The Food and Drug Administration (FDA) found concerning bacteria and a "black mold-like substance" while inspecting a facility that makes Tom's of Maine products, namely toothpaste.
Following the inspection, the FDA sent Tom's of Maine a warning letter, which was posted publicly Tuesday (Nov. 19). The letter notes that inspectors observed "significant violations of Current Good Manufacturing Practice regulations" at the facility in Sanford, Maine.
One issue was that inspectors found a microbe called Pseudomonas aeruginosa in water samples used to rinse off equipment and to make toothpaste — specifically, Tom's Simply White Clean Mint Paste. The bacteria can cause a range of infections and is a particular problem in health care settings, in part because it can often be resistant to antibiotics.
Another microbe, called Ralstonia insidiosa, was also found in many water samples. This bacterial species can infect humans, but it does so infrequently.
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In addition, Paracoccus yeei was found in a specific batch of Wicked Cool! Anticavity Toothpaste. This is another microbe that infects people "opportunistically." On the rare occasion it causes illness, it's most often seen in people with weakened immune systems.
In addition to these water-quality issues, an inspector found a black-mold-like substance in two damp areas in the facility. "The black substance was within one foot of stainless-steel pails and other product-contact equipment used for OTC [over-the-counter] drug production," the letter states.
In light of these and other findings, the FDA has requested an assessment of the company's manufacturing operations, along with a risk assessment of what could happen if any products were to be sold with "potentially objectionable contamination." The agency has requested that Tom's of Maine specify how the company will respond to that risk assessment and improve its water systems, facility management and cleaning procedures.
The FDA's inspection took place in May, and Tom's of Maine responded to its initial results in June. The FDA's latest letter declares that the company's June response was "inadequate," so the agency is calling for further action.
Tom's of Maine, which is owned by Colgate-Palmolive, has released the following statement to news outlets, including CNN:
"We're working with the FDA and are remedying the issues raised in their May inspection of the Tom's 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."
"In addition," the statement continues, "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. Tom's is committed to making safe and effective natural products for our consumers, and to maintaining the trust in our brand."
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