The Food and Drug Administration has issued a warning to Tom's of Maine, a Colgate-Palmolive-owned personal care brand, after an inspection revealed bacteria contamination and unsanitary conditions at its manufacturing facility in Sanford, Maine. The inspection, conducted in May, uncovered multiple violations, including the presence of bacteria in water used to make toothpaste and a "mold-like" black substance near production equipment. The findings have prompted significant concern over product safety and manufacturing practices.
The FDA's warning letter, dated November 5 and made public Tuesday, detailed the discovery of microorganisms such as Pseudomonas aeruginosa, which can cause severe infections, including in the blood and lungs, and Ralstonia insidiosa, a bacteria linked to sepsis. These pathogens were found in water samples and finished toothpaste products, including Tom's Simply White clean mint paste. The contaminated water was also used for rinsing equipment.
The FDA noted that despite these findings, Tom's of Maine continued distributing affected products based on retesting of finished goods without adequately addressing the source of contamination. This decision has raised questions about the company's quality assurance protocols. One batch of the company's Wicked Cool! anticavity toothpaste tested positive for Paracoccus yeei, another harmful bacteria. While Tom's attributed this result to lab contamination, the FDA found insufficient evidence to support this claim.
An FDA investigator also observed unsanitary conditions, including a black mold-like substance at the base of a hose reel and behind a water storage tank, both located less than a foot from equipment used in toothpaste production. Powder residues were spotted on a stainless-steel tray near a batch of Silly Strawberry anticavity toothpaste.
"These findings underscore the importance of maintaining facilities in a state of good repair and ensuring sanitary conditions to prevent contamination," the FDA stated in its letter. The agency demanded a comprehensive review of the facility's water systems, a detailed risk assessment of contamination hazards, and a remediation plan to ensure the safety of future products.
In response to the FDA's findings, Tom's of Maine said it has engaged water specialists to evaluate its systems and implemented additional safeguards to comply with FDA standards. "Tom's is committed to making safe and effective natural products for our consumers and maintaining the trust in our brand," the company said in a statement. It also noted ongoing investments to upgrade the Sanford plant's water systems.
The FDA's letter pointed out that the company failed to investigate hundreds of consumer complaints about product odor, color, and taste. Tom's defended its approach, saying it uses a "risk-based" method for addressing complaints, adding that individual complaints were not deemed indicative of systemic issues.
Tom's of Maine has long marketed itself as a provider of "naturally sourced and derived" personal care products, a reputation that has helped its products secure shelf space in major retailers like Whole Foods, Target, and Walmart. However, the FDA's findings have cast a shadow over the brand's commitment to safety and quality.
The FDA has given the company 15 days to respond with a detailed plan to address the issues outlined in the warning letter. Failure to comply could result in regulatory actions, including product recalls or facility shutdowns.
