FDA issues warning about bacterial contamination in tattoo inks.

  • FDA has the authority to regulate the safety of cosmetics in the United States.  Tattoo inks meet the statutory definition of a “cosmetic,” which means:  “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”  FD&C Act § 201(i) (underlined emphasis added).
  • FDA has issued a warning to tattoo artists and consumers not to use certain tattoo inks due to potential microbial contamination.  FDA tested the inks in the course of assisting the Florida Department of Health in its investigation of an outbreak of mycobacterial infections in individuals who recently got tattoos.  In the course of testing, FDA detected bacteria — including Mycobacterium chelonae — in unopened bottles of inks.  The manufacturer currently is conducting a recall of affected product.
  • Although FDA enforcement action in the cosmetic arena is relatively rare, FDA’s public warning and the adverse publicity surrounding tattoo ink contamination serves a reminder of the Agency’s authority in this space.