Warning against micropigmentation tattooing to apply permanent makeup for lip liner, eyeliner and eyebrow color

Jul 6 2004

The U.S. FDA has alerted the general public to reported adverse events associated with individuals who have undergone certain micropigmentation procedures, a form of tattooing, used to apply "permanent makeup" for 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, in Arlington, TX. FDA is currently investigating this matter.

To date, FDA has been made aware of more than 50 adverse events and is investigating additional reports sent to the manufacturer. Reactions that have been reported include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas (chronically inflamed tissue mass associated with an infection) 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 FDA its intent to remove five of its ink shades from the market, based on six adverse events that had been reported. However, FDA has obtained additional reports of adverse events involving ink shades that were not included in the firm's removal effort. While the investigation continues, FDA is alerting consumers about associated adverse event reports received about Premier Products ink shades identified on the FDA website at http://www.cfsan.fda.gov/~dms/cos-tat2.html.

FDA considers intradermal tattoos (including permanent makeup) 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, FDA has not traditionally regulated tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions.