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Import Alert 04-06

(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 # 04-06
Published Date: 10/06/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination and Surveillance of Enriched Pasta Products for Standard of Identity"

Reason for Alert:
Note: The revision of this Import Alert, dated 7/6/2011 adds additional products to the list of those subject to detention without physical examination and surveillance under Import Alert 04-06, per recommendation from CFSAN.

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, in October 20, 2000, New Jersey District collected and analyzed samples of Enriched Coditos #35, (Enriched Elbow Macaroni), Enriched Spaghettini #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 Section 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).

In June 2005 Southwestern Import District collected and had analyzed samples of "Enriched Macaroni Products SEEDS" marketed under the brand "Pagas" and manufactured by Pastas y Gellatos De Tijuana. The analysis revealed that the macaroni product contained less than the required amount of riboflavin under the standard of identity in 21 CFR section 139.115(a)(1).

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 do not conform to the standard of identity for enriched macaroni products.

Guidance:
Districts may detain, without physical examination, the enriched pasta products from the manufacturer identified in the Red List of this import alert.

Increased surveillance of pasta products from other manufacturers appears warranted.

Contact the Division of Field Science for questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology at 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:
Pasta, Mixed or Blended Pasta Products (all styles including pasta/noodles/spaghetti/macaroni, etc.)

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

Countries

MULTIPLE COUNTRIES (PODS ONLY)
(04 - - - --) Macaroni/Noodle Prod
Desc:Pasta


ITALY

Pastificio Guido Ferrara
Date Published : 03/09/2011

Sede Via Nola 49-80030 , Nola, Paolo Belsito ITALY
04 A - - 05 Spaghetti
Date Published: 03/09/2011

Desc:?Fronte? Spaghetti
Notes:Insufficient Iron


MEXICO

Molinos del Fenix, S.A. de C.V.
Date Published : 09/10/2009

Emilio Carranza Y Ramos Arizpe S/n , Zona Centro , Saltillo, MX-COA MEXICO
04 A - - 06 Vermicelli
Date Published: 09/10/2009

Notes:Excess Iron 9/29/2003
04 A - - -- Macaroni/Spaghetti
Date Published: 09/10/2009

Notes:Star pasta - Excess Iron 10/17/2003

Pastas y Galletas de Tijuana, S. A. de C.V.
Date Published : 09/10/2009

Calle Jose Gallego L. # 13250 , Col. 20 De Noviembre, La Mesa , Tijuana, MX-BCN MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 09/10/2009

Notes:Insufficient Riboflavin 8/4/2006

Productos Alimenticios La Moderna Sa De Cv
Date Published : 10/05/2010

Francisco Y Madero 1675 Norte , Gomez Palaciodurango, MEXICO
04 A - - 05 Spaghetti
Date Published: 10/05/2010

Desc:Spaghetti
Notes:Excess Iron

Productos Alimenticios La Moderna, S.A. de C.V.
Date Published : 04/08/2011

Km:3 Carretera A Nogales , Zapopan , Guadalajara, MX-JAL MEXICO
04 A - - 05 Spaghetti
Date Published: 04/08/2011

Desc:Enriched Spaghetti
Notes:Excess Iron

Productos de Trigo SA de CV
Date Published : 09/10/2009

Quetzal No. 1132 Col Morelos , Guadalajara, Jalisco MEXICO
04 A - - -- Macaroni/Spaghetti
Date Published: 11/27/2009

Notes:All pasta products - excess iron 11/3/2003

Trigos Industrializados de Mexico SA de CV
Date Published : 09/10/2009

Calle Pilares S/n Frente A Ffcc , Colonia San Luis , Hermosillo, MX-SON MEXICO
04 A - - 01 Macaroni Enriched
Date Published: 09/10/2009

Notes:Excess Iron 10/20/2003

 
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