Federal officials discovered “significant violations” at Tom’s of Maine’s manufacturing facility, including using water contaminated with bacteria to produce some of its toothpaste.
The Food and Drug Administration (FDA) outlined such violations in a letter sent to Tom’s of Maine’s parent company, Colgate-Palmolive, earlier this month. The letter was made publicly available on Tuesday.
FOX Business reached out to Colgate-Palmolive for comment.
According to federal health officials, the bacteria Pseudomonas aeruginosa was found “in multiple water samples between June 2021 to October 2022.”
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Investigators discovered that the contaminated water was used to manufacture Tom’s Simply White Clean Mint Paste as well as for the “final rinse of numerous equipment cleaning processes.”
Pseudomonas is a group of bacteria commonly found in soil and water. Pseudomonas aeruginosa is the “most common type causing infections among humans,” such as infections in the blood and lungs.
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Another bacteria known as Paracoccus yeei, was also discovered in the company’s over-the-counter finished product, Wicked Cool! Anticavity Toothpaste.
An environmental bacterium, Ralstonia insidiosa, was recovered from water points of use, health officials said.
“You failed to adequately qualify your water system that produced water used for equipment cleaning and in formulating your product,” the letter said.
Overall, the company “failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair,” federal officials said.
The FDA is demanding that the company conduct several actions to correct these issues, including developing a plan to improve operations at the facility and making sure equipment and facilities are regularly monitored and maintained.
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The FDA is also requesting a “comprehensive assessment of the design and control” of its manufacturing operations, “with a detailed and thorough review of all microbiological hazards.”
The FDA said that the violations cited in the letter are not “an all-inclusive list of violations that exist” at the facility.
“You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations,” the letter said.
