Import Alert 31-03

(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 # 31-03
Published Date: 08/10/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Guanabana (Soursop)"

Reason for Alert:

In February 1990, thirty-four adults and children drank "Rain Drop" Guanabana Drink from Mexico and within 15 minutes they began vomiting. Dallas district laboratory performed microscpic examination of the product and found some seed cells in all "suspect" codes examined. The literature indicates the seeds are toxic and an oil expressed from the seeds has been used as an insecticide and fish poison. According to the Mexican authorities, the product is only manufactured for exportation and not consumed in Mexico.

In February 1993,a sample of Iberia brand soursop nectar( guanabana) from the Dominican Republic was recalled (already on domestic status) due to the presence of the toxic guanabana seeds.

Guidance:

Districts may detain without physical examination all shipments of guanabana (soursop) drinks, juices, nectars, etc. from manufactures /shippers in the Red List. Increase surveillance of this product from other countries. Samples collected for analysis should be forwarded to the following laboratories:

Northeast, Mid-Atlantic and Southwest regions to Southeast Regional Laboratory

Midwest and Southwest regions to Dallas, Pacific Region to Los Angeles Laboratory

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Guanabana (Soursop) drinks, juices, nectars, etc.

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)


CANADA


Hanifs International Foods Ltd
Date Published : 08/10/2018
563 Ebury Place , Delta, BC CANADA
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 08/10/2018

Desc: Guanabana Nectar
Notes: 8/22/2001 - Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.


DOMINICAN REPUBLIC


Caribex Dominicana SA
Date Published : 09/18/2009
Apartado 409-2 , Santo Domingo, DOMINICAN REPUBLIC
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009

Desc: guanabana; soursop
Notes: toxic material from the fruit seed was incorporated into the finished product during the manufacturing process

Goya Santo Domingo SA
Date Published : 09/18/2009
Km 17 Ave 6 De Noviembre , San Cristobal, San Cristobal DOMINICAN REPUBLIC
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009

Notes: Guanabana Fruit Beverage; 11/20/07; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process


MEXICO


ABRAGUZ S. DE R.L. DE C.V.
Date Published : 11/01/2017
Prol. Guadalupe Victori , Col Centro c.P. , Mexico, MEXICO
29 B - - 11 Soda Water with Fruit Flavor, Carbonated
Date Published: 11/01/2017

Desc: Mind Water-Soursop (Guanabana)
Notes: Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

29 R - - 04 Bottled Water with Fruit Flavors, Noncarbonated (Nonmedicinal)
Date Published: 11/01/2017

Desc: Mind Water-Soursop (Guanabana)
Notes: Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Jugos Del Valle S A. De C.V.
Date Published : 09/18/2009
Avenida Insurgentes No. 30 , barrio Texcacoa , Tepotzotlan, Mexico MEXICO
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009

Notes: Guanabana drink; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process

22 K - - 04 Soursop, Juice, Other Fruit Juices or Concentrates
Date Published: 09/18/2009

Notes: toxic material from the fruit seed was incorporated into the finished product during the manufacturing process


PHILIPPINES


Profood International Corporation
Date Published : 02/07/2014
Highway Maguikay , Cebu, Central Visayas PHILIPPINES
21 R - - 99 Subtropical and Tropical Fruit Purees, N.E.C.
Date Published: 02/07/2014

Desc: Guyabana
Notes: Aseptic guyabana (sic) puree; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process; 07-09-2013

22 I - - 04 Soursop (Other Fruit Purees)
Date Published: 02/07/2014

Desc: Soursop (other Fruit Purees)
Notes: toxic material from the fruit seed was incorporated into the finished product during the manufacturing process; 09/18/2009

Summer Fruit Inc (Factory), Marsman-Drysdale Group
Date Published : 09/18/2009
Km 42 By Pass, Bgy, San Vicente , Silang , Cavite, PHILIPPINES
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009

Notes: Guanabana; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process

22 K - - 04 Soursop, Juice, Other Fruit Juices or Concentrates
Date Published: 09/18/2009

Notes: toxic material from the fruit seed was incorporated into the finished product during the manufacturing process

Summer Fruit Inc (Mfr), Marsman-Drysdale Group.
Date Published : 09/18/2009
Marsman Bldg, Sen Gil J Puyat Ave , Cor Washington Street, Makati , Metro Manila, PHILIPPINES
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 09/18/2009

Notes: Guanabana; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process

22 K - - 04 Soursop, Juice, Other Fruit Juices or Concentrates
Date Published: 09/18/2009

Notes: toxic material from the fruit seed was incorporated into the finished product during the manufacturing process


VIETNAM


Agrimexco
Date Published : 09/18/2009
176 Hai Ba Trung St , District 1 , Ho Chi Minh City, VIETNAM
22 H - - 04 Soursop, Dried or Paste
Date Published: 09/18/2009

Notes: 4/23/01; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process

Lucky Shing Co., Ltd.
Date Published : 09/18/2009
An Thanh Village, Ben Luc District , No. 3, 108/1, Road No. 830, Hamlet , Long An Province, VIETNAM
22 H - - 04 Soursop, Dried or Paste
Date Published: 09/18/2009

Notes: 4/11/01; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process; frozen soursop paste

22 I - - 04 Soursop (Other Fruit Purees)
Date Published: 09/18/2009

Notes: 4/11/01; frozen soursop paste; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process