Import Alert 29-02
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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 # 29-02
Published Date: 10/16/2012
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Bottled Water Due to Arsenic"
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.
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 Red List of this alert.
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.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
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.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Bottled Water
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)]."
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS
ARMENIA
"Jermuk" CJSC
Date Published : 09/18/2009
1 Gortaranain Str. , Jermuk, ARMENIA
29 W - - 01 Bottled Water
Date Published: 09/18/2009
Problems:
ARSENIC;
29 W - - 02 Bottled Spring or Mineral Water
Date Published: 09/18/2009
Problems:
ARSENIC;
Arpi Mineral Water Plant JSC
Date Published : 09/18/2009
Alaverdian 83 , Vaik, AM-VD ARMENIA
29 W - - 01 Bottled Water
Date Published: 09/18/2009
Problems:
ARSENIC;
29 W - - 02 Bottled Spring or Mineral Water
Date Published: 09/18/2009
Problems:
ARSENIC;
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