FDA Warning: Henna Tattoos More Dangerous than Most People Realize | DC Metro Area Personal Injury Law Blog

Late Summer is a season of carnivals, festivals and open-air malls — all venues where thousands of young people receive popular black henna tattoos each year.  While popular opinion holds that the brushed-on tattoos must be safer than traditional needle-and-ink versions, that isn’t necessarily the case.  The U.S. Food and Drug Administration (FDA) receives many reports each year of adverse reactions to henna tattoos, many of which are attributed to exposure to p-phenylenediamine (also known as PPD) — a dangerous black dye used to produce henna ink.

According to experts, each exposure to PPD re-challenges the immune system, so each time a person gets a black henna tattoo, there is an increased risk of having an adverse reaction.  Many people are sensitized to PPD, but don’t have a reaction to it.  However, each time a person is exposed to black henna  his or her risk of developing a lifelong allergy to PPD increases.

Some people become sensitized to PPD from just one exposure, and can even develop an allergy that can cause cross lifelong reactions to certain medications.

The FDA offers the following Questions and Answers related to henna tattoos:

“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, the 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 the 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. Here’s how:

• To contact your nearest FDA district office, you can find their phone numbers on FDA’s Web site. These phone numbers also are included in the U.S. Government listings in the Blue Pages of the phone book under United States Government/Health and Human Services.
• To contact FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), call (301) 436-2405 or email writemail (‘CAERS’, ‘cfsan.fda.gov’, ‘[email protected]’)[email protected].”

Previously on the DC Metro Area Personal Injury Law Blog, we have posted articles related to:

• Tattooing safety considerations
• Body art precautions from the FDA and AMA
• Sun exposure tips for kids

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at (202) 960-4596.