A Food and Drug Administration inspection of a plant where Tom’s of Maine toothpaste is produced led to the discovery of “significant violations,” including bacteria in the water used to produce the toothpaste and a substance black “mold-like”.
The FDA sent a warning letter Nov. 5 to parent company Colgate-Palmolive, which was made public Tuesday, detailing how microorganisms were found in water samples and finished toothpaste products during a May inspection of a facility. from Sanford, Maine.
Tom’s of Maine said in a statement Wednesday that it is working with the FDA and remedying the issues raised in the May inspection.
Pseudomonas aeruginosa, which can cause blood and lung infections, was detected in multiple water samples from June 2021 to October 2022, according to the Centers for Disease Control and Prevention. The contaminated water was used to make Tom’s Simply White Clean Mint Paste and for final cleaning of equipment, the letter said.
The bacteria Ralstonia insidiosa was also found where water was used.
“Batches manufactured after these incidents were released based on microbiological testing of the finished OTC product despite the quality of the water used as a component or to clean the equipment,” the FDA letter stated.
Another bacteria, Paracoccus yeei, was found in a final batch of Wicked Cool! anti-cavity toothpaste.
“Their investigation concluded, without sufficient justification, that the growth (of bacteria) was due to contamination of the sample. The batch was released based on the results of a new test,” the warning letter said.
An FDA investigator also found a “black mold-like substance” at the base of a hose reel and behind a water storage tank at the facility, which was about a foot away from equipment used for the production of toothpaste.
The letter noted that Colgate-Palmolive/Tom’s of Maine reported that the black substance, found in a space susceptible to “moisture buildup,” was cleaned up.
The investigator “also observed powder residue on a stainless steel tray” near a batch of Tom’s Silly Strawberry anti-cavity toothpaste.
“It is essential that your facilities be in good repair and sanitary conditions are maintained to protect pharmaceutical products from potential avenues of contamination,” the letter warned.
The FDA noted that the company’s water system did not pass the evaluation and warned about the importance of having a system that “consistently produces water suitable for pharmaceutical use.” The company was asked to make a plan to remediate 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 evaluation of the design and control of manufacturing operations, a review of all microbiological hazards, a detailed risk assessment addressing hazards posed by the distribution of pharmaceutical products over-the-counter products with “potentially questionable contamination” and investigations into all batches of products with possible microbial contamination.
The company was given 15 days to respond and specify any remedial work in response to the violations.
In a statement to our sister network, NBC News, the company said: “Tom’s is committed to making safe and effective natural products for our consumers and maintaining trust in our brand.
“We have always tested finished products before they leave our control and remain fully confident in the safety and quality of the toothpaste we make.”
The statement continues: “In addition, we have hired water specialists to evaluate our systems in Sanford, we have implemented additional safeguards to ensure compliance with FDA regulations and our water tests show no problems. We are also making capital investments such as “part of an ongoing and significant upgrade of the Sanford plant’s water system.”
