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We are announcing the availability of the draft CPG entitled “Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products—Hypoglycin A Toxin.” The draft CPG is intended to provide guidance for FDA staff regarding hypoglycin A in canned ackee, frozen ackee, and other ackee products. We have 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.
The draft CPG is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft CPG, when finalized, will represent our current thinking on hypoglycin A in ackee products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either written comments regarding the draft CPG to the Division of Dockets Management (see
Persons with access to the Internet may obtain the draft CPG either from FDA's Office of Regulatory Affairs history page at