Import Alert 53-14
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 53-14
Published Date: 04/07/2013
Type: DWPE
Import Alert Name:
"Intensified Coverage of Temporary Tattoos Containing Non-Permitted Color Additives and/or Failing to Bear Ingredient Declaration"
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.
Guidance:
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 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.
Product Description:
Temporary Tattoos (Skin Decals)
Charge:
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)]."
OASIS charge code - UNSAFE COL
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)]."
OASIS charge code - COSM MISB2
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]."
"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)]."
OASIS charge code - UNSAFE COL
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)]."
OASIS charge code - COSM MISB2
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]."
CHINA
Jia Shi Ele Co Ltd
Date Published : 12/08/2011
Tang Xia Town Dongguan , Dongguan, CHINA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/08/2011
Desc:Fashion Angels Tattoo Kit
Notes:Product labeling declares Rhodamine 6G; CI 45160 and glitter particles.
Notes:Product labeling declares Rhodamine 6G; CI 45160 and glitter particles.
Silver Fair
Date Published : 09/18/2009
8 On Yip Street , Chai Wan, CHINA
53 Y Y - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009
Notes:9/5/06; temporary tattoos; lacks ingredient declaration
TAIWAN
Chiou Her Ent Co Ltd
Date Published : 09/30/2009
27 Ln 42 Sec 2 Kwang Fu Rd , San Chung City, TAIWAN
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/30/2009
Desc:Disney Camp Rock and Disney Fairies Glitter Temporary Tattoos
Notes:Labeling declares Yellow #12; Yellow #13; Red #74; Heliogen; Carbon Black - non-permitted colors 5/22/09
Notes:Labeling declares Yellow #12; Yellow #13; Red #74; Heliogen; Carbon Black - non-permitted colors 5/22/09
Gala Land Ltd
Date Published : 09/18/2009
398 Chung Sham Rd , Taiwan, TAIWAN
53 Y Y - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009
Notes:temporary tatoo; 3/26/04
Long King Printing
Date Published : 09/18/2009
No.1 Lane 30 Kuang Fu , Sanchung, TAIWAN
53 Y Y - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009
Notes:9/5/06; temporary tattoo; lacks ingredient declaration
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