IA #20-02 - 3/11/96, "DETENTION WITHOUT PHYSICAL EXAMINATION OF APPLE JUICE AND
APPLE JUICE CONCENTRATE CONTAINING AN UNDECLARED SWEETENER"
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert contains guidance to FDA
field personnel only. It does not establish any
requirements, or create any rights or obligations
on FDA or on regulated entities.)
PRODUCT : Apple Juice and Apple Juice Concentrate
PRODUCT CODE : 20S--01
PROBLEM : Undeclared Sweetener (MSSS)
PAC FOR
COLLECTION : 21004
COUNTRY : See Attachment
MANUFACTURER : See Attachment
MANUFACTURER/
SHIPPER I.D.#: See Attachment
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be adulterated in that the product is
represented to be apple juice (or apple juice
concentrate) and hydrolyzed inulin syrup has been
substituted in part for apple juice (or apple
juice concentrate) [Adulteration 402(b)(2)]; and
misbranded in that the product is labeled as apple
juice (or apple juice concentrate), which is false
and misleading [Misbranding 403(a)(1)], and in
that the label fails to list the ingredient,
hydrolyzed inulin syrup [Misbranding, 403(i)(2)].
RECOMMENDING
OFFICE : CFSAN and DIOP
REASON FOR
ALERT : Manufacturers of 100% apple juice and other apple
juice beverages have recently learned and reported
to FDA that some apple juice concentrate supplied
to the industry appears to be adulterated with the
undeclared sweetener, hydrolyzed inulin syrup.
The juice industry has been cooperating fully in
FDA's investigation.
Samples of suspect apple juice concentrate
collected and analyzed by FDA were confirmed to
contain undeclared hydrolyzed inulin syrup. The
presence of this undeclared sweetener produced
from the starch inulin, obtained from Jerusalem
artichokes, chicory or asparagus, does not appear
to constitute a public health hazard. This
cheaper ingredient was apparently substituted
in part for apple juice concentrate before being
imported into the United States.
The samples found by FDA to contain the undeclared
sweetener were from products supplied by the Swiss
firm Amnon Barasch and shipped by that firm's
subsidiary, Carronade International Trading
Limited. Carronade is known to ship from Belgium,
Netherlands, Hungary and Poland.
GUIDANCE : Districts may detain without physical examination
apple juice and apple juice concentrate
manufactured or shipped by the firms listed on the
attachment to this alert.
Additionally, CFSAN analysis of 100% apple juice
obtained for surveillance purposes from domestic
markets has also found another adulterant,
high fructose corn syrup. Determination
has not been made as to whether this is due to
foreign suppliers at this time.
For the time being, districts should NOT
do surveillance sampling except in response to
assignments issued by ORA and/or CFSAN. This is
to enable the Agency to best focus the allocation
of resources.
In order to overcome the appearance of a
violation, importers can, as one approach, have
the product tested for the hydrolyzed inulin
syrup using the "Low" method developed by industry
to determine the presence of the sweetener in
apple juice and apple juice concentrate. This
methodology is new, however, private laboratories
can obtain information on the analytical
methodology, as well as reference materials
containing hydrolyzed inulin syrup, by contacting
Dr. Samuel Page, Division of Natural Products,
Center for Food Safety and Applied Nutrition, FDA,
at telephone number (202) 205-4355.
For the time being, all questions concerning
analysis, sample preparation or analytical
methodology should be referred to CFSAN, Dr.
Samuel Page, at telephone number (202) 205-4355.
ALL analytical packages submitted by private
laboratories should also be referred to CFSAN,
Import Branch, HFS-606, for evaluation
of their sufficiency to remove the appearance of a
violation.
Report violative samples to CFSAN. Complete
analytical packages should be sent to CFSAN,
Import Branch, HFS-606, which in turn
will notify DIOP if firms are to be placed on the
Attachment to this import alert.
PRIORITIZATION
GUIDANCE : II
FOI : No purging is required
KEYWORDS : Undeclared sweetener, apple juice, apple juice
concentrate, Inulin
PREPARED BY : George N. Butler and Linda Wisniowski, DIOP, (301)
443-6553
DATE
LOADED INTO
FIARS : March 11, 1996
ATTACHMENT TO IMPORT ALERT #20-02 - 3/11/96
MANUFACTURERS/SHIPPERS ON DETENTION WITHOUT PHYSICAL EXAMINATION
SWITZERLAND (CH, 855)
Amnon Barasch
1 M Park
Kasermenstrasse 40
CH-9100 Herisau, Switzerland
Carronade International Trading Limited
1 M Park
Kasermenstrasse 40
CH-9100 Herisau, Switzerland
MID# CHCARINT40HER
FEI# 1000281844
Empresa Comercial Internacional De Frutas S.A.
1 M Park
Kasermenstrasse 40
CH-9100 Herisau, Switzerland
MID# CHEMPCOM40HER
FEI# 1000152538
NETHERLANDS (NL, 630)
Empresa Comercial Internacional De Frutas S.A.
Minckelersstr 3
Landgraaf, Netherlands
MID# NLEMPCOM3LAN
FEI# 1000262919
Vriesveem "De Berg" B.V.
Minckelersstr. 3
Landgraaf, Netherlands
MID# NLVRIDK3LAN
FEI#1000162808