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: 05/18/2022
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Guanabana (Soursop)"

Reason for Alert:

NOTE: The revision of this Import Alert (IA) dated 05/18/2022 updates the reason for alert, guidance section, agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***).

***Soursop is a tropical fruit of Annona muricata, an evergreen tree (also known as graviola, guyabano, guanabana, Brazilian pawpaw, corossol or prickly custard apple) that is native to Central and tropical South America. The fruit, along with leaves and bark, contain neurotoxic compounds called acetogenins. The seeds contain high levels of acetogenins rendering them inedible. In the scientific literature, acetogenins are described as associated with neurodegenerative disorders.***

***This alert was created in June 1990 in response to a complaint/injury report and subsequent FDA investigation, after thirty-four adults and children drank "Rain Drop" Guanabana Drink imported from Mexico and began vomiting within 15 minutes. FDA performed microscopic examination of the product and found cells from Annana muricata seeds in all lot codes examined.

In September 2017, a soursop (guanabana)drink from Mexico was found to contain toxic epidermal cells from guanabana seeds. Additionally, in July 2016, soursop juice from the Philippines was found to contain cells similar to soursop seed epidermal cells. FDA has determined that these findings demonstrate that products containing soursop pulp continue to be a public health concern.***

Guidance:

***Divisions may detain, without physical examination, identified products from the firms on the Red List of this alert.

Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO will coordinate review of all recommendations for addition to DWPE with the Center for Food Safety and Applied Nutrition CFSAN.***

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

In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or another responsible party for the affected goods should provide evidence that the product does not contain natural toxins. Such evidence may include private laboratory analysis of a representative sample(s) collected from the affected articles

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical 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):

***In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from DWPE, refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." ***

If a firm and/or a representative thereof would like to petition for removal from DWPE 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 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 not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                ***

Product Description:

***Guanabana (Soursop) drinks, juices, nectars, refrigerated, frozen, or (ready-to- eat) packaged soursop pulp, juice 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.

Rubicon Food Prod
Date Published : 12/10/2021
5-2220 Midland Ave , Scarborough, Ontario CANADA
21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C.
Date Published: 12/10/2021

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 (THE)


Caribex Dominicana SA
Date Published : 09/18/2009
Apartado 409-2 , Santo Domingo, DOMINICAN REPUBLIC (THE)
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 (THE)
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: 12/10/2021

Desc: Guanabana drink
Notes: 8/18/1994 - 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: 12/10/2021

Desc: Guanabana
Notes: 8/18/1994 - 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: 12/10/2021

Desc: Guanabana
Notes: 8/18/1994 - 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 Company 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 G - - 04 Soursop (Other Fruit Products)
Date Published: 04/20/2022

Desc: Guanabana (Other Fruit Products)
Notes: 4/11/01; toxic material from the fruit seed was incorporated into the finished product during the manufacturing process; frozen soursop paste

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