June 2023

Last month, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.

This guidance is designed to assist manufacturers in minimizing microbial contamination in their products and promoting safer practices in tattooing, which is particularly crucial as nearly 30% of Americans now have tattoos.

The guidance follows the most recent Safety Alert for tattoo inks issued in May 2019, when three different ink manufacturers voluntarily recalled their products due to microbial contamination found in sealed ink containers. Such contamination can lead to adverse affects such as rashes, lesions, scarring, and other reactions based on the microbial species present.

While tattoo inks are regulated as cosmetics, skin penetration of the products during application leaves people vulnerable to infection. According to the draft guidance, tattoos penetrate the dermal skin layer by 1.5 to 2 millimeters, providing a direct entry point for contaminants. The draft guidance is a significant stride toward safer tattoo practices – practices we will likely see become law through MoCRA.

Microchem works hand-in-hand with manufacturers to make sure batches are safe to go to market. If you are interested in speaking with an analyst about rapid and routine microbial testing, please contact our lab at [email protected].