Today, the U.S. Food and Drug Administration (FDA) issued guidance to help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms.
The guidance titled “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination” contains recommendations that include:
- Testing ink and ink components for possible microbial contamination;
- Ensuring the manufacturing process does not introduce microbial contamination;
- Ensuring appropriate sterilization methods are used, when applicable; and
- Taking corrective measures to prevent the release of any product containing microbial contamination.
The FDA has received multiple reports of illnesses caused by microbially contaminated tattoo inks, and subsequent testing by the agency has also uncovered microbial contamination in sealed tattoo ink bottles. Between 2003 and 2024, firms conducted 18 voluntary recalls of tattoo inks that were contaminated with a variety of microorganisms. The most recent recall was issued on August 23, 2024.
In May 2019, the FDA issued a Safety Alert advising consumers, tattoo artists and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms. In addition, the agency issued multiple warning letters about microbially contaminated inks in September 2019. This final guidance is intended to help members of industry avoid the conditions that led to the production of contaminated inks and to protect consumers from contaminated tattoo inks.
Reporting Adverse Reactions
You can report adverse reactions from tattoos by using the contact information found here: How to Report a Cosmetic Product Related Complaint.