Import Alert 29-02

(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: 05/23/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Bottled Water due to Arsenic ***and Flavored Water Beverages*** Due to Inorganic Arsenic"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 04/05/2018 broadens the scope of the IA to include flavored water beverages that are not standardized bottled water products. Additionally, guidance was added for removal from DWPE and the Agency’s contact information was updated. Changes are bracketed by asterisks (***).

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.***

Guidance:

Districts may detain without physical examination all bottled water ***and flavored water beverages*** manufactured by firms identified on the Red List of this alert.

***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 (301) 796-6600 or orahqorsmanagement@fda.hhs.gov

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***

Product Description:

Bottled Water ***and Flavored Water Beverages***

PRODUCT Codes:

***29W[][]01 (Bottled Water)
29W[][]02 (Bottled Spring or Mineral Water)
29S[][]04 (Bottled Water with Fruit Flavors, Carbonated Water (Nonmedicinal))
29R[][]04 (Bottled Water with Fruit Flavors, Noncarbonated (Nonmedicinal)***

Charge:

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. ***[Adulteration, Section 402(a)(1)]***” Contains:

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)


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;


MEXICO


Refrescos Union S.A.
Date Published : 05/23/2018
Carr. Panamericana Km. 1588 , Meoqui, MX-CHH MEXICO
29 W - - 01 Bottled Water
Date Published: 05/23/2018

Desc: Nature Strawberry Flavored Water

grupo penafiel
Date Published : 03/04/2015
Parque Idustrial Naucalpan , Estado de Mexico , Mexico City, Edomex MEXICO
29 S - - 05 Mineral Water, Carbonated Water (Nonmedicinal)
Date Published: 04/04/2018

Desc: Carbonated Water

29 S - - 99 Carbonated Water (Nonmedicinal), N.E.C.
Date Published: 03/04/2015

Desc: Carbonated Water