The FDA issued a warning letter, but not a recall, after an inspection found tainted water samples as well as a "black mold-like substance" at one of its plants.
The U.S. Food and Drug Administration has issued a warning letter to the personal-care brand Tom's of Maine after finding a "black mold-like substance" and bacteria during an inspection of one of its manufacturing facilities.
When FDA inspectors visited the facility in Sanford, Maine, in May they observed "significant violations" including the presence of residues and a black mold-like substance, as well as bacteria in water samples used to make the brand's popular toothpastes, according to a letter posted Tuesday on the agency's website.
The letter, dated Nov. 5, said the firm "failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile." However, it did not issue a formal recall.
A bacteria known as Pseudomonas aeruginosa was found in multiple water samples taken by the company between June 2021 and October 2022. That same water was used to manufacture Tom's Simply White Clean Mint Paste, and to rinse equipment, the letter said.
According to the Centers for Disease Control and Prevention, the bacteria can resist antibiotics, making it difficult to treat. It is commonly found in health-care settings and can cause infections in the blood, lungs, urinary tract or other parts of the body after surgery.
Another bacteria, Ralstonia insidiosa, was also found in numerous water sources at the facility, the FDA said.
"Batches manufactured after these incidents were released based on the microbial testing of the finished OTC [over-the-counter] product despite the quality of the water used as a component or to clean the equipment," it read.
Another bacteria, Paracoccus yeei, was found in a batch of the company's Wicked Cool! Anticavity Toothpaste, marketed for children.
An investigation by the company concluded "without sufficient justification," in the FDA's view, that the bacterial growth was "due to sample contamination," and the batch was released for sale based on retest results.
Tom's of Maine did not immediately respond to a request for comment from The Washington Post late Wednesday. But in an emailed statement provided to other media outlets, the company said it is working with the FDA to remedy the issues raised during the May inspection.
The company sells a variety of personal-care products, such as toothpastes, soaps and antiperspirants, using "naturally sourced and naturally derived ingredients," according to its website.
"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," Tom's said in the statement.
In the FDA's letter, the agency said the company's response to finding microorganisms in water and toothpaste products was "inadequate."
An FDA inspector also found a "black mold-like substance" at the base of a hose reel and behind a water storage tank, close to stainless-steel pails and other equipment.
The agency said the company's protocol for looking into complaints was lacking, noting that some 400 complaints related to odor, color and taste in its toothpaste products, including those marketed for children, "were not investigated."
The FDA called for a detailed review of the manufacturing operations and the "hazards posed by distributing [over-the-counter] drug products with potentially objectionable contamination." It requested that the company specify the actions it would take in response to the risk assessment, such as customer notifications and product recalls.
The FDA gave Tom's 15 days to respond to the letter, detailing what the company has done to fix any violations and to prevent their recurrence.