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