Thousands of cosmetic products teeming with bacteria are quietly pulled from store shelves every year.
These contaminated products threaten the lives of people with compromised immune systems, but experts say cosmetic firms do not publicly announce most recalls due to lax industry regulation.
Kutol Products Co., a cleaning product manufacturer, is responsible for two out of the seven major cosmetic recalls this year. In total, the Ohio-based company removed 4,500 units of two moisturizing lotions, Medline Skintegrity and KLM Hand & Body.
According to the Food and Drug Administration (FDA), both products were contaminated with bacteria belonging to the pseudomanas genus — a pathogen that can cause inflammation, pneumonia, blood infections and even sepsis, a potentially fatal whole-body inflammation.
“They don’t normally infect healthy people. [But] If someone is sick, burned or their immunity is compromised, they’re susceptible to infection by these opportunistic bacteria,” said microbiologist Ananda Chakrabarty.
Pseudomonas bacteria can remain dormant in a host’s body for several years without causing any symptoms, said Chakrabarty, who developed a variety of pseudomonas to help clean oil spills. But they can emerge just when the body is at its most feeble.
“They consider the body as their home and try to protect it from outside invaders [diseases],” he said. “But when you’re weak, that’s the time it will work on your immune system and cause an infection.”
Chakrabarty said the most vulnerable are those with cystic fibrosis, a genetic disorder that causes a build-up of fluid in the lungs. For those with the disease, “it can be life threatening or debilitating,” he said.
Veriti Overby, Kutol’s director of quality, said a distributor had found a pink film on one of the moisturizers, leading Kutol to look into all products with similar formulation. A “food type ingredient known to have bacteria in it” caused the contamination, she said.
The Kutol products had been shipped throughout the U.S, Canada and Australia. While Kutol sent a recall letter to distributors, they did not publicly announce they were pulling the products.
The FDA has no authority to order a company to pull a cosmetic product, according to the FDA Recall Policy for Cosmetics. It can, however, "request" a company take a product off the shelves, and, if it "believes that public notification is necessary," it can issue a public notice if the firm fails to do so.
In the case of the Kutol products, the FDA did not think the bacterial contamination warranted notification, Overby said.
The FDA classified those recalls as “Class II” — indicating the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Recalls are classified as Class I, II or III, depending on the health consequences. The agency typically doesn’t issue press releases for Class II recalls, according to an email from FDA press officer Theresa Eisenman. She said public notice "is reserved for urgent situations where other means for preventing use of the recalled product appear inadequate — typically Class I recalls."
"Otherwise, notification of a recall will be made public in the weekly FDA Enforcement Report," she said.
In most cosmetic recalls due to bacterial contamination over the last two years, there was at least a month’s delay between a company pulling the product and the FDA publishing that information in the Enforcement Report. A May recall by Vogue International was only reported by the FDA in September.
Vogue International pulled over 200,000 bottles of OGX Biotin and Collagen Conditioner due to the presence of Burkholderia cepacia. The bacteria can cause life-threatening respiratory infections for individuals with compromised immune systems, according to Eisenman.
Vogue International was not immediately available for comment.
Given the risks to the millions of Americans with compromised immune systems, consumer-rights advocates are calling for better regulation and transparency of the cosmetics industry.
“Consumers have a right to know,” said Alexandra Scranton, director of science and research at Women’s Voices For The Earth, an NGO that works to eliminate toxic chemicals from the environment.
It is the responsibility of the company, distributors and manufacturers to ensure that the products and ingredients are safe, according to information provided on the FDA’s website.
“We are in support of legislations and regulations that give FDA greater authority [over cosmetics],” Scranton said.
Cosmetic chemist Bruce Akers said the most common way bacterial contamination occurs is through the manufacturer’s machinery, plant products or if the bottles themselves are contaminated.
“Once it’s in the product, you’re never going to be able to get rid of it. The product is wasted. You can’t really clean it,” he said, adding that companies don’t usually publicize recalls because it is “bad press.”
A company may halt a recall when there is reasonable belief that none of the products are left for sale, Akers added.
On Saturday, Nutek Disposable, Inc. did what most cosmetic companies fail to do: go public with its nationwide recall.
Regarding its baby wipes, Nutek had received “numerous complaints” of rash, irritation, infections, fever, gastro-intestinal issues and respiratory issues. The wipes were manufactured under several brand names, including Cuties, Tender Touch and Well Beginnings, according to the press release. Microbial testing showed the presence of Burkholderia cepacia.
But simply calling for the removal of products isn’t always enough to get them off the shelves. Demdaco decided to recall over 2,500 jars of its Glow OLOGY body butter due to bacterial contamination in July this year.
Melanie Miller, the supply chain director at Demdaco, said the company reached out to all the customers they had sold products to directly as well as to distributors.
“Sometimes we send multiple requests if they didn’t respond [initially] to send back or destroy the product,” she added.
Miller said Demdaco has also asked customers not to re-sell the products online.
Once the recall is complete the companies destroy the products according to FDA regulations.
Without public notifications, it’s difficult to know the safety of the cosmetics in one’s home and the recall process can take years. Two recalls initiated in 2012 and 2013 — lotions with mold and eye creams with a fungus — are still “ongoing” according to FDA reports. For the years prior to 2012, the reports are archived and have “not been altered or updated since,” according to information on the website.