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November 13, 2008

FDA Issues Blanket Detention Order of Certain Products From Chinese Manufacturers

Below you will find the relevant text of the FDA's import detention order of Chinese-made product, as reported by the AP today. Note the breadth of products potentially affected. Physical inspection is not required under this order for detention. (For some background on melamine, read this FDA paper on melamine contamination in China)

Products affected by this order include:

PRODUCT
Bakery Products/Doughs/Mixes/Icings
Cereal Preparations
Breakfast Food Ready to Eat
Breakfast Food Quick Cook
Snack Foods
Milk/Butter/Dried Milk Products
Cheese/Cheese Products
Ice Cream Products
Filled Milk/imitation Milk Products
Soft Drink, Milk Based (Chocolate Flavored), Noncarbonated
Noncarbonated Soft Drink, N.E.C.
Soft Drink/Waters N.E.C.
Soft Drink, Milk Based (Chocolate Flavored, Etc.) Carbonated
Carbonated Soft Drink, N.E.C.
Beverage Base N/Fruit (Cola Rootbeer Etc)
Beverage Base Non-Fruit Liquid
Soft Candy w/ Nut, seeds, w/out Coconut
Soft Candy w/ Coconut
Soft Candy w/ Fruit
Soft Candy w/ Nuts & Fruits
Soft Candy, w/out Nut/Fruit
Candy Specialties
Candy w/out Chocolate, N.E.C.
Chocolate/Cocoa Products
Custard Pudding mix
Pudding Mix (Not Custard)
Baby Food Products
Iodinated Casein (Cat. I, Type A med. Article)
Iodinated Casein (Combo Cat. I& II, type A, med)
Iodinated Casein (Cat. I med. feed)
Iodinated Casein (Combo Cat. I & II, med. feed)
Dairy Byproducts for Animals
Animal Waste Feed Products
Byproducts for Animals, N.E.C.
Pet Cat Foods
Pet Dog Foods
Pet Fish Foods
Other Pet Foods, N.E.C.
Laboratory Animal Feeds
Pet and Laboratory Animal Foods, N.E.C.

The order (redacted):

IA #99-30, 11/12/2008, IMPORT ALERT #99-30, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL MILK PRODUCTS, MILK DERIVED INGREDIENTS AND FINISHED FOOD PRODUCTS CONTAINING MILK FROM CHINA DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"

PRODUCTS: All milk products
All milk derived ingredients
Finished food products containing milk

PROBLEM: Unsafe Food Additive
Poisonous or Deleterious Substance
Unfit For Food

COUNTRY: China (CN)

MANUFACTURER/
SHIPPER: All

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)]"

REASON FOR
ALERT: In September, 2008, FDA became aware of thousands of infant
illnesses in China due to the consumption of infant formula
reported to contain melamine. Reports indicated over 53,000
illnesses, including almost 13,000 hospitalizations, and at
least four deaths of infants. The illnesses involved the
formation of kidney stones and crystals and related
complications.

The milk used in the infant formula has been implicated as
the source of the melamine contamination. According to
sources, at a bulk fluid milk collection point, water is
added to the bulk fluid milk to increase the apparent volume
of product. Melamine is added to the water/milk mixture to
increase the nitrogen content in order to inflate the
apparent protein content found in the product. Milk is
transported from the collection centers to milk processing
facilities.

The problem of melamine contamination is not limited to
infant formula products. Chinese government sources
indicate contamination of milk components, especially dried
milk powder, which are used in the manufacture of a variety
of finished foods. These contaminated milk components
appear to have been dispersed throughout the Chinese food
supply chain.

FDA analyses have detected melamine and cyanuric acid in a
number of products that contain milk or milk-derived
ingredients, including candy and beverages. In addition,
information received from government sources in a number of
countries indicates a wide range and variety of products
from a variety of manufacturers have been manufactured using
melamine-contaminated milk or milk-derived ingredients,
including: fluid and powdered milk, yogurt, frozen desserts,
biscuits, cakes and cookies, taffy-like soft candy products,
chocolates, and beverages. These products appear to contain
at least one milk-derived ingredient and they are of Chinese
origin. Reports of contamination have come from more than
thirteen countries in Asia, Europe, and Australia, in
addition to the United States. Additional products from
various manufacturers continue to be found to be
contaminated with melamine.

The problem of melamine contamination in Chinese food
products is a recurring one. In 2007, bulk vegetable protein
products imported from China were contaminated with melamine
and melamine analogs, apparently from deliberate
contamination.

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