FDA inspection finds bacteria-tainted water used for Tom’s of Maine toothpaste

Tom’s of Maine toothpaste overview: 

• Who: The U.S. Food and Drug Administration says an inspection found Tom’s of Maine used bacteria-tainted water when producing batches of Tom’s Simply White Clean Mint Paste and Wicked Cool! Anticavity Toothpaste toothpaste products. 
• Why: The FDA attributed the bacterial contamination to the water system Tom’s of Maine uses at its manufacturing facility. 
• Where: The Tom’s of Maine toothpaste manufacturing facility is in Sanford, Maine.

A U.S. Food and Drug Administration inspection found Tom’s of Maine used bacteria-tainted water when manufacturing a pair of its toothpaste products. 

The toothpaste products manufactured with bacteria-tainted water include Tom’s of Maine’s Tom’s Simply White Clean Mint Paste and Wicked Cool! Anticavity Toothpaste, according to the FDA. The water contained pseudomonas aeruginosa, ralstonia insidiosa and gram-negative cocco-bacilli paracoccus yeei. 

“Because your methods, facilities or controls for manufacturing, processing, packing or holding do not conform to (Current Good Manufacturing Practice), your drug products are adulterated,” the FDA says in a warning letter to Tom’s of Maine. 

Tom’s of Maine inadequately responded to bacteria findings, FDA says

The FDA told Tom’s of Maine, a majority-owned subsidiary of Colgate-Palmolive, that the company’s response to the bacterial findings was “inadequate” and failed to include “additional supporting evidence or testing results for the finished products.” 

“In addition, you are resampling the water points of use, 4 days after initial sampling, without further evaluation of manufacturing activities or water use during those 4 days that may impact other products,” the agency says in the warning letter. 

It ordered Tom’s of Maine to provide a comprehensive remediation plan for the design, control and maintenance of the water system used to produce water for equipment cleaning and formulating the toothpaste products. 

The FDA will also require Tom’s of Maine to provide a detailed risk assessment addressing the “potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry.” 

A consumer filed a class action lawsuit against Tom’s of Maine in January 2023 over claims the company produced a fluoride-free toothpaste that falsely purported to prevent plaque. 

Are you concerned about the possibility of bacteria in Tom’s of Maine toothpaste? Let us know in the comments.

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