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 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 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