The inks used in tattoos and permanent makeup (also known as micropigmentation) and the
pigments in these inks are subject to FDA regulation as cosmetics and color additives.
However, FDA has not attempted to regulate the use of tattoo inks and the pigments used in
them and does not control the actual practice of tattooing. Rather, such matters have been
handled through local laws and by local jurisdictions.
But with the growth in popularity of tattooing and permanent makeup, FDA has begun
taking a closer look at related safety questions. Among the issues under consideration are
tattoo removal, adverse reactions to tattoo colors, and infections that result from tattooing.
Another concern is the increasing variety of pigments and diluents being used in
tattooing -- more than fifty different pigments and shades, 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
What Risks Are 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 hepatitis. The risk of infection is the reason the American
Association of Blood Banks requires a one-year wait between getting a tattoo and donating
It is extremely important to make sure that all tattooing equipment is clean and sterilized
before use. Even if the needles are sterilized or never have been used, it is important
to understand that in some cases the equipment that holds the needles cannot be sterilized
reliably due to its design. In addition, the person who receives a tattoo must be sure to
care for the tattooed area properly during the first week or so after the pigments are
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. See "The Most Common Problem:
Dissatisfaction" and "Removal Techniques," below.
Allergic reactions.Although allergic reactions to tattoo pigments are rare,
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
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. Keloids
may form any time you injure or traumatize your skin, and according to Office of Cosmetics
and Colors (OCAC) dermatologist Ella Toombs, M.D., tattooing or micropigmentation is a form
of trauma. 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
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 some pigments.
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, avoid complications, and assure the best results.
The Most Common Problem: Dissatisfaction
According to Dr. Toombs, the most common problem that develops with tattoos is the
desire to remove them. Removing tattoos and permanent makeup can be very difficult.
Skill levels vary widely among people who perform tattooing. According to an article by
J.K. Chiang, S. Barsky, and D.M. Bronson in the June 1999 issue of the Journal of the
American Academy of Dermatology, the main complication with eyelid tattooing is
improperly placed pigment. You may want to ask the person performing the procedure for
references and ask yourself how willing you are to risk permanently wearing someone else's
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.
Methods for removing tattoos include laser treatments, abrasion, scarification, and
surgery. Some people attempt to camouflage an objectionable tattoo with a new one. Each
approach has drawbacks:
Laser treatments can lighten many tattoos, some more easily and effectively than others.
Generally, several visits are necessary over a span or weeks or months, and the treatments
can be expensive. Some individuals experience hypopigmentation -- a lightening of the
natural skin coloring -- in the affected area. Laser treatments also can cause some tattoo
pigments to change to a less desirable shade.
Unfortunately, knowing what pigments are in your tattoo or permanent makeup has always been
difficult and has become more so as the variety of tattoo inks has multiplied. Inks are
often sold by brand name only, not by chemical composition. Because the pigments are sold
to tattoo parlors and salons, not on a retail basis to consumers, manufacturers are not
required by law to list the ingredients on the labels. Furthermore, because manufacturers
may consider the identity and grade of their pigments "proprietary," neither the tattooist
nor the customer may be able to obtain this information.
There also have been reports of individuals suffering allergic reactions after laser
treatments to remove tattoos, apparently because the laser caused allergenic substances in
the tattoo ink to be released into the body.
Dermabrasion involves abrading layers of skin with a wire brush or diamond fraise (a type
of sanding disc). This process itself may leave a scar.
Salabrasion, in which a salt solution is used to remove the pigment, is
sometimes used in conjunction with dermabrasion, but has become less common.
Scarification involves removing the tattoo with an acid solution and creating
a scar in its place.
Surgical removal sometimes involves the use of tissue expanders (balloons
inserted under the skin, so that when the tattoo is cut away, there is less scarring).
Larger tattoos may require repeated surgery for complete removal.
Camouflaging a tattoo entails the injection of new pigments either to form a
new pattern or cover a tattoo with skin-toned pigments. Dr. Toombs notes, however, that
injected pigments tend not to look natural because they lack the skin's natural
According to OCAC Consumer Safety Officer Allen Halper, 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
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."
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. The
agency operates the Cosmetics Adverse Reaction Monitoring (CARM) system to monitor
problems consumers experience with cosmetic products and ingredients, including color
additives. Consumers and healthcare providers can register complaints by contacting their
FDA district office (see the blue pages of your local phone directory) or by sending
written reports of adverse reactions to:
Office of Cosmetics and Colors
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835