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