Tom's of Maine toothpaste made with bacteria-contaminated water, says FDA

An inspection of a Tom's of Maine manufacturing facility found that the brand's toothpaste was produced with water containing bacteria, and a "black mold-like substance" was discovered at the location, according to the Food and Drug Administration.

In a letter to the brand's parent company, Colgate-Palmolive, the FDA said a strain of bacteria called Pseudomonas aeruginosa -- which can cause blood and lung infections -- was found in water samples used to make Tom's Simply White Clean Mint Paste.

The water samples were taken between June 2021 and October 2022, according to the FDA.

Additionally, another strain of bacteria, called Paracoccus yeei, was discovered in a batch of Tom's Wicked Cool! Anticavity Toothpaste.

"Water is a major ingredient in many of your OTC drug products. It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain, and monitor the system to ensure it consistently produces water suitable for pharmaceutical use," the FDA said in the Nov. 5 letter.

The inspection of the facility in Sanford, Maine, found "a black mold-like substance," in multiple areas near production equipment, according to the FDA's letter.

The inspection was conducted in May of this year, the FDA said.

A "powder residue" was also found near a batch of Tom's Silly Strawberry Anticavity toothpaste, which is marketed for "kids and parents," according to the company.

"It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination," the FDA said in the letter.

The agency requested that Colgate-Palmolive supply additional documentation of manufacturing operations with a "thorough review of all microbiological hazards" and submit results of that testing.

In a statement to ABC News, a spokesperson for Colgate-Palmolive said the company is working with the FDA to remedy the issues raised during the inspection.

"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," the company added.