palmolive Co. | Kirkland & Ellis, LLP
By Justin Marcus Smith, J.D.
It was not unreasonable to think that child-friendly labeling meant that mouthrinse products would be appropriate for all ages of children, whereas toothpaste deception claims pertained to proper use, and back labeling provided specific use instructions for small children.
Parents who sued the Colgate-Palmolive Company (Colgate) and Tom’s of Maine, Inc. (Tom’s) pleaded sufficient state statutory consumer deception claims in connection with the child-friendly labeling of certain fluoride mouthrinses, held the federal district court in Chicago, in denying the defendants’ motions to dismiss class actions. The court explained it was not unreasonable for consumers to conclude that a product labeled as being for children would be appropriate for all ages of children. In addition, the Food, Drug, and Cosmetic Act (FDCA) did not preempt the mouthrinse deceptive labeling claims because the labeling was fully consistent with FDCA regulations for mouthrinses, and the plaintiff parents were only challenging voluntarily added deceptive labeling statements. However, the court dismissed deception claims in connection with certain toothpastes because the parents read too much into the front labels. The toothpaste deception claims pertained to proper use, but the manufacturers provided instructions on the back labels that distinguished how children between ages two and six should only use a small amount of fluoride (Harden v. Colgate-Palmolive Co., No. 1:25-cv-00362 (N.D. Ill. Mar. 27, 2026)).
Background. Parents in three related cases alleged they bought oral hygiene products containing fluoride for their children because the labeling and packaging misled them about whether they could be safely used by children under the age of six. The Food and Drug Administration has determined that fluoride poses unique safety risks to children under age six because they might swallow toxic amounts. The parents brought putative class actions asserting claims for violations of Consumer Fraud and Deceptive Business Practices Act (ICFA), 815 ILCS 505/1 et seq., and other substantially similar state consumer-protection laws.
On discrete motions to dismiss, the defendants argued first that the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 379r(a)(2), expressly preempted all three actions. And in the event that preemption did not apply, the defendants contended the mouthrinse actions and toothpaste action all failed to plead that the defendants made any false or misleading representations on the disputed product labeling.
The court denied the defendants’ discrete Fed. R. Civ. P. 12(b)(6) motions to dismiss the actions involving mouthrinse products (mouthrinse action), but it granted dismissal of the action involving toothpaste (toothpaste action).
Mouthrinse action. The court found at relevant times Colgate variously sold mouthrinse with disputed front labels featuring characters from popular children’s movies, labeled as “kids” or “kids fluoride rinse,” or labeled with whimsical names or having flavors like bubble gum. The disputed Tom’s mouthrinse label said “children’s anticavity.” Various aspects of the mouthrinse packaging and labeling appeared to appeal to parents buying for their young children, but excessive fluoride ingestion can lead to mottled teeth coloring, diarrhea, vomiting, and even death in extreme cases. The defendants appeared to be aware of the safety risks and the FDA regulations inasmuch as all of the disputed mouthrinse products had warnings to keep out of reach of children, advice about poison control, and various related instructions.
The plaintiffs in the mouthrinse actions contended the FDA-required warnings and labels were minimized on the back label, concealed, and outweighed by other attributes of the product packaging and labeling that explicitly represented the mouthrinses as being for children. They claimed deception and that they would not have bought the mouthrinses but-for deception.
Toothpaste action. The same contraindications for children under age six did not apply to toothpastes containing fluoride. However, they did apply to children under age two. Even so, the FDA required labeling instructs to keep fluoride toothpastes out of the reach of children under age 6 with related warnings about accidental swallowing.
Despite the apparent consensus that children ages two through six should brush with only small amounts of fluoride toothpaste, the plaintiffs in the toothpaste action alleged that the defendants aggressively marketed their fluoride toothpastes in a way that encouraged children to use the typical amount of toothpaste for people over age six. In other words, the plaintiffs said the defendants were encouraging overconsumption. The disputed toothpaste packaging, like the mouthrinse packaging, involved whimsical flavors and sometimes other attributes that would tend to appeal to kids. Each of the plaintiffs said they allowed their children under six to use the disputed toothpaste products without limiting them to only a smear or pea-sized amount. The plaintiffs said the packaging misled them into believing a full strip of toothpaste was an appropriate amount for their young children.
Mouthrinse deception. The mouthrinse actions pleaded a plausible ICFA claim. The court said it could not conclude, at the pleading stage, that a reasonable consumer would know to draw a line at the age of six when shopping for the disputed mouthrinse products.
All but one mouthrinse product front label involved the word “kids” or “children’s,” and the back label of the remaining product made it clear it was meant for “little brushers.” In this context, it did not strike the court as unreasonable for a consumer to see a product labeled as being for kids or children and believe it to be appropriate for all ages of children. Other aspects of the labeling, like the use of cartoon or movie characters, as well as the whimsical flavors, reinforced the impression of an appeal to young children.
The court rejected the defendants’ contention that consumers would have checked back labels before buying insofar as the consumers would have understood the products to be over-the-counter drugs. The court noted the Seventh Circuit has held that “accurate fine-print” on a grocery product’s back label “does not foreclose as a matter of law a claim that an ambiguous front label deceives reasonable consumers.” The court continued that there was not much to distinguish the mouthrinses from low-cost groceries. The court cited another court in the district as having explained, in denying a motion to dismiss a substantially similar ICFA claim, that reasonable consumers are not likely to check the back label to ensure that a “candy-flavored mouthwash depicting cartoon characters” is safe for preschool children.
Considering the labeling as a whole, consumers could reasonably interpret the explicit and implicit labeling to mean the mouthrinses were children’s products suitable for use by children under six. The ICFA claim was plausible.
Toothpaste deception. Turning to the toothpaste action, the court drew a different conclusion. The consumers failed to state an ICFA claim because the alleged deception pertained to product instructions, which consumers could find on the back labels. The toothpaste action did not object simply to the defendants’ representing their products as being for children, in a context where the FDA has approved use by children as young as two. Instead, the plaintiffs asserted that labeling attributes intended to appeal to children also misleadingly induced parents of children under six to let their children use more than the recommended amount of toothpaste.
The court distinguished that, with one exception, the challenged aspects of the toothpastes’ labels did not make any representation about instructions for proper use, whereas the back labels did include instruction to use only a pea -sized amount for children between age two and six. The FDA did not require this. The defendants apparently added it voluntarily.
Where the back label was the only actual instruction on proper use, it would be unreasonable for a consumer to ignore it and take guidance instead from front label words and images that did not make a representation about the proper quantity for use.
The plaintiffs did not claim there was anything misleading about the instructions on the one Colgate front label that was the exception here. In the view of the court, the graphic depicting a full strip of toothpaste was only meant to represent the act of brushing teeth. It remained that the consumers failed to state an ICFA claim about the toothpaste because they read too much into the toothpaste packaging.
Express preemption. The court held the FDCA did not preempt the mouthrinse actions because the mouthrinse claims were fully consistent with FDCA regulations for fluoride mouthrinses.
The defendants argued that the FDCA preempted the mouthrinse actions because the Anticaries Monograph did not prohibit the attributes of the mouthrinse labels that held them out as a children’s product. Moreover, they asserted the FDA carefully considered the risk of child ingestion and determined the Anticaries Monograph was enough to mitigate the risk. The court acknowledged that some courts in other circuits have interpreted FDCA express preemption as having the expansive scope the defendants claimed. However, the Seventh Circuit has distinguished that preemption will not apply when a plaintiff’s complaint concerns a requirement already imposed by the FDCA or an aspect of labeling that the FDCA does not address. The plaintiffs said there was no preemption because they were not seeking to compel the addition of language, they were only challenging voluntarily added deceptive labeling statements about the suitability of the mouthrinses for children under six.
The court agreed with the plaintiffs. The mouthrinse actions asserted it was deceptive to package and label the mouthrinses as a product for children generally when the Anticaries Monograph requires that those products instruct children under six to consult a dentist or doctor before use. Those directions embody FDA judgment that fluoride rinses are not indicated for children under six on an over-the-counter basis. The court said its conclusion here was in accord with another court in the district that considered substantially similar deception claims about the labeling of children’s mouthrinses.
The Case is No. 1:25-cv-00362.
Judge: Wood, A.
Attorneys: Lisa R. Considine (Nagel Rice, LLP) for Jason Harden. Donna M. Welch (Kirkland & Ellis LLP) for Colgate-Palmolive Co.
Companies: Colgate-Palmolive Co.
SOURCE:
https://www.vitallaw.com/news/advertisi ... 21193dc410