Are tattoos and permanent makeup safe?

FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA has not traditionally regulated tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. FDA is aware of more than 150 reports of adverse reactions in consumers to certain permanent make-up ink shades, and it is possible that the actual number of women affected was greater. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.

In addition to the reported adverse reactions, areas of concern include tattoo removal, infections that result from tattooing, and the increasing variety of pigments and diluents being used in tattooing.

Source: Excerpted from Office of Cosmetics and Colors Fact Sheet, November 29, 2000: Tattoos and Permanent Makeup (Updated July 14, 2006)