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Download the Draft Guidance

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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• Constituent Update: FDA Issues Draft Guidance on Tattoo Inks (June 12, 2023) 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 & Regulations