Federal officials said they found black mold and disease-causing bacteria in a popular brand of toothpaste.
In a letter dated Nov. 5, the U.S. Food and Drug Administration said Tom’s of Maine toothpaste facilities in Sanford, Maine used water in their products that was contaminated with multiple strains of infectious bacteria.
The bacteria found can cause infections in the blood and urinary tract, as well as pneumonia, peritonitis and conjunctivitis, officials said. That water was used to manufacture Tom’s Simply White Clean Mint Paste, the Wicked Cool! Anticavity Toothpaste, and to rinse their equipment.
Investigators also observed ‘a black mold-like substance’ on a hose, wall and a water storage tank in the Maine facility. A powder-residue was found on a tray next to a batch of the Tom’s Silly Strawberry Anticavity toothpaste, the letter stated.
“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 wrote in its letter to Colgate-Palmolive/Tom’s of Maine, Inc.
The FDA sent inspectors to the Tom’s of Maine facility in May, but the letter was publicly released on Nov. 19.
The federal agency said the company, which produces natural body care products like toothpaste, deodorant and soaps, failed to investigate “approximately 400 complaints related to odor, color, and taste in your toothpaste products, including those for children.”
The FDA is requiring Tom’s of Maine to investigate and determine the cause of all violations and prevent them from reoccurring. If they fail to do so, the federal agency said they may withhold export certificates, as well as approvals on applications that are filed under the Tom’s of Maine brand.
USA Today reports no recalls have been issued in connection to the toothpaste brand but Tom’s is required to provide a “detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry.”
In a statement to ABC News, a spokesperson for Colgate-Palmolive said the company is working to address the issues.
“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. “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.”
