FDA Provides Guidance for Preventing Contamination in Tattoo Ink

On June 12, 2023, United States Food and Drug Administration officials provided guidance for reducing microbial contamination in tattoo ink. The draft recommendation, now open for public commentary, was developed to prevent illnesses caused by infected tattoo ink.

The recommendations address concerns brought up in 2019 during an FDA Safety Alert. In May 2019, the safety alert warned against three types of tattoo ink contaminated with microorganisms manufactured by Scalp Aesthetics, Dynamic Color Inc, and Color Art Inc.

“Unlike most cosmetics, tattoo inks are injected into the dermal layer of the skin, and therefore have the potential to introduce harmful pathogens directly into the body. Because of this, it is particularly important for tattoo inks to be manufactured using methods to ensure a product is safe,” said Linda Katz, MD, MPH, director of the FDA's Office of Cosmetics and Colors, in the FDA press release. “The recommended steps outlined by the FDA in the draft guidance provide manufacturers the information and resources needed to help ensure that tattoo inks are not contaminated.”

The guidance included multiple recommendations. One of the most critical recommendations is testing ink and ink components for contamination. Tattoo artists and studios have two options: to test for microbes independently or to purchase from a company that does its microbial testing. Facilities should discard any ink that is contaminated.

Beyond testing at the endpoint, the FDA suggests that the ink manufacturing process transition to a more sterile approach, ensuring the equipment is sanitized and employees wear personal protective equipment. Additionally, the sterilization process should be validated, and any potentially contaminated ink should not be distributed to patients.

“With about 30%of people living in the US having a tattoo, it’s imperative that the FDA take all necessary steps to help ensure that tattoo inks are free of contamination,” concluded FDA Chief Scientist Namandjé Bumpus, PhD, in the release. “Pathogens or other harmful substances in these inks can cause infections and serious injuries. The FDA is issuing this draft guidance to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms and take steps to protect public health.”

Although these recommendations will not be finalized until public commentary closes on September 11, 2023, these harm-reduction strategies may minimize the risk of tattoo-induced illness and the spread of infectious diseases.