Tom’s of Maine — a popular toothpaste brand celebrated for it’s use of all-natural ingredients — has violated federal rules around the safety and hygiene of facilities that produce food, drugs, and cosmetics, according to the U.S. Food and Drug Administration (FDA) for fail
During a recent inspection, the Tom’s of Maine manufacturing facility, located in Sanford, was found to be out of compliance with the required rules for “methods, facilities, or controls for manufacturing, processing, packing, or holding” involved in toothpaste production.
The news emerged from a Nov. 5 warning letter from the FDA.
The letter, addressed to Colgate-Palmolive’s Tom’s of Maine division, cited significant violations of Current Good Manufacturing Practices (CGMP) — the standard applied by the FDA — at the Sanford manufacturing facility.
If Tom’s of Maine doesn’t take steps to come into compliance with FDA rules, the economic consequences could be severe. The federal government could revoke the company’s export certificate or refuse to approve new applications for drugs and supplements that list the company as a supplier or manufacturer.
The violations were observed during an inspection conducted from May 7 to May 22, 2024, according to the FDA.
The FDA warning letter highlights alleged deficiencies in the facility’s methods and controls for manufacturing, processing, packing, and holding over-the-counter (OTC) drug products.
These issues render the products adulterated under the Federal Food, Drug, and Cosmetic Act.
According to the FDA letter, the Tom’s of Maine facility failed to follow proper procedures to prevent microorganisms in non-sterile drug products.
The cited examples include Pseudomonas aeruginosa and other microorganisms in water samples used in product formulation and equipment cleaning, contaminants found in specific batches of toothpaste products, such as Tom’s Simply White Clean Mint Paste and Wicked Cool! Anticavity Toothpaste, and inadequate investigations into microbial contamination incidents and insufficient validation of water quality.
According to the letter, FDA inspectors noted a “black mold-like substance” near equipment and storage areas in the facility, as well as powder residues on manufacturing equipment. These findings indicate a failure to maintain a clean and sanitary environment, per the FDA.
The federal agency also alleges that the company did not thoroughly investigate approximately 400 customer complaints regarding product odor, color, and taste.
In the letter, the FDA lays out the steps Tom’s of Maine and its parent company must take in order to comply with FDA rules.
The first step is for the company to give the FDA a comprehensive remediation plan addressing the manufacturing deficiencies, including risk assessments, product recalls if necessary, and enhanced quality control measures. The agency has also recommended engaging a consultant to assist the company in resolving systemic flaws.
The FDA warned that failure to address these issues could lead to additional regulatory actions, including withholding approval of new applications or supplements involving the facility.
Colgate-Palmolive/Tom’s of Maine has been given 15 working days, staring Nov. 5, to respond with details of corrective actions or to explain any delays in implementation. That would mean the company’s response is due next week.
