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: 08/16/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Apple Juice and Apple Juice Concentration Containing an Undeclared Sweetner"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 06/17/2019 updates the guidance, agency contacts, and add Private Laboratories Sampling, Method and Testing Information. Changes to the import alert are bracketed by asterisks (***).
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.

Note: ORS contact information updated on 08/16/2019

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 ***"The Capillary Gas Chromatographic Method of Low for the Identification of Hydrolyzed Inulin Syrup and High Fructose Corn Syrup in Apple Juice", Method Author, Nicholas Low, Submitting Laboratory, Michael A. McLaughlin and Samuel W. Page, JAOACI 84(2), 486-492 (2001).*** 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 ***Mildred Benjamin (Director, Food Adulteration Assessment Branch- HFS-607, 240-402-1424).***

For the time being, all questions concerning analysis, sample preparation or analytical methodology should be referred to CFSAN, ***Mildred Benjamin, at telephone number 240-402-1424.*** 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.

***Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at (301) 796-6600 or oraorsprivatelabimportalerts@fda.hhs.gov. Resources for private laboratory testing are available at https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing.***

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%

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


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