IA #04-06, 02/26/02, IMPORT ALERT #04-06 "DETENTION WITHOUT PHYSICAL EXAMINATION AND SURVEILLANCE OF ENRICHED PASTA PRODUCTS FOR EXCESS IRON" - ATTACHMENT REVISED 4/15/04 (NOTE: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(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.) TYPE OF ALERT: Detention Without Physical Examination PRODUCT: Pasta, Mixed or Blended Pasta Products (all styles including pasta/noodles/spaghetti/macaroni, etc.) PRODUCT CODE: 04[][][][] PROBLEM: Excess Iron (Standard of Identity) PAF (Problem Area Flag): FDI PAC FOR COLLECTION: 21007 COUNTRY: See Attachment MANUFACTURER and FEI: See Attachment CHARGE: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard [Misbranding, Section 403(g)]." OASIS CHARGE CODE: STD IDENT RECOMMENDING OFFICE: HFR-CE340, Newark District REASON FOR ALERT: The New York State Department of Agriculture and Markets collected and analyzed enriched pasta products from a Mexican manufacturer and found those products to contain excessive iron. Based on this information, on October 20, 2000, New Jersey District collected and analyzed samples of Enriched Coditos #35, (Enriched Elbow Macaroni), Enriched Spaghetttini #9, and Enriched Ziti #74 manufactured by Productos Alimenticios La Moderna, Toluca, Mexico. The analysis performed by Atlanta District revealed the presence of iron at 138%, 133%, and 231% above what is prescribed in the standard of identity for enriched macaroni products, 21 CFR Part 139.115 (a) (1); namely, that each pound of product will contain not less than 13 mg and not more than 16 mg of iron (Fe). Scientific experts in the Center for Food Safety and Applied Nutrition (CFSAN) reviewed the analytical data and supported the conclusion that the above named products contain excessive amounts of iron. GUIDANCE: Districts may detain without physical examination, the enriched pasta products from the manufacturer identified in the attachment of this import alert. Increased surveillance of pasta products from other manufacturers appears warranted. 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: II FOI: No purging is required. KEYWORDS: Pasta, iron, macaroni, ziti, spaghettini. PREPARED BY: Jack Geltman, Opns. & Policy Br., DIOP, HFC-172, (301)443- 6553 DATE LOADED INTO FIARS: February 26, 2002 ATTACHMENT TO IMPORT ALERT #04-06 4/15/04 MEXICO (MX) FIRM PRODUCT/PRODUCT CODE Molinos del Fenix Vermicelli Emilio Carranza y Ramos Arizpe S. 04A[][]06 Saltillo, Mexico 9/29/03 FEI #1000415858 Stars Pasta 04A--- 10/17/03 Pastas Molisaba, S.A. De C.V. Elbow/Codo Pasta Blvd. Diaz Ordaz K.m. 3.33 04A[][][][] Garza Garcia, N. L. Mexico 9/25/02 FEI #3002320863 Small shell pasta 04A[][][][] 6/30/03 Stars Pasta Mellon Seed Pasta 04A[][]05 7/10/03 Spaghetti, Enriched 04A[][]05 10/8/03 (Added these products on 4/15/04) Productos de Trigo All Pasta Products Quetzal No. 1108 04A - - - Guadalajara, Mexico 11/3/03 FEI #3001401047 Trigos Industrializados de Mexico S.A. de C.V. Macaroni Planta: Pilares: S/N 04A -- 01 Frente Estacion Ferrocarril 10/20/03 Col. San Luis Hermosillo, Sonora, Mexico FEI #3003720530