Colgate-Palmolive was flagged by federal regulators for utilizing water that’s contaminated with a harmful micro organism to fabricate its common Tom’s of Maine toothpaste in addition to to wash the gear used to mass produce the product at its key facility.
The Meals and Drug Administration despatched a letter to the corporate on Tuesday accusing it of not doing sufficient to handle the issue, which was first observed three years in the past by Tom’s of Maine, the Kennebunk-based private care agency that was acquired by Colgate-Palmolive in 2006.
In keeping with the FDA, a number of strains of the micro organism Pseudomonas aeruginosa have been found within the water used to make Tom’s of Maine Merely White Clear Mint Paste on the firm’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 may trigger pneumonia, urinary tract infections and eye and blood infections.
The company additionally wrote that Tom’s of Maine reported “multiple incidents too numerous to count” through which the micro organism Ralstonia insidiosa was present in water that was used within the manufacturing course of.
R. insidiosa could cause respiratory tract infections and bloodstream infections if uncovered to people.
The FDA stated that the corporate’s response was “inadequate” and that it wanted to offer “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 advised The Submit that the corporate was “working with the FDA” and was “remedying the issues raised” within 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,” an organization rep advised The Submit.
Tom’s of Maine has “engaged water specialists to evaluate our systems” on the Sanford plant and it has additionally “implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues.”
The corporate additionally stated 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 corporate rep stated.
Tom’s of Maine has gained a popularity for promoting merchandise which can be sourced from pure elements and are devoid of synthetic flavors and preservatives.
