The U.S. Food and Drug Administration has issued a warning letter to Tom's of Maine — the maker of natural personal care products — after an investigator discovered mold and bacteria at its production facility in Sanford last spring.
The FDA said that it found several kinds of bacteria, including one that can cause sepsis and blood and lung infections, in water that's used to make Tom's toothpaste and to rinse equipment.
An investigator also found what was described as a black mold-like substance near equipment.
In its letter, the agency noted that the company failed to investigate roughly 400 complaints about odor, color, and taste in toothpaste products, including those for children.
The FDA is requiring Tom's to submit a detailed plan to fix problems and is urging the company to hire a consultant to help.
In a written response, Tom's of Maine director of impact, Rob Robinson, said the company has implemented safeguards since the FDA inspection and that their water testing shows no issues.
Robinson said Tom's always tests its products and is confident in their safety and quality.