According to the FDA letter, the bacteria were found in water and product samples between May and October 2024. The water used to manufacture the Simply White toothpaste contained bacteria called Pseudomonas aeruginosa, which can cause an infection in the blood and lungs. This infection is often resistant to antibiotics, making treatment often challenging. The Wicked Cool toothpaste had another bacteria called Paracoccus yeei—a pathogen that can cause serious infection.
Instead of investigating the FDA’s concerns, Tom’s of Maine dismissed the finding as “sample contamination and lab error” and released the batch of toothpaste, per the FDA. But these bacteria can be dangerous for children and people with compromised immune systems, infection prevention expert, microbiologist, and author of The Germ Files, Jason Tetro, tells Well+Good. He recommends people throw out their Tom’s of Maine toothpaste.
“When you have a regulated medical or health product, if there is any kind of contamination that has occurred, it should immediately go into the garbage,” says Tetro. “The company needs to reconfirm all the standards of good manufacturing practice, and they need to test their procedures to make sure there are no breeches. They have a lot of work that needs to get done before they release any more products.”
So if there are so many protocols that manufacturers are supposed to have in place, how did this bacteria develop? The FDA said the issue was from an inadequate water system, and they also found a “black mold-like substance” in the manufacturing facility. According to the letter, “approximately 400 complaints related to odor, color, and taste in [your] toothpaste products, including those for children, were not investigated.”
It’s not uncommon for manufacturing facilities in the Northeast to deal with mold issues because of the humid environment. In fact, Tetro says there have been numerous situations where mold and other microbes were found in facilities. “You pretty much need to have a hermetically sealed environment [read: airtight] because if you happen to be in the Northeast especially, there’s a good chance you’re going to get mold and bacteria growing simply because it’s so humid,” he adds.
Tom’s of Maine has issued a statement claiming the brand is “working with the FDA and remedying the issues.” The brand also stated it “remains fully confident in the safety and quality of the toothpaste we make. In addition, 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.”
Tetro says if you notice Tom’s of Maine stock dwindling on the shelves, it’s a good sign. “It means that they’re following the proper protocol” and that it’s likely they will recall specific batches that were affected. “For the time being, don’t purchase Tom’s until you hear the all-clear,” Tetro said. While there is no official recall occurring at the moment, it may be a good idea to stop purchasing the products for now to avoid the risk of developing a bacterial infection.
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