The Ink Is Dry: FDA Issues Final Guidance For Tattoo Industry

On October 25, 2024, FDA issued final guidance to the tattoo industry on the preparation, packing and holding of tattoo inks aimed at preventing the risk of microbial contamination. FDA is getting involved because tattoo ink is considered a cosmetic product regulated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

FDA's new guidance is aimed at tattoo ink manufacturers, distributors, and packers and describes situations that may result in contamination and recommended steps to prevent contamination or remediate any insanitary conditions.

Specifically, the guidance lists the following examples of insanitary conditions that could result in contamination:

• Preparing or packing the inks in unsuitable facilities, such as carpeted areas;