Tattooing is an ancient art form, practiced by humans for millennia. It involves using needles to embed ink just below the skin’s surface, creating permanent designs that hold personal significance. However, the process ideally shouldn’t introduce harmful pathogens. Despite advancements in sterilization practices within the tattoo industry, a recent 2024 study by the US Food and Drug Administration (FDA) has revealed concerning findings.
The FDA study examined 75 sealed tattoo and permanent makeup inks, revealing that one-third contained bacteria capable of causing illness. To ensure this was not an isolated incident, the FDA expanded its research.
A retrospective analysis of four FDA investigations conducted from 2018 to 2024 showed that a third of the 259 unopened jars tested contained bacteria, with more than 250 bacterial isolates found, representing 94 species, including known human pathogens. This confirmed that the 2024 study was not an anomaly.
In a paper published in Scientific Reports, FDA microbiologist Ohgew Kweon and colleagues emphasized the widespread and varied microbial contamination in tattoo and permanent makeup inks, highlighting the need for improved detection, surveillance, and manufacturing standards to ensure product safety.
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All four FDA surveys confirmed that ink contamination is a real issue, even in products labeled as sterile. Each survey examined a different set of products, leaving questions about the prevalence of contamination, the characteristics predicting it, recurring microbes, and undiscovered microbial diversity.
Researchers aimed to fill these knowledge gaps by combining the surveys to analyze 259 unopened tattoo and permanent makeup inks across various brands, colors, and sterility claims. The original tests involved opening inks in laboratory conditions and using genetic sequencing to identify bacteria capable of forming colonies.
By applying a consistent analytical framework to these results, the researchers could identify patterns not apparent in individual datasets. While contamination rates varied, the overall estimate was 35.4 percent.
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A particularly notable finding was the unreliability of the “sterile” label. Nearly a third (30.5 percent) of supposedly sterile samples were contaminated, compared to 35.5 percent of those without a sterility claim. The ink type or origin was also no guarantee of safety, with similar contamination rates for both tattoo and permanent makeup inks, as well as domestic and imported products.
The bacteria identified included 94 species across 38 genera, dominated by Bacillus, Pseudomonas, Staphylococcus, and Lysinibacillus. Approximately a third of these species are considered potential pathogens due to their association with human disease, including Pseudomonas aeruginosa, Bacillus cereus, and Cutibacterium acnes.
While contamination doesn’t guarantee infection, the presence of disease-causing bacteria raises concerns. The study didn’t measure whether contaminated products led to illness.
According to the researchers, these findings are consistent with infection events and product recalls linked to microbial contamination during manufacturing or distribution. However, the 94 identified species may not capture the full scope of the issue. As more samples were tested, the number of species discovered increased, suggesting more could be found with further sampling.
The study was limited to culturable species, potentially missing slow-growing or non-culturable bacteria. There have been reports of tattoo-related infections caused by nontuberculous mycobacteria, which require specialized growth media and longer incubation times than the methods used here.
The study couldn’t determine when and how contamination occurs. Sterility labels, ink type, color, or country of origin were not reliable indicators of safety. No clear metric exists for consumers or practitioners to assess ink safety.
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The researchers suggest that current manufacturing and quality-control practices have deficiencies. They recommend validated controls and sterilization procedures during manufacturing to improve safety.
“These findings underscore the need for improved manufacturing quality control, validated sterilization procedures, and enhanced microbiological surveillance using complementary culture-based and molecular approaches to strengthen microbial risk assessment and improve the safety of tattoo and PMU ink products,” the researchers write.
If you’re considering a tattoo, the advice remains consistent: thoroughly research the artist. Choosing a professional who adheres to strict hygiene standards and is mindful of ink recalls and packaging integrity is wiser than opting for an amateur setup.
The findings are detailed in a publication in Scientific Reports.
This article was fact-checked by Rebecca Dyer and edited by Rebecca Dyer. While we pride ourselves on our process, we are only human. If you spot a mistake, please let us know.
