IA #21-11, 7/3/00 - "DETENTION WITHOUT PHYSICAL EXAMINATION OF
ACKEES (ALL TYPES) ***DUE TO CONTAMINATION BY NATURAL TOXINS***"
NOTE: This revision changes the name of the alert and updates
the alert to the current format and terminology. In
addition, this revision creates an attachment which
lists firms whose ackee products are exempt from
detention without physical examination. Changes are
bracketed by asterisks ( *** ).
TYPE OF ALERT: ***Detention without Physical Examination***
NOTE: ***This import alert represents the Agency's current
guidance to FDA field personnel regarding the
manufacturer(s) and/or product(s) at issue. It does not
create or confer any rights for or on any person, and
does not operate to bind FDA or the public.***
PRODUCT: Ackees all product types including canned, frozen,
raw, dried, etc. The ackee is known as the national
fruit of Jamaica and may be called "akee", "akie", or
"ishin"
PRODUCT CODE: 21S--13, 21R--13, 21T--13, 21U--13, 21V--13
21W--13
PROBLEM: ***Naturally occurring toxins*** Hypoglycin-A and
Hypoglycin-B
***(OASIS charge code = POISONOUS)***
PAF: ***BIO (Biological Toxin)***
PAC: ***07819***
COUNTRY: ***All***
MANUFACTURER/
SHIPPER: ***All, except those listed on the attachment.***
CHARGE: "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the product
appears to contain poisonous and deleterious
substances, namely hypoglycin-A and hypoglycin-B, which
may render it injurious to health [Adulteration,
Section 402(a)(1)]."
RECOMMENDING
OFFICE: CFSAN, HFS-606 and HFS-300
REASON FOR
ALERT: CFSAN has determined, after a study of all available
scientific literature, that ackees contain two toxic
substances when the fruit is either green or over-ripe.
The seeds, ***pinkish membrane under the seeds, and
outer rind*** of the fruit contain the toxic substances
at all times. The substances are hypoglycin-A and
hypoglycin-B which are dangerous natural toxins that
have been known to cause poisoning and death. The
ingestion of ***immature*** ackee is conclusively
linked to "vomiting sickness" in Jamaica. The
literature describes the onset of vomiting sickness as
sudden. One or more periods of vomiting and quiescence
***can be*** followed by convulsions, coma, and death.
***In the unripened fruit, hypoglycin is located
throughout the fruit, seeds, membrane under the seeds,
and outer rind. In ripe ackee, the edible portion of
the fruit is safe to consume. The seeds and outer rind,
however, still contain high levels of hypoglycin and
should not be consumed.***
The above facts, plus the possibility that green or
over-ripe fruits or seeds could get into the cans
during commercial canning, or be consumed when eating
the fresh fruit leads CFSAN to conclude that all
shipments of ackees, ***EXCEPT from those firms
identified in the Attachment to this alert, ***should
be detained without physical examination. ***The
processors listed in the Attachment have food safety
controls in place to ensure that only properly ripened
ackees, without seeds, membrane, or outer rind, are
used for canning.***
***FDA is also aware*** of attempts to smuggle canned
ackees into the United States by either false
declaration on the can labels or by concealing the
canned ackees in containers of other food products and
not declaring ackees on the Customs entry. Numerous
detentions of ackees continued to occur during FY92 and
FY93. Others have been reported since that time.
Specific examples of false declarations are:
1. Canned Ackee labeled as:
-"Montego Brand Jamaican Callaloo in Brine"
(Callaloo is Jamaican slang for spinach)
- "Tropic Ginger Beer, Product of Jamaica"
- "Tropic Banana Fruit"
- "Callaloo"
2. Cartons of canned ackees hidden among cartons of
Jamaican beer (the entire contents of the container
labeled as beer)
GUIDANCE: Districts may detain without physical examination
entries of ackees, in all product types, (canned, raw,
frozen, dried, etc.) ***EXCEPT canned ackee from
processors listed in the Attachment to this import
alert. As other processors are identified to have food
safety controls (HACCP) in place to control the
potential for toxin contamination in the canned fruit,
they will also be identified in this import alert.
Because of the potential for toxin contamination from
ackee, CFSAN has determined that all processors of
canned ackee for export to the United States must be
approved on a plant-by plant basis.***
For questions or issues concerning science, science
policy, sample collection, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301)443-3320 or 3007.
FOI: No purging is required.
KEYWORDS: Ackees, Akie, Akee, Ishin, hypoglycin-A, hypoglycin-B,
toxin, poisonous
PREPARED BY: Doug Randes, DIOP, 301-443-6553.
DATE LOADED INTO FIARS: JULY 3, 2000 ATTACHMENT TO IMPORT ALERT #21-11 2/18/04
LIST of FIRMS/PRODUCTS THAT ARE EXEMPT FROM DETENTION WITHOUT
PHYSICAL EXAMINATION
FIRM PRODUCT/PRODUCT CODE
FCE# 11154 Canned Ackee
Ashman Food Products LTD. 21SEE13
Lot 434 Vineyard Cresent
Bushy Park P.O.
St. Catherine
Jamaica, W.I.
FEI# 3002984792
FCE# 10980 Canned Ackee
Canco Limited 21SEE13
Seaforth, St. Thomas
Jamaica, W.I.
FEI# 3002793762
FCE# 08622 Canned Ackee
Tijule Company, Ltd. 21SEE13
30 Paisley Avenue 3/1/01
Palmers Cross
Clarendon
Jamaica, W.I.
FEI# 3002369845
FCE# 12129 Canned Ackee
West Best Foods, Ltd. 21SEE13
P.O. Box 28 3/1/01
Darliston, Westmoreland
Jamaica, W.I.
FEI# 3003145183
FCE# 08380 Canned Ackee
Southern Fruits and 21SEE13
Food Processors, Ltd. 2/18/04
Bull Savannah P.O.
St. Elizabeth
Jamaica, W.I.
FEI# 3003311226
FCE# 13065 Canned Ackee
Island Packers Limited 21SEE13
C.S. Dick Drive 2/18/04
Lionel Town
Clarendon
Jamaica, W.I.
FEI# 3003882440