PENNSYLVANIA— Any Pennsylvania residents who use Tom’s of Maine toothpaste and have noticed a strange taste or smell from the product aren’t alone, according to the U.S. Food & Drug Administration, which recently detailed how bacteria was found in some of the company’s products and black mold was discovered at a facility.
The agency this month issued a warning letter to Tom’s of Maine Inc. about its “significant violations” of manufacturing regulations for pharmaceuticals, and discussed a May inspection of the facility in Sanford, Maine.
Pseudomonas aeruginosa, a type of bacteria that can cause blood and lung infections, according to the U.S. Centers for Disease Control and Prevention, was found from June 2021 to October 2022 in samples of water that was used to make Tom’s Simply White Clean Mint Paste, the letter stated. The water was also used for the final rinse in equipment cleaning.
Gram-negative cocco-bacilli Paracoccus yeei, which is associated with several infections, according to the Hartmann Science Center, was in a batch of the company’s Wicked Cool! Anticavity Toothpaste, the letter stated.
Ralstonia insidiosa, a waterborne bacteria, according to the Journal of Medical Microbiology, was repeatedly found at water points of use at the facility, the letter stated.
“A black mold-like substance” was discovered within one foot of equipment that came into contact with products, according to the letter, which stated the substance was at the base of a hose reel and behind a water storage tank.
The company received about 400 complaints related to toothpaste odor, color and taste, including in relation to products for children, but the complaints were not investigated, the letter said.
“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,” Tom’s of Maine said, according to News Center Maine. “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.”
In the federal administration’s letter, dated Nov. 5, the agency directed the company to provide multiple risk assessments, reserve sample test results from all unexpired batches, and a water system remediation plan, among other things. The administration requested a written response from Tom’s of Maine within 15 working days.
With reporting by Anna Schier of Patch.
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