Re: UsFDA

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Posted by Catherine Cartwright Jones on July 7, 2001 at 13:07:34:

In reply to: UsFDA posted by Umesh Arora on July 7, 2001 at 10:57:05:

Henna is not approved for use on skin by the FDA. That does not mean
that it is illegal for use on skin, it simply means that it is not
approved. Henna body art is a grey area for the FDA. Until
regulations are changed or clarified, it will remain so. It is, as
far as I can tell, doubtful whether the FDA can or would be inclined
to rule on henna's safety for use on skin. Approval is a lengthy
expensive process, and would probably harm the art more than help it.
(It would open the way for the major cosmetic industries to take
over!)

Presently, there is no particular problem with a person purchasing
plain bulk henna, mixing it herself, according to her own recipe, and
applying it to clients and friends. There is no particular problem
with importing plain 100% pure henna, as long as the package is marked
"henna for hair". Henna is FDA approved for use on hair.

The legal issues come up when there is a pre-made paste manufactured
for purchase to be used in body art, and especially when there are
unlisted (or improperly listed) colorants added to the paste.

It is ILLEGAL to add unlisted, or improperly listed colorants to a
manufactured henna paste for skin and sell sell it. It is absolutely
illegal to add PPD to henna paste to be applied to skin. These
products will be siezed at customs (if they're paying attention.)

Henna paste with the vague labeling "pigments" or "colorants" will
be siezed. That is insufficient. Very few cosmetic colorants are
approved for use on skin. FDA requires that labeling be absolutely
specific, so that people do not inadvertantly use a product that has
something they are allergic to, and that manufacturers are held to a
standard of reliability and accountability.

Increasingly, tubes of henna paste with colorants will be siezed at
customs. Some will get through, of course, because customs really has
far more dangerous things to sort through, like illegal drugs,
endangered species, tainted food products, infested agricultural
products, ... and time and budget has its limits. But, if I were
running a US henna business that depended on import and export, I
would simply chuck colored henna out because the hassle of shipments
getting siezed would be too much of a pain.

Just because people think they want colored henna products doesn't
mean they have to have them. People want lots of things that may be
bad for them, or are sort of useless to begin with. People can be
educated to appreciate the beauty of natural henna!

IMHO, the best thing for henna is to get the information into people's
hands of how to get beautiful dark stains with natural harmless
ingredients and techniques, just mixing their own pastes ... and
concentrate on getting the freshest, finest quality pure henna in
their hands to work with!

Follow Ups

Re: UsFDA Umesh Arora (Divya Products) 19:20:10 7/7/2001 (0)

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: Henna is not approved for use on skin by the FDA. That does not mean : that it is illegal for use on skin, it simply means that it is not : approved. Henna body art is a grey area for the FDA. Until : regulations are changed or clarified, it will remain so. It is, as : far as I can tell, doubtful whether the FDA can or would be inclined : to rule on henna's safety for use on skin. Approval is a lengthy : expensive process, and would probably harm the art more than help it. : (It would open the way for the major cosmetic industries to take : over!) : : Presently, there is no particular problem with a person purchasing : plain bulk henna, mixing it herself, according to her own recipe, and : applying it to clients and friends. There is no particular problem : with importing plain 100% pure henna, as long as the package is marked : "henna for hair". Henna is FDA approved for use on hair. : : The legal issues come up when there is a pre-made paste manufactured : for purchase to be used in body art, and especially when there are : unlisted (or improperly listed) colorants added to the paste. : : It is ILLEGAL to add unlisted, or improperly listed colorants to a : manufactured henna paste for skin and sell sell it. It is absolutely : illegal to add PPD to henna paste to be applied to skin. These : products will be siezed at customs (if they're paying attention.) : : Henna paste with the vague labeling "pigments" or "colorants" will : be siezed. That is insufficient. Very few cosmetic colorants are : approved for use on skin. FDA requires that labeling be absolutely : specific, so that people do not inadvertantly use a product that has : something they are allergic to, and that manufacturers are held to a : standard of reliability and accountability. : : Increasingly, tubes of henna paste with colorants will be siezed at : customs. Some will get through, of course, because customs really has : far more dangerous things to sort through, like illegal drugs, : endangered species, tainted food products, infested agricultural : products, ... and time and budget has its limits. But, if I were : running a US henna business that depended on import and export, I : would simply chuck colored henna out because the hassle of shipments : getting siezed would be too much of a pain. : : Just because people think they want colored henna products doesn't : mean they have to have them. People want lots of things that may be : bad for them, or are sort of useless to begin with. People can be : educated to appreciate the beauty of natural henna! : : IMHO, the best thing for henna is to get the information into people's : hands of how to get beautiful dark stains with natural harmless : ingredients and techniques, just mixing their own pastes ... and : concentrate on getting the freshest, finest quality pure henna in : their hands to work with!
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