First draft of FDA objection letter -- aka LET'S DO SOMETHING HENNA ADDICTS

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Posted by Alissa on August 16, 2001 at 17:33:54:

In reply to: natural henna and the fda...are we going out of business? posted by Amy:-) on August 15, 2001 at 21:56:13:

I've drafted up a letter of objection to this import alert. This is a
work in progress, but hopefully will help all of us in having
something we can mail to express our dissent. Please let me know if
you think more information should be included, or if you have a more
elegant way of expressing these concepts. Perhaps this letter will be
nothing more than a jumping off point for our more scholarly and
informed henna folks to revise on their own.

But please please (!) if you truly are concerned about this, do
something besides post complaints on the forum. When we fail to
express our discontent on an issue, we have silently endorsed it.

**********************************************************************

U.S. Food and Drug Administration
Office of Cosmetics and Colors
HFS-100
200 C Street SW
Washington, DC 20204

Dear Sir or Madam :

I am writing to express my objection to import alert #53-19 on the
product called henna when used for mehndi, or skin art. This alert
addresses all henna products to be used on the skin, and uses the
following statement to assist in identifying dangerous
substances: “The color additive regulation 21 CFR 73.2190
specifically allows for the safe use of henna in coloring the hair
only. The regulation does not allow for the safe use of henna to make
colored designs directly on the skin, including the hands and feet.
Districts may detain, without physical sampling and analysis, all
entries of henna based color products from the firms listed in the
attachment of this Import Alert.”

This regulation does not take into consideration that products
containing ingredients that are 100% lawsonious inermis, hereafter
referred to as "pure", "unadulterated" or "natural" henna, when used
on the skin as well as the hair poses very little physical risk to
the user – adulterated and unnaturally colored “henna” does. Without
physical sampling or analysis, nor proper product labeling, it is
impossible to differentiate between natural henna, and the chemically
altered, potentially hazardous versions. I hope that increased
information on this subject would allow for a revision which includes
this very important differentiation.

Included on your web page regarding this matter,
http://www.cfsan.fda.gov/~dms/cos-tatt.html, is the following
statement, “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.” This statement is false in that not all henna products
shipped into the United States contain a “color additive” and in fact
natural henna does not need an additive in order to produce an
organic stain on the skin as well as the hair.

Natural henna stains, as correctly described within your web page,
result in a reddish brown color and do not require additives in order
to produce them on the hair or skin, but are instead the result of
hennotannic acid released from the ground leaves of an unadulterated
henna plant. Colored “henna” products, such as blue or
black “henna,” are not of the same class as unadulterated henna and
therefore should not be included in your alert as a substance that
warrants prohibition from entering the United States.

Please note that a far more effective ban would be on products
containing the chemical p-phenylenediamine, also known as PPD, which
is also mentioned on your web site. This non-organic substance, when
mistakenly labeled as “black henna,” has been known to cause skin
lesions, permanent scarring, as well as the risk for liver damage.
The chemical PPD, unlike the hennotannic acid within unadulterated
henna, is known to pass through the epidermal layers and into the
blood stream. This product is extremely dangerous and certainly
warrants investigation by your offices. However, do not make the
mistake of assuming that all henna products contain this, or other
harmful additives.

Correct labeling of all “henna” products, as called for within the
terms of this import alert, would certainly assist import officials,
as well as henna users, in differentiating between organic henna and
the inorganic, adulterated and dangerous “henna” products. Please
take note of my request that you revise import alert #53-19 to allow
products known and labeled as pure henna, that is those containing no
ingredients beyond ground leaves from the henna plant, to continue to
be imported and used within the United States.

I kindly thank you for your assistance in this matter.

Sincerely,

Follow Ups

oh hell... a serious revision of this letter Alissa 17:42:28 8/16/2001 (1)
- Re: the funny thing is Amy :-) 00:07:05 8/17/2001 (0)

Post Followup

Name:
E-Mail:
Subject:
: I've drafted up a letter of objection to this import alert. This is a : work in progress, but hopefully will help all of us in having : something we can mail to express our dissent. Please let me know if : you think more information should be included, or if you have a more : elegant way of expressing these concepts. Perhaps this letter will be : nothing more than a jumping off point for our more scholarly and : informed henna folks to revise on their own. : : But please please (!) if you truly are concerned about this, do : something besides post complaints on the forum. When we fail to : express our discontent on an issue, we have silently endorsed it. : : ********************************************************************** : : U.S. Food and Drug Administration : Office of Cosmetics and Colors : HFS-100 : 200 C Street SW : Washington, DC 20204 : : : Dear Sir or Madam : : : I am writing to express my objection to import alert #53-19 on the : product called henna when used for mehndi, or skin art. This alert : addresses all henna products to be used on the skin, and uses the : following statement to assist in identifying dangerous : substances: “The color additive regulation 21 CFR 73.2190 : specifically allows for the safe use of henna in coloring the hair : only. The regulation does not allow for the safe use of henna to make : colored designs directly on the skin, including the hands and feet. : Districts may detain, without physical sampling and analysis, all : entries of henna based color products from the firms listed in the : attachment of this Import Alert.” : : This regulation does not take into consideration that products : containing ingredients that are 100% lawsonious inermis, hereafter : referred to as "pure", "unadulterated" or "natural" henna, when used : on the skin as well as the hair poses very little physical risk to : the user – adulterated and unnaturally colored “henna” does. Without : physical sampling or analysis, nor proper product labeling, it is : impossible to differentiate between natural henna, and the chemically : altered, potentially hazardous versions. I hope that increased : information on this subject would allow for a revision which includes : this very important differentiation. : : Included on your web page regarding this matter, : http://www.cfsan.fda.gov/~dms/cos-tatt.html, is the following : statement, “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.” This statement is false in that not all henna products : shipped into the United States contain a “color additive” and in fact : natural henna does not need an additive in order to produce an : organic stain on the skin as well as the hair. : : Natural henna stains, as correctly described within your web page, : result in a reddish brown color and do not require additives in order : to produce them on the hair or skin, but are instead the result of : hennotannic acid released from the ground leaves of an unadulterated : henna plant. Colored “henna” products, such as blue or : black “henna,” are not of the same class as unadulterated henna and : therefore should not be included in your alert as a substance that : warrants prohibition from entering the United States. : : Please note that a far more effective ban would be on products : containing the chemical p-phenylenediamine, also known as PPD, which : is also mentioned on your web site. This non-organic substance, when : mistakenly labeled as “black henna,” has been known to cause skin : lesions, permanent scarring, as well as the risk for liver damage. : The chemical PPD, unlike the hennotannic acid within unadulterated : henna, is known to pass through the epidermal layers and into the : blood stream. This product is extremely dangerous and certainly : warrants investigation by your offices. However, do not make the : mistake of assuming that all henna products contain this, or other : harmful additives. : : Correct labeling of all “henna” products, as called for within the : terms of this import alert, would certainly assist import officials, : as well as henna users, in differentiating between organic henna and : the inorganic, adulterated and dangerous “henna” products. Please : take note of my request that you revise import alert #53-19 to allow : products known and labeled as pure henna, that is those containing no : ingredients beyond ground leaves from the henna plant, to continue to : be imported and used within the United States. : : I kindly thank you for your assistance in this matter. : : Sincerely,
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