Import Alert 20-05

(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 # 20-05
Published Date: 06/14/2021
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Fruit Juices and Fruit Juice Concentrates Due to Heavy Metal Contamination"

Reason for Alert:

The revision of this Import Alert (IA) dated 06/14/2021 updates the Import Alert name and type of alert to remove surveillance and updates the guidance section. Changes to the import alert are bracketed by asterisks (***).

In 2002, SAN-DO analyzed a shipment of grape juice concentrate and found elevated levels of lead. The average level of lead found in the concentrate was of 0.076mg/l. The calculated exposure to lead from a single 8 oz. serving prepared from this concentrate would be more three times the Provisional Total Tolerable Intake of Lead for children.

In 2008, SEA-DO analyzed a shipment consisting of two lots of pear juice concentrate and found elevated levels of inorganic arsenic. The average levels of inorganic arsenic calculated in reconstituted juice from the concentrate were 28 ng/g and 32 ng/g, respectively. Inorganic arsenic is a toxic substance and known human carcinogen. Oral exposure to inorganic arsenic can cause adverse health effects in many organs. These effects are dependent on dose and duration of exposure.

Guidance:

Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert.

When Divisions collect samples of either a fruit juice or fruit juice concentrate that is found to be violative for heavy metals through laboratory analyses, a recommendation for detention without physical examination and background information, including analytical worksheets, should be forwarded to DIO. DIO will coordinate with CFSAN for a safety assessment of the levels found and concurrence.

***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the detained product, which demonstrates that the product does not contain levels of heavy metal(s) that may render it injurious to health.***

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

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the food producer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, 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 with regard to human food on policy, sample collection recommendations, or any additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov

Product Description:

Fruit juice, Fruit juice concentrate

Charge:

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

OASIS charge code: POISONOUS

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


ARGENTINA


Aerovision S.A
Date Published : 09/25/2019
comandante torres 100 , Rivadavia, Mendoza ARGENTINA
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 10/30/2019

Desc: Grape Juice/Mashed Grapes
Problems: LEAD;

Buenaventura O. Rodriguez Fabrica De
Date Published : 09/16/2009
Dir Postal: 9 De Julio 427 , Mendoza, ARGENTINA
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 09/16/2009

Notes: DWPE date - 3/14/2002
Problems: LEAD;

GIN COTTON SA
Date Published : 10/15/2020
Av San Martin Es 14 P1 D4 , Avellaneda, Sante Fe ARGENTINA
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 10/15/2020

Desc: Grape Juice Concentrate
Notes:                                                                                                     
Problems: ARSENIC;

Gin Cotton S.A.
Date Published : 02/14/2020
Ruta Provincial 34 S/N Costa De Araujo , Lavalle, Mendoza ARGENTINA
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 02/14/2020

Desc: Grape Juice Concentrate
Problems: ARSENIC;

JUVIAR S.A.
Date Published : 10/15/2020
Av San Martin Es 14 P1 D4 , Avellaneda, Sante Fe ARGENTINA
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 10/15/2020

Desc: Grape Juice Concentrate
Notes:                                                                                                        
Problems: ARSENIC;

JUVIAR S.A.
Date Published : 03/21/2020
Ruta Provincial 34 S/N5535 , Lavalle , Costa De Araujo, ARGENTINA
20 D - - 09 Grape Juice, Berry Juice or Concentrates
Date Published: 03/21/2020

Desc: Grape Juice Concentrate
Notes:                                                                                                        


CHINA


Guanxian Nailun Fruit Juice Co., Ltd.
Date Published : 10/26/2009
The East End of Zhenxing Road , Guanxian,China , Guanxian, Shandong CHINA
20 S - - 03 Pear, Core Fruit Juices or Concentrates
Date Published: 10/26/2009

Desc: Pear Juice Concentrate
Notes: Inorganic Arsenic DWPE date - 6/2/2009

Yucheng Amusi Fruit Juice Co., Ltd.
Date Published : 09/16/2009
Industrial Estate, Zhengligu Village , Yucheng, Henan CHINA
20 S - - 03 Pear, Core Fruit Juices or Concentrates
Date Published: 09/16/2009

Notes: Inorganic arsenic DWPE date - 2/18/2009


GUATEMALA


Hispanic Foods S.A.
Date Published : 10/28/2015
Calle 48-55 Zona 3, Mixco 13 z. 3 , Guatemala, Guatemala GUATEMALA
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 10/28/2015

Desc: Apple Nectar
Notes: Inorganic Arsenic

Industrias Alimenticias Kern's CIA SCA
Date Published : 11/14/2017
Ca-9 Norte (Ruta Al Atlantico) , 9-60 Z. 17 , Guatemala, Guatemala GUATEMALA
21 V - - 07 Pineapple, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
Date Published: 11/14/2017

Desc: Pineapple Juice Drink
Notes: Problem(s); Inorganic Arsenic

Industrias Alimenticias Kern's y Cia. S.C.A.
Date Published : 10/28/2015
Km. 6.5 Carretera al Atlantico z. 18 , Guatemala, Guatemala GUATEMALA
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 10/28/2015

Desc: Apple Nectar
Notes: Inorganic Arsenic


TURKEY


MEYBUZ GIDA ENERJI SAN VE TIC AS
Date Published : 09/05/2018
Osb 16. Cad No 4 , Kayseri, TURKEY
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/05/2018

Desc: Apple Juice
Notes: Problems; Inorganic Arsenic

Meybuz Gida Enerji
Date Published : 06/24/2014
10 Cad. , Melikgazi, Kayseri TURKEY
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 06/24/2014

Desc: Apple Juice
Problems: ARSENIC;

Meybuz Gida Enerji Sanayi Ve Ticaret A.S.
Date Published : 06/24/2014
Ankara Asfalti 9 Km 38070 , Melikgazi-Kaysery , Ankara, Kayseri TURKEY
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 06/24/2014

Desc: Apple Juice
Problems: ARSENIC;

Meysu Gida San. ve Tic.
Date Published : 06/26/2019
Organize Sanayi Bolgesi 16 Cadde No 4 , Melikgazi, Kayseri TURKEY
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 06/26/2019

Desc: Apple Juice; 100% Natural
Notes: Problem(s); total inorganic arsenic

PINAR DAIRY PRODUCTS INC.
Date Published : 09/26/2018
Kemalpasa Asfalti No:317 Pinarbasi , Kemalpasa Asfalti No:317 Pinarbasi , Izmir, TR-35 TURKEY
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/26/2018

Desc: Apple Juice
Problems: ARSENIC;

Pinar Sut Mam.San.A.S.
Date Published : 09/26/2018
Mumt Az Zeytinoglu Bulvari No.29 , Eskisehir, TURKEY
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/26/2018

Desc: Apple Juice
Problems: ARSENIC;