Tattoos & Permanent Makeup Edited from FDA
Nov 29, 2000; updated Jun 23, 2008, Feb 1, 2010, Aug 22, 2012
FDA
considers the inks used in intradermal tattoos, including permanent
makeup, to be cosmetics.
When we identify a safety problem associated
with a cosmetic, including a tattoo ink, we investigate and take action,
as appropriate, to prevent consumer illness or injury.
The pigments
used in the inks are color additives, which are subject to premarket
approval under the Federal Food, Drug, and Cosmetic Act. However,
because of other competing public health priorities and a previous lack
of evidence of safety problems specifically associated with these
pigments, FDA traditionally has not exercised regulatory authority for
color additives on the pigments used in tattoo inks. The actual practice
of tattooing is regulated by local jurisdictions.
During
2003 and 2004, FDA became aware of more than 150 reports of adverse
reactions in consumers to certain permanent makeup ink shades, and it is
possible that the actual number of women affected was greater. The inks
associated with this outbreak were voluntarily recalled by the company
that marketed them in 2004. In the spring of 2012, we received reports
of infections from contaminated inks, resulting in their recall and
market withdrawal. In addition, concerns raised by the scientific
community regarding the pigments used in tattoo inks have prompted FDA
to investigate their safe use. FDA continues to evaluate the extent and
severity of adverse events associated with tattooing and is conducting
research on tattoo inks. As new information is assessed, we will
consider whether additional actions are necessary to protect public
health.
In addition to the reported adverse
reactions, areas of concern include tattoo removal, infections that
result from tattooing, and the increasing variety of pigments and
diluents being used in tattooing. More than fifty different pigments and
shades are in use, and the list continues to grow. Although a number of
color additives are approved for use in cosmetics, none is approved for
injection into the skin. Using an unapproved color additive in a tattoo
ink makes the ink adulterated. Many pigments used in tattoo inks are
not approved for skin contact at all. Some are industrial grade colors
that are suitable for printers' ink or automobile paint.
Risks Involved in Tattooing
The following are the primary complications that can result from tattooing:
- Infection.
Unsterile tattooing equipment and needles can transmit infectious
diseases, such as HIV, hepatitis, and skin infections caused by Staphylococcus aureus ("staph") and other bacteria.
- Removal problems. Complete removal without scarring may be
impossible.
- Allergic reactions. Occasionally, people may
develop an allergic reaction to tattoos they have had for years.
- Granulomas. These are nodules that may form around material that the body perceives as foreign, such as particles of tattoo pigment.
- Keloid formation.
If you are prone to developing keloids -- scars that grow beyond normal
boundaries -- you are at risk of keloid formation from a tattoo.
- MRI complications.
There have been reports of people with tattoos or permanent makeup who
experienced swelling or burning in the affected areas when they
underwent magnetic resonance imaging (MRI).
A Common Problem: Dissatisfaction
A
common problem that may develop with tattoos is the desire to remove
them. Removing tattoos and permanent makeup can be very difficult.
Temporary Tattoos, Henna /Mehndi, and "Black Henna"
FDA has received reports
of allergic reactions to temporary tattoos.
Henna
is approved only for use as a hair dye, not for direct application to
the skin. FDA has also received reports of allergic reactions
to temporary tattoos that contain henna and those consisting only of
hair dye. Some reactions have resulted in scarring.
Reporting Adverse Reactions
FDA
urges consumers and healthcare providers to report adverse reactions
from tattoos, permanent makeup, and temporary tattoos, as well as
problems with tattoo removal.