Thursday, November 15, 2012

Ackee Toxin: Natural, Added or Non-Added? Does It Matter?

FDA published a draft Compliance Policy Guide on ackee fruit that contain hypoglycin A, a toxin that can naturally occurs ackee. Adverse effects of consuming the toxin range from none to vomiting, seizures, and even death (a.k.a. Jamaican vomiting sickness).

Does this fall under the Food, Drug, and Cosmetic Act § 402(a)(1) non-added standard? — a food is deemed adulterated if it contains a poisonous or deleterious substance which may render it injurious to health?

Or does this fall under the § 402(a)(1) added substance standard? — a food is deemed adulterated if the quantity of the substance ordinarily renders it injurious to health?

In the case of ackee, deciding which standard to apply presents an interesting challenge. Unripe fruit contains hypoglycin A at high levels, but levels drop to negligible amounts in certain parts of the fruit as it ripens and splits open naturally. The toxin is naturally occurring but does that make it non-added under the FD&C Act? 

If the wrong parts of the fruit are used or if the fruit is not sufficiently ripe, levels of the toxin will be higher. Would this be “added” for purposes of a § 402(a)(1) analysis?

Ackees (Photo credit: kaiton)
To complicate matters further, methods can accelerate the appearance of ripeness, the splitting of the fruit, without the normal drop in the level of the toxin. Because human activity caused the fruit to have higher toxin levels than normal, would this be “added” for purposes of a § 402(a)(1) analysis?

Rather than wrestle with this issue, FDA pressed into service their ace in the hole, § 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.

Hat tip to Ricardo Carvajal for his post on this topic. You may have heard of ackee fruit without realizing it. Listen carefully to the words of this song and image a visit to a tropical island.