Tom's of Maine toothpaste made with bacteria-tainted water, FDA warns. Here are details.

[Mary Wilson]

Updated on: November 19, 2024 / 4:53 PM EST / CBS News

By Aimee Picchi
Edited By Anne Marie Lee

Tom's of Maine toothpaste was manufactured with water containing bacteria, while a "black mold-like substance" was found in a factory where the product was made, according to a warning letter from the U.S. Food and Drug Administration.

The November 5 letter stated that Tom's Simply White Clean Mint toothpaste contained Pseudomonas aeruginosa, a germ that can cause infections in the blood and lungs, the FDA letter said.

The FDA letter also flagged another bacteria, Ralstonia insidiosa, which was found in water sources at the factory and
has been linked to infections acquired in hospital settings. Another Tom's of Maine product, Wicked Cool! Anticavity Toothpaste, was found to include another type of bacteria, Paracoccus yeei, the letter stated. The latter has been linked to infections such as peritonitis and conjunctivitis.

Tom's of Maine, which markets its products as made with "safe and hardworking natural ingredients," manufactures a host of personal hygiene products, from toothpaste to deodorant. ...

https://www.cbsnews.com/news/toms-of-maine-toothpaste-bacteria-water-black-mold-fda-details/

[Mary Wilson]

FDA

Colgate-Palmolive/Tom's of Maine, Inc.MARCS-CMS 687043 — NOVEMBER 05, 2024

• Content current as of: 11/19/2024 ...

Warning Letter 320-25-09

November 5, 2024

Dear Mr. Wallace:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tom's of Maine, Inc., FEI 1218077, at 27 Community Dr., Sanford, ME, from May 7 to 22, 2024.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your June 13, 2024, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. Your firm failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).

Microbiological Results in Water Samples and Finished Product

Your firm produced (b)(4) water and used it as a component in your OTC drug products and as a final rinse after equipment cleaning.

A. You recovered Pseudomonas aeruginosa in multiple (b)(4) water samples, from June 2021 to October 2022. This water was used to manufacture Tom’s Simply White Clean Mint Paste, batch (b)(4), and for the final rinse of numerous equipment cleaning processes. None of these incidents were investigated to assess product impact and water system performance.

B. You also reported multiple incidents where too numerous to count (TNTC) Ralstonia insidiosa was recovered from water points of use. Your investigations included testing of new samples collected at least 4 days after the initial sampling. Batches manufactured after these incidents were released based on the microbial testing of the finished OTC product despite the quality of the water used as a component or to clean the equipment.

C. You recovered gram-negative cocco-bacilli Paracoccus yeei in your OTC finished product, Wicked Cool! Anticavity Toothpaste, batch 3025UST11B. Your investigation concluded, without sufficient justification, that the growth was due to sample contamination. The batch was released based on retest results. ...

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colgate-palmolivetoms-maine-inc-687043-11052024