(NOTE: The company name in this letter is being kept confidential. As an expert and historian on henna, Marie Anakee purposely used a black henna product to ascertain the dangers and authoritatively rely the risks to her readers, students and here in this letter, the FDA. A November posting by the FDA concerning henna body art showed they were unaware about the adulterents being used, especially in so called "black henna" products. The lack of an ingredients label was not anticipated however as the box had what looked to be ingredients but turned out to really be company information.)

Office of Cosmetics & Colors
Cosmetics Adverse Reaction Monitoring Program
200 C Street South West
Washington, DC 20204

Dear Mr. Lambert,

I am witing in regards to an adverse reaction I suffered from a product and to enlighten the FDA to a growing problem in America. Specifically the product I used was called "xxxxxxx xxxxx xx xxxxx" and produced by "xxxxxx xxxx xxx" located at xxxx xxxx xxxx xxxxx xxxxx xxx xxxxx xxxx xx xxxxx xxx. The incident occurred back in January of 2000. I used the product on my left hand, as it is a temporary tattoo henna and later suffered a minor reddening of the skin. After seeing this I immediately washed the area throughly. The dark, puplish-black color stained into my skin literally washed off, which I found quite strage. Underneath, the faint color of orange from the henna remained. Concerned, I retrieved the packaging in which the black henna powder was located so that I could read the ingredients label. To my complete surprise, there was no ingredients label. Only the statement, "100% pure henna". By the color of the henna powder, this was obviously untrue. No ingredients were listed on the paper insert either. To this day I have no idea what was in that product.

Near the end of 2000 I sent the FDA 2 (two) letters asking what was being done to monitor additives to henna body art (or temporary tattoo) products and to mention some of the additives I found questionable. I recieved no response. After reading the article "Tattoos & Permanent Makeup" (Nov. 2000) it was clear to me the FDA is not up-to-date on the extreme danger "black henna" products pose the nation. Especially after reading the line "... henna typically produces a reddish brown tint, raising questions about what ingredients are added to produce the varients of color labeled as "henna", such as "black henna" and "blue henna" products". In an attempt to educate both myself and others I investigated what is typically being used in these "black henna" products. This was not easy as many of these products carry no ingredients labels. As observed in the FDA article, henna indeed produces a reddish brown tint, in addition to always having a chalk green powder when in a natural state. Therefore any powder which is already black in color (such as what I used) or produces a black tint would be considered by the FDA's guidelines adulterated. Here is what is commonly used in these "black henna" products:

"Carmine, Barium peroxide, PPD, Silver nitrate, Titanium dioxide, Iron oxide, Ethyl cellulose, Synthetic dye"

I also discovered these "black henna" products are comprised of only 50% henna and 50% color additives (&/or chemicals). I am very disgusted to think one of the above chemicals was likely present in the product I used on my skin. To create public awareness and a banning of such products, I wonder if I should write a formal citizens petition to the FDA concerning this issue? Please advise.

Sincerely yours,

Marie A. Miczak

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