Bacteria and Mold-Like Substance Found at a Tom’s of Maine Manufacturing Facility, FDA Warns

Tom’s of Maine’s natural health and beauty products may have an unwelcome ingredient—harmful bacteria—according to a warning letter released by the FDA on November 5, 2024. In the letter, the FDA pointed to testing results that found bacteria in the water used to make several types of toothpaste and to clean manufacturing equipment, along with inspections that found a black, mold-like substance and powder residue near equipment used to make their products.

Water used to make Tom’s Simply White Clean Mint Paste in 2021 and 2022 was contaminated with Pseudomonas aeruginosa, a bacteria that can cause infections in the blood, lungs, and urinary tract, and has varieties that are resistant to nearly all antibiotics.

Water containing the bacteria Ralstonia insidiosa, a bacteria that has been linked to blood infections and infectious pneumonia, was used in the manufacturing of products, and the products themselves were released to the public, despite the water testing results.

A batch of Wicked Cool! Anticavity Toothpaste (batch 3025UST11B) was found to contain Paracoccus yeei, a bacteria that has been associated with a range of infections, including pinkeye and blood infections, and was released to the public.

Investigators also found a black, mold-like substance at the base of a hose reel and behind the water storage tank, near equipment that is used in the production of product, and powder residue near the equipment used to make Tom’s Silly Strawberry Anticavity.

No recall has been issued yet, but Tom’s of Maine is required to assess its manufacturing process, test reserve samples of its products for microbiological contamination and strength of the active ingredients, and inform customers and initiate a recall of any products that are found to have an out-of-specification result.

In a press statement, the company says that they are working to address the issues at their Sanford, Maine, factory that were detailed in the letter. And they maintain that their products are safe. “We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make,” Tom’s of Maine said in the statement. “In addition, we have engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues.”