Tom’s of Maine, the folksy, naturally sourced toothpaste of crunchy-granola-types everywhere, has a problem that, on the whole, seems to fit a brand preferred by dirty hippies. The Food and Drug Administration recently admonished the company after a government inspector found evidence of multiple bacteria in the company’s products and at one of its factories.
CBS first reported on the company’s troubles, basing its report on a recently published warning letter sent by the regulatory agency to the toothpaste company. That FDA letter warns the toothpaste company that, among other things, its Tom’s Simply White Clean Mint toothpaste, had been found to contain Pseudomonas aeruginosa, a germ that “can cause infections in the blood and lungs.” At the same time, another troubling bacteria that has been linked to infections, Paracoccus yeei, was found in another one of its products, Wicked Cool! Anticavity Toothpaste.
Also discovered at one of the company’s factories was Ralstonia insidiosa, yet another bacteria, that was found in water samples taken from the facility. The letter also notes that an inspector found “a black mold-like substance” inside the facility where the toothpaste was being produced, in close proximity to a water storage tank.
The government chastised the company, encouraging it to keep its water sources clean, since it plays such a big role in the company’s product base. “Water is a major ingredient in many of your OTC drug products,” the letter notes. “It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain, and monitor the system to ensure it consistently produces water suitable for pharmaceutical use.”
Overall, the FDA accuses the company of having “failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products.”
When reached for comment by Gizmodo, the company said: “We’re working with the FDA 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. 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.”
Tom’s of Maine was founded in 1970 and eventually grew into a $100 million business. It was bought by Colgate-Palmolive in 2006.
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