Import Alert 20-06
(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 # 20-06
Published Date: 05/31/2024
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Apple Juice Products Due to Patulin"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 05/31/2024 updates the guidance section for use of Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory for release of articles subject to DWPE and removal of a firm/product from DWPE under this Alert. Changes to the import alert are bracketed by asterisks (***).
Patulin is a toxic substance produced by molds (Penicillium, Aspergillus, and Byssochlamys) that may grow on apples. Patulin is not destroyed by heat processing, and can occur at high levels in apple juice, including pasteurized apple juice. In the past, studies have demonstrated that high levels of patulin in apple juice could pose a health risk if the juice is consumed over an extended period. In addition, patulin has been found to occur at high levels in some apple juice products offered for sale in or imported into the United States.
Patulin is a toxic substance produced by molds (Penicillium, Aspergillus, and Byssochlamys) that may grow on apples. Patulin is not destroyed by heat processing, and can occur at high levels in apple juice, including pasteurized apple juice. In the past, studies have demonstrated that high levels of patulin in apple juice could pose a health risk if the juice is consumed over an extended period. In addition, patulin has been found to occur at high levels in some apple juice products offered for sale in or imported into the United States.
Guidance:
Divisions may detain, without physical examination, apple juice and apple juice products for the firms identified on the Red List of this import alert.
Recommendations for additions to the Red List of this import alert, should be submitted to the Division of Import Operations (DIO). Divisions should recommend firms/products for addition to the Red List when lab analysis of products indicates levels of patulin greater than the Defect Action Limit of 50 parts per billion (ppb), as described in CPG Sec 510.150: Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin.
Regulatory packages will be evaluated on a case-by-case basis. DIO and CFSAN will recommend products/firms for Detention Without Physical Examination (DWPE) based on the information specific to each regulatory package.
Release of Articles subject to Detention Without Physical Examination under this Import Alert:
*** Beginning 12/01/2024, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm ***
In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain patulin, which may render it injurious to health. Such evidence could include private laboratory analysis of a representative sample of the detained product.
Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
*** Beginning 12/01/2024, private laboratory analytical analyses to support removal from an import alert through successful consecutive testing must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm ***
In order to remove a firm/product from DWPE, information should be provided to FDA to adequately demonstrate that the firm 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 with the Federal Food Drug and Cosmetic Act (FD&C Act).
For further guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)".
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
Recommendations for additions to the Red List of this import alert, should be submitted to the Division of Import Operations (DIO). Divisions should recommend firms/products for addition to the Red List when lab analysis of products indicates levels of patulin greater than the Defect Action Limit of 50 parts per billion (ppb), as described in CPG Sec 510.150: Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin.
Regulatory packages will be evaluated on a case-by-case basis. DIO and CFSAN will recommend products/firms for Detention Without Physical Examination (DWPE) based on the information specific to each regulatory package.
Release of Articles subject to Detention Without Physical Examination under this Import Alert:
*** Beginning 12/01/2024, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm ***
In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain patulin, which may render it injurious to health. Such evidence could include private laboratory analysis of a representative sample of the detained product.
Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
*** Beginning 12/01/2024, private laboratory analytical analyses to support removal from an import alert through successful consecutive testing must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm ***
In order to remove a firm/product from DWPE, information should be provided to FDA to adequately demonstrate that the firm 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 with the Federal Food Drug and Cosmetic Act (FD&C Act).
For further guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)".
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
Product Description:
Apple juice; apple juice food products
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)]"
OASIS charge code - PATULIN
OASIS charge code - PATULIN
Countries
MULTIPLE COUNTRIES
-
(20 S - - 01) Apple, Core Fruit Juices or ConcentratesProblems:PATULIN;
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
MEXICO
Huertas de la Empacadora S de PR de RL
Date Published : 01/24/2012
Arroyo Las Canoas S/N , Mpio De Guerrero
, Guerrero,
Chihuahua MEXICO
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 01/24/2012
Desc: Apple Juice from Concentrate
Problems:
PATULIN;
20 S - - 02 Crab Apple, Core Fruit Juices or Concentrates
Date Published: 01/24/2012
Desc: Apple Juice from Concentrate
Problems:
PATULIN;
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 01/24/2012
Desc: Apple Juice from Concentrate
Problems:
PATULIN;