A popular toothpaste product from all-natural hygiene company (I THINK WE CAN CALL IT THAT?) Tom’s of Maine was found to be made with water that contained dangerous bacteria.
Tom’s of Maine toothpaste, owned by Colgate-Palmolive, was made with water containing three different potentially dangerous bacteria, while a mold-like substance was found at the manufacturing facility.
An FDA warning letter claimed that Tom’s Simply White Clean Mint toothpaste, which sells for $6, contained Pseudomonas aeruginosa and a “black mold-like substance” at the company’s manufacturing facility in Sanford, Florida. Maine, primarily around water tanks and manufacturing equipment.
FDA investigators also found Ralstonia insidiosa, another type of bacteria, in water sources at the Sanford, Maine, factory.
A second product from Tom, Wicked Cool! Anti-cavity toothpaste was found to contain the deadly bacteria Paracoccus yeei.
P. aeruginosa is known to cause blood and lung infections, while R. insidiosa infection is often associated with hospital settings and can cause infections in the bloodstream, lungs, wounds or surgical sites, and urinary tract. And P. yeei is known to cause peritonitis and conjunctivitis.
The FDA inspection of the facility occurred in May.
The agency said in its letter to Tom’s: ‘Water is an important ingredient in many of your over-the-counter medications. It is essential that you employ a water system that is robustly designed and that you effectively control, maintain and monitor the system to ensure that it consistently produces water suitable for pharmaceutical use.’
Tom’s of Maine makes a wide range of personal care products, from shampoo and toothpaste to deodorant. The company states on its website that it prides itself on using “safe” and “hardworking” ingredients.
It promotes the natural ingredients of various products that are safe and chemical-free.
FDA inspectors visited Tom’s of Maine Sanford facilities and found inadequate water system controls, failure to maintain adequate sanitary conditions, and poor handling of product complaints. The facility was found to have mold-like substances in areas near production equipment.
The company, for its part, stated: “We have always tested finished products before they leave our control and remain fully confident in the safety and quality of the toothpaste we make.”
“In addition, we have hired water specialists to evaluate our systems in Sanford, we have implemented additional safety measures to ensure compliance with FDA standards, and our water tests show no problems.”
Although Findings of FDA inspectorsThere have been no product recalls. The FDA has also asked Tom’s owner, Colgate-Palmolive, to provide additional documents on manufacturing operations with a “thorough review of all microbiological hazards” and to submit the results of those tests.
The FDA must inspect cosmetic and over-the-counter drug manufacturing facilities to ensure they follow current good manufacturing practices.
There is no indication that the FDA initiated the inspection for any reason other than a routine requirement.
The FDA still considers the products safe, and has not issued a recall for any of them.
The FDA specifically found that the facility violated current good manufacturing practices by failing to prevent potentially hazardous microorganisms in water samples used in manufacturing products and cleaning equipment.
Agency inspectors also found that the water system used in manufacturing and cleaning did not meet antimicrobial specifications.
The facility was shown to have a black mold-like substance and powder residue in areas where products were manufactured. Mold spores, which travel through the air, may have landed on damp equipment.
And customer complaints about the smell, color or taste of the products were not investigated.
Tom’s of Maine’s Sanford facility is still open, but the company will have to submit a corrective action plan to the FDA. There is no indication that anyone has become ill.
The facility has not been closed. Instead, the agency requires the company to submit a detailed corrective action plan, including a review of health safety risks and any necessary product recalls.
There is no indication that anyone has become ill from any of these pathogens, but if they were to infect someone, the consequences could be serious.
Pseudomonas aeruginosa, a leading cause of hospital-acquired infections, can be serious depending on how it enters the body.
In mild cases, it could cause conditions such as swimmer’s ear (otitis Externa), especially if bacteria enter the ear through toothpaste or contaminated hands. This is usually a treatable infection that causes symptoms such as ear pain and discomfort.
At the more serious end, especially in people with weakened immune systems, Pseudomonas can cause serious infections such as pneumonia, bloodstream infections (sepsis), or bone infections (osteomyelitis). These infections can spread quickly and cause systemic symptoms such as fever, chills, confusion, and shock.
In general, while healthy people are less likely to suffer serious infections, those with compromised immune systems or open wounds are more vulnerable to the harmful effects of the disease.
Ralstonia insidiosa is generally dangerous for people with weak immune systems and is usually acquired in hospital settings. It can cause infections in the bloodstream, lungs, wounds or surgical sites, and urinary tract.
It is usually resistant to antibiotics, making the infection difficult to treat.
And Paracoccus yeei also causes rare infections in people with compromised immune systems and has been linked to a variety of infections, including at wound sites, the bloodstream and the respiratory system, often requiring patients to be connected to respirators.