Colgate-Palmolive Co. is facing a proposed class action lawsuit from parents alleging the company misleadingly advertises its Hello Kids Fluoride Rinse as safe despite FDA guidance that fluoride rinses are too dangerous for children under 6 years old. The complaint was filed in Illinois federal court by lead plaintiff Josh Cook, who seeks to represent parents across multiple states.
The lawsuit centers on the safety risks of fluoride ingestion by young children, who according to the complaint have not developed sufficient control to avoid accidentally swallowing the rinse. Cook argues that fluoride is toxic if swallowed and can cause vomiting, intoxication, and nausea, with each bottle containing enough fluoride to potentially kill a small child.
Product Design and Safety Concerns
The complaint alleges that Colgate’s children’s fluoride rinse is particularly dangerous because it contains the same fluoride concentration as adult products but is marketed in candy and fruit flavors that entice children to swallow it. This design choice allegedly increases the risk of accidental ingestion compared to adult formulations.
Beyond immediate toxicity risks, the lawsuit highlights concerns about dental fluorosis, a tooth enamel defect that causes visible and sometimes disfiguring staining. According to the complaint, fluorosis can only occur while teeth are still developing, making it exclusively a risk for young children, particularly those under 6. The FDA recognizes this risk but doesn’t mandate specific warnings because children under 6 aren’t supposed to use fluoride rinses at all.
Regulatory Violations and Missing Warnings
Cook’s complaint alleges that under the Food, Drug and Cosmetic Act, companies must place prominent warnings on fluoride rinses instructing consumers to read directions carefully. However, the lawsuit claims Colgate’s products lack these required warnings.
The complaint also notes that no demonstrated benefits exist for fluoride rinses in children under 6, as the health risks are considered so severe that scientists have never conducted studies on potential effects in this age group.
Siri & Glimstad LLP attorneys Michael Connett, Aaron Siri, Elizabeth A. Brehm, and Lisa Considine represent the proposed class, which includes residents of 14 states and Washington D.C. who purchased the rinses for children under 6. The lawsuit alleges violations of the Illinois Consumer Fraud and Deceptive Trade Practices Act.
The case is Cook v. Colgate-Palmolive Co. in the U.S. District Court for the Northern District of Illinois.