The Food and Drug Administration called out Colgate-Palmolive for using water contaminated with dangerous bacteria in its products and failing to address the problem.
The FDA sent a warning letter to the multinational brand this week for what it calls "significant violations" of the Current Good Manufacturing Practice (CGMP) regulations. Specifically, the company's Tom's of Maine, Inc. facility in Sanford, Maine, reportedly failed to address safety and health standards in its methods of manufacturing, processing, and packing of products that were discovered three years ago.
In the letter, the agency noted that multiple bacteria were found in the water used for several of its products, from June 2021 to October 2022. These included Pseudomonas aeruginosa which were recovered from the water used to make Tom’s Simply White Clean Mint Paste. The bacteria is capable of causing a variety of infections to its hosts and is known to be antibiotic resistant making it "extremely challenging" to treat, the National Library of Medicine described.
The FDA also noted "too numerous to count" incidents wherein Ralstonia insidiosa was found in the water, as well as Paracoccus yeei in its Wicked Cool! Anticavity Toothpaste. The latter is linked to infections like conjunctivitis and bloodstream infection, the Hartmann Science Center noted.
Moreover, despite warnings about its contaminated water, the agency claimed the company failed to investigate and asses its water system performance. It found the company's response "inadequate."
"You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations," the agency wrote.
The FDA now requires Tom's of Maine to make a comprehensive assessment of its manufacturing operations, investigate product batches with potential contamination, specify if recalls are needed, and provide a summary of the results of all testing made on its products, among other demands. It requires the company to respond within 15 days.
Tom's of Maine is a Maine-based manufacturer of natural personal care products. It was acquired by Colgate-Palmolive in 2006.
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