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: 04/29/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Guanabana (Soursop)"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 04/29/2020 updates the reason for alert, guidance, agency contacts, and PAC Code. Changes to the import alert are bracketed by asterisks (***).

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 microscopic 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:

Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert.

Samples collected for analysis should be forwarded to the following laboratories:

***Pacific Southwest Food and Feed Laboratory (PSFFL), Pacific Northwest Laboratory (PNL), and Northeast Food and Feed Laboratory (NFFL) as per lab capacity.***

***Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO).

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 detained product, which demonstrates that the product does not bear or contain toxins.

Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. 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 (REMOVE FROM RED LIST):

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

Petition for Removal from Detention Without Physical Examination.

If a firm and/or a representative thereof would like 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 (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 or issues with regard to human food on 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:

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. Contains:” [Adulteration, Section 402(a)(1)]

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 Pl , Delta, British Columbia 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 , Autopista 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


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