Import Alert 28-13

(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 # 28-13
Published Date: 05/25/2018
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF ***Spices and Spice Products*** DUE TO LEAD CONTAMINATION

Reason for Alert:

NOTE: The revision of this Import Alert, dated 06/22/2017, updates the Alert from being specific for turmeric to include other spices and spice products. Changes are bracketed by asterisks (***).

As part of its responsibilities for ensuring the safety of the U.S. food supply, the Food and Drug Administration (FDA) monitors levels of certain toxic elements in foods. FDA uses this information to estimate dietary exposure to these contaminants and to identify the relative contributions of these foods to total toxic element exposure. With regard to lead, particular emphasis is placed on foods consumed by children, who are the most sensitive to its adverse health effects.

In 2013, the FDA was notified via the Reportable Food Registry/Risk Control Review of a specific instance of a child found with elevated levels of lead after consuming turmeric spice imported from Bangladesh. Subsequent FDA sampling of imported turmeric products revealed various products having levels of lead that may render the products injurious to health.*** ***

***In 2017, sampling by FDA and State Departments of Health revealed additional types of spices and spice products having high levels of lead that may render the products injurious to health.

Based on the findings in the additional spice products, this import alert has been modified to cover specific firms that have offered spices and spice products with levels of lead that may render a product injurious to health for import into the United States and have met the criteria for detention without physical examination as established in FDAs Regulatory Procedures Manual (RPM) Chapter 9-6.***

In making a determination as to whether a level of lead in a ***spice*** product may render that product injurious to health, FDA takes into account the amount of the metal present in the product, consumption data available for that product, and the segment of the population to be most at risk if they consume the product.

Guidance:

***Divisions*** may detain without physical examination (DWPE) shipments of ***identified products*** from the firms identified on the Red List of this Alert.

Recommendations for additions to the Red List should be forwarded to the Division of Import Operations Management (DIOM). DIOM and FDAs Center for Food and Safety and Applied Nutrition (CFSAN) will evaluate regulatory packages on a case-by-case basis.

Release of Articles Subject to Detention without Physical Examination under this Import Alert:

In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the shipment, which demonstrates that the product does not contain a level of lead that may render it injurious to health.

*** ***

Requests for Removal from DWPE for firms subject to this Import Alert:

In order to remove a firm/product from detention without physical examination, information should be provided to FDA to adequately demonstrate that the firm in question has resolved the conditions that gave rise to the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof wish to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forward to the following address:

Food and Drug Administration
Division of Import Operations Management
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov


CONTACT
INFORMATION:


Questions or issues involving import operations policies should be addressed to ORA/Division of Import Operations Management at (301) 796-0356 or fdaimportinquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at orahqoeiodcimpcomplysysbr@fda.hhs.gov

Questions or issues concerning 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/OC/DE/Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov

Product Description:

PRODUCT
CODE(S): ***28[][][][]; 50L[][][][]***

PRODUCT(S): ***Spices, Spice Products***

PROBLEM(S): LEAD

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)


BANGLADESH


PRAN AGRO LTD
Date Published : 11/28/2014
PRAN-RFL CENTER , 105 MIDDLE BADDA , Dhaka, BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

PRAN Agro Ltd.
Date Published : 11/28/2014
Natore City Bypass Road, Eakdala , Natore, BD-NOTA BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

PRAN Dairy Ltd.
Date Published : 11/28/2014
PRAN Industrial Park, Bagpara , Ghorashal-Palash Road , Narshingdi, BD-42 BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

Pran Exports LTD
Date Published : 11/28/2014
PRAN-Center 105 Ga , Middle Badda , Dhaka, BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

Pran Exports Limited
Date Published : 11/28/2014
Pran Industrial Park, Bagpara, Palash, , Narshingdi, Ghorashal-Palash Road , Narshingdi, BD-NOTA BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

Pran Foods Ltd
Date Published : 11/28/2014
105/1 Ga, Middle Badda , Dhaka, BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

pran dairy ltd
Date Published : 11/28/2014
pran-rfl center , 105 middle badda , Dhaka-1212, BANGLADESH
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;

50 L - - 29 Turmeric
Date Published: 11/28/2014

Desc: Turmeric
Problems: LEAD;


INDIA


IndoVedic Nutrients Pvt. Ltd.
Date Published : 12/16/2016
No. 96, 3 Phase , Peenya Industrial Area , Bangalore, Karnataka INDIA
28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 12/16/2016

Desc: Turmeric

SAATHI INTERNATIONAL
Date Published : 12/13/2017
C/162 Ajwa Road , Vadodara, Gujarat INDIA
28 A - - 16 Cumin, Whole (Spice)
Date Published: 12/13/2017

Desc: Cumin

28 B - - 16 Cumin, Ground, Cracked (Spice)
Date Published: 12/13/2017

Desc: Cumin

28 C - - 16 Cumin, Natural Extract or Flavor (Spice)
Date Published: 12/13/2017

Desc: Cumin

Visakarega Trading Private
Date Published : 06/30/2016
X/165a Pancode P O , Puthencruz, Kerala INDIA
28 A - - 49 Turmeric, Whole (Spice)
Date Published: 06/30/2016

Desc: Tumeric
Notes: Sample 954024

28 B - - 49 Turmeric, Ground, Cracked (Spice)
Date Published: 06/30/2016

Desc: Tumeric
Notes: Sample 954024

28 C - - 49 Turmeric, Natural Extract or Flavor (Spice)
Date Published: 06/30/2016

Desc: Tumeric
Notes: Sample 954024

50 L - - 29 Turmeric
Date Published: 06/30/2016

Desc: Tumeric
Notes: Sample 954024


LEBANON


Daaboul Spices
Date Published : 05/25/2018
Near BLOM Bank , Beyrouth, LB-NOTA LEBANON
28 B - - 13 Cinnamon, Cassia, Ground, Cracked (Spice)
Date Published: 05/25/2018

Desc: Ground Cinnamon

East Transport & Clearing Co.
Date Published : 05/25/2018
Bella Casa Building , Airport Road , Beyrouth, LB-BA LEBANON
28 B - - 13 Cinnamon, Cassia, Ground, Cracked (Spice)
Date Published: 05/25/2018

Desc: Ground Cinnamon


SYRIAN ARAB REPUBLIC


NABELSI CO FOR TRADE NAD INDUSTRY
Date Published : 06/29/2017
C.R. 44 651 Ir, 55 , Damascus, SYRIAN ARAB REPUBLIC
28 A - - 48 Thyme, Whole (Spice)
Date Published: 06/29/2017

Desc: Spice Mix (Product label declares Thyme)
Problems: LEAD;

28 B - - 48 Thyme, Ground, Cracked (Spice)
Date Published: 06/29/2017

Desc: Spice Mix (Product label declares Thyme)
Problems: LEAD;

28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C.
Date Published: 06/29/2017

Desc: Spice Mix (Product label declares Thyme)
Problems: LEAD;

28 F - - 99 Mixed Spice and Seasonings, Ground, Cracked, without Salt, N.E.C.
Date Published: 06/29/2017

Desc: Spice Mix (Product label declares Thyme)
Problems: LEAD;


VIETNAM


THD Saigon Trading and Investment
Date Published : 06/29/2017
Dong Lang Industrial Park , Lot 2; Phu Ninh District , Phu Tho, Phu Tho VIETNAM
28 A - - 13 Cinnamon, Cassia, Whole (Spice)
Date Published: 06/29/2017

Desc: Cinnamon
Problems: LEAD;

28 B - - 13 Cinnamon, Cassia, Ground, Cracked (Spice)
Date Published: 06/29/2017

Desc: Cinnamon
Problems: LEAD;

Viet Nam TH & D Company
Date Published : 09/29/2017
Dong Lang Industrial Park , Phu Ninh District, VN-68 VIETNAM
28 A - - 13 Cinnamon, Cassia, Whole (Spice)
Date Published: 09/29/2017

Desc: Whole Cinnamon
Problems: LEAD;

28 B - - 13 Cinnamon, Cassia, Ground, Cracked (Spice)
Date Published: 09/29/2017

Desc: Ground Cinnamon
Problems: LEAD;