(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 Name:
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.
***In addition, under the FY 18 sample schedule, a sample of imported strawberry flavored water beverage, a product not subject to the bottled water regulations (i.e., 21 CFR 165.110), was found to likely pose a health concern based on its inorganic arsenic level.***
Note: ORS contact information updated on 08/16/2019
***To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the 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)," available at: http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179271.htm
If a firm and/or a representative thereof wishes 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, be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO at (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 firstname.lastname@example.org
Questions or issues on policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov***
Note: ORS contact information updated on 12/09/2020
***29W01 (Bottled Water)
29W02 (Bottled Spring or Mineral Water)
29S04 (Bottled Water with Fruit Flavors, Carbonated Water (Nonmedicinal))
29R04 (Bottled Water with Fruit Flavors, Noncarbonated (Nonmedicinal)***
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)