An inspection conducted by the US Food and Drug Administration (FDA) this year at Tom’s of Maine’s manufacturing facility in Sanford, Maine, revealed multiple health and safety violations, including the presence of bacteria and mold.
According to a warning letter dated November 5, 2024, the inspection uncovered several issues related to the cleanliness and safety of the company’s production environment.
The FDA’s inspection highlighted that water used in the production of Tom’s Simply White Clean Mint toothpaste contained Pseudomonas aeruginosa, a type of bacteria that can cause serious infections in the blood and lungs. Additionally, the water was found to have traces of Ralstonia insidiosa, another bacterium associated with hospital-acquired infections. The agency also flagged the discovery of Paracoccus yeei, a bacteria found in a batch of Tom’s Wicked Cool! Anticavity Toothpaste. This strain is linked to infections such as peritonitis and conjunctivitis.
The FDA emphasized that the water used in the production of over-the-counter drug products must meet rigorous safety standards to prevent contamination. In its letter, the FDA criticized the facility’s water system for being inadequately maintained, which allowed for the presence of these harmful bacteria. The agency also observed a “black mold-like substance” near manufacturing equipment and reported powder residue near the production area of Tom’s Silly Strawberry Anticavity Toothpaste.
Tom’s of Maine, a brand owned by Colgate-Palmolive, responded by stating that it is addressing the concerns raised by the FDA. In a statement to CNN, the company assured consumers that it continues to test finished products for safety and quality before they are shipped out. Tom’s also revealed that it is working with water specialists to enhance the water systems at its Sanford facility and is making significant capital investments to improve the plant’s infrastructure.
CNN, CBS News, and the Boston Globe contributed to this report.
