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          Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial ContaminationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination 
					
		
		June 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2023-D-1083
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


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. 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. 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.

FDA’s 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.

Download the Draft Guidance

Related Resources

Constituent Update: FDA Issues Draft Guidance on Tattoo Inks (June 12, 2023)
	Press Release: FDA Provides Draft Recommendations to Help Reduce Microbial Contamination in Tattoo Inks (June 12, 2023)
	Tattoos, Temporary Tattoos & Permanent Makeup
	More Cosmetic Guidance & RegulationsSubmit Comments
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
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							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2023-D-1083.

                                                                                  Content current as of:
      06/12/2023
         
                  
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