Cosmetics and Colors
November 29, 2000; Revised July 1, 2004, April 11, 2006, and July
Tattoos and Permanent Makeup
FDA considers the inks used in intradermal tattoos, including
permanent makeup, to be 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, because of other
public health priorities and a previous lack of evidence of safety
concerns, FDA has not traditionally regulated tattoo inks or the
pigments used in them. The actual practice of tattooing is regulated
by local jurisdictions. FDA is aware of more than 150 reports of
adverse reactions in consumers to certain permanent make-up ink
shades, and it is possible that the actual number of women affected
was greater. In addition, concerns raised by the scientific
community regarding the pigments used in these inks have prompted
FDA to investigate the safe use of tattoo inks. FDA continues to
evaluate the extent and severity of adverse events associated with
tattooing and is conducting research on inks. As new information is
assessed, the agency 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.
Nevertheless, many individuals choose to undergo tattooing in its
various forms. For some, it is an aesthetic choice or an initiation
rite. Some choose permanent makeup as a time saver or because they
have physical difficulty applying regular, temporary makeup. For
others, tattooing is an adjunct to reconstructive surgery,
particularly of the face or breast, to simulate natural
pigmentation. People who have lost their eyebrows due to alopecia (a
form of hair loss) may choose to have "eyebrows" tattooed on, while
people with vitiligo (a lack of pigmentation in areas of the skin)
may try tattooing to help camouflage the condition.
Whatever their reason, consumers should be aware of the risks
involved in order to make an informed decision.
What Risks Are Involved in Tattooing?
The following are the primary complications that can result from
• Infection. Unsterile tattooing equipment and needles can
transmit infectious diseases, such as hepatitis and skin infections
caused by Staphylococcus aureus ("staph") bacteria*. Tattoos
received at facilities not regulated by your state or at facilities
that use unsterile equipment (or re-use ink) may prevent you from
being accepted as a blood or plasma donor for twelve months.
• Removal problems. Despite advances in laser technology,
removing a tattoo is a painstaking process, usually involving
several treatments and considerable expense. Complete removal
without scarring may be impossible.
• Allergic reactions. Although FDA has received reports of
numerous adverse ractions associated with certain shades of ink in
permanent makeup, marketed by a particular manufacturer, reports of
allergic reactions to tattoo pigments have been rare. However, when
they happen they may be particularly troublesome because the
pigments can be hard to remove. 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
• 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. Keloids may form any time you injure
or traumatize your skin. Micropigmentation: State of the Art, a book
written by Charles Zwerling, M.D., Annette Walker, R.N., and Norman
Goldstein, M.D., states that keloids occur more frequently as a
consequence of tattoo removal.
• 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).
This seems to occur only rarely and apparently without lasting
There also have been reports of tattoo pigments interfering with the
quality of the image. This seems to occur mainly when a person with
permanent eyeliner undergoes MRI of the eyes. Mascara may produce a
similar effect. The difference is that mascara is easily removable.
The cause of these complications is uncertain. Some have theorized
that they result from an interaction with the metallic components of
However, the risks of avoiding an MRI when your doctor has
recommended one are likely to be much greater than the risks of
complications from an interaction between the MRI and tattoo or
permanent makeup. Instead of avoiding an MRI, individuals who have
tattoos or permanent makeup should inform the radiologist or
technician of this fact in order to take appropriate precautions and
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
Although tattoos may be satisfactory at first, they sometimes fade.
Also, if the tattooist injects the pigments too deeply into the
skin, the pigments may migrate beyond the original sites, resulting
in a blurred appearance.
Another cause of dissatisfaction is that the human body changes over
time, and styles change with the season. The permanent makeup that
may have looked flattering when first injected may later clash with
changing skin tones and facial or body contours. People who plan to
have facial cosmetic surgery are advised that the appearance of
their permanent makeup may become distorted. The tattoo that seemed
stylish at first may become dated and embarrassing. And changing
tattoos or permanent makeup is not as easy as changing your mind.
Consult your healthcare provider about the best removal techniques
What About Temporary Tattoos?
Temporary tattoos, such as those applied to the skin with a
moistened wad of cotton, fade several days after application. Most
contain color additives approved for cosmetic use on the skin.
However, the agency has issued an import alert for certain
foreign-made temporary tattoos.
The temporary tattoos subject to the import alert are not allowed
into the United States because they don't carry the FDA-mandated
ingredient labels or they contain colors not permitted by FDA for
use in cosmetics applied to the skin. FDA has received reports of
allergic reactions to temporary tattoos.
In a similar action, FDA has issued an import alert for henna
intended for use on the skin. Henna is approved only for use as a
hair dye, not for direct application to the skin. Also, henna
typically produces a reddish brown tint, raising questions about
what ingredients are added to produce the varieties of colors
labeled as "henna," such as "black henna" and "blue henna." FDA has
also received reports of allergic reactions to products applied to
the skin that contain henna.
Reporting Adverse Reactions
FDA urges consumers and healthcare providers to report adverse
reactions to tattoos and permanent makeup, problems with removal, or
adverse reactions to temporary tattoos. Consumers and healthcare
providers can register complaints by contacting their FDA district
office (see the blue pages of your local phone directory) or by
contacting FDA's Center for Food Safety and Applied Nutrition (CFSAN)
Adverse Events Reporting System (CAERS) by phone at (301) 436-2405
or by email at.
FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by bxm/dav/cjm July 14, 2006