The Food and Drug Administration (FDA) is alerting the public and practitioners about 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, marketed as Premier Products, in Arlington, Texas. The FDA is currently investigating this matter.

As of July 2004, the more than 50 adverse events have been reported to the FDA and additional reports are under investigation. Reported reactions include swelling, cracking, peeling, blistering, and scarring as well as granuloma formation in treated areas. In some cases, serious disfigurement and difficulty with eating and talking has occurred.

The 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.

As this investigation continues, consumers and healthcare providers are urged to report adverse reactions from tattoos, including permanent makeup, to the FDA as well as to state and local health authorities.

COPYRIGHT 2004 Journal of Drugs in Dermatology, Inc.
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