Permanent cosmetics warning

Swelling, peeling, blistering and scarring are among the more than 50 reported adverse events associated with permanent cosmetic ink shades sold by Arlington, Tex.-based Premier Products, according to FDA talk paper released July 2. Firm reported it would remove certain ink shades for lipliner, eyeliner and eyebrow color from the market following six adverse events last year, agency notes, but additional reports were obtained for shades that were not removed. FDA is conducting an ongoing investigation of the company. Tattoos, including permanent makeup, are considered cosmetics, and the pigment used in the inks are color additives that require premarket approval under the FD&C Act, FDA notes, but adds the agency has not traditionally regulated tattoo inks or pigments...