Tattooing :: Reactions associated with tattooing – permanent makeup

Certain micropigmentation procedures, a form of tattooing, used to apply “permanent makeup” for lip liner, eyeliner, or eyebrow color may be having adverse reactions to health.

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.

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.


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