CNN
—
Sealed bottles of tattoo and permanent makeup ink, including bottles labeled sterile, contain millions of potentially dangerous bacteria, according to new research from the U.S. Food and Drug Administration.
“In light of our study findings, we want to emphasize the importance of continued monitoring of these products to ensure the microbial safety of tattoo inks,” Seong-Jae (Peter) Kim, a staff microbiologist at the FDA’s National Center for Toxicological Research in Jefferson, Arkansas, said in a statement. Kim is a corresponding author on the July 2 report published in the journal Applied and Environmental Microbiology.
Because the ink is injected deep into the skin, where bacteria can thrive, contaminated tattoo ink can cause infections and serious injuries, said Linda Katz, co-author of the study and director of the FDA’s Office of Cosmetics and Colors.
“Pathogens or other harmful substances in this ink can travel from the injection site through the blood and lymphatic system to other parts of the body,” Katz said in an email.
When systemic spread occurs, bacteria can cause life-threatening complications such as endocarditis, a potentially fatal inflammation of the heart lining, or septic shock, which is the final and most severe stage of sepsis, the body’s extreme response to infection that can lead to multi-organ failure, Katz said.
If not treated promptly, sepsis can “rapidly lead to tissue damage, organ failure, and death,” according to the U.S. Centers for Disease Control and Prevention.
Other more commonly reported symptoms of tattoo ink infections include a rash at the injection site; impetigo (a highly contagious bacterial skin infection); erysipelas (a bright red and tender rash); and cellulitis (a deep infection of the skin that requires antibiotics), Katz says.
People with multiple or large tattoos are at greater risk for contaminated ink, Katz said, because larger tattoos increase the chance of exposure to microorganisms. Applying permanent makeup can also increase the risk of infection, she said.
Nagaiets/iStockphoto/Getty Images
Previous studies have shown that sealed and sterile ink bottles harbor high levels of bacterial contamination.
“While both tattoos and permanent makeup carry risks if contaminated ink is used, permanent makeup applied around the eyes may pose a higher risk to consumers because microbes can enter the eyes and cause infection,” Katz said.
Unfortunately, the study’s findings weren’t surprising, said John Swierk, an assistant professor of chemistry at Binghamton University, State University of New York, who has studied tattoo ink contamination. He was not involved in the new study.
“We know that contamination in tattoo inks is a common occurrence,” Swierk said in an email. “Part of the problem is that there is no agreed-upon, industry-standard method for sterilizing ink. Our work and the current study really highlight the need for good, standardized manufacturing processes in the tattoo ink industry.”
The tattoo industry is increasingly working with regulators to ensure safety standards are met, said tattoo artist Selina Medina, director of research at the Alliance of Professional Tattooists, a nonprofit organization of artists that advocates for tattoo health and safety.
“Manufacturers are investing in advanced sterilization technologies and formulation improvements to improve their production environments to reduce the risk of contamination,” Medina said in an email.
“This includes the use of clean rooms and improved quality control processes to limit problems like these.”
The latest study tested 75 samples of sealed tattoo and permanent makeup ink sold in the United States by 14 manufacturers not named by the FDA. Some of the samples were labeled as sterile.
Researchers found that 26 samples from 10 manufacturers, or 35% of the sample set, had some level of bacterial contamination. While most samples showed a bacterial count of less than 250 CFUs (colony forming units) per gram, a few samples contained bacterial counts as high as 105said Katz.
Each CFU represents the growth of a colony of a single microbe in a Petri dish. So 10 to the power of 5 equals 100,000 bacteria per gram.
Previous FDA studies found that 35% of unopened and sealed ink from U.S. manufacturers had bacteria levels as high as 108 CFU, or 100 million bacteria per gram, Katz said.
That amount should be zero, said infectious disease expert Dr. Robert Schooley, a distinguished professor of medicine in the division of infectious diseases and global public health at the University of California, San Diego.
“The level of bacteria in materials injected into the skin or that come in contact with abraded or damaged skin should be ‘not detected,’” said Schooley, who was not involved in the FDA study.
“The other issue here is that tattooing has also been linked to the transmission of viral infections, including hepatitis C, hepatitis B and HIV,” said Schooley, who is also co-director of the Center for Innovative Phage Applications and Therapeutics, which is using one of the bacteria’s long-time enemies, phages, to combat superbug infections.
“These (infections) were not studied in the FDA manuscript, but the fact that so much ink failed bacterial sterility tests suggests that other organisms such as viruses and fungi can also slip through the cracks,” he said.
Many certified tattoo artists are aware of the danger and may already be taking steps to prevent contamination, Medina said.
“Transparency with customers is essential. Artists must openly communicate the steps they are taking to ensure ink safety and address any concerns customers may have,” Medina said.
“Before using new batches of ink, some artists and studios conduct their own testing or require proof of testing from suppliers. This may include microbial testing to detect possible contamination.”
Additionally, tattoo artists can resterilize the ink before applying it using an autoclave, a machine that uses steam to apply high pressure and heat to objects to eliminate bacteria, Medina said.
miodrag ignjatovic/E+/Getty Images
Ask your tattoo artist about ink safety before getting a tattoo, experts say.
The way an artist handles the ink while working on a tattoo is also crucial, she said. For example, using the same gloves to touch a client and the ink bottle is a hazard that can lead to tattoo ink contamination.
Artists should ensure ink bottles are tightly sealed when not in use and stored in a cool, dry place away from direct sunlight to minimize the risk of contamination, Medina added.
According to experts, the ultimate solution is for the tattoo and permanent ink industry to submit to regulations that require testing and certification before ink can be marketed.
“Tattoo inks are currently regulated under the Modernization of Cosmetics Regulation Act (of 2022), but much of that legislation regarding tattoo inks has yet to be implemented,” Swierk said.
“We expect MoCRA to be phased in over the next few years and that this will be the first serious regulation of tattoo inks in the U.S. Much of this will focus on good manufacturing practices and safety justification.”
The FDA published a draft guidance for the tattoo industry in June 2023, which includes how manufacturers should implement quality control measures, including sterilization.