By Ricardo Carvajal –
FDA published a draft Compliance Policy Guide ("CPG") that sets out enforcement criteria for ackee fruit products that contain hypoglycin A, a toxin that is naturally present in the fruit. Adverse effects of consuming the toxin can range from none to vomiting, seizures, and even death (a.k.a. Jamaican vomiting sickness). At first blush, it would seem that FDC Act § 402(a)(1) provides the framework for addressing this issue, as that section specifies the circumstances under which a food is deemed adulterated by virtue of containing a poisonous or deleterious substance, and specifies different standards depending on whether the poisonous or deleterious substance is added or naturally occurring. On further examination, deciding which standard to apply in the case of ackee presents an unusual challenge.
In unripe fruit, hypoglycin A is found at high levels, which drop to negligible levels in certain parts of the fruit as it ripens and splits open of its own accord. It follows that if a processor includes the “wrong” parts of the fruit in the finished product or does not allow sufficient time for the fruit to ripen, levels of the toxin will be higher than would otherwise be the case. To complicate matters, there are methods of accelerating the splitting of the fruit that are not accompanied by a drop in the levels of the toxin. In these scenarios, the levels of the toxin are not actually increased by human intervention, which begs the question of whether the toxin could be regarded as having been added for purposes of a § 402(a)(1) analysis.
Rather than wrestle with this issue, FDA pressed into service the ever pliable § 402(a)(4):
The presence of hypoglycin A in the finished ackee product at levels above 100 ppm can be attributed to improper processing of the product and may pose a health risk. . . . Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C. 342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Canned ackee, frozen ackee, and other ackee products may be considered adulterated within the meaning of section 402(a)(4) of the FD&C Act when hypoglycin A is present in the food at levels greater than 100 ppm.
If that approach makes you want to run away to a tropical island, you could find yourself in good company (extra credit for an accurate transcription of the reference to ackee).