CFSAN Constituent Update
August 23, 2012
The Food and Drug Administration (FDA) is alerting tattoo artists, ink and pigment manufacturers, public health officials, health care professionals, and consumers that some tattoo inks, and the pigments used to color them, can become contaminated by bacteria, mold, and fungus. Contaminated inks are known to have caused serious infections in people in at least five states over the past year.
Anyone who receives a tattoo with a contaminated ink is at risk for infection.
Tattoos inks can become contaminated with a variety of bacteria, but the family of bacteria called nontuberculous Mycobacteria (NTM), which has been linked to a 2011-2012 outbreak of infections, is of particular concern.
M. chelonae, one of several disease-causing NTM species, can cause a rash or raised red bumps in a tattooed area within a couple of weeks of receiving a tattoo. The infection can be difficult to diagnose and may be mistaken for an “allergic” reaction. M. chelonae can also cause lung disease, joint infection, eye problems, and other organ infections, and can require treatment lasting six months or more.
Tattoo artists can help to minimize the risk of infection by only using inks that have been processed to be free from harmful microorganisms. When purchasing inks, artists should ask the ink distributors what steps were taken to ensure that the product is free from harmful microorganisms.
Use of sterile water to dilute inks helps to ensure that bacteria are not introduced during the dilution process. (Unboiled tap, bottled, distilled, and filtered water are not sterile and should not be used to dilute inks.)
Companies and individuals who manufacture or market cosmetics, including tattoo inks, have a legal responsibility to ensure the safety of their products. Steps to help ensure tattoo inks are free of harmful contaminants may include: carefully choosing the inks ingredients, using hygienic processing techniques, using preservatives to prevent the growth of microorganisms, validating post-manufacture processing and testing to ensure safety, or a combination of these and/or other approaches.
At present there is no specific FDA regulatory requirement that tattoo inks be sterile; however, consumers can reduce the likelihood of experiencing infections by asking tattoo artists if the inks have been formulated or processed to ensure they are free from harmful pathogens. In addition consumers should ask that the artist only use sterilized water to dilute the inks.
For more information:
- Tattoo Inks Pose Health Risks
- New England Journal of Medicine: Tattoo Ink–Related Infections — Awareness, Diagnosis, Reporting, and Prevention
- Centers for Disease Control Morbidity and Mortality Weekly Report: Tattoo-Associated Nontuberculous Mycobacterial Skin Infections — Multiple States, 2011–2012