FDA Guidance on Tattoo Ink Contamination

The U.S. Food and Drug Administration (FDA) recently released guidance on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.  The guidance is intended to “help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms,” and recommends steps “manufacturers and distributors could take to help prevent the occurrence of these conditions.”  Identified insanitary conditions include uncovered ink, ink components, and primary packaging containers; use of uncleaned and unsanitized containers and utensils; and failure of manufacturing personnel to use hairnets, lab coats, aprons, gowns, masks, or gloves.  Recommendations include test ink and ink components for microbial contamination or purchase materials from suppliers that do such testing; validate the sterilization method; and ensure the sterilization method does not adulterate the finished product.  For additional information, see the FDA guidance document and Tattoos, Temporary Tattoos & Permanent Makeup page.