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.
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.
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.
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.
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.
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."
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 .
See also: Tattoos and Permanent Makeup and
Warning Letters to Industry on Cosmetic-Related Issues