FDA warns of dangerous infections linked to tattoo ink

The US Food and Drug Administration (FDA) has issued new draft guidance aimed at reducing the use of pathogen-contaminated tattoo ink. Tattooing involves puncturing the epidermis with needles and depositing ink below the surface of the skin, and contaminated ink can cause serious infections. Some 30% of Americans now have at least one tattoo, up from 21% in 2012. Infections associated with tattoo ink can include rashes, blisters, painful nodules and severe abscesses. One of the most common bacteria found in contaminated tattoo ink is related to the bacteria that causes tuberculosis and can be found in soil and water. Common sources of contamination include unsanitary manufacturing conditions such as hard-to-sanitize facilities, ink or ink components left uncovered near open air ducts, unsanitary mixing of tattoo inks, and lack of appropriate attire by staff. While reputable ink manufacturers use gamma radiation to kill microorganisms in the ink and its packaging, tattoo ink is considered a cosmetic product and is not subject to the same regulatory oversight as prescription medication. Although the incidence of unclean needles spreading hepatitis and HIV has decreased, infections caused by rare bacteria that exist in stagnant water and are injected into the body are on the rise. Such infections can be difficult to treat, sometimes requiring surgical removal of the tattoo and leaving a surgical scar. Reputable ink manufacturers are well-known among tattoo artists, who themselves regulate the quality of ink they use. However, there have been 18 recalls of tattoo inks contaminated with various microorganisms between 2003 and 2023, and the FDA issued a safety alert in May 2019 advising consumers, tattoo artists and retailers to avoid using or selling certain tattoo inks contaminated with microorganisms.