IA #29-02, 3/27/07 - IMPORT ALERT #29-02, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF BOTTLED WATER DUE TO ARSENIC", ATTACHMENT 1/12/09
This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer(s) and/or product(s) at issue. It does
not create or confer any rights for, or on any person, and does not operate to
bind the FDA or the public.
TYPE OF ALERT: Detention Without Physical Examination
PRODUCT: Bottled Water
PRODUCT 29W[][]01
CODE: 29W[][]02
PROBLEM: Contains arsenic
PAF: MET
PAC: 04019A
OASIS CHARGE
CODE: POISONOUS
COUNTRY: See Attachment
MANUFACTURER/: See Attachment
SHIPPER
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a poisonous
and deleterious substance (i.e., arsenic) which may render
it injurious to health. [Adulterated 402(a)(1)]."
RECOMMENDING
OFFICE: LOS-DO (HFR-PA256)
REASON FOR
ALERT: Los Angeles District was among several Districts that
sampled products under the FY 07 sample schedule for
Compliance Program 7304.019AC, Toxic Elements in Foods and
Radionuclides in Foods (Domestic and Import).
Three samples of bottled water imported from three different
manufacturers in Armenia were found to contain high levels
of arsenic. Arsenic is a toxic substance and known human
carcinogen that can occur in water sources throughout the
world. Symptoms of acute arsenic exposure usually occur
within several hours of consumption. The most likely
effects include nausea, vomiting, diarrhea, and stomach
pain. Over the period of a few days to weeks, the kidneys,
liver, skin, and cardiovascular and nervous systems could be
affected. Extended exposure could lead to cancer and death.
FDA testing of this water revealed greater than 450
micrograms of arsenic per liter. FDA's standard of quality
for bottled water allows no more than 10 micrograms per
liter.
GUIDANCE: Districts may detain without physical examination all
bottled water manufactured by firms identified on the
attachment to this alert.
FOI: No Purging Required
PREPARED BY: Judy Baron, DIOP, HFC-170
DATE LOADED
INTO FIARS: March 27, 2007
ATTACHMENT TO IMPORT ALERT #29-02, 1/12/09
FIRM NAME & ADDRESS
Arpi Mineral Water Plant JSC
Alaverdian 83
Vaik, Armenia
FEI# 3004328027
Jermuk CJSC
aka Jermuk Mayr Gortsaran CJSC
1 Gortaranain Str.
(Gortsaranajin 1)
Jermuk, Armenia
FEI# 3004287962
Jermuk Group CJSC
1, Barekamutian, Str.
Jermuk, Armenia
FEI# 3004141192
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