IA #72-05, 2/25/08, 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 (TRIAZINES)"
(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).
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
72L[][]99 - Lab Animal food
72E[][]99 - Other Pet Food
72Y[][]99 - Pet/Laboratory Animal Food NEC
PROBLEM: Poisonous or Deleterious Substance
Unsafe Food Additive
Unfit for Food
PAF: PES
PAC FOR
COLLECTION: 71R853
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
poisonous or deleterious substance which may render it
injurious to health [Adulteration, section 402(a)(1)]"
and
"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 that is unsafe within the meaning of section
409 [Adulteration, section 402(a)(2)(C)(i)]"
and
"The article is subject to refusal of admission pursuantto
section 801(a)(3) in that it appears to be unfit for food
[Adulteration, 402(a)(3)]"
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 (triazines) 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 (Triazines)
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: The identified products offered for importation from the
manufacturers and/or shippers listed on the attachment to
this import alert may be detained without physical
examination.
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 (triazines) analysis.
Sample collection for melamine and/or melamine analogs
(triazines) 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 Cathie Marshall, Center for
Veterinary Medicine (CVM) HFV-232 (240) 276-9217 for
evaluation.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact Thomas Savage, Division of Field
Science (DFS) (301) 827-1026.
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, triazines
PREPARED BY: Cathie Marshall, CVM, HFV-232 (240) 276-9217
Sammi L. Hadden, DIOP, HFC-170 (301) 443-6553
DATE LOADED
INTO FIARS: February 25, 2008
Attachment to Import Alert #72-05 2/25/08
MANUFACTURER
OR SHIPPER PRODUCT/
FIRM NAME AND ADDRESS (M/S) PRODUCT CODE DWPE DATE
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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