FDA Orders Cleanup at Tom’s of Maine

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The Federal Drug Administration is threatening to withhold export certificates and take other punitive measures against Colgate-Palmolive if it fails to fix a raft of significant health violations at its Tom’s of Maine plant in south Sanford, according to the agency.

The FDA issued a warning letter to the company Nov. 5 outlining dangerous bacterial contamination in water recovered at various stages of the manufacturing process. The investigation encompassed written documentation that Tom’s of Maine self-reported in 2021 and 2022 as well as a plant inspection that FDA conducted this May.

An FDA investigator observed a “black mold-like substance” in three locations in the plant. The letter cited that the bacteria Pseudomonas aeruginosa, which can cause blood and lung infections, was found in multiple water samples collected by the company from June 2021 to October 2022. This water was used to manufacture Tom’s Simply White Clean Mint Paste, and for cleaning equipment. The FDA indicated that none of these incidents were investigated by the company to assess product impact and water system performance. Other types of bacteria were also found.

The FDA said the company response has been inadequate to date. The FDA is requesting a comprehensive remediation plan for the design, control, and maintenance of the water system, as well as more complete investigation of sources of contamination, tougher oversight processes and more rigorous complaint investigation.

“The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations,” according to the letter from Francis Godwin, director of manufacturing quality in the office of compliance for drug evaluation and research.

According to Maine Public and other news sources, Tom’s of Maine spokesman Rob Robinson said the company has put in new safeguards since the inspection and that it always tests its products and is confident they are safe.