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U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 3, 1995

TATTOOS and PERMANENT MAKEUP

While temporary and permanent tattoos are subject to regulation as cosmetics and are under the jurisdiction of the Food and Drug Administration; state and local agencies have direct jurisdiction over the practice of tattooing by salon technicians. FDA is currently evaluating the safety of tattoos and permanent makeup as a result of their growing popularity. Among the issues being considered are tattoo removal, adverse reactions to tattoo colors and infections and infectious disease that result from the use of these products.

The inks, or dyes, used for tattoos are color additives. Currently no color additives have been approved for tattoos, including those used in permanent makeup.

Consumers should be aware of some of the risks presented by tattoos and permanent makeup:

1. Unsterile tattooing equipment and needles can transmit infectious disease, such as hepatitis; it is extremely important to confirm that all equipment is clean and sanitary before use;
2. Tattoos and permanent makeup are not easily removed and in some cases may cause permanent discoloration; think carefully before getting a tattoo and consider the possibility of an allergic reaction; and
3. Blood donations cannot be made for a year after getting a tattoo or permanent makeup.

The 1993 FDA Consumer magazine article reprinted below provides additional information on tattooing.

U.S. Food and Drug Administration
FDA Consumer
October 1993

TATTOOING IN THE 90'S:
ANCIENT ART REQUIRES CARE AND CAUTION

by Marilynn Larkin

Tattooing, a technique of marking the skin with colors, has been practiced since antiquity. Now this ancient art form appears to be enjoying a renaissance. Movie and television stars have begun sporting small tattoos on unobtrusive parts of the body, and others are following their lead.

Tattooing also has cosmetic medical explanations, including covering "port wine stains," coloring the skin of people with vitiligo (a disorder that gives the skin a "mottled" appearance because areas have become depigmented), and obscuring color defects in the lips after facial surgery. It is also promoted for "permanent" eyeliner, however, there are safety concerns about this procedure (see "Permanent Eyeliner," which accompanies "Hair Dye Dilemmas" in the April 1993 FDA Consumer).

Although there are no firm statistics, an unpublished 1990 random survey of 10,000 U.S. households revealed that three percent of the population as a whole, and five percent of men surveyed, had tattoos. Brisk sales of tattoo inks also suggest that the number of people receiving tattoos is increasing rapidly, according to a letter in the January 16, 1992, New England Journal of Medicine.

Today's tattoos are applied in one of two ways. "Permanent" tattoos are applied by tattooists using a machine that pierces the skin with needles. "Temporary" tattoos can be applied by anyone by pressing a color-permeated design against the skin with a moistened wad of cotton.

Permanent tattooing is generally safe when done by an experienced tattooist who sterilizes the equipment and follows appropriate sanitation procedures, according to Kris Sperry, M.D., co-founder with tattooist Mick Michieli-Beasley of the Alliance of Professional Tattooists (APT), a nonprofit organization that educates tattooists in proper infection control practices. However, medical complications may occur if the tattooist is careless about cleanliness, or if the person who receives the tattoo doesn't care for the tattooed area properly in the first week or so after it is applied.

Tattooing is illegal in some cities and states, largely because, historically, tattoo parlors often operated without a concern for health and safety, Beasley says. In New York City, for example, tattooing was banned in the mid-1960's after an outbreak of hepatitis B was traced to unsterilized equipment in tattoo parlors. To improve safety, APT organizes seminars for tattooists throughout the country to instruct them in cleanliness and sterilization techniques.

SELECTING A TATTOOIST

The first step when getting a permanent tattoo is to select a good tattooist, according to Beasley. "Tattooing in unsanitary conditions can set the stage for infection of the customer or the tattooist," says Beasley, who is also co-owner of a tattoo parlor.

"'Scratchers' who work out of their kitchen or the back of a van should be scrupulously avoided," adds Sperry, a forensic pathologist in Atlanta, Ga., who has several tattoos. "A tattooist who is genuinely concerned with both his and his customer's health will not risk his livelihood and reputation by failing to follow appropriate health measures."

Beasley and Sperry decided to form APT after meeting with Cathy Backinger, Ph.D., a public health analyst in the Food and Drug Administration's Office of Training and Assistance. In 1988, Backinger developed a resource curriculum for personal service workers - people other than health-care workers whose work puts them in close personal contact with clients, and who may be exposed to a client's blood or risk transmitting blood from client to client. These include people who perform ear piercing, electrolysis, acupuncture, and tattooing.

"Our primary concern was prevention of the transmission of blood- borne pathogens such as human immunodeficiency virus and hepatitis B," Backinger explains. "The curriculum is designed to help state health departments set up courses to educate personal service workers in the techniques of infection control." The curriculum was distributed in 1989 to all state health departments, but not all states have used it as yet, Backinger says.

To help ensure that tattooists were appropriately trained, Beasley and Sperry worked with Backinger to customize the curriculum for tattooists that is presented by APT at national tattoo conventions.

"Our APT guidelines are often more rigorous than those imposed by local health departments," Beasley notes. "Thus, the fact that a tattoo parlor is operating and has not been closed down by the health department does not necessarily mean that the tattooists are following stringent health practices." Tattooists who complete the course receive a certificate. When selecting a tattooist, a consumer can ask whether the tattooist has taken the infection control course and ask to see the certificate.

According to the APT guidelines, these practices should be followed:

Beasley advises visiting several tattoo parlors to see whether the tattooists follow these recommended safety guidelines, and asking questions about cleanliness and sterilization. "If a tattooist refuses to discuss cleanliness and attempts to minimize your concerns, go elsewhere," she says.

APPLYING PERMANENT TATTOOS

Permanent tattoos are applied using a small electric machine with a needle bar that holds from one to 14 needles, each in its own tube. Tattoo needles are regulated by the FDA.

The tattooing machine operates like a mini-sewing machine: The needle bar moves up and down as it penetrates the superficial (epidermis) and middle layer (dermis) of the skin. The tattooist holds the machine steady while guiding it along the skin. The electric current is controlled by a foot switch.

The needles protrude only a couple of millimeters from the tubes, so they don't penetrate deep into the skin. Each needle has it own tube, which enables the needle bar shaft to operate smoothly without damaging the needles. A single needle is used to make fine, delicate lines. A row of needles is used for shading and denser lines.

The end of the needle tube is dipped in a small amount of ink. As the tattooist guides the machine - not the tube - over the skin, the needle moves up and down, puncturing the skin and depositing ink along the way. Excess ink, and the small amount of blood that oozes from the skin puncture, are continuously removed with absorbent tissues.

Before beginning a tattoo, the tattooist, wearing medical latex gloves, inspects the customer's skin to make sure there are no open cuts or scrapes. The skin is sprayed with an antiseptic and the hairs in the area are shaved (the tattooist should immediately dispose of razors in a special container).

The tattooist then makes a stencil transfer of the tattoo outline onto the skin, or draws the outline on the skin with a pen. A thin layer of ointment such as petroleum jelly is spread over the area to be tattooed.

Getting a tattoo can be painful. The severity of the pain depends on the site of the tattoo and the person's level of pain tolerance. Small tattoos (up to three inches) can generally be completed within an hour. Larger ones may take several hours or more, and may be done in more than one sitting.

Once the tattoo is completed, the area is washed with mild soap and water and covered with an antiseptic ointment. Customers are instructed to keep the area clean with soap and water, leave it exposed to the air when possible, and apply a mild hand cream to keep the tattooed area moist until healing is complete (usually seven to ten days).

The tattoo should not be exposed to direct sunlight for at least two weeks to prevent sunburn or pigment changes. Sunscreen should be applied during subsequent sun exposure to prevent fading of pigments. Swimming in fresh, salt or chlorinated pool water is also discouraged during the first few weeks after the application of a tattoo to prevent the pigments from leaching out.

TATTOO INKS

The inks, or dyes, used for tattoos are considered "color additives" under the Federal Food, Drug and Cosmetic Act. The known incidence of adverse reactions or injury from tattoo ink is "minimal," says Allen Halper of FDA's division of cosmetics and colors. However, consumers should be aware that their safety has not been established. FDA is evaluating its role in the regulation of tattoo ink. At present, many states and local health departments regulate tattooing.

The colors used in temporary tattooing, which fade several days after application, also fall under FDA jurisdiction. Although no adverse reactions have been reported to FDA, the agency has issued an "import alert" for several foreign-made temporary tattoos, says Halper. These tattoos 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.

REMOVING TATTOOS

Although tattoos applied to the skin with needles are called "permanent," methods exist to remove them, according to Steven Snyder, M.D., a dermatologist in private practice in Owings Mills, Md.

These techniques include surgical removal; using tissue expanders (balloons inserted under the skin, so when the tattoo is cut away, there is less scarring); dermabrasion, which involves sanding the skin with a wire brush to remove the epidermis and dermis; salabrasion, the use of a salt solution to soak the tattooed skin (sometimes the solution can seep too deeply into the skin and leave an unsightly scar, according to Synder); and scarification, which involves removing the tattoo with an acid solution and creating a scar in its place.

Three lasers, regulated by FDA, are also being used for tattoo removal: the Q-switched ruby laser, the neodymium YAG laser, and the Alexandrite laser. These lasers can remove most color with very little scarring. However, the ruby laser does not work very well in removing red, yellow and orange colors, whereas the YAG laser does not work well on green pigment, according to Snyder.

Another problem with laser removal is called "paradoxical darkening," according to Ray Geronemus, M.D., associate professor of dermatology at NYU Medical Center in New York City. Light colors such as beige, pink and white may turn black when treated by the laser. To circumvent this problem, a small spot of color should be tested first to see whether darkening occurs, he says. If the tattoo ink is available, the laser-ink reaction can be tested in a laboratory dish.

Geronemus suggests that tattoo parlors or clients themselves keep records of the dyes used in their tattoos, including the lot number of each pigment, in case the client later wants the tattoo removed. "This would be like a medical record. Rather than dealing with a hodgepodge of inks, the dermatologist would know exactly what dyes were applied, which can assist in removal," he says.

People considering having a tattoo removed should make sure that the physician they select has training in the use of lasers and other removal techniques, Geronemus cautions. He suggests contacting a local hospital, the American Society for Laser Medicine, or the American Society for Dermatological Surgery for referrals.

Another way to "remove" an undesirable tattoo is to cover it up with another tattoo, notes Sperry. The new tattoo is usually larger than the tattoo it is replacing, incorporating and hiding the previous tattoo in new contours and colors.

Tattoos can also be covered with a special waterproof makeup foundation, according to cosmetologist Maurice Stein, founder of Cinema Secrets, a Burbank, Calif.-based supplier to cosmetologists and medical facilities. Originally developed for use by burn victims and people with skin discolorations, the foundation is also used by people who feel their tattoos are inappropriate in certain situations. "The typical scenario is a woman with a tattoo on her bust line who wears a low-cut dress at a church wedding or other conservative setting. The tattoo can be covered for that particular occasion," Stein says.

Men also use the foundation. "My father had a tattoo he was embarrassed about, so he hardly ever wore short sleeves or went to the beach," Stein says. "Many men who got tattoos during the service are in a similar situation. The foundation allows them to feel more comfortable in public."

Health Risks

Contracting blood-borne illnesses such as hepatitis B or human immunodeficiency virus, which leads to AIDS, is a frequent worry of those considering getting tattooed.

According to Kris Sperry, M.D., a forensic pathologist in Atlanta, Ga., and co-founder of the Alliance of Professional Tattooists, based in Glen Burnie, Md., "If a tattooist follows appropriate cleanliness procedures, and the person who receives a tattoo takes proper care of it, the risk of infection at the site of the tattoo is minimal, and the risk of picking up any type of blood-borne pathogen is virtually nil."

Temporary inflammation around the tattoo is common for the first day or so. As part of the healing process, the skin that is tattooed crusts slightly and peels within the first week after application.

Some people occasionally have an adverse reaction to a particular pigment used in the tattoo, which may result in swelling or itching. This can usually be relieved by using a topical corticosteroid cream and keeping the tattoo out of direct sunlight (which may make the reaction worse).

Hepatitis B, a viral infection, can be transmitted from one customer to another if tattoo needles are inadequately sterilized, says Sperry.

Because HIV may be transmitted through the introduction of contaminated blood or blood products into the body through the skin, "it is theoretically possible that tattooing could transmit this viral disease," Sperry wrote in the January 1992 issue of American Journal of Forensic Medicine and Pathology. "To date, there has not been an unequivocally proven case where tattooing passed the human immunodeficiency virus from one individual to another. However, the prolonged incubation period of AIDS would make documentation of HIV transmission by tattoo difficult. The sterilization techniques commonly used by professional tattooists all adequately kill HIV, but the amateur tattooist who does not sterilize equipment could conceivably transfer HIV with dirty needles."

--M.L.

Marilynn Larkin is a medical writer in New York City.

U.S. Food and Drug Administration
FDA CONSUMER, October 1993