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: 11/20/2023
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of All Dried Shark Fins and Dried Fish Maws Due to Filth"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 09/15/2021 updates the guidance, agency contacts, and charge code language. 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. 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/maws, 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 according to the procedures outlined in LIB 2957, Examination of Dried Fish for Microscopic Filth. Contact the Office of Regulatory Science for a copy of the Laboratory Information Bulletin.

***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 import 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. The evidence submitted should demonstrate compliance of the article in that the product does not appear to 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 10 subsamples, containing one pound (1 lb.) per subsample;
or,
10 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 remove a firm from detention without physical examination, 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 ORA/DIO (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 oraorsprivatelabimportalerts@fda.hhs.gov.

Questions on compliance policy, sample collection recommendations, or any 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:

Dried Shark Fins (All types, e.g., whole, shredded, cakes) Dried Fish Maws Dried Shark Cartilage Powder (utilizing dried shark fins/ maws 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

Countries

MULTIPLE COUNTRIES

  • (16 Y - H 07) Fish Maw, Fishery Products, n.e.c., Ntrl/Artfcl Dried
  • (16 Y - H 08) Shark Fin, Fishery Products, n.e.c., Ntrl/Artfcl Dried
  • (54 G - - 04) Shark (Animal By-Products and Extracts)
  • (54 G - - 99) Animal By-Products and Extracts, 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 , Barranco, 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