FDA Warns Of Bacteria In Tom's Of Maine Toothpaste

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(RTTNews) - The U.S. Food and Drug Administration has warned against toothpaste manufactured with bacteria-laden contaminated water by Tom's of Maine Inc., a unit of Colgate-Palmolive Co.

The warning letter, which summarizes significant violations, has been issued after inspecting Tom's' drug manufacturing facility in Sanford, Maine from May 7 to 22.

The inspectors found several violations in the facility, including microbiological results in water samples and finished product. There was bacteria in water to make Tom's products, and also observed a black mold-like substance near the equipment used for OTC drug production in the facility.

The contaminated water was used as a component in the company's OTC drug products and as a final rinse after equipment cleaning.

Further, the agency noted that Pseudomonas aeruginosa was recovered in multiple water samples, from June 2021 to October 2022. This water was used to manufacture a particular batch of Tom's Simply White Clean Mint Paste.

Ralstonia insidiosa was also recovered from water points of use, and gram-negative cocco-bacilli Paracoccus yeei was recovered in OTC finished product, Wicked Cool! Anticavity Toothpaste.

The FDA noted, "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 agency noted that the firm failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile.

In response to the letter, the agency requested a comprehensive assessment of the design and control of the manufacturing operations, with a detailed and thorough review of all microbiological hazards, as well as detailed findings regarding the root causes of the contamination, among others.

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