FDA Regulation of Ackee Fruit Products

Ackee fruit is harvested from the ackee tree (Blighia sapida), which is native to West Africa, but is also found in Central and South America, many Caribbean countries, and southern Florida.  Ackee is an evergreen tree that grows about 10 meters tall, with a short trunk and a dense crown.  Its fruit is pear-shaped.  When it ripens, it splits open to reveal three large, shiny black seeds, surrounded by soft flesh, the edible arilli.  The fruit is rich in essential fatty acids, vitamin A, zinc, and protein.

Canned, frozen, and other ackee products are marketed in the United States, largely to people from Caribbean cultures.  Most of the ackee products in the United States are imported from tropical countries, such as Jamaica, Belize, and Haiti; however, in recent years, there has been interest by a domestic processor(s) to market ackee products in interstate commerce.

The ackee fruit’s seeds and arilli naturally contain the toxin hypoglycin A (a/k/a simply hypoglycin), which drops to negligible levels in the edible portion of the fruit when it is fully ripe.  Hypoglycin may pose a health risk in concentrations above 100 parts per million (ppm), according to an FDA risk assessment.  The presence of hypoglycin in a finished ackee product at levels above 100 ppm can be attributed to improper processing of the product.

FDA Import Alert 21-11 authorizes the agency’s District Offices to detain, without physical examination, all ackee products offered for import, except for those from firms that are identified on a “Green List” included in the Import Alert.  The firms 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.

FDA also has published a final Compliance Policy Guide (CPG) that provides guidance for FDA staff on the agency’s enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin.  The CPG (section 550.050) recommends seizure or import refusal of canned, frozen, and other ackee products that contain greater than 100 ppm of hypoglycin.  Beginning today, persons wishing to comment on the final CPG may submit electronic or written comments to FDA.

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