Import Alert 20-05
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(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: 04/13/2013
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination and Surveillance of Fruit Juices and Fruit Juice Concentrates Due to Heavy Metal Contamination"
Reason for Alert:
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.
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:
Districts may detain without physical examination fruit juices and fruit juice concentrates from specified fruits from the firm(s) listed on the red liat for this alert.
When Districts 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 DIOP, HFC-171. DIOP will coordinate with CFSAN for concurrence.
Surveillance of heavy metal levels in fruit juices and fruit juice concentrates from all countries is warranted.
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.
For guidance on removal from detention without physical examination,
refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
When Districts 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 DIOP, HFC-171. DIOP will coordinate with CFSAN for concurrence.
Surveillance of heavy metal levels in fruit juices and fruit juice concentrates from all countries is warranted.
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.
For guidance on removal from detention without physical examination,
refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Grape juice, grape juice concentrate
Fruit juice
Fruit juice
Charge:
"The article is subject to refusal of admission to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, which may render it injurious to health. [Adulteration, Section 402(a)(1)]"
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS
ARGENTINA
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;
Coop De Comercialization Y Transformation Echarren
Date Published : 04/16/2012
404 Rio Colorado Rio Negro , Rio Negro, ARGENTINA
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 04/16/2012
Desc:Apple Juice Concentrate Arsenic
Problems:
ARSENIC;
20 S - - 02 Crab Apple, Core Fruit Juices or Concentrates
Date Published: 04/16/2012
Desc:Apple Juice Concentrate Arsenic
Problems:
ARSENIC;
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 04/16/2012
Desc:Apple Juice Concentrate Arsenic
Problems:
ARSENIC;
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
Notes:Inorganic Arsenic DWPE date - 6/2/2009
Yucheng Amusi Fruit Juice Co., Ltd.
Date Published : 09/16/2009
Industrial Estate, Zhengligu Village , Yucheng, CN-41 CHINA
20 S - - 03 Pear, Core Fruit Juices or Concentrates
Date Published: 09/16/2009
Notes:Inorganic arsenic
DWPE date - 2/18/2009
TURKEY
Drops Gida Sanayi ve Ticaret Anonim Sirketi
Date Published : 05/21/2012
Yeni Mahalle Kayseri Caddesi No. 32 , Aktas , Nigde, Nigde TURKEY
21 D - - 99 Mixed Fruit, Juices or Concentrates N.E.C.,
Date Published: 05/21/2012
Desc:Pomegranate Juice
Problems:
LEAD;
22 K - - 01 Pomegranate, Juice, Other Fruit Juices or Concentrates
Date Published: 05/21/2012
Desc:Pomegranate Juice
Problems:
LEAD;
22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C.
Date Published: 05/21/2012
Desc:Pomegranate Juice
Problems:
LEAD;
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