Import Alert 20-02
-
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).
Import Alert # 20-02
Published Date: 10/07/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Apple Juice and Apple Juice Concentration Containing an Undeclared Sweetner"
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.
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 Red List for 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, Product Adulteration 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, Product Adulteration Branch, HFS-606, which in turn will notify DIOP if firms are to be placed on the red list for this alert.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
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, Product Adulteration 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, Product Adulteration Branch, HFS-606, which in turn will notify DIOP if firms are to be placed on the red list for this alert.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Apple Juice and Apple Juice Concentrate
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)]"
OASIS charge code - SUBSTITUTE
and
"...misbranded in that the product is labeled as apple juice (or apple juice concentrate), which is false and misleading. [Misbranding 403(a) (1)]"
OASIS charge code - FALSE
and
"...in that the label fails to list the ingredient, hydrolyzed inulin syrup. [Misbranding, 403(i)(2)]"
OASIS charge code - JUICE%
OASIS charge code - SUBSTITUTE
and
"...misbranded in that the product is labeled as apple juice (or apple juice concentrate), which is false and misleading. [Misbranding 403(a) (1)]"
OASIS charge code - FALSE
and
"...in that the label fails to list the ingredient, hydrolyzed inulin syrup. [Misbranding, 403(i)(2)]"
OASIS charge code - JUICE%
NETHERLANDS
Empresa Comercial Internacional De Fructus S.A.
Date Published : 09/18/2009
Minckelersstr 3 Vriesveem De Berg B.V. , Landgraaf, NETHERLANDS
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/18/2009
Vriesveem "De Berg" B.V.
Date Published : 09/18/2009
Minckelersstr.3 , Landgraaf, Holland NETHERLANDS
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/18/2009
SWITZERLAND
Amnon Barasch
Date Published : 09/18/2009
1 M Park , Kasermenstrasse 40 , Herisau, SWITZERLAND
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/18/2009
Carronade International Trad Ltd
Date Published : 09/18/2009
40 Kassernstrasse , Merdau, Herisau SWITZERLAND
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/18/2009
Empresa Comercial Internacional De Frutas S.A.
Date Published : 09/18/2009
Im Park Kasernenstrasse 40 , Herisau, SWITZERLAND
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 09/18/2009
-
