FDA Warning Letter Cites Significant CGMP Violations at Tom’s of Maine Factory

The US Food and Drug Administration (FDA) has sent a warning letter to Colgate-Palmolive CEO Nicole Wallace regarding an inspection at a Tom’s of Maine manufacturing facility in Sanford, ME that uncovered bacteria and powdery and mold-like substances.

The inspection was conducted from May 7-22, 2024. The warning letter was dated Nov. 5, 2024.

Among the issues cited by FDA was Pseudomonas aeruginosa recovered in multiple water samples from June 2021 to October 2022. The water was used to manufacture Tom’s Simply White Clean Mint Paste, and for the final rinse of numerous equipment cleaning processes, according to FDA.

FDA stated that the factory “also reported multiple incidents where too numerous to count (TNTC) Ralstonia insidiosa was recovered from water points of use.”

FDA also stated that gram-negative cocco-bacilli Paracoccus yeei was recovered in Wicked Cool! Anticavity Toothpaste (batch 3025UST11B).

FDA also said its investigator observed a black mold-like substances near product-contact equipment and powdery residues near a where it compounded an oral care product.

FDA also said that Tom’s “failed to establish and follow 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 and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192 (21 CFR 211.198(a)).”

FDA said Tom’s complaint procedure is inadequate because not all quality related issues are investigated. You only investigate complaints related to adverse event, foreign matter, and incorrect product.

As an example, FDA noted approximately 400 complaints related to odor, color, and taste in toothpaste products, including those for children, were not investigated. FDA called Tom’s response to the complains as inadequate.

FDA said Colgate and Tom’s would need to respond to its office in writing within 15 working days if receipt of the letter.

Colgate acquired Tom’s of Maine in 2006.

Tom’s of Maine released the following statement to Happi.com today:

“We’re working with the FDA and are remedying the issues raised in their May inspection of the Tom’s toothpaste 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.”