Have received reports of adverse reactions to some henna and black henna tattoos, says the regulator, issues detailed clarification
The USFDA has clarified that henna is a hair dye and not to be used on the skin. This clarification came after it received several complaints about allergic reactions to what it calls “henna” and “black henna” tattoos.
“Henna, a coloring made from a plant, is approved only for use as a hair dye. It is not approved 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. It is unlawful, for example, to introduce an adulterated cosmetic into interstate commerce.
Because 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.” Even brown shades of products marketed as henna may contain other ingredients intended to make them darker or make the stain last longer on the skin,” the regulator has said.
The allergic reaction to black henna in particular, is because of an extra ingredient used to blacken henna which is a coal-tar hair dye containing p-phenylenediamine (PPD), the statement added. It is because of additives such as these that hair dyes often come with a warning to conduct a patch test before use.
FDA has issued warnings against temporary tattoos in the past too.
Henna or mehendi are commonly used in India in various social functions across communities. The system of regulation and reporting of adverse reactions to cosmetics is far more lax in India.
