An investigation by the U.S. Food and Drug Administration (FDA) has uncovered alarming health and safety violations at the Tom's of Maine manufacturing facility in Sanford, Maine. The facility, owned by Colgate-Palmolive, was found to have used water contaminated with harmful bacteria to produce its toothpaste, alongside the discovery of a "black mould-like substance" near production equipment.
These findings were detailed in an FDA warning letter issued on 5 November following an inspection conducted from 7 May to 22 May.
Bacterial Contamination in Toothpaste Production
According to the FDA warning letter, water samples collected from the facility between June 2021 and October 2022 tested positive for Pseudomonas aeruginosa, a potentially harmful bacterium. This contaminated water was used in the production of Tom's Simply White Clean Mint toothpaste and for cleaning equipment.
"Water is a major ingredient in many of your over-the-counter (OTC) drug products," the FDA stated, emphasising the need for a robust water system that consistently produces water suitable for pharmaceutical use.
The Centers for Disease Control and Prevention (CDC) explains that Pseudomonas aeruginosa can cause severe infections in the blood, lungs, and urinary tract, among other body parts. These infections can pose significant risks to individuals with weakened immune systems.
Further testing revealed Paracoccus yeei in the Wicked Cool Anticavity Toothpaste, a product marketed specifically for children transitioning to adult toothpaste. According to CBS News, this bacterium has been linked to conjunctivitis (pink eye) and peritonitis, a serious abdominal infection caused by inflammation of the peritoneum.
The Mayo Clinic describes peritonitis as a potentially life-threatening condition that often results from bacterial or fungal infections.
Mould and Residue in the Facility
In addition to bacterial contamination, FDA investigators discovered a "black mould-like substance" near critical areas of the facility. The mould was found at the base of a hose and behind a water storage tank, just a foot away from tools and equipment used in toothpaste production.
The inspection also identified "powder residue" on trays near a batch of Tom's Silly Strawberry Anticavity toothpaste, another product marketed to children. The FDA noted that the presence of mould and residue poses significant contamination risks, stating, "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."
No Recalls Issued Despite Concerns
Despite the severity of the findings, no recalls have been issued for Tom's of Maine toothpaste products linked to the investigation. The FDA has urged the company to conduct a thorough risk assessment of the potential effects of water system failures on the quality of products currently in distribution or within their expiry dates.
The agency has also required Tom's of Maine to submit test results for reserve samples of its toothpaste and to outline corrective actions. These measures could include notifying customers or issuing product recalls.
Company Responds to FDA Findings
Colgate-Palmolive, the parent company of Tom's of Maine, has pledged to address the issues highlighted by the FDA. In a statement to ABC News, a company spokesperson stated:
"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."
Broader Health Concerns
The discovery of bacterial contamination and mould raises broader health concerns for consumers, especially children, who are the primary users of certain products implicated in the inspection. For example, Tom's Wicked Cool Anticavity toothpaste and Silly Strawberry toothpaste are specifically marketed to children, raising fears about the potential risks of exposure to harmful bacteria.
While Colgate-Palmolive has vowed to cooperate with the FDA to resolve these issues, the situation raises critical questions about oversight and transparency in the production of widely used consumer goods. The lack of a recall thus far may leave consumers in a precarious position, relying on the company's assurances amid ongoing investigations.
