Sealed bottles of tattoo ink and permanent makeup tested positive for millions of bacteria, FDA says

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Sealed bottles of tattoo ink and permanent makeup, some marked as sterile, contained millions of potentially dangerous bacteria, according to a new study from the U.S. Food and Drug Administration.

“In light of our study results, we want to emphasize the importance of ongoing monitoring of these products to ensure the microbial safety of tattoo inks,” Seong-Jae (Peter) Kim, a microbiologist at the FDA’s National Center for Toxicological Research in Jefferson, Arkansas, said in a statement. Kim is the corresponding author of the July 2 report published in the journal Applied and Environmental Microbiology.

Because the ink is injected deep into the skin where some bacteria can grow, contaminated tattoo ink can cause serious infections and injuries, said Linda Katz, study co-author and director of the FDA’s Office of Cosmetics and Colors.

“Pathogens or other harmful substances contained in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body,” Katz said in an email.

When systemic spread occurs, the bacteria can cause life-threatening complications such as endocarditis, a life-threatening inflammation of the heart wall, or septic shock, which is the last and most serious stage of sepsis, the body’s extreme response to an infection that can lead to multiple organ failure, Katz said.

According to the U.S. Centers for Disease Control and Prevention, if sepsis is not treated promptly, it can quickly lead to tissue damage, organ failure and death.

Other more commonly reported symptoms of tattoo ink infections include rash at the injection site; impetigo, a highly contagious bacterial skin infection; erysipelas, a bright red, tender rash; and cellulitis, a deep skin infection that requires antibiotic treatment, according to Katz.

People with many or large tattoos are at higher risk of getting contaminated with ink, Katz explained, because large tattoos increase the likelihood of exposure to microorganisms. Applying permanent makeup can also increase the risk of infection, she added.

“While both tattoos and permanent makeup carry risks if contaminated ink is used, permanent makeup applied around the eye area may pose a higher risk to consumers because microbes could enter the eye and cause an infection,” Katz said.

Unfortunately, the study’s results aren’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 of tattoo inks is a common occurrence,” Swierk said in an email. “Part of the problem is that there is no standardized, industry-recognized method for sterilizing inks. Our work and the current study really underscore the need for standardized, efficient manufacturing processes across the tattoo ink industry.”

The tattoo industry is increasingly working with regulators to ensure safety standards are met, said tattoo artist Selina Medina, research director at the Alliance of Professional Tattooists, a nonprofit alliance of artists dedicated to promoting tattooing health and safety.

“Manufacturers are investing in advanced sterilization technologies and formulation advancements to improve their production environments to reduce the risk of contamination,” Medina said in an email.

“This includes the use of clean rooms and enhanced quality control processes to mitigate these types of issues.”

The latest study tested 75 samples of sealed tattoo and permanent makeup inks sold in the United States by 14 manufacturers not named by the FDA. Some of the samples were labeled as sterile.

The researchers found that 26 samples from 10 manufacturers, or 35% of all samples, had some degree of bacterial contamination. While most samples had bacterial counts below 250 CFU (colony forming units) per gram, a few samples had bacterial counts as high as 10⁵Katz said.

Each CFU represents the growth of a colony of a single microbe in a Petri dish, so 10 to the fifth power equals 100,000 bacteria per gram.

Previous studies by the FDA found that 35% of unopened, sealed inks from U.S. manufacturers had bacteria counts as high as 108 CFU, or 100 million bacteria per gram, Katz said.

That amount should be zero, said Dr. Robert Schooley, an infectious disease specialist and 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 into contact with abraded or injured skin should be ‘none detected,'” said Schooley, who was not involved in the FDA study.

“The other problem here is that tattooing has also been associated with 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 uses one of bacteria’s ancient enemies, phages, to fight superbug infections.

“These (infections) were not studied in the FDA manuscript, but the fact that so many inks failed bacterial sterility tests suggests that other organisms like viruses and fungi can also slip through the cracks,” he said.

Many certified tattoo artists are aware of the danger and can already take steps to avoid contamination, Medina said.

“Transparency with customers is key. Artists need to be open about the steps they are taking to ensure ink safety and address any customer concerns they may have,” Medina said.

“Before using new batches of ink, some artists and studios conduct their own testing or ask suppliers to provide proof of testing. This may include microbial testing to detect potential contamination.”

Additionally, tattoo artists can resterilize inks before application using an autoclave, a machine that uses steam to apply high pressure and temperature to objects to kill bacteria, Medina said.

How an artist handles the ink while working on a tattoo is also critical, she said. For example, using the same gloves to touch a client and the ink bottle is a hazard that can lead to contamination of the tattoo ink.

Artists should ensure ink bottles are tightly closed when not in use and stored in cool, dry places, away from direct sunlight, to minimize the risk of contamination, Medina added.

Experts believe the ultimate solution would be for the tattoo ink and permanent ink manufacturing industry to be subject to regulations requiring testing and certification before the inks are allowed on the market.

“Tattoo inks are being regulated under the Cosmetic Regulatory Modernization Act (of 2022), but much of that law dealing with tattoo inks has not yet been implemented,” Swierk said.

“We anticipate that MoCRA will be phased in over the next several years and will be the first serious regulation of tattoo inks in the United States. Much of this will focus on good manufacturing processes and safety justification.”

The FDA released draft guidelines for the tattoo industry in June 2023, which includes details on how manufacturers should carry out quality control measures, including sterilization.