Import Alert 21-11

(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 # 21-11
Published Date: 08/16/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Ackees"

Reason for Alert:

NOTE:The revision of this Import Alert dated 02/20/2019 updates the Alert to change the word processor to facility (multiple instances). Also, adds DWPE and contact information. Changes are bracketed by asterisks (***).

Ackee is a tropical fruit that contains a natural heat-stable toxin, hypoglycin A. The ingestion of hypoglycin A may result in no symptoms or symptoms that range from mild (e.g., some vomiting) to severe (e.g., vomiting with profound hypoglycemia, drowsiness, muscular exhaustion, prostration, and possibly coma and death).

The toxin, hypoglycin A, is found at high levels in unripe arils (the fleshy portion of the fruit), seeds, raphe (thin membrane between the seed and the aril), and rind of ackee (roughly at a level of 1,000 parts per million (ppm)). Once ackee fully ripens, the hypoglycin A drops to negligible levels in the arils and raphe, making them safe to consume (although the raphe is removed prior to packaging). However, the rind and seeds still have high levels of hypoglycin A when the fruit is fully ripe and should not be consumed. Additionally, there is the possibility that unripe ackee, ackee seeds, or ackee rind could get into finished ackee products during processing. This led FDA to conclude that all shipments of ackees and ackee products, except for ackee products from those firms identified in the Green List to this alert, should be detained without physical examination. The facilities listed in the Green List have demonstrated to FDA that they have food safety controls in place to ensure that only properly ripened ackees, without seeds or rind, are included in finished products.

Note: ORS contact information updated on 08/16/2019

Guidance:

Districts may detain without physical examination, shipments of ackees of all product types (raw, frozen, canned, dried, etc.), except for ackee products from firms listed on the Green List below.

Based on the potential for harmful levels of the toxin, hypolgycin A, from improper processing of ackee, FDA intends to assess all ***facilities*** of ackee for export to the United States on a plant-by-plant basis prior to considering the admissibility of their ackee product(s) offered for import into the United States. As foreign ***facilities*** are identified to have food safety controls in place to control for the toxin, hypoglycin A, in their ackee products, the firm and product(s) will be identified on the Yellow List of this Import Alert.

If a firm wishes to request inclusion on the Yellow List to export their ackee product(s) to the U.S., they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Division of Enforcement
Food Adulteration Assessment Branch (HFS-607)
5100 Campus Drive
College Park, MD 20740

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 contain a level of hypoglycin A that may render the product injurious to health.

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:

In order to remove a firm's product from DWPE, information should be provided to the Agency to adequately demonstrate that the food facility has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).***

For those firm/product(s) on the Yellow List of this Import Alert, in order to secure release of an individual shipment subject to detention without physical examination, the owner or consignee should provide the private laboratory analytical results of a representative sample of the shipment which verifies the product does not contain a level of hypoglycin A that may render the product injurious to health.

Sampling and analytical records should be submitted to the appropriate FDA District 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 collect and analyze audit samples before rendering a final decision on the admissibility of the article.

Requests for Removal from Detention Without Physical Examination Under This Import Alert:

Foreign ***facilities*** listed on the Yellow List of this import alert requesting removal from detention without physical examination should provide documentation with sufficient evidence to demonstrate future shipments of their ackee product(s) will not be adulterated.

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

If a firm and/or a representative thereof wishes 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/Import Compliance Branch (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 (301) 796-6600 or oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues on policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov

COUNTRY: SEE RED LIST

FIRM(S): SEE RED LIST***


FOI: Please purge all FCE's as indicated by  

Product Description:

Ackees, all product types (raw, frozen, canned, dried, etc.). The ackee may also be referenced as "akee", "akee apple", "vegetable brain" (seso vegetal in Spanish), "akie", or "ishin."

Charge:

"The article is subject to refusal of admission pursuant Section 801(a)(3) in that it article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contam
contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]."

OASIS charge code - INSANITARY

PAF: (BIO) Naturally Occurring Toxins REG

PAC: 07819 - Foodborne Biological Hazards

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (21 R - - 13) Ackees (Subtropical and Tropical Fruit Purees)
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."
  • (21 S - - 13) Ackees (Subtropical and Tropical Fruit)
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."
  • (21 T - - 13) Ackees, Dried or Paste
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."
  • (21 U - - 13) Ackees, Jam, Jelly, Preserves, Marmalade, Butter or Candied
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."
  • (21 V - - 13) Ackees, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."
  • (21 W - - 13) Ackees, Topping or Syrup
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."
  • (21 X - - 13) Ackees (Subtropical/Tropical Fruit Pulp)
    Desc: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee"; "akee apple"; "vegetable brain" (seso vegetal in Spanish); "akie"; or "ishin."

Red - Firms, countries and/or products that are subject to detention without physical examination of the product identified in the criteria of the alert
Yellow - List of firms and their products subject to intensified surveillance; or firms that may have satisfied GMP issues of concern, but the nature of violations may warrant further field examinations of individual entries and/or additional analyses (a.k.a. Yellow List)
Green - Firms are excluded from the criteria of the alert

Go to Yellow List   Green List  


List of firms and their products subject to intensified surveillance; or firms that may have satisfied GMP issues of concern, but the nature of violations may warrant further field examinations of individual entries and/or additional analyses (a.k.a. Yellow List)


JAMAICA


Goshen Manufacturing & Distributors
Date Published : 09/26/2017
159 B Orange St , Kingston, JAMAICA
21 S - - 13 Ackees (Subtropical and Tropical Fruit)
Date Published: 09/26/2017

Desc: Canned Ackee

21 X - - 13 Ackees (Subtropical/Tropical Fruit Pulp)
Date Published: 09/26/2017

Desc: Canned Ackee

Norsai Enterprise Ltd.
Date Published : 06/22/2018
Yallahs Industrial Estate , Lot 3; Poorman' Corner , Yallahs, Saint Thomas JAMAICA
21 S - - 13 Ackees (Subtropical and Tropical Fruit)
Date Published: 06/22/2018

Desc: Canned Ackee in brine

Tripple C Mamufacturing &Commodities Distribution
Date Published : 09/19/2016
Lot 9 Twickenham Park, Industrial Estate , Spanish Town P.O Box 420, JM-14 JAMAICA
21 S - - 13 Ackees (Subtropical and Tropical Fruit)
Date Published: 09/19/2016

Desc: Ackees (canned ackees in brine)


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)


BELIZE


Fruit Processors Ltd.
Date Published : 12/18/2009
7 miles Southern Hwy , Dangriga, BZ-SC BELIZE
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 12/18/2009

Desc: Canned Ackees
Notes:           


HAITI


ANTILLEAN CANNING S.A.
Date Published : 06/03/2010
Route Aeroport , SE corner of runway - GREEN GATES , Port-Au-Prince, ouest HAITI
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 06/03/2010

Desc: Canned Ackees
Notes:            3/21/05; Address update 6/3/10


JAMAICA


Ashman Food Products Ltd.
Date Published : 09/16/2009
Lot 434 Vineyard Crescent, Bushy Park P.O. , St. Catherine, JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees           

Canco Limited
Date Published : 09/16/2009
Seaforth , Saint Thomas, St. Thomas JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees           

Central Food Packers Ltd.
Date Published : 09/16/2009
Mandela Highway , Central Village, St. Catherine JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees           

DOUBLE DEUCE JAMAICA LTD.
Date Published : 03/24/2010
Yallahs Industrial Estate , Poorman's Corner , Yallahs, Saint Thomas JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 03/24/2010

Desc: Canned Ackees
Notes:           

Exotic Products Jamaica Limited
Date Published : 05/22/2013
Danvers Pen , St. Thomas, JM-03 JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 05/22/2013

Desc: Canned Ackees
Notes:           

Island Packers
Date Published : 09/16/2009
C.S. Dick Drive , Lionel Town, Clarendon JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees           

Southern Fruits & Food Processors Ltd
Date Published : 09/16/2009
Bull Savannah , Bull Savannah P.A. , St. Elizabeth, JM-11 JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees           

Stanmark Processors Company Limited
Date Published : 09/16/2009
Lots 213-216 , Surry Ave. South Haven , Yallahs, Saint Thomas JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees           

Tijule Company Ltd.
Date Published : 09/16/2009
30 Paisley Avenue, Palmers Cross , May Pen, Clarendon JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 05/22/2013

Desc: Canned and Frozen Ackees
Notes:             

21 S - D 13 Ackees (Subtropical and Tropical Fruit), Raw - Fresh, Frozen, Natural State
Date Published: 09/16/2009

Notes: Canned and Frozen Ackees           

West Best Foods Limited
Date Published : 09/16/2009
Darliston District , Westmoreland, JAMAICA
21 S E E 13 Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile
Date Published: 09/16/2009

Notes: Canned Ackees