Tom’s of Maine Toothpaste Made with Bacteria-Infested Water, FDA Says

“There are no safety issues with our toothpaste,” the company tells PEOPLE in response to the FDA’s public warning letter

Toothpaste from the popular Tom’s of Maine brand is made with bacteria-tainted water, the U.S. Food and Drug Administration says in a recent warning letter they sent to the company and made public.

The letter, which outlines "significant violations" discovered at the Sanford, Maine, facility, warns the company, "You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations."

Among the FDA's findings: Water samples used to manufacture Tom’s Simply White Clean Mint Paste contained Pseudomonas aeruginosa, which can cause infections in the blood or lungs, according to the U.S. Centers for Disease Control.

Related: Scientists Concerned About Unknown Levels of Toxicity in Chemical Common in U.S. Drinking Water  

Paracoccus yeei — which the National Library of Medicine calls an “Emergent opportunistic pathogen” — was found in samples of Wicked Cool! Anticavity Toothpaste.

The FDA also said ralstonia insidiosa — which can cause pneumonia, the National Library of Medicine says — was "recovered from water points of use.”

According to the FDA, the condition of the equipment in the plant, which was inspected from May 7 to 22, didn’t meet their standards.

“Our investigator observed a black mold-like substance,” on equipment, the letter said, pointing out that the substance was found elsewhere.

“The black substance was within one foot of stainless-steel pails and other product-contact equipment,” the letter states, saying it was noted on the wall behind a water tank.

Related: 5 People Hospitalized After Eating Pesto That May Be Contaminated with Botulism

In a statement to PEOPLE, a representative for Tom’s of Maine said “We are confident there are no safety issues with our toothpaste and that it is safe to use. We test every batch of toothpaste we make — including for harmful bacteria and mold — to ensure its safety before it is released for sale."

"We have been working with the FDA to remedy the issues raised in their May inspection of the Tom’s toothpaste manufacturing plant in Sanford, Maine, including implementing additional safeguards and making capital investments as part of ongoing plant upgrades. Tom’s is committed to continuing to make safe and effective natural products for our consumers and to maintaining the trust in our brand.”

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