Colgate-Palmolive has been found guilty by federal regulators of using water contaminated with dangerous bacteria to manufacture its popular Tom’s of Maine toothpaste, as well as cleaning up equipment used to mass produce the product at its flagship facility. Was marked for.
The Food and Drug Administration sent the company a letter Tuesday accusing it of not doing enough to address the problem, which was first noticed three years ago by Kennebunk-based personal care firm Tom’s of Maine, which was acquired by Colgate-Palmolive. Had gone. in 2006.
According to FDAMultiple strains of Pseudomonas aeruginosa bacteria were found in 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 events were investigated to assess product effects and water system performance,” the FDA wrote.
Pseudomonas aeruginosa, or P. aeruginosa, is an antibiotic-resistant pathogen that can cause pneumonia, urinary tract infections, and eye and blood infections.
The agency also wrote that Tom’s of Maine has “reported too many incidents to count” in which the bacteria Ralstonia insidiosa was found in water that was used in the manufacturing process.
Upon coming in contact with humans, R. insidiosa can cause respiratory tract infections and bloodstream infections.
The FDA said the company’s response was “inadequate” and that it needed to provide a “comprehensive assessment of the design and controls 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 use a water system that is soundly designed, and that you control, maintain and monitor the system effectively to ensure that it consistently produces water suitable for pharmaceutical use. produces.”
A spokesperson for Tom’s of Maine told The Post that the company was “working with the FDA” and “addressing the issues raised” in the letter.
“We have always tested finished goods before they leave our control, and we are completely confident in the safety and quality of the toothpastes we produce,” a company representative told The Post.
Tom’s of Maine has “hired water experts to evaluate our systems” at the Sanford plant and it has also “implemented additional safety measures to ensure compliance with FDA standards, and our water testing revealed no issues. It is visible.”
The company also said it was making the capital investment “as part of an ongoing, significant upgrade of the Sanford plant’s water system.”
“Tom is committed to creating safe and effective natural products for our consumers and maintaining trust in our brands,” a company representative said.
Tom’s of Maine has gained a reputation for selling products that are derived from natural ingredients and devoid of artificial flavors and preservatives.
