Import Alert 16-02
(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 # 16-02
Published Date: 02/21/2025
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of All Dried Shark Fins, Dried Fish Maws and Dried Shark Cartilage Powder from Shark Fins Due to Filth"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 07/25/2024 updates the name of the alert, reason for alert, guidance section including agency contacts, product description section and product codes. Changes to the import alert are bracketed by asterisks (***).
Insect, rodent or other animal filth have long been a problem with dried shark fins of all types and dried fish maws (***fish maws are fish swim bladders***). The FY-93 national detention data identified over 160 detentions from more than 20 countries.
This import alert replaces Import Alert #16-01 "Automatic Detention of Shark fins (Sharkfin Cake) From Hong Kong", and Import Alert #16-02, "Automatic Detention of Dried Shark Fins And Dried Fish Maws From Talle, Ecuador " and combines and expands both alerts. The violation rate for both products has remained the same, and criteria for detention without physical examination have been met for expansion to world-wide. Because no non-violative geographical area can be identified, both products are on detention without physical examination on a world-wide basis.
Insect, rodent or other animal filth have long been a problem with dried shark fins of all types and dried fish maws (***fish maws are fish swim bladders***). The FY-93 national detention data identified over 160 detentions from more than 20 countries.
This import alert replaces Import Alert #16-01 "Automatic Detention of Shark fins (Sharkfin Cake) From Hong Kong", and Import Alert #16-02, "Automatic Detention of Dried Shark Fins And Dried Fish Maws From Talle, Ecuador " and combines and expands both alerts. The violation rate for both products has remained the same, and criteria for detention without physical examination have been met for expansion to world-wide. Because no non-violative geographical area can be identified, both products are on detention without physical examination on a world-wide basis.
Guidance:
***Divisions may detain, without physical examination, all shipments of dried shark fins, dried fish maws, and dried shark cartilage powder derived from shark fins, except those listed on the Green List of this Import Alert. Dried shark fins (all types, e.g., whole, shredded, cakes) dried fish maws, and shark cartilage powder shall be examined for filth.***
Release of Articles Subject to Detention without Physical Examination Under this Import Alert:
In order to secure release of an individual shipment identified for detention without physical examination under this import alert, the owner, consignee and/or another responsible party ***for the affected goods should provide the results of private laboratory analysis of a representative sample(s) of the shipment as evidence that the product does not bear or contain unacceptable levels of filth.***
The responsible parties should use the following information as a template when submitting third party sampling and private lab analytical results in an attempt to overcome the apparent violation:
1. Samples should be collected by a third party and tested by a private laboratory qualified in the analyses;
2. Each sample should consist of ***6 subsamples, containing minimum
900g -> 1.36kg (2-3lb) per subsample (see CP7303.842;
or,
6 subsamples*** per lot of consumer sized packages containing up to one pound (1 lb.);
or;
For consumer sized packaging in excess of one pound (1 lb.) or other unique sample collection situations, please contact CFSAN for further guidance.
Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
Removal from Detention Without Physical Examination (ADDITION TO THE GREEN LIST):
In order to **add a firm to the Green List***, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future shipments will be in compliance.
For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, Detention Without Physical Examination (DWPE).
If a firm would like to petition to be added to the Green List of this Import Alert, all relevant information supporting the request should be forward 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 OII/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
Release of Articles Subject to Detention without Physical Examination Under this Import Alert:
In order to secure release of an individual shipment identified for detention without physical examination under this import alert, the owner, consignee and/or another responsible party ***for the affected goods should provide the results of private laboratory analysis of a representative sample(s) of the shipment as evidence that the product does not bear or contain unacceptable levels of filth.***
The responsible parties should use the following information as a template when submitting third party sampling and private lab analytical results in an attempt to overcome the apparent violation:
1. Samples should be collected by a third party and tested by a private laboratory qualified in the analyses;
2. Each sample should consist of ***6 subsamples, containing minimum
900g -> 1.36kg (2-3lb) per subsample (see CP7303.842;
or,
6 subsamples*** per lot of consumer sized packages containing up to one pound (1 lb.);
or;
For consumer sized packaging in excess of one pound (1 lb.) or other unique sample collection situations, please contact CFSAN for further guidance.
Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
Removal from Detention Without Physical Examination (ADDITION TO THE GREEN LIST):
In order to **add a firm to the Green List***, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future shipments will be in compliance.
For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, Detention Without Physical Examination (DWPE).
If a firm would like to petition to be added to the Green List of this Import Alert, all relevant information supporting the request should be forward 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 OII/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
Product Description:
***Dried Shark Fins (All types, e.g., whole, shredded, cakes) Dried Fish Maws and Dried Shark Cartilage Powder (utilizing dried shark fins as the source material)***
Charge:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or to be otherwise unfit for food [Adulteration, Section 402(a)(3)].
OASIS charge code - FILTHY
OASIS charge code - FILTHY
Countries
MULTIPLE COUNTRIES
-
(54 G - - 04) Shark (Animal By-Products and Extracts)
-
(54 G - - 99) Animal By-Products and Extracts, N.E.C.
-
(16 Y - - 07) Fish Maw, Fishery Products, n.e.c.
-
(16 Y - - 08) Shark Fin, Fishery Products, n.e.c.
List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)
ARGENTINA
Gaveteco S.A. Ind. Com.
Date Published : 09/10/2009
Avenida Belgrano 1281
, Ciudad Autonoma Buenos Aires,
Buenos Aires ARGENTINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes: Shark Cartilage Powder
Added - 3/12/1997
AUSTRALIA
Cottee Dairy Products Pty Ltd.
Date Published : 09/10/2009
Level 2, 25 Merriwa Street
, Gordon,
Nsw AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes: Ahark cartilage powder
Added - 5/2/1997
Name change - 4/78/1998
Cottee Health Products Pty Limited
Date Published : 09/10/2009
15b Rodborough Rd
, Frenchs Forest,
New South Wales AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes: Shark Cartilage Powder
Added - 11/19/1999
Lane Labs Australia PTY Ltd.
Date Published : 09/10/2009
36 Central Dr, Andrews , (formerly Box 840, Manly, Sydney 2095)
, Brisbane,
AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: Shark Cartilage Powder
Notes: Added - 6/1/1995
Address correction - 2/17/1998
Probiotic PTY LMTD
Date Published : 09/10/2009
Paradise Point , 68 O'Grady Dr
, Paradise Point,
Queensland AUSTRALIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage powder
Notes: Sodium chondroitin
Date added - 10/18/2002
CANADA
CV Technologies Inc.
Date Published : 12/30/2009
9411 20 Ave Nw
, Edmonton,
Alberta CANADA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 12/30/2009
Desc: Shark cartilage
Notes: Added - 6/4/1996
Name/address change - 10/7/2002
Factors Group of Nutritional Companies Inc.
Date Published : 09/10/2009
1550 United Blvd
, Coquitlam,
British Columbia CANADA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage
Notes: Sodium chondroitin
Date added - 7/28/2003
CHILE
Lucrecia Ltda
Date Published : 07/09/2015
Apolo Iv 1853 Vitacura
, Santiago,
CHILE
16 Y - - 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 07/09/2015
Desc: Dried Fish Maws
CHINA
DingTao Sun Biochemical Factory
Date Published : 09/10/2009
Zhangwan Industrial park Dingtao town , Heze City, China
, Heze,
Shandongsheng CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 12/30/2009
Desc: Chondroitin sulfate
Notes: Added - 12/30/2002
JiaXing HengJie Biopharmaceutical Co., Ltd.
Date Published : 08/18/2015
No.20 TONGYI ROAD , Xinfeng Industrial Park
, Jiaxing,
Zhengjiang CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 08/18/2015
Desc: Shark Cartilage Powder
Jiangyin TSI Pharmaceutical Company LTD.
Date Published : 09/10/2009
No. 2 Jinxiu Road Huangtu Town
, Jiangyin,
Jiangsu CHINA
16 Y - H 07 Fish Maw, Fishery Products, n.e.c., Ntrl/Artfcl Dried
Date Published: 09/10/2009
Notes: Added - 2/5/2007
16 Y - H 08 Shark Fin, Fishery Products, n.e.c., Ntrl/Artfcl Dried
Date Published: 09/10/2009
Notes: Added - 2/5/2007
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: Shark cartilage powder
Notes: Added - 2/5/2007
SIRIO PHARMA CO., LTD.
Date Published : 08/13/2021
No. 83 Shan Chonggonglu , Taishan Rd; Longhu
, Shantou,
Guangdong CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 08/13/2021
Desc: Shark Cartilage Soft Capsules
Notes: 8/1/2011
54 H - - 04 Fish Oil (Fats and Lipid Substances)
Date Published: 08/13/2021
Desc: Shark Cartilage Soft Capsules
Notes: 8/1/2011
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/13/2021
Desc: Shark Cartilage Soft Capsules
Notes: 8/1/2011
Shing Hop Trading Seafood Products Mfg Co.
Date Published : 09/10/2009
He Tang , Fung Jiang District
, Jiangmen,
Guangdong CHINA
16 Y - H 07 Fish Maw, Fishery Products, n.e.c., Ntrl/Artfcl Dried
Date Published: 09/10/2009
Notes: Date added - 11/8/2005
Shun Chang Warehousing Services
Date Published : 09/10/2009
Zhang Mu , 47 Xinxing Road; Tou Town
, Dongguan,
Guangdong CHINA
16 Y - - 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 08/11/2021
Desc: Dried Fish Maw
Notes: 7/20/2005
Sinotrans Guangdong Import&Export Trading Co.
Date Published : 09/10/2009
1125 Guang Yuan Road C
, Guangzhou,
CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage
Notes: Sodium chondroitin
Date added - 2/2/1996
Sirio Pharma Co., Ltd.
Date Published : 08/01/2011
No.11, Zhuye St., Huangshan Rd
, Shantou,
Guangdong CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 08/01/2011
Desc: Shark Cartilage Soft Capsules
54 H - - 04 Fish Oil (Fats and Lipid Substances)
Date Published: 08/01/2011
Desc: Shark Cartilage Soft Capsules
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/01/2011
Desc: Shark Cartilage Soft Capsules
Yantai TSI Nutrition Products Co., Ltd.
Date Published : 09/10/2009
Yanqing Road , Laiyang
, Yantai,
Shandong CHINA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage concentrate
Notes: Sodium chondroitin
Date added - 2/4/2004
54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 08/11/2021
Desc: shark cartilage concentrate
Notes: Sodium chondroitin
Date added - 2/4/2004
COLOMBIA
Comexa
Date Published : 09/10/2009
Sector Albornoz. , Via A Mamonal 25 196
, Cartagena,
Bolivar COLOMBIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes: Shark Cartilage
Date added - 1/2/1996
COSTA RICA
Corporacion Procesdora de Cartilago S.A.
Date Published : 09/10/2009
Apartado Postal 86-5400
, Puntarenas,
Puntarenas COSTA RICA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes: Shark Cartilage
Added - 7/26/1995
HONG KONG SAR
Hang Tai Marine Products Co.
Date Published : 09/10/2009
Shop 2, G/Fl. , 155 Connaught Road West
, Hong Kong,
HK-NA HONG KONG SAR
16 Y - - 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 09/10/2009
Notes: Fish maws
Added - 2/23/2006
Kwan Kee Shark Fins Ltd
Date Published : 08/03/2010
58, Des Voeux Rd, 3/F
, Hong Kong,
HK-NA HONG KONG SAR
16 Y - - 08 Shark Fin, Fishery Products, n.e.c.
Date Published: 08/03/2010
Desc: Dried Shark FIn
Shing Hop Trading Company
Date Published : 09/10/2009
G/F , 12 Sai Yuen Lane
, Sai Ying Pun,
Hong Kong Island HONG KONG SAR
16 Y - - 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 11/20/2023
Desc: Fish maws
Notes: Date added - 11/8/2005
INDIA
Shark Line Exports
Date Published : 09/10/2009
Bldg Xi 290, Industrial Nagar
, Changanacherry,
IN-KL INDIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage/bones
Notes: Sodium chondroitin
Date added - 10/9/1997
INDONESIA
PT Eksindo Jaya Terang Mustika
Date Published : 09/10/2009
Jln. Pisangan Lama I 7
, Jakarta,
Jabotabek INDONESIA
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage
Notes: Sodium chondroitin
Date added - 3/6/1996
JAPAN
Kenko Corporation
Date Published : 09/10/2009
3 Chome 1-2 , Iwamoto-Cho
, Chiyoda,
Tokyo JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: Shark Cartilage Powder
Notes: Sodium Chondroitin Sulfate
Added - 5/13/1997
Maruha Nichiro Corporation
Date Published : 09/10/2009
8 Chome 1 , Yuinomori
, Utsunomiya,
Tochigi JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: Shark Cartilage Concentrate
Notes: Sodium chondroitin
Date added - 10/23/1995
Maruha Nichiro Foods, inc.
Date Published : 09/10/2009
1 Chome 1-2 , Ote-Machi
, Chiyoda,
Tokyo JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: Shark Cartilage Concentrate
Notes: Sodium chondroitin
Date added - 10/23/1995
Seikagaku Corporation
Date Published : 09/10/2009
Corporation Takahagi Plant, 258-5, Aza-Matsukubo, Oaza-Akhama , Oazaakahama
, Takahagi,
Ibaraki JAPAN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: shark cartilage/bones
Notes: Sodium chondroitin
Date added - 11/4/1997
MEXICO
Corporacion Nacional De Ventas, S.A.
Date Published : 09/10/2009
Avenida Insurgentes Sur No. 605-505 , Otro Napoles, Benito Juarez
, Ciudad De Mexico,
Ciudad de Mexico MEXICO
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Notes: Shark Cartilage
Added - 2/2/1996
Jose Jorge Peralta Pena
Date Published : 09/10/2009
Avenida Rayon No. 343 , Col. Obrera, Ensenada
, Ensenada,
Baja California MEXICO
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 09/10/2009
Desc: Shark Cartilage
Notes: Shark cartilage
Added - 7/20/2000
Name change - 8/14/2003
NEW ZEALAND
Aroma (NZ) Limited
Date Published : 03/06/2015
12 Senior Place , Bromley
, Christchurch,
NEW ZEALAND
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 03/06/2015
Desc: Shark cartilage
SPAIN
Bioiberica, SAU
Date Published : 06/07/2017
C/ Antic Cami De Tordera 109-119
, Palafolls,
Barcelona SPAIN
54 G - - 04 Shark (Animal By-Products and Extracts)
Date Published: 06/07/2017
Desc: Palbio Marine
54 G - - 99 Animal By-Products and Extracts, N.E.C.
Date Published: 06/07/2017
Desc: Palbio Marine