IA #21-11, 7/3/00 - "DETENTION WITHOUT PHYSICAL EXAMINATION OF ACKEES (ALL
TYPES) ***DUE TO CONTAMINATION BY NATURAL TOXINS***" Attachment 8/2/07
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 8/2/07
LIST of FIRMS/PRODUCTS THAT ARE EXEMPT FROM DETENTION WITHOUT PHYSICAL
EXAMINATION
FIRM PRODUCT/PRODUCT CODE
FCE# 07250
Stanmark Processors Co., Ltd. Canned Ackees
South Haven, Yallahs P.O. 21SEE13
St. Thomas 8/2/07
Jamaica, W.I.
FEI# 3004299403
FCE# 08380
Southern Fruits and Food Canned Ackees
Processors Ltd. 21SEE13
Bull Savannah P.O. 8/2/07
St. Elizabeth
Jamaica, W.I.
FEI# 3004195903
FCE# 08622
Tijule Company Ltd. Canned Ackees
30 Paisley Ave. 21SEE13
Palmers Cross 1/12/07
Clarendon
Jamaica, W.I. Frozen Ackees
FEI# 3002369845 21S-D13
1/12/07
FCE# 09212
Central Food Packers, Ltd. Canned Ackees
Central Village, St. Catherine 21SEE13
P.O. Box 75 12/20/06
Kingston
Jamaica, W.I.
FEI# 1000280286
FCE# 10980
Canco Limited Canned Ackees
Seaforth, St. Thomas 21SEE13
Jamaica, W.I.
FEI# 3004267007 12/20/06
FCE# 11154
Ashman Food Products Ltd. Canned Ackees
Lot 434 Vineyard Crescent 21SEE13
Bushy Park P.O. 8/2/07
St. Catherine
Jamaica, W.I.
FEI# 3004018019
FCE# 12129
West Best Foods Ltd. Canned Ackees
P.O. Box 28 21SEE13
Darliston, Westmoreland 8/2/07
Jamaica, W.I.
FEI# 3004315278
FCE# 12416 Canned Ackees
Antillean Canning S.A. (ANCASA) 21SEE13
Habitation Bales 3/2/05
Croix de Bouquets
P.O. Box 1757
Port-au-Prince
Haiti
FEI# 3003908155
FCE# 13065
Island Packers Ltd. Canned Ackees
C.S. Dick Drive 21SEE13
Lionel Town 8/2/07
Clarendon
Jamaica, W.I.
FEI# 3003882440
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