Colgate-Palmolive was flagged by federal regulators for using water that is contaminated with a dangerous bacteria to manufacture its popular Tom’s of Maine toothpaste as well as to clean the equipment used to mass produce the product at its key facility.
The Food and Drug Administration sent a letter to the company on Tuesday accusing it of not doing enough to address the problem, which was first noticed three years ago by Tom’s of Maine, the Kennebunk-based personal care firm that was acquired by Colgate-Palmolive in 2006.
According to the FDA, several strains of the bacteria Pseudomonas aeruginosa were discovered in the water used to make Tom’s of Maine Simply White Clean Mint Paste at the company’s Sanford, Maine manufacturing plant between June 2021 and October 2022.
“None of these incidents were investigated to assess product impact and water system performance,” the FDA wrote.
Pseudomonas aeruginosa, or P. aeruginosa, is an antiobiotic-resistant pathogen that can cause pneumonia, urinary tract infections and eye and blood infections.
The agency also wrote that Tom’s of Maine reported “multiple incidents too numerous to count” in which the bacteria Ralstonia insidiosa was found in water that was used in the manufacturing process.
R. insidiosa can cause respiratory tract infections and bloodstream infections if exposed to humans.
The FDA said that the company’s response was “inadequate” and that it needed to provide “a comprehensive assessment of the design and control of your firm’s manufacturing operations.”
“Water is a major ingredient in many of your OTC (over the counter) drug products,” the FDA wrote in its warning letter.
“It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain, and monitor the system to ensure it consistently produces water suitable for pharmaceutical use.”
A spokesperson for Tom’s of Maine told The Post that the company was “working with the FDA” and was “remedying the issues raised” in the letter.
“We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make,” a company rep told The Post.
Tom’s of Maine has “engaged water specialists to evaluate our systems” at the Sanford plant and it has also “implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues.”
The company also said it was “making capital investments as part of an ongoing, significant upgrade of the Sanford plant’s water system.”
“Tom’s remains committed to making safe and effective natural products for our consumers and to maintaining the trust in our brand,” the company rep said.
Tom’s of Maine has gained a reputation for selling products that are sourced from natural ingredients and are devoid of artificial flavors and preservatives.
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