Is your toothpaste hiding a dirty secret? Shocking FDA findings revealed!
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We trust the products we use every day, especially when it comes to our health. But what if your toothpaste isn’t as safe as you think?
A shocking FDA report has uncovered troubling issues with a popular natural brand.
During an FDA inspection of a Tom's of Maine manufacturing facility in Sanford, Maine, officials uncovered “significant violations” that may have compromised the safety of the toothpaste produced there.
The inspection, which took place in May, revealed the presence of bacteria in the water used to manufacture toothpaste, as well as a disturbing “mold-like” substance in the production area.
The FDA's warning letter, dated November 5 and released to the public, detailed the discovery of microorganisms in water samples and finished toothpaste products.
Among the bacteria found was Pseudomonas aeruginosa, a pathogen known to cause serious infections, particularly in individuals with weakened immune systems.
This bacterium was detected in water samples collected from June 2021 to October 2022, which was used in the production of Tom's Simply White clean mint paste and for rinsing equipment.
Additionally, the bacteria Ralstonia insidiosa and Paracoccus yeei were identified in water points of use and in a final batch of Wicked Cool! anticavity toothpaste, respectively.
Despite these findings, batches of toothpaste were released based on microbial testing of the finished products, without adequately addressing the quality of the water used in production or for cleaning equipment.
The FDA's letter emphasized the critical nature of maintaining a sanitary and well-maintained facility to prevent contamination of drug products, which includes over-the-counter toothpaste.
The agency pointed out that Colgate-Palmolive, the parent company of Tom's of Maine, had failed to qualify its water system to ensure it consistently produces water suitable for pharmaceutical use.
The FDA has requested that the company provide a comprehensive assessment of its manufacturing operations, review all microbiological hazards, conduct a detailed risk assessment, and investigate all batches of products with potential microbial contamination.
The company was given 15 days to respond with a remediation plan for the water system, including “total microbial count limits” to monitor the water's suitability for production.
In response to the FDA's findings, Tom's of Maine has stated that it is working closely with the FDA to address the issues raised from the May inspection.
The company has expressed its commitment to producing safe and effective natural products and maintaining consumer trust.
“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,” the company said in the statement.
The company remains confident in the safety and quality of its toothpaste and assures that finished goods are always tested before distribution.
How do you decide which personal care products to trust? Have you ever considered switching to “natural” products, and what factors influenced your decision? What steps would you take if a product you use was found to have contamination issues? Share your thoughts with us in the comments below!
A shocking FDA report has uncovered troubling issues with a popular natural brand.
During an FDA inspection of a Tom's of Maine manufacturing facility in Sanford, Maine, officials uncovered “significant violations” that may have compromised the safety of the toothpaste produced there.
The inspection, which took place in May, revealed the presence of bacteria in the water used to manufacture toothpaste, as well as a disturbing “mold-like” substance in the production area.
The FDA's warning letter, dated November 5 and released to the public, detailed the discovery of microorganisms in water samples and finished toothpaste products.
An FDA inspection found significant violations at Tom's of Maine manufacturing facility, including bacteria-contaminated water used in toothpaste production. Image source: Tom’s of Maine.
Among the bacteria found was Pseudomonas aeruginosa, a pathogen known to cause serious infections, particularly in individuals with weakened immune systems.
This bacterium was detected in water samples collected from June 2021 to October 2022, which was used in the production of Tom's Simply White clean mint paste and for rinsing equipment.
Additionally, the bacteria Ralstonia insidiosa and Paracoccus yeei were identified in water points of use and in a final batch of Wicked Cool! anticavity toothpaste, respectively.
Despite these findings, batches of toothpaste were released based on microbial testing of the finished products, without adequately addressing the quality of the water used in production or for cleaning equipment.
The FDA's letter emphasized the critical nature of maintaining a sanitary and well-maintained facility to prevent contamination of drug products, which includes over-the-counter toothpaste.
The FDA warning letter to Colgate-Palmolive detailed the presence of multiple bacterial contaminants in water samples and finished toothpaste products. Image source: Tom’s of Maine.
The agency pointed out that Colgate-Palmolive, the parent company of Tom's of Maine, had failed to qualify its water system to ensure it consistently produces water suitable for pharmaceutical use.
The FDA has requested that the company provide a comprehensive assessment of its manufacturing operations, review all microbiological hazards, conduct a detailed risk assessment, and investigate all batches of products with potential microbial contamination.
The company was given 15 days to respond with a remediation plan for the water system, including “total microbial count limits” to monitor the water's suitability for production.
In response to the FDA's findings, Tom's of Maine has stated that it is working closely with the FDA to address the issues raised from the May inspection.
The company has expressed its commitment to producing safe and effective natural products and maintaining consumer trust.
“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,” the company said in the statement.
The company remains confident in the safety and quality of its toothpaste and assures that finished goods are always tested before distribution.
