Safety claims toothpaste and mouthwash manufacturers make about their fluoride-containing products for young children violate consumer protection and other laws, according to multiple complaints filed against companies on Monday.
Parents of preschoolers filed complaints against the Procter & Gamble Co., which makes Kid’s Crest toothpaste; the Colgate-Palmolive Co., which makes both toothpastes and mouthwashes for children; Chattem Inc., which makes ACT Anticavity Fluoride Rinses labeled for children; Hello Products LLC, which makes strawberry and bubble gum flavored fluoride rinse; and Perrigo Co., which makes Firefly Anticavity Fluoride Rinses designed with popular cartoon figures for retailers including Walmart Inc.
The complaints ask US District Courts for the Northern District of Illinois, Southern District of California, and Northern District of California to rule on questions such as whether their advertising claims are false or misleading, whether they have violated state and federal consumer protection and other laws, and if the companies should pay monetary damages.
The complaints follow a court ruling that found low levels of fluoride in drinking water pose an unreasonable risk to children.
Fluorosis
Recent US and international drinking water studies also show fluoride could affect young children’s behavior and IQ. And Robert F. Kennedy Jr., President-elect Donald Trump’s choice to lead the US Department of Health and Human Services, has said fluoride’s use in drinking water should be reconsidered.
The six complaints, however, focus on tooth discoloration and pitting, called fluorosis, following ingestion of fluoride in dental products designed for children. The Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and World Health Organization (WHO) have long recognized the risks of fluorosis and issued rules for industry or guidance for consumers and other parties to avoid that problem.
An FDA rule, for example, said that fluoride-containing rinses “should not be within easy reach of any children,” and aren’t recommended for children under 6 unless prescribed by a physician.
Young children can have a hard time spitting, the CDC said in a warning about fluorosis that can result from the excessive fluoride toothpaste they often use. A “smear” or rice-grain size amount of fluoride toothpaste should be used after the appearance of the first tooth until age 3, the CDC and the American Academy of Pediatrics say. A pea-sized amount of toothpaste should be used after age 3, they said.
Some fluoride-containing products displayed on store shelves suggest what ages can use them, while others do not. Some of the brands sued also offer fluoride-free products, yet fluoride-free toothpastes are sometimes advertised for all ages and other times as being for ages 2 and older. Some companies’ websites provide details about the ages their products can be used for, but not all parents visit websites, the complaints say.
Warnings on dental products marketed for children can easily be missed, and images on the toothpaste boxes and product ads suggest far larger strips of paste should be used than is recommended, the complaints said.
Crest’s Kid’s products are marketed “in ways that lead parents and caregivers to believe they are formulated to be extra safe for children—which defendant knows is false,” that complaint said.
Among the “deceptive” tactics Colgate uses on its children’s toothpastes is to conceal FDA’s required warnings and directions “by hiding them behind a label containing promotional claims,” where “only the most diligent consumer will notice there is any information hidden beneath the back label, let alone information about the product being potentially poisonous if swallowed,” that complaint said.
Fluoride rinses “convey the false and misleading impression that the products are specially formulated to be safe,” even though such rinses aren’t recommended for young children, the complaints said. And some of the products named violate the FDA’s regulatory requirements, according to the complaints.
Mouth rinses from Tom’s of Maine, part of Colgate, mention real fruit being used to make them. “Presenting fluoride mouthrinse as a kids’ flavored drink product, or as a candy-like product in the case of Colgate Rinse, is both deceptive and dangerous,” that complaint said.
Similarly, Firefly is among the companies that make products aimed at children made in bubble gum and other flavors. Yet the FDA says “marketing dangerous products to children through the use of candy or food flavoring is a ‘misleading’ marketing tactic that can render a product ‘misbranded,” the complaint against Perrigo said.
The candy, fruit, and bubblegum flavorings used for rinses and toothpaste increase the risks of overdoses, the plaintiffs said. The rate of dental fluorosis has “skyrocketed” since the introduction of candy-like fluoride products in the 1980s, the complaints said.
Legal Impacts
None of the companies named in the complaints immediately replied to requests for comment.
Given the nation’s “hyper-litigious” society “it would seem logical to conclude product manufacturers may be at risk under state consumer protection laws prohibiting false and misleading claims, fraudulent claims, and related ‘truth in advertising’ type claims,” said Lynn Bergeson, managing partner of Bergeson & Campbell PC, which specializes in a range of chemical statutes.
Bergeson, who had not seen the complaints, said the success of consumer lawsuits is questionable and can be modest, such as repackaging and revising claims.
“But other causes of action similarly are not difficult to envision—tort claims for adverse health effects, failure to warn, breach of contract, for example,” she said. “What is certain is the cost of litigation is high and adverse media attention and brand damage is certain to follow.”
The cases include Gurrola v. Procter & Gamble Co., N.D. Ill., No. 25-00358, Complaint 1/13/25, Verbish et al v. Colgate-Palmolive Co., N.D. Cal., No. 25-00426, 1/13/25, Harden et al v. Colgate-Palmolive Co., N.D. Ill., No. 25-00362, 1/13/25, and Gibson v. Perrigo Co., N.D. Ill., No. 25-00348, Complaint 1/13/25.
(Updated story published Jan. 13 to include and information from all filed complaints.)
Original article online at: https://news.bloomberglaw.com/environment-and-energy/crest-colgate-sued-over-kids-products-that-contain-fluoride