IA #53-15 - REVISED 1/26/96, IMPORT ALERT #53-15, "AUTOMATIC DETENTION OF
            EYE AREA COSMETICS CONTAINING KOHL, KAJAL, OR ***SURMA***"

NOTE:       This alert has been revised to add an additional name for the
product, create an attachment, and to update the format.  Additional changes are
bracketed by asterisks (***).

TYPE OF ALERT:    Automatic Detention

                  ***(Note:  This import alert contains guidance to FDA field
                  personnel only.  It does not establish any requirements or
                  create any rights or obligations on FDA or on regulated
                  entities.)***

PRODUCT:          Any eye area cosmetic containing Kohl, Kajal, or ***Surma***

PRODUCT CODE:     53C[][][][]

PROBLEM:          Unapproved Colors (UCNC)

PAC FOR
COLLECTION:       29002

COUNTRY:          Germany (DE, 394)
                  ***India (IN, 455)
                  Pakistan (PK, 700)***

MANUFACTURER/
SHIPPER:          See attachment

MANUFACTURER/
SHIPPER I.D.#:    See attachment

IMPORTER'S
I.D. #:           N/A

CHARGE:           "The article is subject to refusal of admission pursuant to
                  Section 801 (a)(3) in that it is not a hair dye and it appears
                  to be, or to bear or contain, a color additive which is unsafe
                  within the meaning of Section 721(a) [Adulteration, Section
                  601(e)]."

                  If the product labeling states or suggests "FDA Approved," add
                  a second charge:

                  "The article is subject to refusal of admission pursuant to
                  Section 801(a)(3) in that its labeling appears to be false or
                  misleading [Misleading, section 403(a)]."

                  If the outer carton labeling (or immediate container labeling
                  in cases where no outer carton exists) fails to bear an
                  ingredient declaration, the following charge should be added:

                  The article is subject to refusal of admission pursuant to
                  Section 801(a)(3) in that the label fails to bear an
                  ingredient declaration in accordance with the requirements of
                  Section 1454(c)(3)(B) of the Fair Packaging and Labeling Act
                  and 21 CFR 701.3."

RECOMMENDING
OFFICE:           DIOP (HFC-170)

REASON FOR
ALERT:            This alert was ***first*** initiated in response to a report
                  from the State of California, Department of Health Services,
                  Food and Drug Branch, concerning the use of eye area cosmetic
                  (e.g., pencils and eyeliners) containing Kohl and/or Kajal.
                  These cosmetics were reportedly being imported from Germany
                  and are labeled as having "FDA approval."

                  ***A subsequent report received from the New York State
                  Department of Health indicated that Surma, a powdered eye area
                  product manufactured and used in Pakistan, India, and other
                  Middle Eastern countries, was believed to be the source of
                  lead poisoning in a young child.  Available reference
                  materials indicate that the Indian colorant "Surma" is also
                  known in Arab countries as Kohl.

                  The products generally bear limited English language labeling.
                  They are frequently imported in personal baggage and are being
                  sold in stores that specialize in Middle Eastern commodities.

                  There are no color additive regulations allowing for the use
                  of these substances in cosmetics.  Furthermore, the use of
                  these colors may present a hazard to health because of their
                  heavy metal content (i.e., they may contain more than
                  acceptable trace levels of lead).***

GUIDANCE:         ***Districts may detain, without physical examination, eye
                  area cosmetics which contain Kohl, Kajal, ***Surma*** or lack
                  an ingredient declaration.

                  For eye area cosmetics that bear ingredient declarations,
                  automatically detain only those products that list colors not
                  ***specifically*** permitted ***by color additive
                  regulation*** for use in the area of the eye.

                  ***For questions or issues concerning science, science policy,
                  sample collection, analysis, preparation, or analytical
                  methodology, contact the Division of Field Science at (301)
                  443-3320 or 3007.***

PRIORITIZATION
GUIDANCE:         I

FOI:              No purging required.

KEYWORDS:         Kohl, Kajal, ***Surma***, ***Cosmetics***, Color additive, Eye
                  area cosmetics, Lead

PREPARED BY:      Ted Poplawski, DIOP, 301-443-6553

DATE LOADED
INTO FIARS:       January 26, 1996
              ATTACHMENT FOR IMPORT ALERT #53-15  REVISED 1/26/96

                         KNOWN SHIPPERS/MANUFACTURERS


                              PAKISTAN (PK, 700)

Mohammed Hashin Idgah M.A.
Karachi, Pakistan
MID# PKMOHHASKA R
FEI# 1000474327