The Food and Drug Administration has sent a warning letter to personal hygiene company Tom’s of Maine after the agency said it found a “black mold-like substance” in its factory.
The FDA told the company it found Pseudomonas aeruginosa in water used to make Tom’s Simply White Clean Mint toothpaste. The germ can cause blood and lung infections, ABC News reported.
The FDA said Ralstonia insidiosa was found in factory water sources while Paracoccus yeei was found in the Wicked Cool! Anticavity Toothpaste.
The contamination was all found during an inspection in May at the Sanford, Maine factory.
The “black mold-like substance” was found at the base of a hose reel and behind a water storage tank.
The agency told Tom’s of Maine, “Water is a major ingredient in many of your OTC drug products. 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.”
Tom’s of Maine released a statement to CNN saying it is “working with the FDA and are remedying the issues raised in their May inspection of the Tom’s manufacturing plant in Sanford, Maine.”
“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,” the company said. “In addition, we have engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues.”
Tom’s of Maine, which is owned by Colgate-Palmolive, is marketed to contain “safe and hardworking natural ingredients.”
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