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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