IA #99-31, 10/10/2008, IMPORT ALERT #99-31, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF FOOD PRODUCTS DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE
ANALOGS" ATTACHMENT 12/23/08
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 products 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).
PRODUCTS/
PRODUCT
CODE: See Attachment
PROBLEM: Unsafe Food Additive
Poisonous or Deleterious Substance
Unfit for food
PAF: PES
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: Center for Food Safety and Applied Nutrition (CFSAN), HFS-607
REASON FOR
ALERT: In September 2008, FDA became aware of thousands of infant
illnesses in China associated with the consumption of infant
formula suspected of containing melamine. As recently as
October 1, 2008, reports indicated there have been over
53,000 illnesses, nearly 13,000 hospitalizations, 100
seriously ill cases and at least four infant deaths in
China.
As a result, the U.S. and other countries have been sampling and
testing infant formula, milk-derived ingredients, and finished
food products containing milk. Information received from a number
of sources, and from a number of different countries, indicates a
wide range and variety of products, such as candies, desserts, and
beverages, have been found to be contaminated with melamine.
To date, FDA testing has found melamine contamination in multiple
products imported from China. FDA is continuing its testing of a
variety of products for melamine and its analogs.
Melamine is a compound used primarily in commercial and industrial
applications. There is no approved melamine use in direct
addition to human or animal food in the U.S.
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.
Appropriate screening criteria have been set.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact Mr. Thomas Savage, Division of Field Science, at 301-827-
1026.
In order to secure release of an individual shipment subject to
this Import Alert, the importer should provide the results of a
third-party laboratory analysis of a representative sample of the
lot verifying that the product does not contain melamine or
melamine analogs. Third-party laboratories may use any methods
that are found acceptable to FDA, see:
http://www.cfsan.fda.gov/~comm/labmeth.html#melamine
In order to remove a firm from detention without physical
examination, information should be provided to FDA to adequately
demonstrate that the manufacturer has resolved the conditions that
gave rise to the appearance of the violation, so that the agency
will have confidence that future entries will be in compliance.
Requests for removal from DWPE should be directed to FDA's
Division of Import Operations and Policy at:
Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
5600 Fishers Lane, Room 12-36
Rockville, MD 20857
PREPARED
BY: CFSAN, HFS-606, Salvatore Evola at (301) 436-2164
DIOP, HFC-170, Stella Notzon at (301) 443-6553
LOADED
INTO FIARS: October 10, 2008
ATTACHMENT TO IMPORT ALERT #99-31 12/23/2008
Firm: Product/Product Code/Charge:
Guan Sheng Yuan Food, Ltd., Taffy candy - "White Rabbit"
AKA: Shanghai Quan Sheng Yuan Food, Ltd. 33H[][][][], 33J[][][][],
220 Can Bao Road 33G[][][][], 33K[][][][],
Shanghai, China 33L[][][][], 33S[][][][],
FEI# 3003619135 33Y[][][][]
CHARGE: 402(a)(2)(c)(i)
10/10/08
Shanghai Guan Sheng Yuan Taffy candy - "White Rabbit"
International Trade Co. Ltd. 33H[][][][], 33J[][][][],
No. 1418 Xinzha Road 33G[][][][], 33K[][][][],
Shanghai, China 33L[][][][], 33S[][][][],
FEI# 3003625317 33Y[][][][]
CHARGE: 402(a)(2)(c)(i)
10/10/08
Kun Bo (kun Po) Foodstuff I/E Co., Ltd. Milk based flavored drink
Zhongshan City, China - "Blue Cat"
FEI# 3004275116 09[][][][][], 29A[][][]70,
29B[][][]70, 29A[][][]99,
29B[][][]99
CHARGE: 402(a)(2)(c)(i)
10/10/08
Inner Mongolia Yili Dairy Products Yeast flavored milk drink
Drink-Co. Ltd. - Yili Brand
8 Jinshan Road, Jinshan Development 09[][][][][], 29A[][][]70
Hohhot, China 29B[][][]70, 29A[][][]99,
FEI# 3004920511 29B[][][]99
CHARGE: 402(a)(2)(c)(i)
10/10/08
Zhongshan Lebang Chocolate Food Co., Ltd All chocolate products
Torch High-tech Industrial Development 34----
Zhongshan, China CHARGE: 402(a)(1)
FEI# 3005152461 10/23/08
Update charge
12/3/08
Zhongshan Lebang C All chocolate products
Torch Hi-Tech Deve 34----
Guangdong, China CHARGE: 402(a)(1)
FEI#3005458486 10/23/08
Update charge
12/3/08
Zhongshan Lebang Chocolate Product All chocolate products
Yixian Industrial Zone 34----
Torch, China CHARGE: 402(a)(1)
FEI# 3007155450 10/23/08
Update charge
12/3/08
Zhongshan Lebang Chocolate Food Co All chocolate products
Yat-Sen Ind Dist,Zhangjiabian Torch 34----
Hi-Tech Area,Zhongshan, China CHARGE: 402(a)(1)
FEI# 3006328525 10/23/08
Charge update
12/3/08
Lebang Food Co Ltd All chocolate products
Area 34----
Zhongshan, China CHARGE: 402(a)(1)
FEI# 3006476004 10/23/08
Charge update
12/3/08
Major Distributor of Chocolates from Zhongshan Lebang:
Boxer Games All chocolate products
63 Norwood Ave from Zhongshan Lebang
West Yorkshire, GB 34----
FEI# 3006085942 CHARGE: 402(a)(1)
10/23/08
Charge Update
12/3/08
Weifang Gourmet Art and Craft Co., Ltd. Hot Chocolate Mix
Qimei Street New-high Technology Dev. Zone 34[][][][]
Weifang, China Cn-37 261061 35[][][][]
FEI# 2000041143 CHARGE: 402(a)(2)(C)(i) &
402(a)(1)
11/18/2008
Update Charge
12/3/08
Shipper:
Weifang Gourmet Art and Craft Co., Ltd. Hot Chocolate Mix
No 598 Lanxiang Street 34[][][][]
Kuiwen District, Weifang 35[][][][]
Shandong, P.R. China CHARGE: 402(a)(2)(C)(i) &
FEI# 3007178539 402(a)(1)
11/18/2008
Update Charge
12/3/08
KING CAR FOOD INDUSTRY CO., LTD. INSTANT COFFEES
NO. 230 ROOSEVELT ROAD, SEC #3 31[][][][]
TAIPEI, TAIWAN
Headquarters (office) CHARGE: 402(a)(2)(C)(i)
FEI# 3004816349 & 402(a)(1)
12/1/2008
(Updated 12/23/2008)
KING CAR FOOD INDUSTRY CO., LTD. INSTANT COFFEES
Ping-Chen Plant 31[][][][]
527, Chung-Hsing Road,
Ping Chen City, Taoyuan, Taiwan 324 CHARGE: 402(a)(2)(C)(i)
FEI# 3004260618 & 402(a)(1)
12/1/2008
(Updated 12/23/2008)
Candy Manufacturer Inc. Cocoa Powder
Unit 103, No17, QiaoXing North Road
Xinhui District, JiangMen 34[][][][]
CN-44, China 35[][][][]
FEI# 3006280353 CHARGE: 402(a)(2)(C)(i)
12/1/2008
Candy Manufacturer Inc. Cocoa Powder
H.K Office: Room A, 1st. Floor, 111 Pak 34[][][][]
Kowloon, China 35[][][][]
FEI#: 3005926157 CHARGE: 402(a)(2)(C)(i)
12/1/2008
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