Import Alert 45-02
(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 # 45-02
Published Date: 12/21/2010
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors"
Reason for Alert:
This revision to Import Alert #45-02 incorporates import alerts previously issued for illegal or undeclared food color additives.
There continues to be a large number of detentions for illegal and undeclared food color additives. In FY-93, there were more than 450 detentions of products for illegal or undeclared color additives, from approximately 35 countries.
There continues to be a large number of detentions for illegal and undeclared food color additives. In FY-93, there were more than 450 detentions of products for illegal or undeclared color additives, from approximately 35 countries.
Guidance:
* The attachmnet for this alert identifies manufacturers and products, by country, subject to detention without physical examination under this Import Alert, and the undeclared or illegal colors found in such products.
The Green List identifies manufacturers and products, by country, exempted from detention without physical examination of products.
Districts may detain without physical examination all products that appear on the attachment for this alert. If the product is shown as containing an illegal color, detain the product with charge (1). If the product is shown as containing an undeclared color additive, detain the product with charge (2).
When districts encounter violative shipments of products for illegal and/or undeclared color, recommendation for detention without physical examination and accompanying information, including laboratory worksheets, should be forwarded to DIOP, HFC-170. DIOP, in turn, will coordinate with CFSAN.
* Products which list a non-permitted color on the label may be detained without physical examination. Recommendations for detention without physical examination should be forwarded to DIOP, HFC-170, along with the label and invoice. Refer to IOM Appendix A for the Color Additive Status List.
Products which contain illegal color additives are adulterated and
cannot be reconditioned.
FOREIGN COLOR DESIGNATIONS
Foods which contain EEC or other foreign food color designations should be detained with the illegal color charge (1) above. These colors do not originate from FDA certified lots as required by U.S. regulations. When used in foods presented for entry into the U.S., colors subject to certification must originate from FDA certified lots. If FDA certification lot numbers are provided, the numbers can be confirmed by FDA/CFSAN's Office of Cosmetics and Colors, Color Certification Branch.
OTHER ALERTS
Dried, preserved fruit from Hong Kong, PROC, Taiwan, and Singapore should be detained without physical examination, where appropriate,under IA #21-04. Dried preserved fruit products from these countries have been found to contain illegal and undeclared colors, in addition to filth and non-nutritive sweeteners.
Vanilla products from Mexico, Philippines, Dominican Republic,and Haiti have been found to contain coumarin and/or FD&C Red #2.Vanilla products from these countries should be covered as instructed in IA #28-07.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605 begin_of_the_skype_highlighting (301) 827-7605 end_of_the_skype_highlighting.
The Green List identifies manufacturers and products, by country, exempted from detention without physical examination of products.
Districts may detain without physical examination all products that appear on the attachment for this alert. If the product is shown as containing an illegal color, detain the product with charge (1). If the product is shown as containing an undeclared color additive, detain the product with charge (2).
When districts encounter violative shipments of products for illegal and/or undeclared color, recommendation for detention without physical examination and accompanying information, including laboratory worksheets, should be forwarded to DIOP, HFC-170. DIOP, in turn, will coordinate with CFSAN.
* Products which list a non-permitted color on the label may be detained without physical examination. Recommendations for detention without physical examination should be forwarded to DIOP, HFC-170, along with the label and invoice. Refer to IOM Appendix A for the Color Additive Status List.
Products which contain illegal color additives are adulterated and
cannot be reconditioned.
FOREIGN COLOR DESIGNATIONS
Foods which contain EEC or other foreign food color designations should be detained with the illegal color charge (1) above. These colors do not originate from FDA certified lots as required by U.S. regulations. When used in foods presented for entry into the U.S., colors subject to certification must originate from FDA certified lots. If FDA certification lot numbers are provided, the numbers can be confirmed by FDA/CFSAN's Office of Cosmetics and Colors, Color Certification Branch.
OTHER ALERTS
Dried, preserved fruit from Hong Kong, PROC, Taiwan, and Singapore should be detained without physical examination, where appropriate,under IA #21-04. Dried preserved fruit products from these countries have been found to contain illegal and undeclared colors, in addition to filth and non-nutritive sweeteners.
Vanilla products from Mexico, Philippines, Dominican Republic,and Haiti have been found to contain coumarin and/or FD&C Red #2.Vanilla products from these countries should be covered as instructed in IA #28-07.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605 begin_of_the_skype_highlighting (301) 827-7605 end_of_the_skype_highlighting.
Product Description:
Foods/food products
Charge:
(1) Illegal Color Additives: "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 402(c)]."
OASIS charge code - UNSAFE COL
(2) Undeclared Color Additives: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an undeclared artificial color additive [Misbranding, Section 403(k)]."
OASIS charge code - COLOR LBLG
OASIS charge code - UNSAFE COL
(2) Undeclared Color Additives: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an undeclared artificial color additive [Misbranding, Section 403(k)]."
OASIS charge code - COLOR LBLG
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