The Food and Drug Administration (FDA) recently revealed that Tom’s of Maine Toothpaste is made with bacteria-infested water.
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In a letter dated Nov. 5, the federal agency addressed the situation to Noel Wallace, the CEO of Colgate-Palmolive/Tom’s of Maine, Inc. The company had received “significant violations” of Current Good Manufacturing Practice (CGMP) regulations. This happened following an inspection at its Sanford, Maine facility from May 7 to the 22.
“You are responsible for investigating and determining the causes of any violations and for preventing their recurrence,” the FDA stated. “Or the occurrence of other violations.”
In the agency’s findings, it was revealed that water samples that were used to manufacture Tom’s Simply White Clean Mint Paste contained Pseudomonas aeruginosa. The Centers for Disease Control warns that this type of bacteria may cause infections in the blood or lungs.
Another bacteria that was discovered from “water points of use” was Ralstonia insidiosa, which can cause pneumonia.
Meanwhile, a gram-negative cocco-bacilli Paracoccus yeei was also found in the product, Wicked Cool! Anticavity Toothpaste, batch 3025UST11B. To which, the FDA stated, “Your investigation concluded, without sufficient justification, that the growth was due to sample contamination. The batch was released based on retest results.”
The FDA stated the company’s team was performing a “retrospective review” of their microbial incidents in water. The OTC products would be reviewed as well. “You also acknowledge that you do not have adequate specifications for the water used for the final rinse of equipment.”
“You also state in your response that the root cause for P. yeei was related to a laboratory error,” the agency continued. “Even though the initial investigation stated no laboratory errors were identified.”
The FDA called the response “inadequate” and doesn’t include additional supporting evidence or testing results for the finished product.
The FDA Reveals Other Findings of Tom’s of Maine Toothpaste As Company Stands By Its Products
The investigator observed a black mold-like substance at the base of the hose reel and behind the water storage tank in the clean out of place room.
“The black substance was within one foot of stainless-steel pails and other product-contact equipment,” the FDA letter states.
Despite the findings and warnings, Tom’s of Maine released a statement to PEOPLE standing by its products. “We are confident there are no safety issues with our toothpaste and that it is safe to use,” the statement reads.
The company further stated, “We test every batch of toothpaste we make — including for harmful bacteria and mold — to ensure its safety before it is released for sale.”
“We have been working with the FDA to remedy the issues raised in their May inspection of the Tom’s toothpaste manufacturing plant in Sanford, Maine,” the company continued. “Including implementing additional safeguards and making capital investments as part of ongoing plant upgrades.”
The company then added, “Tom’s is committed to continuing to make safe and effective natural products for our consumers and to maintaining the trust in our brand.”