SANFORD, Maine (WJW) — Water contaminated with dangerous bacteria was used to manufacture batches of Tom's of Maine toothpaste, a brand owned by Colgate-Palmolive, according to the U.S. Food and Drug Administration.
The FDA said in a Nov. 5 warning letter that inspectors found Pseudomonas aeruginosa — a bacteria that can cause blood and lung infections — in water used to produce the brand's Simply White Clean Mint Paste and to rinse cleaning equipment at its Sanford, Maine, plant.
Another bacteria linked to infections like conjunctivitis, Paracoccus yeei, was detected in a batch of Wicked Cool! Anticavity Toothpaste, according to the FDA.
The agency also noted that Tom's of Maine reported finding Ralstonia insidiosa in water sources on multiple occasions that are "too numerous to count." That particular bacteria can cause bloodstream and respiratory tract infections.
Additionally, the FDA’s inspection, conducted May 7-22, uncovered a "black mold-like substance" near production equipment and "powder residues" close to a batch of Tom’s Silly Strawberry Anticavity toothpaste.
"It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination," the FDA said in its warning.
The FDA also said that it may withhold export certificates if these violations aren't addressed. Tom's of Maine has 15 business days to respond with specifics on how the company is addressing the violations.
In a statement to Nexstar's WJW, Tom's of Maine said it's cooperating with the agency.
"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," the statement read. "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."
The company said has enlisted water specialists to evaluate the systems at its Sanford facility, and it has also implemented extra safeguards to meet FDA standards.
"We are also making capital investments as part of an ongoing, significant upgrade of the Sanford plant’s water system," the company said. "Tom’s is committed to making safe and effective natural products for our consumers, and to maintaining the trust in our brand."
