FDA Inspection Discovered Tom’s of Maine Toothpaste Contamination

Colgate-Palmolive’s Tom’s of Maine toothpaste facility finds itself under scrutiny after an FDA inspection uncovers alarming safety violations, including bacteria-contaminated water used in its production.

At a Glance

An FDA inspection revealed bacteria in water at Tom’s of Maine toothpaste facility.
Pseudomonas aeruginosa was detected, exposing a potential infection risk.
A warning letter has been sent to Colgate-Palmolive, and it highlights sanitary issues.
Tom’s of Maine has committed to upgrading its water system and maintaining product safety.

FDA Findings at Tom’s of Maine

The FDA’s inspection at Tom’s of Maine revealed significant regulatory breaches, raising safety concerns. The facility was found to have bacteria-laden water with Pseudomonas aeruginosa, capable of causing infections. Ralstonia insidiosa was also detected, presenting further contamination risk. These findings, alongside the presence of a black mold-like substance near production equipment, prompted immediate attention. The FDA sent a warning letter to Colgate-Palmolive, detailing these concerns.

This investigation also uncovered Paracoccus yeei in a batch of the Wicked Cool! anticavity toothpaste, underscoring the urgent need for remediation. Furthermore, a “powder residue” was detected near Silly Strawberry Anticavity toothpaste production. The FDA criticized the facility for failing to maintain necessary sanitary conditions and adequate water system standards.

Bacteria in the water used to make toothpaste and a black “mold-like” substance were discovered during an FDA inspection of a Tom’s of Maine manufacturing facility. https://t.co/mlEMB14BOj

— NBC News (@NBCNews) November 20, 2024

Response and Ongoing Measures

Colgate-Palmolive and Tom’s of Maine were given 15 days to address these violations and propose a remediation plan. They have committed to resolving issues by engaging water specialists, implementing additional FDA compliance safeguards, and making capital investments to upgrade the Sanford facility’s water system. Tom’s of Maine said, “We are also making capital investments as part of an ongoing, significant upgrade of the Sanford plant’s water system. Tom’s is committed to making safe and effective natural products for our consumers, and to maintaining the trust in our brand.”

The FDA’s emphasis on a robust water system for pharmaceutical production highlights the critical nature of the shortfalls observed. The FDA may withhold export certificates if these remediation measures are not met, further pressuring Tom’s of Maine to address these issues promptly.