FDA Issues Final Guidance on Ackee Products
CFSAN Constituent Update
April 14, 2014
The U.S. Food and Drug Administration (FDA) today is announcing the availability of a final Compliance Policy Guide that provides guidance for FDA staff on FDA’s enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain the toxin hypoglycin A.
Ackee fruit is harvested from the ackee tree, which is native to West Africa but is also found in Central and South America, many Caribbean countries, and Southern Florida. 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 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 the edible portion of the fruit when it is fully ripe. Hypoglycin A may pose a health risk in concentrations above 100 parts per million (ppm), according to an FDA risk assessment. The presence of hypoglycin A in a finished ackee product at levels above 100 ppm can be attributed to improper processing of the product. Accordingly, FDA’s final Compliance Policy Guide recommends seizure or import refusal of canned, frozen and other ackee products that contain greater than 100 ppm of hypoglycin A.
FDA has an Import Alert (IA-21-11) stating that FDA’s district offices may 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.
For more information on FDA’s policy on ackee products, see the final Compliance Policy Guide and FDA Import Alert 21-11. Additionally, persons wishing to comment on the final Compliance Policy Guide may submit electronic comments on the CPG to http://www.regulations.gov. Written comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The comment period begins April 15, 2014.