IA #31-03 REVISION - 8/23/01, IMPORT ALERT #31-03, 8/8/01, "***DETENTION WITHOUT PHYSICAL EXAMINATION*** OF GUANABAN***A*** (SOURSOP) NOTE: This revision is being issued to revise the alert into the current format and terminology. Changes are bracketed by asterisks (***). TYPE OF ALERT: *** Detention Without Physical Examination (DWPE)*** PRODUCT: Guanabana (Soursop) drinks, juices, nectars, etc. 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. PRODUCT CODE: 20S[][]99 PROBLEM: Toxic material from the fruit seeds was incorporated into the finished product during the manufacturing process PAF: *** BIO *** PAC: 07F800 COUNTRY: See Attachment MANUFACTURER/ SHIPPER ID #: See Attachment IMPORTER'S I.D.#: N/A CHARGE: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which may render it injurious to health [Adulteration, Section 402(a)(1)]." OASIS CHARGE CODE: ***POISONOUS*** RECOMMENDING OFFICE: Division of Import Operations and Policy, HFC-170 REASON FOR ALERT: In February 1990, thirty-four adults and children drank "Rain Drop" Guanabana Drink from Mexico and within 15 minutes they began vomiting. Dallas district laboratory performed microscpic examination of the product and found some seed cells in all "suspect" codes examined. The literature ***indicates*** the seeds are toxic and an oil expressed from the seeds has been used as an insecticide and fish poison. According to the Mexican authorities, the product is only manufactured for exportation and not consumed in Mexico. ***In*** February 1993, a sample of Iberia brand soursop nectar (guanabana) from the Dominican Republic was recalled (already on domestic status) due to the presence of the toxic guanabana seeds. ***GUIDANCE:*** ***Districts may detain without physical examination*** all shipments of guanabana (soursop) drinks, juices, nectars, etc. from manufacturers/shippers in the attachment. Increase surveillance of this product from other countries. Samples collected for analysis should be forwarded to the following laboratories: Northeast, Mid-Atlantic and Southwest regions to Southeast Regional Laboratory Midwest and Southwest regions to Dallas, Pacific Region to Los Angeles Laboratory ***For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827- 7605.*** ***PRIORITIZATION GUIDANCE: I*** FOI: No purging is necessary. KEYWORDS: Guanabana, Soursop, Drink, Nectar, Juice, Guyabano PREPARED BY: Jack Geltman, DIOP, 301-443-6553 DATE LOADED INTO FIARS: August 23, 2001 Attachment to Import Alert #31-03 8/23/01 LIST OF MANUFACTURERS/SHIPPERS ON ***DETENTION WITHOUT PHYSICAL EXAMINATION*** DOMINICAN REPUBLIC (DO, 320) Caribex Dominicana SA Apartado 409-2 Santo Domingo, Dominican Republic MID #DOCARDOM409SAN MEXICO (MX, 595) Jugos del Valles S.A. de C.V. Km 43.5 Auto Pisto Mexico Tepot Zotlan Tado de Mexico 54600 MID #MXJUGDEL435TEP PHILIPPINES (PH, 725) Summer Fruit Inc. (Mfr) Marsman-Drysdale Group Marsman Bldg. Sen. Gil. J. Puyat Avenue Cor. Washington Street Makati, Metro Manila MID #PHSUMFRUMET Km 42 By Pass, Bgy, San Vicente (Factory) Silang, Cavite, Philippines MID #PHSUMFRU42CAV ***Profood International Corp. Aseptic Guyabana (sic) Puree 653 Hiway Maguikay, No. 7 /20U[][]99 Gochan Compound Mandaue City, Philippines 6000 FEI #8192*** VIETNAM (VN) Agrimexco Fzn. Soursop Paste/ 176 Nai Ba Trung St. 22H[][]04 District 1 4/23/01 Ho Chi Minh City, Vietnam FEI #1000429310 Lucky Shing Enterprise Co. Ltd. Frozen Soursop Paste/ 579 Quoc Lo An Lac Village 22H[][]04/22I[][]04 Ho Chi Minh City, Vietnam 4/11/01 FEI #3001757812