Import Alert 21-11

Import Alert # 21-11

Published Date: 04/25/2025

Type: DWPE

Detention Without Physical Examination of Ackees Due to Hypoglycin A

Note: The revision of this Import Alert (IA) dated 04/25/2025 updates the guidance section of the alert including agency contacts. 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. FDA 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 on the Green List to this alert, should be detained without physical examination. The facilities listed on 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.

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 (U.S.) 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 U.S. 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.

***All requests for addition of a firm to the yellow list of this Import Alert should be referred to Human Foods Program/Import Enforcement Branch for evaluation at HFP-OCE-Imports@fda.hhs.gov***

***Removal from Detention Without Physical Examination Under This Import Alert (ADD TO GREEN LIST):***

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 addition to the green list (removal from detention without physical examination) under this Import Alert all relevant information supporting the request should be via email to:Importalerts2@fda.hhs.gov***

Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology should be addressed to FDAPRIVATELABIMPORTALERTS@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 (or live) entry, should be addressed to Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov.

                                                                                                                                                          ***

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"

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

Desc: Canned Ackee in brine

Desc: Canned Ackees

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Desc: Canned Ackees

Notes:            3/21/05; Address update 6/3/10

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Desc: Canned and Frozen Ackees

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Desc: Ackees (canned ackees in brine)

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