Bacteria Found in Tom’s of Maine Toothpaste, Inspectors Say

The U.S. Food and Drug Administration issued a warning letter, but not a recall, after microorganisms were found in water samples and finished toothpaste products.

An inspection of a Tom’s of Maine manufacturing facility last spring found “significant violations” including the presence of a “black mold-like substance,” and an internal investigation found bacteria in the water used to make the brand’s popular toothpaste, federal regulators said this month.

The U.S. Food and Drug Administration issued a warning letter dated Nov. 5 to the parent company Colgate-Palmolive reporting that microorganisms were found in water samples and finished toothpaste products during the inspection at a facility in Sanford, Maine, between May 7 and 22.

The letter, which accused the company of failing “to follow appropriate written procedures,” was not a formal recall.

Donald W. Schaffner, a professor of food and science at Rutgers University, said in an email that the bacteria found might cause illness, particularly for those who are immunocompromised.

“If customers read about this issue and they have concerns,” he said, “I think throwing out their toothpaste is a reasonable choice.”

The bacteria Pseudomonas aeruginosa was recovered in multiple water samples that the company took from June 2021 to October 2022, according to the letter. It can cause infections in the blood, lungs and other parts of the body after surgery, according to the Centers for Disease Control and Prevention.

That water was used to produce a batch of Tom’s Simply White Clean Mint Paste and to rinse down several pieces of equipment, the letter said.

The bacteria Ralstonia insidiosa was also found in its water, according to the F.D.A.

Another bacteria, Paracoccus yeei, was found in a batch of the company’s Wicked Cool! Anticavity Toothpaste, which is marketed toward children.

In a statement on Wednesday, Tom’s of Maine said: We’re working with the F.D.A. and are remedying the issues raised in their May inspection of the Tom’s toothpaste manufacturing plant in Sanford, Maine. 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.”

An investigator with the F.D.A. also reported finding a “black mold-like substance” at the base of a hose and behind a water storage tank in the facility, one foot from pails and other equipment used to produce the toothpaste.

The F.D.A. asked the company 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,” as well as an independent assessment of its cleaning effectiveness “to evaluate the scope of cross-contamination hazards.”

The agency said that the company had 15 days to respond and specify any work to prevent the recurrence of the violations.

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