[News] Tom's of Maine toothpaste contained bacteria-contaminated water, FDA says

[Aronus]

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. 

The FDA sent a warning letter Nov. 5 to parent company Colgate-Palmolive, which was publicly released Tuesday, detailing how microorganisms were found in water samples and finished toothpaste products during a May inspection of a Sanford, Maine, facility.

Tom’s of Maine said in a statement Wednesday that it is working with the FDA and remedying issues raised from the May inspection.

Pseudomonas aeruginosa — which can cause infections in the blood and lungs, according to the Centers for Disease Control and Prevention — was recovered in multiple water samples from June 2021 to October 2022. That water was used to manufacture Tom’s Simply White clean mint paste and for the final rinse of numerous equipment cleaning processes, the letter said.

The bacteria Ralstonia insidiosa was also recovered from water points of use. 

“Batches manufactured after these incidents were released based on the microbial testing of the finished OTC product despite the quality of the water used as a component or to clean the equipment,” the FDA letter said.

Another bacteria, Paracoccus yeei, was found in a final batch of the product Wicked Cool! anticavity toothpaste.

“Your investigation concluded, without sufficient justification, that the growth was due to sample contamination. The batch was released based on retest results,” the warning letter said. 

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 letter noted that Colgate-Palmolive/Tom's of Maine said the black substance, found in a space susceptible to "moisture accumulation" was cleaned.

 

 

 

Tom's of Maine toothpaste contained bacteria-contaminated water, FDA says