FDA Uncovers Contamination Issues in Tom’s of Maine Toothpaste

The FDA publicly revealed significant contamination concerns in Colgate-Palmolive’s Tom’s of Maine toothpaste on Wednesday, November 20th. An inspection conducted at the Sanford, Maine facility earlier this year found water contaminated with bacteria, including Pseudomonas aeruginosa and Paracoccus yeei, used in toothpaste manufacturing. The FDA also noted the presence of a black mold-like substance near production equipment, raising alarms about sanitary conditions at the plant.

The inspection, conducted from May 7 to May 22, uncovered water samples testing positive for bacteria between June 2021 and October 2022. These microorganisms are linked to infections such as conjunctivitis, peritonitis, and pneumonia. Products affected included Tom’s Simply White and the children’s Wicked Cool! Anticavity toothpaste. Despite the findings, some contaminated batches were released after retesting, a practice criticized by the FDA as insufficiently justified.

The FDA’s warning letter, issued on November 5th, highlighted other hygiene violations, including powder residues found near toothpaste production areas. The black mold-like substance was located a foot from tools used for manufacturing, further jeopardizing the plant’s compliance with safety standards. The agency demanded an immediate remediation plan to overhaul the facility’s water system and improve sanitary protocols.

In response, Colgate-Palmolive stated it is working to address the FDA’s concerns, emphasizing its commitment to product safety. The company has implemented additional safeguards, engaged water specialists, and begun upgrading the Sanford plant’s infrastructure. A spokesperson reaffirmed confidence in the safety of Tom’s of Maine products, citing rigorous testing procedures for finished goods before distribution.

No recalls have been announced as of the time of reporting, but the FDA instructed the company to conduct a risk assessment of potentially contaminated products still in circulation. The agency emphasized the importance of maintaining sanitary manufacturing environments to safeguard consumer health and trust.

This incident highlights the critical need for stringent oversight in personal care product manufacturing. While Tom’s of Maine is known for promoting natural products, these findings raise questions about whether production practices align with the brand’s image and consumer expectations.