IA #04-06, 8/2/06, IMPORT ALERT #04-06 "DETENTION WITHOUT PHYSICAL EXAMINATION
AND SURVEILLANCE OF ENRICHED PASTA PRODUCTS FOR *** STANDARD OF IDENTITY ***"
- ATTACHMENT REVISED 9/21/06
NOTE: This alert has been revised to update the title and
text. Changes are bracketed by asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination
(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.)
PRODUCT: Pasta, Mixed or Blended Pasta Products (all styles including
pasta/noodles/spaghetti/macaroni, etc.)
PRODUCT CODE: 04[][][][]
PROBLEM: 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, *** 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 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.
PREPARED BY: Judy Baron, DIOP, HFC-170, 301-443-6553
DATE LOADED
INTO FIARS: August 2, 2006 ATTACHMENT TO IMPORT ALERT #04-06 9/21/06
MEXICO (MX)
FIRM PRODUCT/PRODUCT CODE
Molinos del Fenix Vermicelli
Emilio Carranza y Ramos Arizpe S. 04A[][]06
Saltillo, Mexico 9/29/03
FEI *** #3004404023 *** *** Excess Iron ***
Stars Pasta
04A---
10/17/03
*** Excess Iron ***
Pastas y Galletas de Tijuana Macaroni Seeds
Calle Jose Gallego L. #13250 04A[][]01
Col. 20 de Noviembre, La Mesa 8/4/06
Tijuana *** Insufficient
Baja California, Mexico 22430 Riboflavin ***
FEI #3004277449
Productos de Trigo All Pasta Products
Quetzal No. 1108 04A - - -
Guadalajara, Mexico 11/3/03
FEI #3001401047 *** Excess Iron ***
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 *** Excess Iron ***
Hermosillo, Sonora, Mexico
FEI *** #3004342815 ***
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