The FDA has revealed troubling findings regarding Tom’s of Maine toothpaste, with an inspection of the brand’s manufacturing facility uncovering significant contamination issues. According to a letter sent to the brand’s parent company, Colgate-Palmolive, the FDA discovered that certain batches of Tom’s toothpaste were produced using water contaminated with bacteria. This included the presence of Pseudomonas aeruginosa, a potentially dangerous bacterium that can cause severe infections, including blood and lung infections.
FDA Reveals Tom’s of Maine Toothpaste Contaminated with Bacteria-Infested Water following an inspection conducted between June 2021 and October 2022. Samples from the Tom’s Simply White Clean Mint Paste were found to contain Pseudomonas aeruginosa, raising concerns about the safety of the product. Additionally, another bacterial strain, Paracoccus yeei, was identified in a batch of Tom’s Wicked Cool! Anticavity Toothpaste, adding to the list of contamination findings.
The FDA’s letter emphasized the importance of a robust water system, noting that water is a key ingredient in many over-the-counter (OTC) drug products like toothpaste. The agency stressed the need for Colgate-Palmolive to ensure the water used in the manufacturing process meets stringent standards for pharmaceutical use, warning that inadequate controls could result in contamination risks.
FDA Reveals Tom’s of Maine Toothpaste Contaminated with Bacteria-Infested Water, further investigation into the Sanford, Maine facility revealed the presence of a “black mold-like substance” near production equipment. In addition, the FDA reported finding a “powder residue” near a batch of Tom’s Silly Strawberry Anticavity toothpaste, a product marketed for children and parents. The agency’s findings suggest that the facility may not be adequately maintained, calling into question the cleanliness and overall state of repair.
The FDA has requested that Colgate-Palmolive provide additional documentation regarding their manufacturing operations, including a thorough review of all microbiological hazards and test results. In response, Colgate-Palmolive reassured the public that the company is working with the FDA to resolve these issues.
A spokesperson for the company stated, “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.” The company also highlighted that it has engaged water specialists to assess the systems at the Sanford facility and implemented new safeguards to meet FDA standards. Colgate-Palmolive also noted that recent water testing had shown no issues.
Despite the contamination concerns, Colgate-Palmolive remains committed to addressing the FDA’s findings and ensuring the safety of its products moving forward.
