(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 Name:
Reason for Alert:
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***.
***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 science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at firstname.lastname@example.org
Questions or issues on human food policy, or sample collection recommendations, should be addressed to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
FOI: Purge all FCE's as indicated by
OASIS charge code – INSANITARY***
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 PasteDesc: 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
(21 V - - 13) Ackees, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit
(21 W - - 13) Ackees, Topping or Syrup
(21 X - - 13) Ackees (Subtropical/Tropical Fruit Pulp)
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)
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)