IA #72-05, REVISED 2/23/2009, IMPORT ALERT #72-05, "DETENTION WITHOUT PHYSICAL
EXAMINATION AND SURVEILLANCE OF PET AND LABORATORY ANIMAL FOOD DUE TO
THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"
NOTE: The revision of this Import Alert dated 2/23/2009 updates the text of the alert, updates the PAC
code, updates FDA contact information, and includes information regarding third-party laboratory
testing of detained articles. Changes are bracketed by asterisks (***).
(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 an
y
person, and does not operate to bind FDA or the public).
TYPE OF ALERT: Detention Without Physical Examination (DWPE)
PRODUCTS: Cat Food/Treats
Dog Food/Treats
Pet Food/Treats
Fish Food/Treats
Bird Food/Treats
PRODUCT 72A[][][] - Pet Cat Food
CODES: 72B[][][] - Pet Dog Food
72C[][][] - Pet Bird Food
72D[][][] - Pet Fish Food
72E[][]99 - Other Pet Food
72L[][]99 - Lab Animal food
72Y[][]99 - Pet/Laboratory Animal Food NEC
PROBLEM: Poisonous or Deleterious Substance
Unsafe Food Additive
Unfit for Food
PAF: PES
PAC FOR
COLLECTION: *** 71R854***
COUNTRIES: China, Taiwan
MANUFACTURER/
SHIPPER: See Attachment
CHARGES: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in
that it appears to bear or contain a food additive, namely melamine and/or a
melamine analog, that is unsafe within the meaning of section 409 [Adulteration,
section 402(a)(2)(C)(i)]"
*** OASIS charge code: MELAMINE ***
and/or
"The article is subject to refusal of admission pursuant to section 801(a)(3) in
that it appears to bear or contain a poisonous or deleterious substance which may
render it injurious to health [Adulteration, section 402(a)(1)]"
*** OASIS charge code: POISONOUS ***
and/or
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it
appears to be unfit for food [Adulteration, 402(a)(3)]"
*** OASIS charge code: UNFIT4FOOD ***
RECOMMENDING
OFFICE: CVM/HFV-232
REASON
FOR ALERT: In March 2007, FDA began investigating pet deaths in the United States associated with
the consumption of pet food. FDA found melamine and melamine analogs *** and
melamine analogs *** in the pet food, and traced this contamination to products labeled
as "wheat gluten" and "rice protein concentrate" imported from China.
As one result of the investigation, FDA issued Import Alert #99-29 "Detention without
Physical Examination of All Vegetable Protein Products from China for Animal or
Human Food Use Due to the Presence of Melamine and/or Melamine Analogs". In
addition, FDA issued field-sampling assignments for various imported human and animal
food products containing plant proteins. To date, FDA collected and analyzed 222
samples of a variety of human, bird and fish food as well as pet treats. Of these 222
samples, analysis revealed multiple pet food samples were contaminated with melamine
and/or melamine analogs. However, FDA's evaluation of all sample results determined
the levels of melamine and/or melamine analogue contamination presented a health risk
in only four of the pet food samples.
Melamine, a compound used primarily in commercial and industrial applications and its
related compounds have not been approved in the United States for use as an ingredient in
animal or human food.
GUIDANCE: *** Districts may detain without physical examination the identified products offered for
importation from the manufacturers and/or shippers listed on the attachment to this import
alert.***
If district resources permit, sample collection is warranted of pet food including, but not
limited to, pet treats, bird food or fish food from Chinese and Taiwanese firms not
identified on the attachment to this alert for melamine and/or melamine analogs analysis.
Sample collection for melamine and/or melamine analogs analysis is also warranted of
other pet treats, bird food or fish food products not subject to detention without physical
examination originating from the firms listed on the attachment to this import alert.
Local district offices should forward worksheets of all FDA or private laboratory analyses
found positive for melamine and/or melamine analogs to *** Linda Wisniowski, Center
for Veterinary Medicine (CVM, HFV-232), 240-276-9233, for Center evaluation. ***
***In order to secure release of an individual shipment detained pursuant to this Import
Alert, the importer should provide results of a third-party laboratory analysis, of a
representative sample of the lot, which verifies the product does not contain melamine or
cyanuric acid. Third-party laboratories may use any method that is found acceptable to
FDA and which meets the method performance of the LC-MS/MS methods available at
http://www.cfsan.fda.gov/~comm/labmeth.html#melamine ***
*** For questions or issues concerning science, science policy, analysis, preparation, or
analytical methodology, contact the Division of Field Science at (301) 827-7605. ***
In order to remove a firm from detention without physical examination, information
should be provided to enable the agency to assess whether the firm has resolved the
conditions that gave rise to the appearance of a violation, so that the agency will have
confidence that future entries will be in compliance.
Questions concerning removal from detention without physical examination, such as the
types of supporting documentation to provide, should be addressed to the Division of
Import Operations and Policy (DIOP) (301) 443-6553. It is recommended that DIOP be
contacted prior to submission of a request for removal from detention without physical
examination.
Local FDA offices should forward requests for removal from DWPE to DIOP, HFC-170.
Removals from detention without physical examination require CVM concurrence.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Feed, pet food, melamine, melamine analogs,
***ORGINAL ISSUE
DATE***: February 25, 2008
***ORIGINAL
PREPARED
BY***: Cathie Marshall, CVM, HFV-232, (240) 276-9217
Sammi L. Hadden, DIOP, HFC-170, (301) 443-6553
*** REVISED BY: John E. Verbeten, DIOP, 2/23/2009 ***
DATE LOADED
INTO FIARS: February 23, 2009
Attachment to Import Alert #72-05 2/25/08
MANUFACTURER
OR SHIPPER PRODUCT/ DATE
FIRM NAME AND ADDRESS (M/S) PRODUCT CODE DWPE
Five Eels Industry Corp. (M) Fish Food 2/25/08
No. 44, Lane 74, 72[][][][]
Sanchun Street
Shulin City, Taiwan
FEI# 3003321696
JC-Sunny International (S) Fish Food 2/25/08
Co. Ltd. 72[][][][]
4f-3, No. 23, Sec. 2
Keelung Road
Taipei, Taiwan
FEI# 2000009453
Jinjiang Qimei Gifts (M) Fish Food 2/25/08
and Favorites 72[][][][]
Dong Cheng Industrial Area
Dongshi Town
Jinjiang, Quanshou
Fujian, China
FEI# 2000012161
Jiangsu Peidi Brand (S) and (M) Pet/Laboratory 2/25/08
Food Products Animal Food
No. 8 Zhenbei Road 72[][][][]
Xuzhuang Town
Gaogang County
Taizhou City,
Jiangsu, China
FEI# 3004329918
Hai Feng Feeds Co., Ltd (M) Fish Food 2/25/08
NO. 7, Tzu-Li 1st Road 72[][][]
Nangang Industrial Park
Nantou, Taiwan
FEI# 3002636711
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