Tattoos and Permanent Makeup Alarm

The inks used in tattoos and permanent makeup are subject to FDA regulation as cosmetics and color additives. However, the FDA has not attempted to regulate these inks. They have also not attempted to regulate tattooing and permanent makeup but have left them to local authorities and local laws. But now with more and more people opting for tattooing and permanent makeup, the FDA has come out with a public alert

One concern of the FDA is the quality of pigments and color additives being used, many of which are not approved for skin contact but are instead industrial grade, for example, "suitable for printers' ink or automobile paint." The FDA also wants consumers to be aware of the risks of tattooing and permanent makeup which include infections, allergic reactions, granulomas and keloids (disfiguring scars), and can even complicate a medical procedure (such as an MRI). This is not to speak of the difficulties removing tattoos or permanent makeup. Consumers are urged to report adverse tattooing reactions to the FDA.

Comment: The FDA now has more than 50 reports of "adverse events" and they are investigating "additional reports" regarding ONE manufacturer. How many reports will it take for the FDA to do more than issue another "Talk Paper?" The FDA is supposed to protect the health of the American public.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com

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FDA Alerts Consumers About Adverse Events Associated With "Permanent Makeup"

The Food and Drug Administration (FDA) is alerting the public to a number of 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.

Source: FDA Talk Paper # To4-20, July 2, 2004


Last Editorial Review: 7/6/2004




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