The U.S. Food and Drug Administration (FDA) has revealed that several types of harmful bacteria were found in samples of water used to make batches of Tom's of Maine toothpaste and said the company's response to a May 2024 FDA inspection was inadequate.
The subsidiary of Colgate-Palmolive discovered multiple instances of microbial contamination between June 2021 and October 2022 and ignored them, according to the FDA in a November 5 warning letter that specified:
- Pseudomonas aeruginosa, which can cause blood, lung, and urinary tract infections, was discovered in water samples used to make Tom's Simply White Clean Mint Paste.
- Gram-negative cocco-bacilli Paracoccus (P.) yeei, a bacteria that can cause infections in immunocompromised people, was found in Tom's Wicked Cool! Anticavity Toothpaste, which is marketed to children.
- Ralstonia insidiosa, which can cause infections in people who are immunocompromised, was found "too numerous to count (TNTC)" in water used for manufacturing and cleaning equipment at Tom's plant in Sanford, ME. Toothpaste was released to the public despite the water quality, according to the letter.
The FDA's warning letter summarized what it considered significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The issues were flagged during an FDA inspection at the Community Drive Tom's facility. Methods, facilities, and controls for manufacturing, processing, packing, or holding are expected to conform to CGMP or the FDA may deem products as adulterated.
According to the FDA, Tom's of Maine received about 400 complaints about the color, taste, and odor of its toothpaste but failed to investigate.
"None of these incidents were investigated to assess product impact and water system performance," according to the FDA letter.
The FDA called the company's June 13 response "inadequate," calling out specific points such as:
- Performing a retrospective review of its microbial incidents in water and OTC products ... presenting the performance qualification evaluation of the water system, for quality assurance (QA), after the inspection, and, in addition, some criterions missed.
- Acknowledging not having adequate specifications for the water used for the final rinse of equipment ... lacking an evaluation of the quality of OTC products already distributed that may be impacted by the use of water with possible microbial issues.
- Stating that the root cause for P. yeei was related to a laboratory error, even though the initial investigation stated no laboratory errors were identified.
For example, the response did not include additional supporting evidence or testing results for the finished products. In addition, the FDA pointed out that Tom's resampled the water points of use, four days after initial sampling, without further evaluation of manufacturing activities or water use during those four days that may have impacted other products.
Tom's is expected to respond to the warning letter with at least 13 specific projects that include a corrective and preventive action (CAPA) plan and status to implement routine, vigilant operations management oversight of facilities and equipment, as well as establishing and following adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications.
The FDA investigator also flagged state of repair and sanitary conditions in the manufacturing facility. In one example, the FDA investigator observed a black mold-like substance within one foot of stainless-steel pails and other product-contact equipment used for over-the-counter (OTC) drug production. Overall, the Tom's team only addressed the equipment and manufacturing areas cited during the inspection but did not include a comprehensive evaluation, according to the letter.
For clinical laboratory directors, supervisors, and quality management teams, Tom's troubles highlight the importance of being inspection-ready for the FDA and other surveyors, and immediately addressing and correcting deficiencies flagged during an inspection. Tom's has only 15 working days to respond to the FDA's warning letter and complete its corrective actions. For hospital and health system leaders, the situation is a reminder that receiving a letter from a regulatory agency requires an immediate and adequate response.
Ultimately, Tom's and Colgate-Palmolive's failure to address all of the CGMP violations could cause the FDA to withhold issuance of the company's export certificates, the letter stated. FDA also may withhold approval of new applications or supplements listing the firm as a drug manufacturer until any violations are completely addressed and compliance with CGMP is confirmed.
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