Bacteria, Mold Found in Tom’s of Maine Facility, FDA Says
FDA Inspection Reveals "Significant Violations"
An FDA inspection of a Tom’s of Maine manufacturing facility led to the discovery of "significant violations," including bacteria in water used to make toothpaste and a black "mold-like" substance.
Water Samples Contain Bacteria
The FDA sent a warning letter to parent company Colgate-Palmolive on November 5, detailing how microorganisms were found in water samples and finished toothpaste products during a May inspection of a Sanford, Maine, facility. Pseudomonas aeruginosa, which can cause infections in the blood and lungs, was recovered in multiple water samples from June 2021 to October 2022. The bacteria Ralstonia insidiosa was also recovered from water points of use. Additionally, Paracoccus yeei was found in a final batch of the product Wicked Cool! anticavity toothpaste.
"Black Mold-Like Substance" Found
An FDA investigator also observed a "black mold-like substance" at the base of a hose reel and behind a water storage tank at the facility, which was within a foot away from equipment used for toothpaste production. The company claimed the substance was cleaned, but the FDA warned that the facility must be in a good state of repair and sanitary conditions must be maintained to protect drug products from potential routes of contamination.
Company Fails to Meet FDA Standards
The FDA said the company failed to qualify its water system and warned of the importance of having a system that "consistently produces water suitable for pharmaceutical use." The company was asked to make a remediation plan for the water system, including "total microbial count limits" to monitor whether the water is suitable for production.
Company Response
Tom’s of Maine said in a statement that it is working with the FDA to remedy issues raised from the May inspection. The company stated that it has always tested finished goods before they leave its control and remains fully confident in the safety and quality of the toothpaste it makes. The company has engaged water specialists to evaluate its systems at Sanford, implemented additional safeguards to ensure compliance with FDA standards, and its water testing shows no issues.
Conclusion
The discovery of bacteria and a "black mold-like substance" in a Tom’s of Maine facility highlights the importance of maintaining high standards of cleanliness and sanitation in the production of consumer goods. The FDA’s warning letter serves as a reminder to companies of the importance of compliance with regulatory standards to ensure the safety and quality of their products.
FAQs
- What was found in the Tom’s of Maine facility?
- Bacteria, including Pseudomonas aeruginosa, Ralstonia insidiosa, and Paracoccus yeei, and a "black mold-like substance".
- What was the FDA’s response to the findings?
- The FDA sent a warning letter to parent company Colgate-Palmolive, detailing the "significant violations" found during the inspection.
- What did the company do in response to the FDA’s findings?
- The company is working with the FDA to remedy the issues raised from the May inspection and has implemented additional safeguards to ensure compliance with FDA standards.
