Bacteria and 'Black Mold-Like' Substance Found at a Tom's of Maine Facility, FDA Says

Several violations were discovered during an inspection of a Tom's of Maine facility in Sanford, Maine. Bacteria in water used to make toothpaste and "a black mold-like substance" near manufacturing equipment were discovered during the inspection, according to a letter released by the U.S. Food and Drug Administration (FDA) on November 5, 2024.

The letter states that the FDA found Pseudomonas aeruginosa in water used to rinse equipment and manufacture Tom's Simply White Clean Mint Paste in 2021 and 2022. This strain of bacteria can infect the lungs and blood and can be resistant to medications, making it hard to treat, according to the Centers for Disease Control and Prevention (CDC). The water was also contaminated with the bacteria Ralstonia insidiosa.

A batch of Wicked Cool! Anticavity Toothpaste (batch 3025UST11B) was contaminated with Paracoccus yeei, a bacteria associated with several infections, including peritonitis. The products included in the warning letter were released to the public.

The agency also found that Tom's of Maine "failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair." During the inspection, a black mold-like substance was found in two damp areas. Powder residue was also found near a batch of Tom's Silly Strawberry Anticavity toothpaste.

Colgate-Palmolive and Tom's of Maine were asked to provide a comprehensive assessment of how its manufacturing operations were designed and controlled, review all microbiological hazards, and specify actions it will take in response to the risk assessment, such as customer notifications and product recalls.

The FDA gave the company 15 days to respond and provide plans to remedy the violations highlighted in the letter.