The FDA Puts Tom’s of Maine on Notice After Finding “Significant Violations” During Inspection

If Tom's of Maine toothpaste is your go-to product for taking care of your dental health, you're going to want to see what an official letter from the U.S. Food and Drug Administration (FDA) has to say about the product.

The makers of the skincare and wellness line have been called out by the government organization after a routine inspection uncovered hazardous conditions at a facility responsible for manufacturing some of the company's toothpaste.

Keep reading to find out what the FDA found and what you should know if you use Tom's of Maine toothpaste to care for your oral health.

The FDA did not mince words in a letter dated Nov. 5, 2024 that was sent to the organization. In the letter, an FDA representative broke down the list of the violations they uncovered while inspecting the Sanford facility, which included several violations of Current Good Manufacturing Practice (CGMP).

Inspectors found the following violations:

• Microbiological samples in the water used to make toothpaste
• Inadequate water systems for cleaning equipment and formulating products
• Black mold-like substances within the facility
• Powder residue on trays near production

CNN broke down some of the microbiologic samples that were retrieved by the plant, and they included several that are known to cause significant infections in humans, including one that has been shown to be resistant to treatment.

Tom's of Maine responded to CNN's inquiries about the letter in a statement, telling the news agency that it is "working with the FDA and are remedying the issues raised in their May inspection of the Tom’s manufacturing plant in Sanford, Maine."

Further, the company said it doesn't believe any contaminated products were shipped out of the facility. "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," the statement continued.

"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."

According to a statement from the American Dental Association, some of Tom's of Maine's toothpaste has received the organization's coveted seal of acceptance. For example, the company says that the Simply White Clean Mint Toothpaste is effective in whitening teeth and preventing tooth decay when used as directed.

And the same can be said of other products, including the company's Natural Wicked Cool! Fluoride Toothpaste.

While Tom's of Maine was once an independent startup, these days, it's owned by the massive oral care conglomerate the Colgate-Palmolive company. Colgate-Palmolive purchased a controlling 84% of the company back in 2006, according to a statement from the company.

The letter from the FDA was addressed to Colgate-Palmolive CEO Noel Wallace, which has been tasked with addressing the government agency's concerns.

Hopefully Wallace and the higher ups at Colgate-Palmolive are ready to tackle the FDA's to-do list before the organization faces any additional trouble from the agency.