SANFORD, Maine — The U.S. Food and Drug Administration said it found significant violations at the Tom's of Maine manufacturing facility in Sanford.
Those violations include bacteria in water used to make toothpaste and a black "mold-like" substance, the FDA said in a warning letter issued Nov. 5.
In a statement, Tom's of Maine said it is working with the FDA to fix the situation.
"We’re working with the FDA and are remedying the issues raised in their May inspection of the Tom’s manufacturing plant in Sanford, Maine. 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," the company said. "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. We are also making capital investments as part of an ongoing, significant upgrade of the Sanford plant’s water system."
The company added that it is committed to making safe and effective natural products for customers.
The FDA said Pseudomonas aeruginosa, a bacteria that can cause infections in the blood and lungs, was found in multiple water samples from June 2021 to October 2022. That water was used in the making of the company's Simply White clean mint paste, as well as for the final rinse of some equipment cleaning processes, according to the FDA.
Ralstonia insidiosa, another bacteria, was also recovered from water used in manufacturing, the FDA said.
Read the FDA's full letter here.
