Tom’s of Maine toothpaste was manufactured with water containing bacteria, while a “black mold-like substance” was found in a factory where the product was made, according to a warning letter from the U.S. Food and Drug Administration.
The November 5 letter stated that Tom’s Simply White Clean Mint toothpaste contained Pseudomonas aeruginosa, a germ that can cause infections in the blood and lungs, the FDA letter said.
The FDA letter also flagged another bacteria, Ralstonia insidiosa, which was found in water sources at the factory and
has been linked to infections acquired in hospital settings. Another Tom’s of Maine product, Wicked Cool! Anticavity Toothpaste, was found to include another type of bacteria, Paracoccus yeei, the letter stated. The latter has been linked to infections such as peritonitis and conjunctivitis.
Tom’s of Maine, which markets its products as made with “safe and hardworking natural ingredients,” manufactures a host of personal hygiene products, from toothpaste to deodorant. The company was bought by Colgate-Palmolive in 2006.
In a statement emailed to CBS News, Tom’s of Maine said that the company is working with the FDA to remedy the issues found during the agency’s May inspection of its Sanford, Maine-based manufacturing plant.
“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 in the statement. “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 added that it is making capital investments to upgrade the plant’s water system.
What did the FDA find?
The FDA cited an “inadequate water system” at the plant, and also said its investigator observed “a black mold-like substance at the base of the hose reel and behind the water storage tank” in one area.
“Water is a major ingredient in many of your OTC drug products,” the FDA letter said. “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.”
According to the letter, Tom’s of Maine determined that the Wicked Cool! toothpaste had P. yeei bacteria “due to sample contamination,” and that the batch was released after retesting, but the FDA said that conclusion was “without sufficient justification.”
The FDA also noted that although company blamed the “root cause” of the P. yeei bacteria was due to a “laboratory error,” no lab errors were identified in its initial investigation.
“Your response is inadequate. It does not include additional supporting evidence or testing results for the finished products,” the FDA said.
