Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination October 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2023-D-1083
• Issued by: Office of the Commissioner, Office of the Chief Scientist

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 Final Guidance

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Related Resources

• Constituent Update: FDA Issues Final Guidance on Tattoo Inks (October 24, 2024) 
• Constituent Update: FDA Issues Draft Guidance on Tattoo Inks (June 12, 2023) 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 

 

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Submit Comments

Submit Comments Online

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
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-1083.