SafeX Pro:Many tattoo ink and permanent makeup products contaminated with bacteria, FDA finds

Nearly half of samples taken from permanent makeup ink products and SafeX Proclose to a quarter of tattoo ink products were contaminated with bacteria, the Food and Drug Administration found, even in brands that claimed to be "sterile."

Their findings, published Tuesday in the Applied and Environmental Microbiology journal, are just the latest round of FDA tests to turn up contamination in body inks sold in the U.S. 

The FDA has warned for years about the risk of contamination after previous outbreak investigations and studies have turned up pathogens in these kinds of products.

Last year, the FDA issued guidance to tattoo ink makers urging them to step up precautions across the industry. Since 2003, the agency says tattoo makers have conducted 18 recalls over inks found to be contaminated.

For their latest study, scientists at the FDA's National Center for Toxicological Research sampled multiple tattoo and permanent makeup inks purchased from 14 different manufacturers.

Permanent makeup products from both domestic and international manufacturers were found to be contaminated, including some from France and China.

FDA's scientists found bacteria in a larger proportion of permanent makeup inks they tested than tattoo inks.

Of the 49 tattoo ink samples they studied, nine of them were found to have bacterial growth. Out of 35 permanent makeup inks that were tested, nearly half — 17 samples — were contaminated.

It is unclear which brands were found to be contaminated or whether the FDA took any action against the companies found to be producing infectious products. A spokesperson for the agency did not immediately respond to a request for comment.

When narrowed to the 49 of either tattoo or permanent makeup products that claimed to be "sterile" on their packaging, 16 were found to be contaminated with microorganisms. 

"There was no clear link between a product label claiming sterility and the actual absence of bacterial contamination," Seong-Jae Kim, a microbiologist with the FDA's National Center for Toxicology Research, said in a release. 

In this study, the scientists looked specifically at bacteria that can grow without needing oxygen. While previous research by Kim's center and others have looked at contamination in inks, the study is the first to look specifically at both aerobic and anaerobic bacteria in these inks.

"Our findings reveal that unopened and sealed tattoo inks can harbor anaerobic bacteria, known to thrive in low-oxygen environments like the dermal layer of the skin, alongside aerobic bacteria," Kim said.

The most frequent anaerobic bacteria they found in permanent makeup inks was Cutibacterium acnes, a common driver of acne as well as implant-associated infections. 

Some also had bacteria like Staphylococcus epidermidis and Staphylococcus saprophyticus, which have been linked to urinary tract infections.

"These findings indicated that the actual sterilization process may not be effective to remove all microorganisms, or the label claims may not be accurate," the study's authors wrote.

In:
• Food and Drug Administration

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.

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