FDA Report Exposes Disturbing Health Violations at Tom’s of Maine Factory

The U.S. Food and Drug Administration (FDA) uncovered serious health violations at a Tom’s of Maine manufacturing plant. A Nov. 5 warning letter from the FDA noted the presence of a “mold-like” substance as well as bacteria-laden water used to make its toothpaste. The letter resulted from an inspection of the company’s Sanford, Maine, facility in May.

Specifically, Pseudomonas aeruginosa was discovered in water samples. The bacteria group, which can cause blood and lung infections, had contaminated water used to manufacture Tom’s Simply White Clean Mint Paste. The bacteria were also present in water used to clean equipment. A batch of another product, Wicked Cool! Anticavity Toothpaste, contained the bacteria Paracoccus yeei. An additional bacterium, Ralstonia insidiosa, was also detected at the facility.

“Water is a major ingredient in many of your OTC drug products,” wrote the FDA. “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.”

An FDA representative discovered a black substance that resembled mold within a few feet of toothpaste-making equipment. The material was found on a hose reel and behind a water storage tank. A mysterious powder-like residue was also noted near a steel tray where Silly Strawberry anticavity toothpaste is made.

Tom’s of Maine Responds

Tom’s of Maine, which is owned by Colgate-Palmolive, defended itself by noting that the area with the black substance was hard to reach and susceptible to moisture. The substance was thoroughly cleaned after the FDA’s inspection. The powder residue was also removed.

“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 a statement to NBC News.

Tom’s of Maine has committed to rectifying the water issues found in the May inspection and will continue cooperating with the FDA. The company has 15 days to respond to the FDA with a plan of action to remedy the violations.

Neither Tom’s of Maine nor the FDA has issued any recalls related to any products as of yet. While Tom’s prides itself on using “naturally derived” ingredients in products, recalls related to contamination happen occasionally. Just this week, organic carrots from Grimmway Farms sold at various retailers like Trader Joe’s were taken off shelves after an outbreak of E. coli killed one person and sickened dozens of others.