Microbiological Survey of 47 Permanent Makeup Inks Available in the United States
Sunghyun Yoon1, Sandeep Kondakala1, Seong Won Nho1
1Division of Microbiology, National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Abstract:
In two previous surveys, the U.S. Food and Drug Administration (FDA) identified microbial contamination in 53 of 112 (47%) unopened tattoo inks and tattoo-ink-related products (e.g., diluents) from 15 manufacturers in the U.S. In this study, we primarily focused our microbiological survey on permanent makeup (PMU) inks. We conducted a survey of 47 unopened PMU inks from nine manufacturers and a comparative species-centric co-occurrence network (SCN) analysis using the survey results. Aerobic plate count and enrichment culture methods using the FDA's Bacteriological Analytical Manual (BAM) Chapter 23 revealed that 9 (19%) inks out of 47, from five manufacturers, were contaminated with microorganisms. The level of microbial contamination was less than 250 CFU/g in eight inks and 980 CFU/g in one ink. We identified 26 bacteria that belong to nine genera and 21 species, including some clinically relevant species, such as Alloiococcus otitis, Dermacoccus nishinomiyaensis, Kocuria rosea, and Pasteurella canis. Among the identified microorganisms, the SCN analysis revealed dominance and a strong co-occurrence relation of spore-forming extreme environment survivors, Bacillus spp., with close phylogenetic/phenotypic relationships. These results provide practical insights into the possible microbial contamination factors and positive selection pressure of PMU inks.
Insights
Microbial contamination was found in 19% of permanent makeup inks. Spore-forming bacteria like Bacillus spp. were dominant, suggesting potential contamination factors in these cosmetic products.
Area of Science:
- Microbiology
- Cosmetic Science
- Public Health
Background:
- Previous U.S. Food and Drug Administration (FDA) surveys found microbial contamination in 47% of tattoo inks.
- Microbial contamination in permanent makeup (PMU) inks remains a significant concern for consumer safety.
Purpose of the Study:
- To assess the microbiological quality of unopened PMU inks.
- To identify bacterial contaminants and analyze their co-occurrence patterns in PMU inks.
Main Methods:
- Survey of 47 unopened PMU inks from nine manufacturers.
- Microbiological analysis using FDA's Bacteriological Analytical Manual (BAM) Chapter 23 methods.
- Species-centric co-occurrence network (SCN) analysis.
Main Results:
- 19% (9 of 47) of PMU inks were contaminated with microorganisms from five manufacturers.
- 26 bacteria from nine genera and 21 species were identified, including clinically relevant species.
- SCN analysis revealed dominance and strong co-occurrence of spore-forming Bacillus spp.
Conclusions:
- PMU inks can harbor microbial contamination, posing potential health risks.
- Bacillus species appear to be prevalent and co-occur frequently in contaminated PMU inks.
- Findings provide insights into contamination sources and selection pressures in PMU inks.


