Ink: The Not-Just-Skin-Deep Guide to Getting a Tattoo
by Ph.D., Terisa Green 
For virgins or the heavily tattooed, whether you're looking for an anklet or a back piece, this is the exhaustive & indispensable guide to making the best possible choices when it comes to getting inked. Think Before You Ink


Temporary Tattoos & Henna/Mehndi

April 18, 2001; Updated September 18, 2006

FDA has received reports of adverse reactions to some temporary skin-staining products. The following information is intended to respond to questions about the safety and legality of such products.

What about "decal"-type temporary tattoos?

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Many contain color additives approved for cosmetic use on the skin. However, FDA has received reports of allergic reactions to some temporary tattoos.

An import alert is in effect for several foreign-made temporary tattoos. According to Consumer Safety Officer Allen Halper of FDA's Office of Cosmetics and Colors, the temporary tattoos subject to the import alert are not allowed into the United States because they don't have the required ingredient declaration on the label or they contain colors not permitted for use in cosmetics applied to the skin.

What about henna, or mehndi?

Henna, a coloring made from a plant, is approved only for use as a hair dye, not for direct application to the skin, as in the body-decorating process known as mehndi. This unapproved use of a color additive makes these products adulterated and therefore illegal. An import alert is in effect for henna intended for use on the skin. FDA has received reports of injuries to the skin from products marketed as henna.

Since henna typically produces a brown, orange-brown, or reddish-brown tint, other ingredients must be added to produce other colors, such as those marketed as "black henna" and "blue henna." So-called "black henna" may contain the "coal tar" color p-phenylenediamine, also known as PPD. This ingredient may cause allergic reactions in some individuals. The only legal use of PPD in cosmetics is as a hair dye. It is not approved for direct application to the skin. Even brown shades of products marketed as henna may contain other ingredients intended to make them darker or make the stain last longer.

In addition to color additives, these skin-decorating products may contain other ingredients, such as solvents.  

How do I know what's in a temporary tattoo or henna/mehndi product?

Cosmetics including temporary skin-staining products that are sold on a retail basis to consumers must have their ingredients listed on the label. Without such an ingredient declaration, they are considered misbranded and are illegal in interstate commerce. FDA requires the ingredient declaration under the authority of the Fair Packaging and Labeling Act (FPLA).

Because the FPLA does not apply to cosmetic samples and products used exclusively by professionals--for example, for application at a salon, or a booth at a fair or boardwalk--the requirement for an ingredient declaration does not apply to these products.

Does FDA approve color additives?

By law, except for coal tar colors used in hair dyes, color additives used in cosmetics must be approved by FDA for their intended uses. Some may not be used unless FDA has certified in its own labs that the composition of each batch meets the regulatory requirements. Cosmetics--including temporary tattoo products--that do not comply with restrictions on color additives are considered adulterated and are illegal in interstate commerce.

Does FDA approve other cosmetic ingredients?

Except for color additives, FDA does not have the authority to approve cosmetic products or ingredients, although the use of several substances in cosmetics is prohibited or restricted due to safety concerns. However, if the safety of the product or its ingredients has not been substantiated, the product is misbranded--and therefore illegal in interstate commerce--if it does not have this warning on the label:

"Warning-The safety of this product has not been determined."

How do I report an adverse reaction to a temporary tattoo or other cosmetic?

FDA encourages consumers to report any adverse reactions to cosmetics either to their nearest FDA district office or to FDA's Office of Cosmetics and Colors. You can use the contact information in Your Guide to Reporting Problems to FDA.

Related Links:
Our pages are created to provide medically accurate information that is intended to complement, not replace or substitute in any way the services of your physician. Any application of the recommendations set forth in the following pages is at the reader's discretion and sole risk. Before undergoing medical treatment, you should consult with your doctor, who can best assess your individual needs, symptoms and treatment. 
Color additives are subject to a strict system of approval under U.S. law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21 U.S.C. 379e]. 
Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product. More>
Does the FDA control tattoos?
Most states, cities, or towns oversee tattooing or permanent make-up practices, such as using clean equipment. Tattoo inks themselves are cosmetics and by federal law, the colors used in them must be shown to be safe. However, none is approved and the inks used in tattooing have not been strictly regulated by the FDA. The FDA is trying to find out why some women had bad reactions to certain permanent make-up inks. When more is known, FDA will decide what action to take to make tattooing safer.

Tattoos and piercings: What to know beforehand - Find out what risks tattoos and piercings pose, ways to protect yourself and what to do if you no longer want the body art.
How to report a bad reaction or report a complaint?
You can report it to your FDA district office, listed in the blue pages of your phone book, or FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS) in one of the following ways:
• By phone at 1-800-FDA-1088
• By email at CAERS@cfsan.fda.gov
For related information on infections from tattooing, see the following documents from the Centers for Disease Control: Viral Hepatitis B Fact Sheet and "Methicillin-Resistant Staphylococcus aureus Skin Infections Among Tattoo Recipients --- Ohio, Kentucky, and Vermont, 2004-2005"