Personal care brand Tom’s of Maine received a warning from the Food and Drug Administration earlier this month after the agency found powdered substances that looked like germs and mold on its products and equipment.
In a letter to Tom’s released Tuesday, FDA inspectors identified several types of bacteria, including Paracoccus eaii, in the Sanford, Maine, facility’s tap water. Pseudomonas aeruginosa. It can cause blood, lung, and urinary tract infections. Ralstonia insidiosa, which can cause sepsis.
The brand used the water to rinse its products and equipment, according to the FDA.
Toms did not immediately respond to NPR’s request for comment. However, the company told CBS News it is working with the FDA to resolve the issues it discovered at its main plant.
Tom’s sells personal care products such as toothpaste, mouthwash, lip balm and fragrances made with “natural ingredients and ingredients,” according to its website. It is owned by Colgate-Palmolive and its products are sold at major retailers such as Whole Foods, Target, Walmart, and Kroger.
The FDA said that despite the results of the microbial tests it conducted, Tom’s continued to distribute the product based on the test results of the finished product, but did not investigate the quality of the water used in the process. .
According to the FDA, Tom’s told the FDA it was retrospectively investigating the incident and that the detection of Paracoccus eaii was due to a testing error. But the agency said there was no evidence of that.
The agency also said it found a “black mold-like substance” and “powder residue” on or near some of the equipment.
Tom’s said the black substance was located in a damp area that was difficult to reach, but has since been thoroughly cleaned. The company said it removed powder residue from trays used to make Silly Strawberry Anticavity toothpaste before adding the solids.
The FDA also said Tom’s failed to investigate hundreds of product complaints about odor, color and taste that did not indicate a trend.
According to the FDA, Tom’s takes a “risk-based approach” to complaints and responded that individual complaints alone are not sufficient to determine that a product is inappropriate.
The agency is asking Tom’s to submit multiple documents, including an evaluation of its operations and improvement plans, risks of contamination, testing methods and cleaning procedures.