Tom’s of Maine Faces FDA Warning Over Bacteria in Toothpaste
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.
Bacteria Found in Water and Toothpaste
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, a bacteria that can cause infections in the blood and lungs, was recovered in multiple water samples from June 2021 to October 2022. Ralstonia insidiosa and Paracoccus yeei were also found in water points of use.
Quality Control Issues
The FDA letter stated that batches of toothpaste were released despite the quality of the water used to manufacture them. The company’s investigation concluded that the growth of bacteria was due to sample contamination, but the FDA disagreed.
Facility Observations
An FDA investigator 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.
Remediation Plan Required
The FDA asked the company to make a remediation plan for the water system, including "total microbial count limits" to monitor whether the water is suitable for production. The company was also asked to provide a comprehensive assessment of the design and control of manufacturing operations and a review of all microbiological hazards.
Company Response
Tom’s of Maine stated that it is committed to making safe and effective natural products and maintaining the trust in its brand. The company claimed to have always tested finished goods before they leave its control and remains fully confident in the safety and quality of its toothpaste.
Conclusion
The FDA warning highlights the importance of maintaining proper quality control and sanitation in the manufacturing process. Tom’s of Maine must take immediate action to address the issues raised by the FDA and ensure the safety and quality of its products.
Frequently Asked Questions
Q: What type of bacteria was found in the water and toothpaste?
A: Pseudomonas aeruginosa, Ralstonia insidiosa, and Paracoccus yeei were found in the water and toothpaste.
Q: What was the FDA’s response to the findings?
A: The FDA sent a warning letter to Colgate-Palmolive, citing significant violations and requiring a remediation plan for the water system.
Q: Has Tom’s of Maine responded to the FDA’s findings?
A: Yes, the company stated that it is committed to making safe and effective natural products and maintaining the trust in its brand.
Q: What actions is Tom’s of Maine taking to address the issues?
A: The company is making capital investments to upgrade its water system and has engaged water specialists to evaluate its systems.
