Adverse events associated with 'permanent makeup'

The FDA has alerted the public to a number of reported adverse events associated with so-called "permanent makeup," a form of tattooing called micropigmentation. The procedure is used to apply lip liner, eyeliner, or eyebrow color. The adverse events are associated with certain ink shades of the Premier Pigment brand of permanent makeup inks, which are manufactured by the American Institute of Intradermal Cosmetics, doing business as Premier Products of Arlington, Texas.

Reactions that have been reported include swelling, cracking, peeling, blistering, and scarring as well as formation of chronically inflamed tissue mass associated with an infection (granulomas) in the areas of the eyes and lips. In some cases, the effects reported caused serious disfigurement, resulting in difficulty in eating and talking.

In July 2003, the manufacturer reported to the FDA its intent to remove five of its ink shades from the market. However, the agency has obtained additional reports of adverse events involving ink shades not included in the firm's removal effort. While the investigation continues, the FDA is alerting consumers to associated adverse event reports received about Premier Products ink shades identified on its Web site at www.cfsan.fda.gov/~dms/cos-tat2.html.> The FDA considers tattoos, including permanent makeup, to be cosmetics. And the agency considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, the agency traditionally has not regulated tattoo inks or pigments used in them. The actual practice of tattooing is governed by state and local regulations.

The FDA urges people to report adverse reactions from tattoos and permanent makeup to state and local health authorities. Adverse events also may be reported to the FDA's Emergency Operations Center at (301) 443-1240 or the Center for Food Safety and Applied Nutrition Adverse Events Reporting System (CAERS) at (301) 436-2405. People also may send e-mail to CAERS@cfsan.fda.gov.