Temporary Tattoos (Including Decal-Type) Are Not Risk Free

On January 23, 2013, in The Tattoo Epidemic: What Are The Health Risks?we discussed FDA and local government regulation of tattooing, the health risks associated with tattoos, and provided Centers for Disease Control and Prevention recommendations to tattoo artists and consumers.

Today, with Spring break and the beach season around the corner, perhaps someone who has been hesitant to get a permanent tattoo is instead thinking about a temporary tattoo. However, according to the FDA, even these temporary tattoos are not free of risk. In fact, problems reported to FDA’s MedWatch program include redness, blisters, raised red weeping lesions, loss of pigmentation, increased sensitivity to sunlight, and even permanent scarring. Some reactions have required medical care, including visits to hospital emergency rooms. These reactions may occur immediately or even up to two or three weeks after application.

Henna-Containing Tattoos

Unlike permanent tattoos, which are injected into the skin, temporary tattoos marketed as “henna” are applied to the skin’s surface. Henna is a reddish-brown color additive made from a flowering plant that grows in tropical and subtropical regions of Africa and Asia. For thousands of years people have used dried henna, ground into a paste, to decorate skin, hair, fingernails, leather, silk and wool. This decorative process, sometimes referred to as mehndi, is still used around the world today. Henna, however, is FDA-approved only for use as a color additive in hair dye (see 21 CFR 73.2190). It is not approved for direct application to the skin, as in the mehndi process.

This unapproved use makes these henna-containing temporary tattoo products adulterated under section 601(e) of the federal Food, Drug & Cosmetic Act (FDCA) [21 U.S.C. 361(e)], in that they are cosmetics and they contain a color additive that is unsafe within the meaning of section 721(a) of the FDCA [21 U.S.C. 379e], and therefore illegal.

In fact, on February 11, 2013, an Import Alert was issued by FDA for henna intended for use on the skin.  The alert allowed FDA district offices to detain, without physical sampling and analysis, all entries of henna-based color products from certain named firms importing from India, Bangladesh, Morocco, Pakistan, Saudi Arabia, and United Arab Emirates.

 Black Henna Inks

Another coloring, called “black henna,” is often used to make the temporary tattoo darker and longer lasting. Inks marketed as black henna may be a mix of henna with other ingredients, or may really be hair dye alone. The use of black henna, however, may be harmful because the extra ingredient used to blacken henna is often a coal-tar hair dye containing p-phenylenediamine (PPD), which can cause dangerous skin reactions in some people. By law, PPD is not permitted in cosmetics intended to be applied to the skin.

The FDA cautions that “black henna” use may occur in some ethnic and specialty shops, on boardwalks, at holiday destinations, or at temporary tattoo kiosks at beaches. The FDA warns that oversight of tattooing varies and while some states have laws and regulations for temporary tattooing, others do not. As a consequence, depending on the state, it is possible that no one has checked to make sure the tattoo artist is following safe practices or even knows what may be harmful. 

Decal-Type Temporary Tattoos

Decal-type temporary tattoos, such as those applied to the skin with a moistened wad of cotton, must contain color additives approved by the FDA for use on the skin. Over the years, however, the FDA has received reports of allergic reactions to some decal-type temporary tattoos. In fact, in late 2011, an Import Alert was issued for several foreign-made temporary tattoos. The Alert was initiated because of numerous trade complaints received from manufacturers and distributors concerning the importation and distribution of temporary skin decals from countries including Taiwan, Japan, the United Kingdom and Hong Kong that either contain unsafe color additives, fail to bear ingredient declarations, or fail to bear an “FDA Approved” statement.

As with permanent tattoos, the FDA urges caution in the use of all temporary tattoos and recommends seeking medical attention and contacting MedWatch if problems are encountered.