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: 08/24/2020
Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Ackees Due to Hypoglycin A

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 08/24/2020 updates the name of the alert, the reason for the alert, the guidance section to clarify Yellow List and the charge section. Changes to the import alert 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. *** FDA has determined that canned ackee, frozen ackee, or other ackee products containing concentrations of hypoglycin A above 100 ppm have not been processed properly and that finished product may pose a health risk***. 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.

***Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C. 342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Canned ackee, frozen ackee, and other ackee products may be considered adulterated within the meaning of section 402(a)(4) of the FD&C Act when hypoglycin A is present in the food at levels greater than 100 ppm. See Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products - Hypoglycin A Toxin***.

Guidance:

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

***Firms seeking to export ackees to the United States must first petition FDA to be added to the Yellow List of this alert. Once a firm has been added to the Yellow List of this alert, the firm can then initiate exporting to the United States and provide private laboratory analysis for release of each shipment. Firms listed on the Yellow List that are able to export a number of non-violative shipments to the United States, can then petition FDA to be added to the Green List of this alert. Once a firm/product has met the criteria and has been added to the Green List of this alert, the firm/product are exempt from DWPE under this alert.***

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 would like to request inclusion on the Yellow List to export their ackee product(s) to the U.S., they should forward information regarding their food safety controls currently in place to control for the toxin, hypoglycin A. Such information may include, but is not limited to: supplier and raw materials specifications, process and procedure flow charts, a hazard analysis, a food safety plan, a HACCP plan, a recall plan, process preventive controls, employee GMP training records, processing and monitoring records, an export certificate from the Bureau of Standards Jamaica, third party audits and certifications.

Their petition with supporting information should be submitted 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

Or, sent via email: CFSANEnforcement@fda.hhs.gov

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 ***petition for addition of their firm/product to the Green List of this Import Alert and *** provide documentation ***of a minimum of five (5) consecutive import entries that have been released by FDA based on private laboratory analyses of shipments *** 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 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 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


FOI: 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 to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]

OASIS charge code – INSANITARY***

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


GK Foods & Services Limited-Grace Agro Processors
Date Published : 07/28/2020
1 Foga Road , Denbigh, Clarendon JAMAICA
21 S - - 13 Ackees (Subtropical and Tropical Fruit)
Date Published: 07/28/2020

Desc: Canned Ackees

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 , Saint Thomas, St. Thomas 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