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: 10/13/2021
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Apple Juice Products Due to Patulin"

Reason for Alert:

Note: The revision to this Import Alert (IA) dated 08/13/2021 updates the reason for alert, guidance, and agency contacts. Changes to the import alert are bracketed by asterisks (***).

*** Patulin is a toxic substance produced by molds (Penicillium, Aspergillus, and Byssochylamys) 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:

In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the shipment should provide the results of private laboratory analysis of a representative sample of the shipment, which demonstrates that the product does not bear or contain patulin, which may render it injurious to health.

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

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 OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@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 on policy, sample collection recommendations, or any other additional questions, 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

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (20 S - - 01) Apple, Core Fruit Juices or Concentrates
    Problems:PATULIN;

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


ARGENTINA


JUGOS LUGA S.A.
Date Published : 06/02/2014
National Road 22, 1152.5 Km , Mainque, Rio Negro ARGENTINA
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 06/02/2014

Desc: Apple Juice Concentrate


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;