FDA Issues Draft Guidance On Processed Ackee Fruit
The U.S. Food and Drug Administration (FDA) is seeking comments on newly issued draft compliance pol…The U.S. Food and Drug Administration (FDA) is seeking comments on newly issued draft compliance policy guide for FDA staff regarding canned ackee, frozen ackee and other ackee products that contain hypoglycin A.
The document, published in the Federal Register on Nov. 8, addresses ackee fruit that 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.
The agency has concluded that canned ackee, frozen ackee, and other ackee products containing concentrations of hypoglycin A above 100 parts per million (ppm) have not been processed properly, and that the finished product may be injurious to health. As stated in the draft CPG, canned ackee, frozen ackee, and other ackee products may be considered adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(4)) when hypoglycin A is present in the food at levels greater than 100 ppm. The draft CPG also contains information that may be useful to the regulated industry and to the public.