June 12, 2023
The U.S. Food and Drug Administration today issued draft guidance to tattoo ink manufacturers and distributors to help recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially injurious to health. This guidance also recommends certain steps that manufacturers and distributors could take to help prevent the occurrence of these conditions, or to identify and remediate insanitary conditions that already exist during manufacturing and distribution.
The FDA received multiple reports of illnesses caused by microbially contaminated tattoo inks, and subsequent testing by the agency also uncovered microbial contamination in sealed tattoo ink bottles. Between 2003 and 2023, firms conducted 18 recalls of tattoo inks that were contaminated with a variety of microorganisms, some of which can cause serious infections. 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.
Today the FDA is taking additional steps to protect consumers from contaminated tattoo inks by providing manufacturers with information and tools to help them reduce the microbial contamination in the inks they manufacture.
The FDA urges consumers and healthcare providers to report adverse reactions from tattoos. Consumers and healthcare providers can report problems to MedWatch, the FDA’s problem-reporting program, by calling 1-800-332-1088, or by contacting the nearest FDA consumer complaint coordinator. For more information on mandatory reporting of serious adverse events required as a result of the Modernization of Cosmetics Regulation Act, please see: Modernization of Cosmetics Regulation Act of 2022.
To Submit Comments
Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-1083 and with the title of the guidance document.