IA #20-05, 2/19/09, IMPORT ALERT #20-05, "DETENTION WITHOUT PHYSICAL EXAMINATION
AND SURVEILLANCE OF ***FRUIT JUICES AND FRUIT JUICE CONCENTRATES DUE TO HEAVY
METAL CONTAMINATION"***
***The revision of this Import Alert dated 2/18/2009 changes the title, expands
the products of interest to include all types of fruit juice and fruit juice
concentrates, and expands the problem area to include all heavy metals.***
TYPE OF
ALERT: Detention Without Physical Examination (DWPE)
(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).
PRODUCT: ***Fruit Juices and Fruit Juice Concentrates***
PRODUCT
CODE: ***See Attachment***
OASIS CHARGE
CODE: ***POISONOUS***
PAF: MET
PAC: 04019A
COUNTRY: ***See Attachment***
MANUFACTURER/
SHIPPER: See Attachment A
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***
RECOMMENDING
OFFICE: SAN-DO (HFR-PA140)
FLA-DO (HFR-SE240)
***SEA-DO (HFR-PA340)***
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 0.076mg/l. The calculated
exposure to lead from a single 8 oz. serving prepared from
this concentrate would be more than 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: ***Districts may detain without physical examination fruit juices
and fruit juice concentrates from specified fruits from the firm(s)
listed on Attachment A of 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)827-7605.
For guidance on removal from detention without physical examination,
refer to the Regulatory Procedures Manual, Chapter 9, "Detention
Without Physical Examination (DWPE)".***
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Lead, inorganic arsenic, heavy metals, fruit juice,
fruit juice concentrate
ORIGINAL
ISSUE DATE: February 13, 2002
ORIGINAL
PREPARED
BY: Ted Poplawski, DIOP
REVISED BY: Patrick Bowen, DIOP, 301-594-3845
Standra Purnell, CFSAN, 301-436-1613
DATE LOADED
INTO FIARS: February 19, 2009
ATTACHMENT A TO IMPORT ALERT #20-05 2/18/2009
Firms and products recommended for Detention Without Physical Examination
FIRM PRODUCT/PRODUCT CODE Problem
ARGENTINA (AR)
Buenaventura O. Rodriguez Grape Lead
Dir Postal 9 De Julio 427 20D[][]09
Mendoza, Argentina
FEI# 1000377025 3/14/2002
CHINA (CN)
Hebei Fengte Fruit & Pear Inorganic Arsenic
Vegetable Juice Co., Ltd. 20S[][]03
Yingbin Road Industrial
Development Zone 2/18/2009
Bo Tou, China
FEI# 2000028220
Yucheng Amusi fruit Co., Ltd. Pear Inorganic Arsenic
Industrial Estate, 20S[][]03
Zhengligu Village,
Yucheng, China 2/18/2009
FEI# 3006312990
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