Personal care brand Tom's of Maine received a warning from the Food and Drug Administration earlier this month after the agency found disease-causing bacteria and mold-like and powdery substances in its products and facilities.
In a letter to Tom's that was published Tuesday, an FDA inspector identified several types of bacteria in the water supply at its facility in Sanford, Maine, including Paracoccus yeei; Pseudomonas aeruginosa, which can lead to blood, lung and urinary tract infections; and Ralstonia insidiosa, which can lead to sepsis.
The brand used the water in its products and to rinse equipment, the FDA said.
Tom's did not immediately respond to NPR for comment. However, the company did tell CBS News that it is working with the FDA to resolve the issues the agency found in the Maine plant.
Tom's sells personal care products, such as toothpaste, mouthwash, lip balms and fragrances using "naturally sourced and naturally derived ingredients," according to its website. It is owned by Colgate-Palmolive and its goods are sold in major retailers such as Whole Foods, Target, Walmart and Kroger.
The FDA said despite the results of microbial tests it conducted, Tom's continued to distribute merchandise based on the test results of final products, but did not investigate the quality of water used in the process.
Tom's responded to the FDA by saying it is retrospectively looking into the incidents, and that the detection of Paracoccus yeei was due to a lab error, according to the FDA. Though, the agency said there is no evidence of that.
The agency also says it found "a black mold-like substance" and "powder residues" on or near pieces of equipment.
Tom's said the black substance was located in an area that was hard to reach and prone to moisture, but that it has since thoroughly been cleaned. It said it cleaned the powder residue off a tray used to make the company's Silly Strawberry Anticavity toothpaste before adding solid materials.
The FDA also said Tom's failed to investigate hundreds of product complaints regarding odor, color and taste because they were not indicative of a trend.
According to the FDA, Tom's responded by saying it handles complaints with a "risk-based approach," and that individual complaints are not enough to deem a product inadequate.
The agency is requiring Tom's to submit several documents, including assessments and remediation plans for its operations, contamination hazards, testing methods, cleaning procedures and more.
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