SANFORD, Maine — A new warning letter from the U.S. Food and Drug Administration says some batches of Tom’s of Maine toothpaste were made with bacteria-contaminated water.
The letter, which was sent earlier this month, comes after an FDA inspection of the Tom’s of Maine manufacturing plant in Sanford back in the spring.
According to the FDA, a strain of bacteria called pseudomonas aeruginosa, which can cause infections of the blood and lungs, was found in samples of the water used to rinse equipment and to make “Tom’s Simply White Clean Mint Paste.”
The agency said it also found another strain of bacteria, paracoccus yeei, in a finished batch of the company’s “Wicked Cool! Anticavity Toothpaste.”
“Water is a major ingredient in many of your OTC drug products,” the FDA wrote in its letter. “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.”
Inspectors say they also found a “black mold-like substance” near some of the equipment in the manufacturing facility.
“The black substance was within one foot of stainless-steel pails and other product-contact equipment used for OTC drug production,” the agency wrote. “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.”
In response to the FDA’s findings and warning, a spokesperson for Tom’s of Maine issued the following statement:
“We’re working with the FDA and are remedying the issues raised in their May inspection of the Tom’s manufacturing plant in Sanford, Maine. 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. 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 said Tom’s of Maine had 15 days to respond to its letter with what the company is doing to address the violations and prevent future ones from occurring. The agency also recommended Tom’s of Maine hire a consultant to help them meet certain requirements.
Tom’s of Maine, which is based in Kennebunk, was founded in 1970 by Tom and Kate Chappell. A controlling interest in the brand was sold to Colgate-Palmolive in 2006.
