Breaking: 6 Lawsuits Filed Today Accuse Makers of Children’s Fluoride Toothpaste of Violating Federal Law

Six class action lawsuits filed today accuse major dental product manufacturers of deceptively marketing products containing fluoride to young children and misleading parents.

by Brenda Baletti, Ph.D.

Six class action lawsuits filed today accuse major dental product manufacturers of deceptively marketing products containing fluoride to young children, and misleading parents to believe the products are safe for toddlers.

The lawsuits name children’s toothpaste brands Crest and Colgate/Tom’s of Maine, and the children’s mouth rinse brands Act, Colgate/Tom’s of Maine, Firefly and Hello.

Plaintiffs include parents and caregivers in multiple states, including California, Illinois and New York. In the case of Crest toothpaste, the proposed class is nationwide. The lawsuits were filed in federal courts in California and Illinois.

According to the complaints, the plaintiffs were misled by the product marketing and as a result, didn’t follow public health guidelines when using the products. The lawsuits also allege the companies fail to adequately flag instructions for proper use, as mandated by the U.S. Food and Drug Administration (FDA).

According to the complaints, the companies design their product labels with candy and fruit juice flavors and images and cartoon characters to appeal to young children, often misleading them to think the products are meant to be consumed as food.

The complaints also accuse the defendants of using false and misleading labeling that leads parents and caretakers to believe the products are “extra safe for children.” As a result, they “unwittingly permit and encourage” children to use more toothpaste or mouth rinse than recommended.

According to the lawsuits, the brands’ deceptive marketing tactics put “the health of millions of children at risk” and violated the Federal Food, Drug & Cosmetic Act (FD&C Act) and several state consumer fraud statutes. The complaints highlight the serious risks to children’s health from ingesting excess fluoride. These include flu-like symptoms from acute toxicity, dental fluorosis, neurotoxicity, endocrine disruption and even death.

Attorney Michael Connett, partner at Siri & Glimstad, is representing the plaintiffs.

Connett successfully represented plaintiffs in the landmark lawsuit against the Environmental Protection Agency (EPA) over water fluoridation. In that case, a federal judge ruled in September 2024 that water fluoridation at current U.S. levels poses an unreasonable risk of reduced IQ in children and ordered the EPA to take regulatory action.

The lawsuits seek to hold the companies accountable for including packaging elements on their products that allegedly mislead consumers and violate the act. Plaintiffs seek statutory damages to compensate for their financial loss incurred by purchasing more of the products than they needed because they were misled to overuse them. They also seek punitive damages.

“I am delighted to see class action lawsuits against manufacturers that have been knowingly and deceptively marketing toothpaste and mouthwash to children in ways that could harm them through excessive use,” Children’s Health Defense CEO Mary Holland told The Defender.

“These corporations have known of the risks of fluoride to children — IQ loss, dental fluorosis and other serious health concerns — for decades. Their continued marketing to kids is akin to how illegal cigarette ads target kids,” she said. “This litigation is an important step building on the victory against the EPA for its failure to address risks demonstrated by fluoride science.”

Advertising strategy ‘more than misleading and irresponsible … it’s unethical’

Each class action challenges similar practices by the major manufacturers, although the practices vary depending on the type and brand of product.

The Centers for Disease Control and Prevention (CDC), the American Dental Association (ADA), the American Academy of Pediatrics and others recommend that children under age 3 should use no more than a “smear” of fluoride toothpaste and children ages 3 to 6 should use no more than a “pea-sized” amount.

Two of the complaints allege Procter & Gamble, maker of Crest Kids and Colgate-Palmolive, maker of Colgate and Tom’s of Maine, understand that encouraging caregivers to use the safe, recommended amount of toothpaste “is bad for their bottom line.”

As a result, they use “misleading” and “aggressive” tactics to prompt parents to use “far more than is safe” — a practice researchers have long linked to toothpaste overconsumption by children.

For example, both companies’ packaging and websites show images of a toothbrush with a full strip of toothpaste. The lawsuit alleges the image implies a full strip is the recommended quantity. However, it is eight to 10 times more than the recommended amount for a child under 3 and three to four times the recommended amount for a child ages 3-6.

Colgate uses pictures of fruit with matching flavors and names like “Watermelon Burst,” which sounds like a candy product or a juice drink — a common signal to a child that toothpaste is intended to be consumed as if it were food.

Colgate Kid’s natural product, marketed as “Silly Strawberry” by Tom’s of Maine, also features the word “natural,” implying that the product is free from toxic ingredients — which it isn’t — and that there is no need to limit how much paste goes on the brush.

Crest offers flavors like “Bubblegum” and “Sparkle Fun” with cartoon animals on the box. Candy flavors and cartoons make it tempting for children to eat toothpaste, according to the National Capital Poison Center, increasing the risk of overdose.

The lawsuits also accuse the brands of hiding the required FDA warnings behind a label containing promotional claims. The stamp of the ADA, for example, which is often featured prominently, is much larger than the FDA-mandated warning that parents must carefully follow instructions.

The mouth rinse companies — including Chattem Inc., a subdivision of Sanofi, and Perrigo — also market their products as candy-like and juice-flavored, and use strategies to encourage kids to use more than the recommended dosage. For example, Firefly Rinse resembles a toy and includes a cup that holds more than the recommended serving size.

The lawsuits also note that the mouth rinse products prominently feature cartoon characters, with names like “Groovy Grape” and “Pineapple Punch,” and the word “kids,” despite the FDA’s warning that fluoride mouth rinses are too dangerous for children under age 6.

Integrative biologic dentist Dr. Griffin Cole told The Defender these marketing strategies are highly effective for getting kids to consume more dental products.

“The advertising of toothpastes is more than misleading and irresponsible … it’s unethical,” he said. “The use of vibrant colors, bubblegum flavors and pretty swirls is clearly aimed at children and misleads parents into thinking these products, which contain fluoride, are safe.”

Products contain ‘enough fluoride to kill a toddler’

Children’s rinses generally has the same amount of fluoride as adult rinses, according to the lawsuits, but poses a greater risk to children who receive a higher dose by body weight.

Children under age 6 lack the developed swallowing reflexes that allow them to control how much they ingest, increasing the likelihood they will swallow the products.

The CDC reports that 35% of children frequently eat toothpaste, and an additional 22% have tried eating it. It also reports that some children under age 6 swallow substantial amounts of mouth rinse.

Excessive fluoride intake can lead to dental fluorosis, a tooth discoloration caused by overexposure during childhood. Since the introduction of candy-like fluoride products in the 1980s, the rate of dental fluorosis among U.S. schoolchildren has skyrocketed. Rates rose from 23% of children in 1986-87 to “a staggering 68%” of children by 2015-16, the complaint alleges.

Ingesting too much fluoride can also cause acute toxicity, with flu-like symptoms such as nausea, stomach upset and vomiting — symptoms that parents may not recognize as being related to fluoride. The complaints note that swallowing just one full strip of toothpaste can cause these effects in toddlers.

They also allege that a third of a tube of “kids” fluoride toothpaste contains “enough fluoride to kill a toddler.” The same is true for a little over half a bottle of the sweet-tasting Act, Firefly or Hello mouth rinses.

Each year, Poison Control receives between 10,000 and 15,000 calls due to excess consumption of fluoride toothpaste, most of which involve young children and hundreds of which result in hospitalization, according to the complaints. There are also thousands of calls related to the ingestion of mouth rinse.

Kathleen Thiessen, Ph.D., who authored the 2006 National Research Council report on fluoride in drinking water, told The Defender the dangers of fluoride go beyond immediate toxicity and include “neurotoxicity concerns, endocrine disruption, increased risk of bone fracture.”

The evidence supporting these claims is growing. Scientists at the National Toxicology Program last week published a meta-analysis in the JAMA Pediatrics linking fluoridated water and IQ loss in children. It “found significant inverse associations between fluoride exposure and children’s IQ scores.”

They also published a monograph in August that also found a link between higher fluoride exposure and lower IQ in children. In May, a study in JAMA Open Network found children born to women exposed during pregnancy to fluoridated drinking water were more likely to have neurobehavioural problems.

Cole said that excessive use of fluoride-containing dental products adds to the risks associated with fluoridated drinking water and that manufacturers must include more responsible labeling at a minimum.

“The warnings on the packages clearly state that very small amounts are to be used and that a poison control center is to be contacted should a child swallow more than a pea-sized portion,” he said. “Assuming parents read these warnings and carefully watch their children as they brush, perhaps dangerous accidents can be avoided.”

“Even better,” Cole added, “The manufacturers should do the right thing and remove this unnecessary and clearly harmful chemical from all pastes.”