The U.S. Food and Drug Administration issued a warning to Tom’s of Maine earlier this month after investigators found bacterial contamination, black mold and poor safety procedures at the company’s Sanford manufacturing facility.
In the Nov. 5 letter to Noel Wallace, CEO of Tom’s of Maine parent company Colgate-Palmolive, the FDA said the company failed to follow procedures designed to keep “objectionable microorganisms” out of its products, did not keep its facilities in good repair and failed to investigate customer complaints.
In the letter, the FDA referred to a previous response that it called “inadequate.”
Pseudomonas aeruginosa, an antibiotic resistant bacteria that more often infects people with compromised immune systems, was found in multiple water samples used to make Tom’s Simply White Clean Mint Paste from June 2021 to October 2022.
Multiple times, Ralstonia insidiosa, water-borne bacteria that can cause numerous types of infections, was recovered in quantities “too numerous to count” from water points of use. Paracoccus yeei, another pathogen, was found in the finished product of Wicked Cool! Anticavity Toothpaste.
The FDA said Tom’s released batches manufactured after these incidents based on microbial testing of the finished product despite the quality of the water used in the product or to clean equipment.
“Water is a major ingredient in many of your OTC drug products,” the FDA wrote. “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.”
While inspecting the manufacturing facility, an investigator saw a “black mold-like substance” at the base of the hose reel and behind a water storage tank within one foot of equipment used for over-the-counter drug production, according to the FDA.
The investigator also saw powder residue near equipment used to produce Tom’s Silly Strawberry Anticavity before any of the solid raw materials were added.
The FDA said Tom’s did not investigate roughly 400 complaints related to odor, color, and taste in its toothpaste products, including those for children, because it only investigates when a trend is identified.
In response, the FDA requested that Tom’s provide a variety of assessments of its facility and processes, and a list of actions the company will take to correct the violations.
If the company does not comply, the FDA said it may withhold approvals.
A representative of Tom’s of Maine told the Bangor Daily News the company is working with the FDA and remedying the problems raised in the May inspection of the Sanford facility.
“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,” the representative said. “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.”
The representative also said the company is investing to upgrade 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,” he said.
