Import Alert 23-14

Detention Without Physical Examination of Food Products due to the Presence of
Aflatoxin

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.

NOTE: Issuance of this import alert replaces the following commodity-specific import alerts also addressing the problem of Aflatoxin in foods:

IA #21-15 "DWPE of Dried Fig Paste due to presence of Aflatoxin"
IA #23-10 "Surveillance of In-Shell Brazil Nuts"
IA #23-11 "DWPE of Nuts and Nut containing products for Aflatoxin"
IA #23-13 "DWPE of Pumpkin seeds due to Aflatoxin"
IA #33-11 "DWPE of Halva (Candy) containing pistachio Nuts due to Aflatoxin"

Aflatoxins are mycotoxins produced by the fungi Aspergillus flavus and Aspergillus parasiticus. They are known human carcinogens, but their occurrence in foods is not entirely avoidable. Food products containing aflatoxin might be considered adulterated and, if adulterated, are subject to refusal of admission.

Districts may detain, without physical examination, the specified products from the firms listed in the Red List of this import alert.

Districts should submit a recommendation for detention without physical examination under this import alert of firms whose products have been sampled and all of the following analytical conditions have been met for the presence of aflatoxins in the sample:

1. Original and check analysis contain aflatoxin above 20 ppb
2. Confirmed identity of aflatoxin B1 by chemical derivative formation
3. Confirmed identity of aflatoxin B1 by negative ion chemical ionization mass spectrometry

DIOP and CFSAN will evaluate regulatory packages on a case-by-case basis.

For additional guidance refer to the following FDA Compliance Policy Guides:
1) CPG Sec. 555.400 Foods Adulteration with Aflatoxin
2) CPG Sec. 570.200 Brazil Nuts Adulteration with Aflatoxin
3) CPG Sec. 570.375 Aflatoxin in Peanuts and Peanut Products
4) CPG Sec. 570.500 Pistachio Nuts Aflatoxin Adulteration

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

See Red List

CHARGE: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain aflatoxin, a poisonous or deleterious substance, which may render it injurious to health [Adulteration, Section 402(a)(1)]."

OASIS CHARGE CODE: AFLATOXIN