By Anna Edney | Bloomberg
US inspectors found Tom’s of Maine toothpaste was made with water containing multiple strains of dangerous bacteria and sold to consumers anyway, according to a warning letter posted Tuesday.
Water used to make Tom’s Simply White Clean Mint Toothpaste, sold by Colgate-Palmolive Co., contained Pseudomonas aeruginosa bacteria that can cause blood and lung infections, Food and Drug Administration inspectors found. Multiple instances of contamination clocked by Tom’s in 2021 and 2022 were ignored, according to the letter sent to Colgate on Nov. 5.
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“None of these incidents were investigated to assess product impact and water system performance,” the FDA said in the letter. Tom’s said its products are safe, and it’s working with the FDA to fix the problems the agency found. The company said it always tests finished products and has engaged water specialists.
Tom’s of Maine toothpaste has been marketed for decades with claims that it’s made from natural ingredients. The once-independent brand was acquired by Colgate in 2006. Tom’s also sells mouthwash, antiperspirant and deodorant.
Complaints ignored
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FDA inspectors visited Tom’s factory in Sanford, Maine, in May, according to the agency. The same contaminated water used to make toothpaste was used to clean manufacturing equipment, the inspectors said.
Tom’s records showed that another bacteria, Ralstonia insidiosa, had appeared at points in the factory where it used water, the FDA said. Occurrences of the bacteria were “too numerous to count,” yet the company re-tested the water and released the products for sale. After finding yet another bacteria in Wicked Cool! Anticavity Toothpaste, Tom’s re-tested that and released it for sale too.
Tom’s ignored 400 complaints about odor, color and taste related to toothpaste, including products for children, FDA inspectors found.
Inspectors also found a black mold-like substance within a foot of equipment used to make its products. They found the same mold-like substance on a wall behind the company’s water tank, according to the letter.
The FDA told Tom’s it should hire a consultant to help it come into compliance with US manufacturing standards. The agency asked for a response in 15 working days detailing what the company has done to correct violations.
