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 1/23/07
KNOWN SHIPPERS/MANUFACTURERS
PAKISTAN (PK, 700)
Mohammed Hashin Idgah M.A.
Karachi, Pakistan
MID# PKMOHHASKA R
FEI# 1000474327
Taimoor Enterprises 53C- - -
Flat 28-29 2nd Floor P.M.C. 1/23/07
Khyber Bazar Peshawar
Pakistan
FEI # 3005757794
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