Toothpaste is meant to keep bacteria at bay, but an inspection from the Food and Drug Administration found that water contaminated with risky bacteria was used to manufacture batches of Colgate-Palmolive’s Tom’s of Maine toothpaste. A “mold-like substance” was also discovered at the manufacturing firm.

An investigation conducted from May 7 to May 22 of this year found that the manufacturing firm that creates the toothpaste in Sanford, Maine, “failed to pursue appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile,” according to a warning note issued by the FDA on Nov. 5.

Multiple types of bacteria were found at the firm in the last two years, according to the FDA.

USA TODAY has reached out to the manufacturer, Colgate-Palmolive, for comment.

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Bacteria found in toothpaste

Multiple samples of water taken from the firm from June 2021 to October 2022 contained Pseudomonas aeruginosa, the note stated. The water that was sampled was used to make Tom’s Simply White tidy Mint Paste and to rinse off equipment.

“Water is a major ingredient in many of your OTC drug products,” the FDA stated in its note. “It is essential that you employ a water structure that is robustly designed, and that you effectively control, maintain, and monitor the structure to ensure it consistently produces water suitable for pharmaceutical use.

The bacteria is commonly found in soil and water, but it can factor infections among humans, according to the Centers for Disease Control and Prevention, CDC.

The bacteria can factor infection in the following:

• Blood
• Lungs (i.e. pneumonia)
• Urinary tract

The bacteria can also factor infections in other parts of the body, but these are the areas listed by the CDC.

Paracoccus yeei was found in finished products of Tom’s of Maine’s Wicked chilly! Anticavity Toothpaste, batch 3025UST11B, stated the FDA.

The toothpaste is marketed towards children “transitioning to grown-up toothpaste,” according to Tom’s of Maine’s website.

The bacteria found in the product have been linked to conjunctivitis and peritonitis, according to CBS information.

Conjunctivitis is commonly known as “pink eye.” Peritonitis is “a solemn state that starts in the abdomen,” according to the Mayo Clinic. It occurs when the peritoneum, a thin layer of tissue in the abdomen, becomes inflamed. This is usually due to an infection from bacteria or fungi.

‘Black mold-like substance’ found in buildings

The FDA’s investigator found “black mold-like substance” in the firm at the base of a hose and behind a water storage tank.

The substance was a foot away from tools and objects used to produce the toothpaste.

Investigators also found “powder residue” on trays next to a batch of Tom’s Silly Strawberry Anticavity toothpaste, which is also marketed towards children.

The investigator spotted the residue on the trays before “the addition of any solid raw materials,” according to the note.

“It is essential that your facility is in a excellent state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination,” it stated.

No recalls

No recalls have been issued at this period for any of the Tom’s of Maine toothpastes related to the FDA’s investigation.

However, the FDA advised the corporation to provide a “detailed uncertainty assessment addressing the potential effects of the observed water structure failures on the standard of all drug product lots currently in U.S. distribution or within expiry.”

It also states that the corporation is required to submit the results of test savings samples of toothpastes and indicate the actions it will receive pending the test results.

The FDA asked the corporation to specific what actions it would receive in response to its uncertainty assessment, which could also include customer notifications or product recalls.

corporation to fix the issues

Colgate-Palmolive is working with the FDA to address the issues raised during the inspection, a spokesperson told ABC information in a statement.

“We have always tested finished goods before they leave our control, and we remain fully confident in the safety and standard of the toothpaste we make,” according to the corporation.

“In addition, we have engaged water specialists to assess our systems at Sandord, have implemented additional safeguards to ensure regulatory adherence with FDA standards, and our water testing shows no issues.”

This narrative has been updated to explain one of the bacteria found in the toothpaste.

Julia is a trending reporter for USA TODAY. You can connect with her on LinkedIn, pursue her on X, formerly known as Twitter, Instagram and TikTok: @juliamariegz, or email her at [email protected]