Toothpaste is generally used to help prevent bacterial growth, yet a recent inspection by the Food and Drug Administration revealed that contaminated water was utilized in the production of Colgate-Palmolive’s Tom’s of Maine toothpaste. Additionally, a “mold-like substance” was identified at the manufacturing facility.

The FDA conducted an investigation from May 7 to May 22 of this year, concluding that the Sanford, Maine-based manufacturing facility “did not adhere to the proper written protocols intended to deter objectionable microorganisms from drug products that are not required to be sterile,” according to a warning letter issued by the agency on November 5.

Over the past two years, various types of bacteria have been discovered at the facility, according to the FDA.

YSL News has reached out to Colgate-Palmolive for their input on the matter.

Bacteria Detected in Toothpaste

Samples collected from the manufacturing facility between June 2021 and October 2022 showed the presence of Pseudomonas aeruginosa, as outlined in the FDA letter. This water was used for producing Tom’s Simply White Clean Mint Paste and for rinsing equipment.

The FDA mentioned, “Water is a key ingredient in many over-the-counter drug products. It is crucial that you maintain a water system that is properly designed and effectively monitored to ensure it consistently delivers water suitable for pharmaceutical purposes.”

Pseudomonas aeruginosa is often found in soil and water, but it can pose infection risks to humans, according to the Centers for Disease Control and Prevention (CDC).

This bacteria can result in infections in these areas:

• Bloodstream
• Lungs (pneumonia)
• Urinary tract

While infections can occur in other body parts, these are the primary locations indicated by the CDC.

Another bacteria, Paracoccus yeei, was found in batch 3025UST11B of Tom’s of Maine’s Wicked Cool! Anticavity Toothpaste, according to the FDA.

This toothpaste is targeted at children “transitioning to adult toothpaste,” as per Tom’s of Maine’s website.

The bacteria found in the toothpaste have been associated with conditions such as conjunctivitis and peritonitis, as reported by CBS News.

Conjunctivitis is popularly referred to as “pink eye,” while peritonitis is “a serious abdominal condition,” as explained by the Mayo Clinic, resulting from inflammation of the thin tissue layer in the abdomen typically caused by bacterial or fungal infections.

Mold-Like Substance Discovered

The FDA’s investigator reported discovering a “black mold-like substance” at the facility near a hose’s base and behind a water storage tank.

This substance was located just a foot away from instruments and items used in toothpaste production.

Additionally, investigators noted “powder residue” on trays beside a batch of Tom’s Silly Strawberry Anticavity toothpaste, which is also aimed at children.

The residue was present before the addition of any solid ingredients, as stated in the letter.

The FDA emphasized, “Your facility must be well-maintained and sanitary to protect drug products from potential contamination pathways.”

No Recalls Issued

As of now, there have been no recalls for any Tom’s of Maine toothpaste in connection with the FDA’s investigation.

Nonetheless, the FDA has recommended that the company conduct a “thorough risk assessment regarding the impact of the observed issues with the water system on the quality of all drug product lots currently available or nearing expiration in the U.S.”

The agency also requires the company to report the results from testing reserve toothpaste samples and outline the steps it plans to take based on these results.

The FDA requested detailed actions from the company responding to its risk evaluation, which may include consumer notifications or recalls of the products.

Company Commits to Resolving Issues

Colgate-Palmolive is collaborating with the FDA to resolve the concerns raised during the inspection, a spokesperson informed ABC News.

The company stated, “We always test our finished products prior to leaving our facilities, and we remain fully confident in the safety and quality of our toothpaste.”

They also added, “We have brought in water experts to assess our systems at Sanford, have put additional measures in place to comply with FDA regulations, and our water testing indicates no issues.”

This article has been updated to clarify information regarding one of the bacteria discovered in the toothpaste.