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.
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Tom’s of Maine said in a statement Wednesday that it is working with the FDA to remedy 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.
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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.
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“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.
The investigator “also observed powder residues at a stainless-steel tray” near a batch of Tom’s Silly Strawberry anticavity toothpaste.
“It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination,” the letter warned.
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, and include “total microbial count limits” to monitor whether the water is suitable for production.
Colgate-Palmolive/Tom's of Maine was asked to provide a comprehensive assessment of the design and control of manufacturing operations, a review of all microbiological hazards, a detailed risk assessment addressing the hazards posed by distributing over-the-counter drug products with “potentially objectionable contamination,” and investigations into all batches of products with potential microbial contamination.
Overall, the company was given 15 days to respond and specify any remediation work in response to violations.
In a statement sent to NBC News, the company said: “Tom’s is committed to making safe and effective natural products for our consumers, and to maintaining the trust in our brand.
"We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make."
The statement continued: "In addition, we have engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues. We are also making capital investments as part of an ongoing, significant upgrade of the Sanford plant’s water system."
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