FDA researchers are exploring the safety of tattoo inks.

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www.fda.gov/consumer/features/tattoos120607.html Consumer Health Information P"(t( by Mad($a Yama$awa f(* FDA 1 / FDA Consumer Health Information / U.S. Food and Drug Administration DECEMBER 6, 2007 Permanent tattoos are made by using needles to inject colored ink below the skin 9s sur&ace. Permanent make-up is considered a permanent tattoo that mimics the results o& cos- metic products such as an eyebrow pencil, lip liner, eyeliner, or blush.

While state and local authorities oversee the practice o& tattooing, ink and ink colorings (pigments) used in tattoos are subject to FDA regula- tion as cosmetics and color additives. However, because o& other public health priorities and a previous lack o& evidence o& sa&ety concerns, FDA has not traditionally regulated tattoo inks or the pigments used in them. FDA has received reports o& bad reactions to tattoo inks right a&ter tattooing or even years later.

Some people report itchy or in amed skin around their tattoos in the summer when they 9ve been out in the sun. Recent reports associated with per- manent make-up inks have prompted FDA to study tattoo ink sa&ety. cOur hope is to get a better understanding o& the body 9s response to tattoos and their impact on human health, and to ... more. less.

identi&y products at greatest risk, d says Linda Katz, M.D., M.P.H., Director o& FDA 9s O&fce o& Cosmetics and Colors in the Center &or Food Sa&ety and Applied Nutrition. What are the Risks? " Infection 3 Dirty needles can pass in&ections, like hepatitis and HIV, &rom one person to another. " Allergies 3 Allergies to various ink pigments in temporary tattoos have been reported and can cause problems. " Scarring 3 Unwanted scar tissue may &orm when getting or removing a tattoo. " Granulomas 3 These small knots or bumps may &orm around material that the body perceives as &oreign, such as particles o& tattoo pigment. " MRI complications 3 People may Think BeFore You ink Are Tattoos Safe? A s t" f p(p-la*#ty (f tatt((s c('t#'- fs t( g*(w, s( d( fs t" f c('c f*' ab(-t p(t f't#al *#s$s. S(m f *#s$s, s-c" as t" f sp* fad (f #'f fct#('s t"*(-g" t" f -s f (f -'st f*#l#z fd ' f fdl fs, "av f l('g b f f' $'(w'. B-t w"at #s' 9t cl fa* #s t" f saf fty (f tatt(( #'$s. TATTOO TIPS 1. n( tatt(( #'$ p#gm f'ts "av f b f f' FDA app*(v fd. 2. Tatt(( * fm(val #s t#m f c('s-m#'g, c(stly, a'd d( fs' 9t always w(*$. 3. D(' 9t -s f d(-#t-y(-*s flf tatt(( * fm(val p*(d-cts. 4. C('s-lt y(-* " falt" ca* f p*(v#d f*, '(t a tatt(( pa*l(*, ab(-t tatt(( * fm(val. 5. D(' 9t av(#d a' Mri #f y(- ' f fd (' f. www.fda.gov/consumer/features/tattoos120607.html Consumer Health Information 2 / FDA Consumer Health Information / U.S. Food and Drug Administration DECEMBER 6, 2007 have swelling or burning in the tattoo when they have magnetic resonance imaging (MRI). This happens rarely and does not last long. Tattoo Ink Research In a laboratory within FDA 9s Arkan- sas-based National Center &or Toxi- cological Research (NCTR), research chemist Paul Howard, Ph.D., and his team are investigating tattoo inks to fnd out " the chemical composition of the inks and how they break down (metabolize) in the body; " the short-term and long-term sa&ety o& pigments used in tattoo inks; " how the body responds to the interaction o& light with the inks. cThere have been no systematic studies o& the sa&ety o& tattoo inks, d says Howard, cso we are trying to ask 4and answer 4some &undamen- tal questions. d For example, some tattoos &ade over time or &ade when they are exposed to sunlight. And laser light is used to remove tattoos. cWe want to know what happens to the ink, d says Howard. cWhere does the pigment go? d NCTR researchers are exploring several possibilities: " The body cells may digest and destroy the ink, just as they rid the body o& bacteria and other &oreign matter as a de&ense against in&ection. NCTR studies show that a common pigment used in yellow tattoo inks, Pigment Yellow 74, may be broken down by enzymes, or metabolized. cJust like the body metabolizes and excretes other substances, the body may metabolize small amounts o& the tattoo pigment to make it more water soluble, and out it goes, d says Howard. " Sunlight may cause the ink to break down so it is less visible. NCTR researchers have &ound that Pigment Yellow 74 decomposes in sunlight, breaking down into components that are colorless. The pigment components may still be there, says Howard, and we don 9t know i& these are potentially toxic. " The skin cells containing the ink may be killed by sunlight or laser light and the body may excrete the dead cells or may disperse ink breakdown products through the body. Research has also shown that some pigment migrates &rom the tattoo site to the body 9s lymph nodes, says Howard. Lymph nodes are part o& the lymphatic system, a collection o& uid-carrying vessels in the body that flter out disease-causing organ- isms. Whether the migration o& tat- too ink has health consequences or not is still unknown. NCTR is doing &urther research to answer this and other questions about the sa&ety o& tattoo inks. Tattoo Tips for Consumers Ink " FDA has not approved any tattoo inks &or injection into the skin, and many ink pigments used are industrial strength colors suitable &or printers 9 ink or automobile paint. " The use of henna in temporary tattoos has not been approved by FDA. Henna is approved only &or use as a hair dye. Similar to other inks, the use o& ultraviolet (UV) ink &or glow-in-the-dark tattoos also has not been approved by FDA. Permanence " Consider tattoos permanent. Removal is time-consuming, costly, and doesn 9t always work. The most common method o& tattoo removal is by laser treatment, which delivers short ashes o& light at very high intensities to the skin to break down the tattoo ink. FDA allows several types o& lasers to be marketed &or tattoo removal. Some color inks are harder to remove than others. Many repeat visits every several weeks may be required to remove a tattoo, and it may never be entirely gone. " Do not buy or order online do-it- yoursel& tattoo removal products. These acid-based products are not FDA-approved and can cause bad skin reactions. " Consult your health care provider 4not a tattoo parlor 4i& you want a tattoo removed. The American Society &or Laser Medicine and Surgery ( http://www. aslms.org/index.shtml ) can help you fnd a doctor experienced in tattoo removal. Don 9t Avoid an MRI " If you need to have an MRI done, don 9t avoid it. In&orm the radiologist or technician that you have a tattoo so appropriate precautions can be taken. For More Information www.fda.gov/oc/opacom/hottopics/ tattoos.html Consider tattoos permanent. Removal is time-consuming, costly, and doesn 9t always work.

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