Microbial contamination of tattoo and permanent makeup inks marketed in the US: a follow-up study
1Division of Microbiology, National Center for Toxicological Research, U.S. FDA, Jefferson, AK, USA.
Abstract:
In a 2018 survey, U.S. Food and Drug Administration (FDA) identified microbial contamination in 42 (49%) of 85 unopened tattoo and permanent makeup (PMU) inks purchased from 13 manufacturers in the US between November 2015 and April 2016. To confirm the results of our previous survey, we evaluated the level of microbial contamination in an additional 27 samples from 10 manufacturers from September 2017 to December 2017, including 21 unopened tattoo and PMU inks which were selected based on our previous survey results and 6 ink diluents that were not previously analysed. Aerobic plate count and enrichment culture methods from the FDA's Bacteriological Analytical Manual revealed 11 (52%) out of 21 inks, from six manufacturers, were contaminated with micro-organisms, with contamination levels up to 3·6 × 108 CFU per gram, consistent with our previous survey results. We identified 25 bacterial strains belonging to nine genera and 19 species. Strains of Bacillus sp. (11 strains, 44%) were dominant, followed by Paenibacillus sp. (5 strains, 20%). Clinically relevant strains, such as Kocuria rhizophila and Oligella ureolytica, were also identified, as similar to the findings in our previous survey. No microbial contamination was detected in any of the six ink diluents.
Insights
Microbial contamination persists in tattoo and permanent makeup inks, with over half of tested samples showing contamination. This highlights ongoing risks associated with these products for consumers.
Area of Science:
- Microbiology
- Public Health
- Dermatology
Background:
- A previous survey by the U.S. Food and Drug Administration (FDA) in 2018 found significant microbial contamination in tattoo and permanent makeup (PMU) inks.
- Concerns remain regarding the safety and sterility of inks used in cosmetic procedures.
Purpose of the Study:
- To re-evaluate the level of microbial contamination in tattoo and PMU inks and ink diluents.
- To confirm findings from a prior FDA survey on ink contamination.
Main Methods:
- Analysis of 21 unopened tattoo and PMU inks and 6 ink diluents from 10 manufacturers (September–December 2017).
- Utilized FDA's Bacteriological Analytical Manual methods, including aerobic plate count and enrichment culture.
- Identified bacterial strains using standard microbiological techniques.
Main Results:
- Microbial contamination was detected in 11 (52%) of the 21 tested inks from six manufacturers.
- Contamination levels reached up to 3.6 × 10^8 CFU per gram.
- Identified 25 bacterial strains from nine genera, with Bacillus sp. and Paenibacillus sp. being dominant. Clinically relevant strains were also found.
- No contamination was detected in the six ink diluents.
Conclusions:
- Microbial contamination in tattoo and PMU inks remains a significant issue, consistent with previous findings.
- The presence of bacteria, including clinically relevant strains, poses potential health risks to individuals undergoing tattooing or permanent makeup procedures.
- Ink diluents appear to be a safer alternative, showing no microbial contamination in this study.
More Related Videos
06:18Absorbent Microbiopsy Sampling and RNA Extraction for Minimally Invasive, Simultaneous Blood and Skin Analysis
Published on: February 21, 2019
06:36Effects of Mechanical Methods Used in Peri-implantitis Treatment on Implant Surface Decontamination and Roughness
Published on: March 14, 2025
