Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  
 
Insanitary Conditions in the Preparation, 
Packing, and Holding of Tattoo Inks and 
the Risk of Microbial Contamination:  
Guidance for Industry  
   
 
Draft Guidance
 
This guidance is being distributed for comment purposes only. 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 90 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number FDA-2023-D-1083 listed 
in the notice of availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-1130. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
June 2023 
   
     
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table of Contents
 
 
I. Introduction ................................................................................... 3
   
II. Background .................................................................................... 4
   
III. Discussion ....................................................................................... 5
   
A.  General Considerations .................................................................................................... 5 
B.  Examples of Insanitary Conditions ................................................................................. 5 
C.  Recommendations ............................................................................................................. 6 
IV. References ...................................................................................... 7
   
 
  2  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Insanitary Conditions in the Preparation, 
Packing, and Holding of Tattoo Inks and 
the Risk of Microbial Contamination:  
Guidance for Industry1
 
  
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page. 
 
I.  Introduction 
 
Under section 601(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
361(c)), a cosmetic is deemed to be adulterated if it has been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health.  Cosmetic products prepared, packed, or held under 
insanitary conditions could become contaminated and cause serious adverse events.  The risk of 
such adverse events is even greater in products such as tattoo inks, which are introduced through 
the skin.   
 
Tattooing has become increasingly popular in the United States.  Polling and data suggest that 
about 30 percent of all Americans, and 40 percent of those aged 18-34, have at least one tattoo 
(Refs. 1 and 2).  State and local jurisdictions generally regulate the practice of intradermal 
tattooing, including permanent makeup.  FDA regulates, among other things, the inks used in 
that practice.2  Tattoo inks are cosmetics as defined by section 201(i) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(i)) because they are articles intended to be 
introduced into or otherwise applied to the human body for beautifying, promoting 
attractiveness, or altering the appearance.    
 
FDA is issuing this guidance to help tattoo ink manufacturers and distributors recognize 
situations in which a tattoo ink may become contaminated with microorganisms, and thus, be 
potentially injurious to health.  This guidance also recommends certain steps that manufacturers 
and distributors could take to help prevent the occurrence of these conditions, or to identify and 
remediate insanitary conditions that already exist during manufacturing and distribution. 
 
1 This guidance has been prepared by the Office of Cosmetics and Colors and the Office of Regulations and Policy 
in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
2 Pigments, which are color additives regulated by FDA, are a component of finished tattoo inks.  This guidance 
focuses on microbial contamination of finished inks. 
  3  Contains Nonbinding Recommendations 
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FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
Human skin is composed of multiple layers, including the epidermis, or outermost skin layer that 
serves as the bodys primary physical barrier against pathogens and other harms; and the dermis, 
or deeper layer that contains, among other things, blood and lymphatic vessels.  Microorganisms 
are normally present on the epidermis, but not in deeper skin layers, such as the dermis.  
Microorganisms normally regarded as nonpathogenic when applied topically may become 
opportunistically pathogenic and virulent when introduced in other ways (e.g., in wounds or via 
cosmetics introduced into or through the skin).3  The presence of microorganisms in deeper skin 
layers may give rise to infection and inflammation.  
 
Tattooing involves puncturing the epidermis about 100 times per second with needles and 
depositing ink 1.5 to 2 millimeters below the surface of the skin, deep into the dermis (Ref. 3).  It 
generally causes bleeding because the needles pierce the blood vessels (Refs. 4 and 5).  
Contaminated tattoo ink can cause infections and serious injuries.  Because these inks are 
injected, 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.  Commonly reported 
symptoms of tattoo ink-associated infections include injection-site rashes and other lesions, 
including blisters and granulomas, some of which have resulted in permanent scarring.  Tattoo-
associated microbiological infections can also include impetigo,4 erysipelas,5 cellulitis,6 and 
systemic infections that can cause life-threatening complications such as endocarditis, septic 
shock, and multi-organ failure (Ref. 8).  Indications of an infection can be difficult to recognize, 
as other conditions (e.g., allergic reactions or other sources of inflammation) may initially have 
similar signs and symptoms, leading to misdiagnosis and ineffective treatments. 
 
We have received multiple reports of illness caused by microbially contaminated tattoo inks, and 
subsequent testing has found many sealed tattoo inks in the United States with microbial 
contamination.  For instance, in 2012, contaminated tattoo inks caused a multi-state outbreak of 
nontuberculous mycobacterial skin infections (Ref. 9).  Nontuberculous mycobacterial skin 
infections can produce a range of symptoms, from mild inflammation (e.g., rash, papules, 
 
3 See Subpart J, Microbiological Findings, in Bacteriological Analytical Manual, Chapter 23: Methods for 
Cosmetics, available at https://www.fda.gov/food/laboratory-methods-food/bam-chapter-23-methods-cosmetics 
(accessed January 5, 2022). 
4 Impetigo is a contagious superficial pus-forming bacterial infection which begins with a superficial blister that 
ruptures and forms a yellowish crust (Ref. 6). 
5 Erysipelas is a specific, acute, superficial infection of the skin caused by bacterium and characterized by hot, red, 
swollen, thickened, and sharply defined eruptions (Ref. 6). 
6 Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the 
skin.  If untreated, it can spread and cause serious health problems (Ref. 7). 
  4  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
nodules) to severe abscesses requiring extensive and multiple surgical debridements7 and 
antimicrobial therapies.  Between 2003 and 2019, tattoo ink firms conducted 15 voluntary ink 
recalls, 14 of which resulted from findings of microbial contamination.  Eight of these recalls 
(Refs. 11-16) occurred after FDA conducted multiple surveys of tattoo inks available in the U.S. 
market and tested them for microbial contamination.  Many of these inks were heavily 
contaminated with a variety of microorganisms, some of which (such as Pseudomonas 
aeruginosa and Bacillus cereus) can cause serious infections (Refs. 16 and 17).  In 2018, an 
article in the Journal of Applied Microbiology reported that 49 percent of the surveyed tattoo 
inks on the U.S. market were contaminated with microorganisms (Ref. 17).  In 2019, we alerted 
consumers, tattoo artists, and retailers of the potential for serious injury from use of certain tattoo 
inks contaminated with bacteria, and we worked with manufacturers and retailers to remove the 
products from the market (Ref. 16).8 
 
Facilities where tattoo inks are prepared, packed, or held are responsible for ensuring that the 
tattoo inks are not prepared, packed, or held under insanitary conditions whereby the tattoo ink 
may become contaminated with filth, or whereby it may have been rendered injurious to health. 
Tattoo inks prepared, packed, or held under such conditions are adulterated under the FD&C 
Act.  Therefore, upon identification, such insanitary conditions would need to be remediated.   
 
III.  Discussion 
 
A.  General Considerations 
 
In evaluating whether tattoo inks are adulterated because they have been prepared, packed, or 
held under insanitary conditions whereby they may have been contaminated with filth, or 
whereby they may have been rendered injurious to health, we generally consider the following 
factors: 
 
  Tattoo inks are used by a wide variety of consumers.  Therefore, when evaluating the 
potential harms associated with tattoo inks, we consider use by any person, including 
anyone who may be immunocompromised or have other relevant underlying medical 
conditions.   
 
  Tattoo inks bypass the bodys primary physical barrier against pathogens, because they 
are inserted below the epidermis. 
 
  Pathogens that may cause no harm in a topical product may cause harm when inserted 
below the epidermis because of their type or amount. 
 
 
 
7 Debridement is the removal, usually via surgery, of torn, dead, or contaminated tissue (Ref. 10). 
8 Note that the Modernization of Cosmetics Regulation Act of 2022 (Consolidated Appropriations Act, 2023, Pub. 
L. No. 117-328,  3502 (2022)) establishes new requirements for the reporting to FDA of serious adverse events 
associated with the use of cosmetic products. 
  5  Contains Nonbinding Recommendations 
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B.  Examples of Insanitary Conditions 
 
The following insanitary conditions during manufacturing and distribution could render a tattoo 
ink injurious to health: 
 
  Preparing or packing of tattoo inks in facilities not suitable for such activities (e.g., 
spaces that are difficult to clean and sanitize, such as carpeted areas); 
 
  Ink, ink components (e.g., pigments, water, solvents), and primary packaging containers 
held uncovered, especially near open air ducts, potentially exposing them to airborne 
microbial contaminants and filth; 
 
  The presence of ink and ink components (e.g., pigments, water, other solvents) 
contaminated with microorganisms; 
 
  Ink and ink components (e.g., pigments, water, other solvents) held in containers that 
have not been cleaned and sanitized; 
  
  Insanitary mixing of tattoo inks, including:  
 
  The use of containers and utensils that are not cleaned and sanitized; and 
o
  The use of containers without covers that expose in-process inks to microbial 
o
contaminants from the air;  
 
  Lack of appropriate attire by personnel during manufacturing, including the failure to use 
hairnets, lab coats, aprons, gowns, masks, or gloves; 
 
  Failure to equip employee restrooms with soap and water, or the lack of signage directing 
employees to wash their hands;  
 
  Disposal of used personal protection clothing (e.g., gloves, masks, gowns) in the 
production area; and 
 
  Storage of packaged products in locations that render them susceptible to contamination 
(e.g., around heavy buildup of dust and debris). 
 
C.  Recommendations 
 
Manufacturers can take measures to help ensure that tattoo inks are not prepared, packed, or held 
under insanitary conditions whereby they may be contaminated with microorganisms, including: 
 
  Test ink and ink components (e.g., pigments, water, other solvents) for microbial 
contamination or purchase these materials from suppliers that test for microbial 
contamination.  Discard any materials that contain microorganisms of a type or at a level 
that may harm any consumer if present in the finished product;  
 
  6  Contains Nonbinding Recommendations 
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  Ensure that the manufacturing process itself does not introduce microbial contamination 
(e.g., by conducting adequate cleaning and sanitization of manufacturing equipment, 
providing personal protective equipment to employees); 
 
  Ensure that any sterilization method used is validated.  For example, if products are 
intended to be sterile, perform appropriate validated sterilization of the finished 
product; 
 
  Ensure that any cleaning or sterilization method used does not adulterate the finished 
product (e.g., that irradiation causes no byproducts in the ink that could create poisonous 
or deleterious substances in the ink which may render it injurious to users under expected 
conditions of use); and 
 
  Take corrective measures to prevent the release of any final product that microbiological 
testing shows contains microorganisms of a type or at a level that may harm any 
consumer and reexamine manufacturing and validation procedures to determine the cause 
of final product contamination. 
 
We also suggest examining and, where appropriate, establishing good manufacturing practices 
(GMPs) or applying GMPs that pertain to cosmetics generally (see, for example, International 
Organization for Standardization (ISO) standard pertaining to cosmetics, ISO 22716, titled 
Cosmetics  Good Manufacturing Practices (GMP)  Guidelines on Good Manufacturing 
Practices (Ref. 18)).9  We note that we intend to conduct rulemaking to establish good 
manufacturing practice regulations as part of the implementation of the Modernization of 
Cosmetics Regulation Act of 2022, which requires FDA to establish good manufacturing 
practice regulations that, to the extent practicable and appropriate, are consistent with national 
and international standards.10   
 
IV.  References 
 
The following references marked with an asterisk (*) are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 
4 p.m., Monday through Friday; they also are available electronically at 
https://www.regulations.gov.  References without asterisks are not on public display at 
https://www.regulations.gov because they have copyright restriction.  Some may be available at 
the website address, if listed.  References without asterisks are available for viewing only at the 
Dockets Management Staff.  FDA has verified the website addresses, as of the date this 
document publishes in the Federal Register, but websites are subject to change over time.  
 
 
9 FDA has published a draft guidance entitled Cosmetic Good Manufacturing Practices (June 2013) (available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-
good-manufacturing-practices (accessed December 19, 2022)).   
10 See Consolidated Appropriations Act, 2023, Pub. L. No. 117-328,  3502 (2022).   
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1.  Giulbudagian, M., I. Schreiver, A.V. Singh, et al., Safety of Tattoos and Permanent Make-
up: A Regulatory View.  Archives of Toxicology, 94: 357-369 (2020).   
2.  Ipsos poll.  More Americans Have Tattoos Today than Seven Years Ago, August 29, 
2019.  Available at: https://www.ipsos.com/en-us/news-polls/more-americans-have-tattoos-
today (accessed January 19, 2023). 
3.  Grant, C.A., P.C. Twigg, R. Baker, et al., Tattoo ink Nanoparticles in Skin Tissue and 
Fibroblasts.  Beilstein Journal of Nanotechnology, 6: 1183-1191 (2015). 
4.  Laumann, A.  Chapter 101.  Body Art.  Goldsmith, L.A., S.I. Katz, B.A. Gilchrest, et al. 
(Eds.), Fitzpatricks Dermatology in General Medicine, 8e.  McGraw Hill (2012). 
5.  Klugl, I., K.A. Hiller, M. Landthaler, et al., Incidence of Health Problems Associated 
With Tattooed Skin: A Nation-Wide Survey in German-Speaking Countries. 
Dermatology, 221: 43-50 (2010). 
6.  Stedmans Medical Dictionary.  Baltimore, MD.  Lippincott Williams & Wilkins.  Online 
Electronic Medical Library.  2016. 
*7.  Centers for Disease Control and Prevention.  Cellulitis: All You Need to Know.  Centers 
for Disease Control and Prevention, May 29, 2020.  Available at: 
https://www.cdc.gov/groupastrep/diseases-public/cellulitis.html (accessed January 19, 
2023). 
8.  Serup, J., H.K. Carlsen, and M. Sepehri, Tattoo Complaints and Complications: Diagnosis 
and Clinical Spectrum.  Current Problems in Dermatology,  48: 48-60 (2015). 
*9.  Centers for Disease Control and Prevention. Tattoo-Associated Nontuberculous 
Mycobacterial Skin Infections--Multiple States, 2011-2012.  Morbidity and Mortality 
Weekly Report, 61: 653-656 (2012). 
10.  Debridement.  Merriam-Webster.com Dictionary, Merriam-Webster.  Available at: 
https://www.merriam-webster.com/dictionary/debridement (accessed January 19, 2023). 
*11. Food and Drug Administration, Fusion Ink: Recall, posted November 30, 2017; available 
at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=158974 (accessed 
January 19, 2023). 
*12. Food and Drug Administration, Radiant Colors: Recall, posted December 21, 2017; 
available at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=160130 
(accessed January 19, 2023).  
*13. Food and Drug Administration, Solid Ink: Recall, posted June 20, 2018; available at 
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164628 (accessed January 
19, 2023).  
*14. Food and Drug Administration, Intenze Ink: Recall, posted July 31, 2018; available at 
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=165649 (accessed January 
19, 2023).  
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*15. Food and Drug Administration, Eternal Ink: Recall, posted October 24, 2018; available at 
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=167698 (accessed January 
19, 2023).  
*16. Food and Drug Administration, FDA Advises Consumers, Tattoo Artists, and Retailers to 
Avoid Using or Selling Certain Tattoo Inks Contaminated with Microorganisms; available 
at https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-tattoo-
artists-and-retailers-avoid-using-or-selling-certain-tattoo-inks (accessed January 19, 2023). 
*17. Nho, S.W., S-J. Kim, O. Kweon, et al.  Microbiological Survey of Commercial Tattoo and 
Permanent Makeup Inks Available in the United States.  Journal of Applied Microbiology, 
124: 1294-1302 (2018). 
18.  ISO 22716:2007, Cosmetics--Good Manufacturing Practices (GMP)--Guidelines on Good 
Manufacturing Practices. Available at: https://www.iso.org/obp/ui/#iso:std:iso:22716:ed-
1:v2:en (accessed May 16, 2023). 
 
 
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