FDA Finds Potentially Dangerous Bacteria in Sealed Tattoo and Permanent Makeup Inks

Research by the US Food and Drug Administration (FDA) has discovered that sealed bottles of tattoo and permanent makeup ink, some marked as sterile, contain millions of potentially harmful bacteria.

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

Tattoo ink is injected deep into the skin, creating an environment where some bacteria can thrive, potentially causing infections and serious injuries. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, explained, “Pathogens or other harmful substances in these inks can travel from the injection site through the blood and lymphatic systems to other parts of the body.”

This systemic spread of bacteria can lead to severe, life-threatening complications such as endocarditis, an inflammation of the heart lining, and septic shock, the final and most severe stage of sepsis. The US Centers for Disease Control and Prevention (CDC) warn that if not treated quickly, “sepsis can rapidly lead to tissue damage, organ failure, and death.”

Common symptoms of tattoo ink infections include injection-site rashes, impetigo (a contagious bacterial skin infection), erysipelas (a bright red and tender skin rash), and cellulitis (a deep skin infection requiring antibiotic treatment). According to Katz, individuals with multiple or large tattoos are at a higher risk due to the increased likelihood of exposure to microorganisms. Permanent makeup, especially around the eye area, poses additional risks as microbes can enter the eye and cause infections.

John Swierk, an assistant professor of chemistry at Binghamton University, noted, “We know that contamination in tattoo inks is a common occurrence. Part of the problem is that there is no agreed upon, industry-standard method for sterilizing inks. Our work and the current study really highlight the need for good, standardized manufacturing processes across the tattoo ink industry.”

The tattoo industry is working with regulatory bodies to comply with safety standards. Selina Medina, director of research at the Alliance of Professional Tattooists, stated, “Manufacturers are investing in advanced sterilization technologies and formulation advancements to improve their production environments to reduce the risk of contamination. This includes using clean rooms and enhanced quality control processes to mitigate against problems like this.”

The latest study examined 75 samples of sealed tattoo and permanent makeup ink from 14 US manufacturers. Researchers found that 26 samples from 10 manufacturers, or 35% of the sample set, had some degree of bacterial contamination. While most samples had bacterial counts of less than 250 CFUs (colony-forming units) per gram, a few contained bacterial counts as high as 105, or 100,000 bacteria per gram.

Earlier FDA studies found that 35% of unopened and sealed inks from US manufacturers had bacterial counts as high as 108 CFU, or 100 million bacteria per gram. Infectious disease expert Dr. Robert Schooley emphasized that the bacterial level in materials injected into the skin should be zero. “The level of bacteria in materials that are injected into the skin or that come into contact with abraded or injured skin should be ‘none detected,’” said Schooley.

Schooley also noted that tattooing has been associated with the transmission of viral infections like hepatitis C, hepatitis B, and HIV. He added, “These (infections) were not studied in the FDA manuscript, but the fact that so many of the inks failed bacterial sterility tests suggests that other organisms like viruses and fungi also can slip through the cracks.”

Many certified tattoo artists are aware of the contamination risks and take steps to avoid them. Medina emphasized, “Transparency with clients is vital. Artists should communicate openly about the steps they take to ensure ink safety and address any concerns clients may have.”

Some artists conduct their own testing or require proof of testing from suppliers, including microbial testing for potential contamination. Tattoo artists can also resterilize inks before application using an autoclave, a machine that uses steam to apply high pressure and temperature to eliminate bacteria.

The way ink is handled during tattooing is crucial. For instance, using the same gloves to touch a client and the ink bottle can lead to contamination. Artists should ensure ink bottles are tightly sealed when not in use and stored in cool, dry places away from direct sunlight to minimize contamination risks.

Experts advocate for regulations requiring testing and certification of tattoo and permanent makeup inks before they are marketed. Swierk mentioned, “Tattoo inks are in the process of being regulated due to the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, but much of that law dealing with tattoo inks has yet to be implemented.”

“We anticipate that MoCRA will be phased in over the next few years and that will represent the first serious regulation of tattoo inks in the US. Most of this will focus on good manufacturing processes and safety substantiation.”

In June 2023, the FDA released draft guidance for the tattoo industry, detailing how manufacturers should conduct quality control measures, including sterilization.