FDA has issued import alerts and warning letters when manufacturers have violated the law.
SILVER SPRING, Md., June 19, 2018 /PRNewswire/ -- Summer vacation season is here… time to hit the beach and perhaps indulge in a little harmless fun. What about getting a black henna temporary tattoo? Who could it hurt? It could hurt you.
Learn more:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm343932.htm
http://www.fda.gov/cosmetics/productsingredients/products/ucm108569.htm
A henna tattoo is temporary, but that doesn’t mean it’s risk free. This is especially true if you use “black henna,” which can cause serious skin reactions.
For centuries, traditional henna, a reddish-brown plant extract, has been used around the world. Henna, a coloring made from a plant, is safe and permitted for coloring hair in the United States, but not for the skin or areas around the eyes.
You may find “black henna” in temporary tattoo kiosks at beaches, boardwalks, holiday destinations, and ethnic or specialty shops. Oversight for tattoo parlors and artists differs from state to state. While the U.S. Food and Drug Administration (FDA) does not regulate the practices of tattooing, it does monitor product safety problems. FDA has issued import alerts and warning letters when manufacturers have violated the law. Enforcement can include product seizure and legal actions.
“Black henna” has been marketed for application on the skin’s surface as a form of temporary tattoo. However, inks marketed as “black henna” - or sometimes improperly called “henna” - can potentially be harmful because they may contain other ingredients, most often p-phenylenediamine (PPD), which can cause dangerous sensitization reactions in some people. Coal tar hair dyes that contain PPD are required by law to have a caution statement and directions to patch test before use. However, PPD, by law, is not permitted in cosmetics intended for direct application to the skin.
Too many consumers have learned the risks of using “black henna” the hard way. Dozens have reported their bad reactions to FDA, but it is believed that many more problems have gone unreported. Some experienced reactions immediately after the application of “black henna” temporary tattoos; in others, reactions occurred up to two or three weeks later. Reports of problems have included (but are not limited to): redness, blisters, raised red weeping lesions, loss of pigmentation, increased sensitivity to sunlight, and even permanent scarring. Some reactions have led to emergency room visits and prolonged skin sensitivity.
Some people may experience cross-sensitization, meaning that because of a previous exposure and bad reaction to one chemical, they become sensitized (allergic) to related compounds, such as rubber and other latex products, certain medications, hair dye ingredients, and textile dyes. When exposed to one of these products, a person may develop a rash or other allergic reactions.
If you have a reaction to “black henna” or any other tattoo, contact your health care professional. Also, please contact FDA’s Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or http://www.fda.gov/Safety/MedWatch/default.htm) or an FDA consumer complaint coordinator (http://www.fda.gov/safety/reportaproblem/consumercomplaintcoordinators).
Contact: Media: 1-301-796-4540; Consumers: 1-888-SAFEFOOD (toll free)
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SOURCE U.S. Food and Drug Administration
