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IA #53-14 - 5/23/94, "Intensified Coverage of Temporary Tattoos Containing
           Non-Permitted Color Additives and/or Failing to Bear
          Ingredient Declarations" Attachment 3/26/04

TYPE OF ALERT  :    Intensified Coverage

PRODUCT        :    Temporary Tattoos (Skin Decals)

PRODUCT CODE   :    53YY--99

CODE           :    4908.90.0000

PROBLEM        :    Unapproved Colors/Lack of Ingredient Declaration

PAC            :    29002

COUNTRY        :    Various to include Taiwan, United Kingdom, Japan and
                    Hong Kong

SHIPPER        :    N/A

SHIPPER I.D.#  :    N/A

CHARGES        :    If the ingredient declaration lists colors that are not
                    permitted for use in cosmetic products the following charge
                    should be used:

               "The article is subject to refusal of admission pursuant to
               Section 801(a)(3) in that it appears 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"

               "The article is subject to refusal of admission pursuant to
               Section 801(a)(3) in that it appears that its labeling is
               false or misleading in any particular [Misbranding, Section

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

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

OFFICE         :    Division of Import Operations and Policy, HFC-170 and
                    CFSAN/Office of Cosmetics and Colors/Division of Programs
                    and Enforcement Policy, HFS-105.

ALERT          :    This alert was initiated in response to numerous trade
                    complaints received from manufacturers and distributors
                    concerning the importation and distribution of temporary
                    tattoos (skin decals) from countries including Taiwan,
                    Japan, the United Kingdom and Hong Kong that either contain
                    unsafe color additives, fail to bear ingredient
                    declarations, and/or bear an "FDA Approved" statement.

INSTRUCTIONS   :    Intensified coverage of all temporary tattoo entries is
                    indicated. Detain temporary tattoos (skin decals) which
                    appear to contain unsafe color additives, non-permitted
                    colors, lack an ingredient declaration, and/or bear an "FDA
                    Approved" statement.

               For temporary tattoos that bear ingredient declarations,
               detain only those products which list unsafe color
               additives, i.e., those additives that are not used in
               conformity with a regulation issued pursuant to Section

               No color additive analyses are required for detention of
               temporary tattoo products in cases where labels bear
               ingredient declarations indicating that colors other than
               those permitted by color additive regulations are being

                    For further guidance contact Allen R. Halper, Office
                    of Cosmetics and Colors, HFS-105 at (202) 205-4602.

GUIDANCE       :    III

FOI            :    No purging is required.

KEYWORDS       :    Temporary Tattoos, Skin Decals, Unapproved Colors,
                    Ingredient Declarations, Non-permitted color additives,
                    Unsafe color additives, Tattoos

                    Attachment          3/26/04

                               TAIWAN (TW)

Firm Name and Address:             Product/Product Code:

Gala Land Ltd.                      Temporary tattoos
398 Chung Sham Road                     53Y[]99
Taiwan, Republic of China               03/26/04
FEI# 3004158496