A Tom’s of Maine factory had a “black mold-like substance” and “powder residues” in its water supply and equipment, according to a warning letter from the Food and Drug Administration (FDA).
An FDA inspection tested water samples from the company’s factory in Sanford, Maine, and found the bacteriaPseudomonas aeruginosaandRalstonia insidious.
P. aeruginosacan cause antibiotic-resistant infections in the blood, lungs, and urinary tract.The contaminated water was used to manufacture Tom’s Simply White Clean Mint Paste.Ralstonia insidiosahas been linked to pneumonia and infections in hospital settings.
The FDA’s warning letter stated that Tom’s of Maine uses this water supply to clean equipment and manufacture its personal care products.
Samples of the brand’s Wicked Cool! toothpaste was also found to be contaminated withParacoccus yeeibacteria. The company claimed this was due to “a lab error,” but the FDA did not find evidence to support that cause.
Although Tom’s of Maine responded to the violations in June, the FDA said that the company continued to distribute products based on the results of “retests” and did not take steps to investigate the quality of its water supply. The agency deemed the company’s response “inadequate.”
The letter also noted that Tom’s of Maine failed to investigate “approximately 400 complaints related to odor, color, and taste in your toothpaste products” because it would only be required to do so if there was an apparent trend.
However, the FDA said the company “did not provide a documented evaluation determining the lack of trend for the quality issue specific to each complaint” and provided a “general statement from the procedure in each of the complaint’s documentation” instead.
As of November 21, no recalls involving Tom’s of Maine had been reported. In addition to toothpaste, the company sells many other natural personal care products at major retailers throughout the United States. The FDA will now allow the company to respond and take “corrective actions” to address the violations cited in the warning letter.
“We are confident there are no safety issues with our toothpaste and that it is safe to use. We test every batch of toothpaste we make—including for harmful bacteria and mold—to ensure its safety before it is released for sale,” Tom’s of Maine said in a press statement.
“We have been working with the FDA to remedy the issues raised in their May inspection of the Tom’s toothpaste manufacturing plant in Sanford, Maine, including implementing additional safeguards and making capital investments as part of ongoing plant upgrades,” the company added. “Tom’s is committed to continuing to make safe and effective natural products for our consumers and to maintaining the trust in our brand.”
The Key Culprits Behind Foodborne Illness Outbreaks? Humans.
What This Means for YouIf you use Tom’s of Maine products, be aware of the FDA’s findings about contamination and water quality issues at their facility. While the company has responded to these concerns, the FDA deemed their actions insufficient. It’s a good idea to monitor updates from the company or consider alternative products if you have concerns about safety.
What This Means for You
If you use Tom’s of Maine products, be aware of the FDA’s findings about contamination and water quality issues at their facility. While the company has responded to these concerns, the FDA deemed their actions insufficient. It’s a good idea to monitor updates from the company or consider alternative products if you have concerns about safety.
3 Sources
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Food and Drug Administration.Colgate-Palmolive/Tom’s of Maine, Inc.
CDC.About Pseudomonas aeruginosa.
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