Toms of Maine is being made with bacteria-filled water, says FDA

Tom’s of Maine has always been known for using natural ingredients to make its products—like toothpaste, deodorant, and mouthwash—ingredients, which the company says are “good for you and the planet.” But it turns out that some of its toothpaste has been made with bacteria-contaminated water.

Batches of Tom’s of Maine toothpaste were made with water containing multiple types of bacteria, including strains that have been linked to blood infections, according to a warning letter to the company from the U.S. Food and Drug Administration (FDA).

Pseudomonas aeruginosa, a strain of bacteria that can cause blood, lung, and urinary-tract infections, was found in water samples used to make Tom’s Simply White Clean Mint Paste as well as to rinse off equipment at its manufacturing facility. The company itself found—and ignored—multiple instances of this contamination from June 2021 to October 2022, per the FDA warning letter. “None of these incidents were investigated to assess product impact and water system performance,” inspectors wrote.

Tom’s of Maine also reported ”too numerous to count” instances of Ralstonia insidiosa, a bacteria that can cause infections in immunocompromised people, in water used both for manufacturing and to clean equipment. The products made after those incidents were still released to consumers based on testing of those finished products, “despite the quality of the water,” according to the FDA.

Another bacteria, Paracoccus yeei, was found in the brand’s Wicked Cool! Anticavity Toothpaste, and that batch of product was still released for sale. (The timing of both of these contaminations isn’t clear.)

Tom’s of Maine also received “approximately 400 complaints” related to the color, taste, and odor of its toothpaste, per the FDA, and yet did not investigate those complaints. (Here too, the window of those complaints isn’t immediately clear.)

FDA inspectors visited the Tom’s of Maine manufacturing facility in Sanford, Maine, in May 2024. The agency sent the warning letter to Tom’s on November 5. But this wasn’t the agency’s first communication with the company. Before a company receives an FDA warning, it gets an inspection followed by an FDA form, which details objectionable conditions. Tom’s of Maine responded to that form in June, saying it was performing a review of those microbial instances in its water and manufactured products.

Tom’s of Maine, which was acquired by Colgate-Palmolive in 2006, said in a statement that it is working with the FDA to remedy the issues, and that it has always tested finished goods before they leave the facility. “We remain fully confident in the safety and quality of the toothpaste we make,” they added. Tom’s also says it has engaged water specialists, implemented safeguards, and is upgrading the plant’s water system, and that its water testing shows no issues.

At their inspection, FDA inspectors also observed “a black mold-like substance” at the base of hoses and behind a water storage tank at the manufacturing facility, and “within one foot” of production equipment.

Per the agency, Tom’s told the FDA in its form response that it doesn’t have “adequate specifications for the water used for the final rinse of equipment.” The company also said that the root cause of the Paracoccus yeei contamination was due to a laboratory error, “even though the initial investigation stated no laboratory errors were identified,” the letter reads.

“Your response is inadequate,” the FDA told Tom’s of Maine. The agency requested that the company provide complete investigations into all batches that could have microbial contamination, an assessment of all of the factory’s microbiological hazards, a remediation plan for the maintenance of the site’s water system, and additional steps.

“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 letter reads.

The agency recommended Tom’s hire a a consultant, and requested a response of what the company has done to address these violations and prevent them from reoccurring within 15 days.