The U.S. Food and Drug Administration has sent a warning letter to Tom’s of Maine, telling the personal care products company that FDA inspectors found a “mold-like” substance at its plant, along with other safety violations.
The black mold-like substance was found at the base of the hose reel and behind the water storage tank, according to the FDA inspector’s report.
“Your firm failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)),” the FDA wrote in a letter to Tom’s of Maine CEO Noel Wallace.
Bacteria in the water supply
The FDA said it found several types of bacteria in the water supply and the company’s plant in Sanford, Maine. It identified the bacteria as Paracoccus yeei, Pseudomonas aeruginosa and Ralstonia insidiosa.
Pseudomonas aeruginosa can cause blood, lung and urinary tract infections. Ralstonia insidiosa can lead to sepsis.
Of concern to the FDA inspector who filed the report, the company used the bacteria-tainted water to clean equipment at the plant.
Tom's of Maine is known for products such as toothpaste, mouthwash and lip balms. Founded as an independent disrupter in the personal care products space, it is now owned by Colgate-Palmolive, which gives the products wide distribution.
In a statement to the news media, Tom’s of Maine said it is working with the FDA to resolve all of the issues noted in the warning letter.