IA #53-14 - 5/23/94, "Intensified Coverage of Temporary Tattoos Containing
Non-Permitted Color Additives and/or Failing to Bear
Ingredient Declarations" Attachment 9/5/06
TYPE OF ALERT : Intensified Coverage
PRODUCT : Temporary Tattoos (Skin Decals)
PRODUCT CODE : 53YY--99
HARMONIZED
CODE : 4908.90.0000
PROBLEM : Unapproved Colors/Lack of Ingredient Declaration
PAC : 29002
COUNTRY : Various to include Taiwan, United Kingdom, Japan and
Hong Kong
MANUFACTURER/
SHIPPER : N/A
MANUFACTURER/
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)].
and/or
If the product labeling states or suggests "FDA Approved"
charge:
"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
602(a)].
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].
RECOMMENDING
OFFICE : Division of Import Operations and Policy, HFC-170 and
CFSAN/Office of Cosmetics and Colors/Division of Programs
and Enforcement Policy, HFS-105.
REASON FOR
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
721(b).
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
used.
For further guidance contact Allen R. Halper, Office
of Cosmetics and Colors, HFS-105 at (202) 205-4602.
PRIORITIZATION
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 9/5/06
CHINA (CN)
FIRM PRODUCT/PC PROBLEM:
Silver Fair Temporary Tattoos Lacks ingredient
8 on Yip Street 53Y[][]99 declaration
Chai Wan, China 9/5/06
FEI #3005735364
TAIWAN (TW)
Firm Name and Address: Product/Product Code: Problem:
ABC Cosmos Trading Co. Ltd Glitter Tattoo Temporary lacks ingredients
8F, No. 33, Sec. 2 Chien 53Y[][]99 declaration
Kuo N. Road 2/7/05
Taipei, Taiwan
FEI #3002616624
Gala Land Ltd. Temporary tattoos
398 Chung Sham Road 53Y[]99
Taiwan, Republic of China 3/26/04
FEI #3004158496
Long King Printing Temporary Tattoos Lacks ingredient
No. 1 Lane 30 Kuang Fu 53Y[][]99 declaration
Sanchung, Taiwan 9/5/06
FEI #3005735366
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