FDA Proposes Changes in Regulation of Processed Ackee Fruit

November 8, 2012 FDA today published in the Federal Register a draft Compliance Policy Guide that, when finalized, will provide guidance for FDA staff on our enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin A. Ackee fruit is harvested from the ackee tree, which is native to West Africa but has been grown for its fruit in Jamaica since the 18th century and is now a widespread fruit tree in many countries in the Caribbean and Central and South America. Canned and frozen ackee fruit is marketed in the United States almost exclusively to people from Caribbean cultures. Most of the ackee and ackee products in the United States are imported from tropical countries, such as Jamaica, Belize, and Haiti. However, ackee trees also grow in southern Florida and in recent years there has been interest by a processor in Florida to market ackee products in interstate commerce. The ackee fruit naturally contains the toxin hypoglycin A, which drops to negligible levels in certain parts of the fruit when it is fully ripe. Hypoglycin A may pose a health risk in amounts in excess of 100 parts per million, according to an FDA risk assessment. If the ackee fruit is not processed properly, levels of hypoglycin A above 100 ppm may be present in the processed ackee product. FDA has in place an Import Alert which states that districts may detain without physical examination all ackee products offered for import, except for those ackee products from firms that are identified on a “green list” included in the Import Alert. The firms on the green list are those firms that have demonstrated to FDA that future shipments of their ackee products will not be adulterated. The Import Alert also includes a “yellow list.” Firms on the “yellow list” of the import alert have been identified as having food safety controls in place to control the toxin, hypoglycin A, in their ackee products. Firms on this list must provide test results demonstrating that their product does not contain a level of hypoglycin A that may render the product injurious to health, in order to secure release of the shipment. FDA assesses all processors of ackee for export to the United States on a facility-by-facility basis. See the Federal Register notice for the Draft Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products--Hypoglycin A Toxin for more information. Interested parties can submit comments on the draft during a 60-day comment period. View the FDA Import Alert for ackee fruit (IA 21-11) on the FDA website.