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An FDA inspection of Tom’s of Maine’s manufacturing facility found “serious violations” including bacteria and a black “mold-like” substance in the water used to make the toothpaste.
The FDA sent a warning letter to parent company Colgate-Palmolive on Nov. 5, which was made public Tuesday, explaining how the microorganisms were discovered in water samples and finished toothpaste products during a May inspection of a facility in Sanford, Maine. Taka was detailed.
Tom’s of Maine said in a statement Wednesday that it is working with the FDA to remediate issues raised during the May inspection.
Pseudomonas aeruginosa, which can cause infections in the blood and lungs, was detected in multiple water samples from June 2021 to October 2022, according to the Centers for Disease Control and Prevention. The water was used to make Tom’s Simply White Clean Mint Paste, the letter said, and included the final rinse for numerous equipment cleaning processes.
The bacterium Ralstonia insidiosa was also recovered from the water station.
“Batches manufactured after these incidents were released based on microbial testing of the finished OTC product, despite the quality of the water used as parts or to clean the equipment,” the FDA letter said. It has been stated.
Another bacteria, Paracoccus yeei, was found in the final batch of the product Wicked Cool! Cavity prevention toothpaste.
“Your investigation concluded, without sufficient evidence, that the growth was due to sample contamination. This batch was released based on the results of retesting,” the warning letter states. There is.
FDA investigators also observed a “black mold-like substance” at the base of the facility’s hose reel and behind a water storage tank, both within a foot of equipment used to make toothpaste.
The letter said Colgate-Palmolive/Tom’s of Maine said the black material found in spaces prone to “moisture accumulation” had been removed.
Researchers “also observed powder residue on a stainless steel tray” near a batch of Tom’s Silly Strawberry Cavity Prevention Toothpaste.
“It is essential that facilities are in good repair and sanitary conditions are maintained to protect medicines from potential contamination vectors,” the letter warns.
The FDA said the company failed to certify its water system and warned of the importance of having a system that “consistently produces water suitable for pharmaceutical use.” The company was required to develop a remediation plan for its water system and include a “total microbial count limit” to monitor whether the water is suitable for production.
Colgate-Palmolive/Tom’s, Inc. of Maine conducted a comprehensive evaluation of the design and controls of its manufacturing operations, reviewed all microbiological hazards, and assessed the risks posed by the distribution of “potentially hazardous” over-the-counter drugs. We were asked to provide a detailed risk assessment addressing sex. Investigate all batches of products with possible “nasty contamination”, microbial contamination.
In all, the company was given 15 days to respond to the violations and designate remedial actions.
In a statement to NBC News, the company said: “Tom’s is committed to creating safe and effective natural products for consumers and maintaining trust in our brand.
“We always test finished products before they come under our control, and we continue to have full confidence in the safety and quality of the toothpaste we produce.”
The statement continued, “Additionally, we have hired water experts to evaluate Sanford’s systems and have implemented additional safety measures to ensure compliance with FDA standards, and we have Tests have shown there are no issues, and we are also making capital investments as part of our ongoing plans.” , a major upgrade to the Sanford plant’s water system. ”
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