IA #99-30, 11/12/2008, IMPORT ALERT #99-30, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL MILK PRODUCTS, MILK DERIVED INGREDIENTS AND FINISHED
FOODPRODUCTS CONTAINING MILK FROM CHINA DUE TO THE PRESENCE OF MELAMINE AND/OR
MELAMINE ANALOGS"
TYPE OF ALERT: Detention Without Physical Examination (Countrywide)
(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).
PRODUCTS: All milk products
All milk derived ingredients
Finished food products containing milk
PRODUCT
CODES: 03[][][][] Bakery Products/Doughs/Mixes/Icings
05Y[][][] Cereal Preparations
05A[][][] Breakfast Food Ready to Eat
05B[][][] Breakfast Food Quick Cook
07[][][][] Snack Foods
09[][][][] Milk/Butter/Dried Milk Products
12[][][][] Cheese/Cheese Products
13[][][][] Ice Cream Products
14[][][][] Filled Milk/imitation Milk Products
29A[][]70 Soft Drink, Milk Based (Chocolate Flavored),
Noncarbonated
29A[][]99 Noncarbonated Soft Drink, N.E.C.
29Y[][]99 Soft Drink/Waters N.E.C.
29B[][]70 Soft Drink, Milk Based (Chocolate Flavored,
Etc.) Carbonated
29B[][]99 Carbonated Soft Drink, N.E.C.
30F[][][] Beverage Base N/Fruit (Cola Rootbeer Etc)
30G[][][] Beverage Base Non-Fruit Liquid
33G[][][] Soft Candy w/ Nut, seeds, w/out Coconut
33H[][][] Soft Candy w/ Coconut
33J[][][] Soft Candy w/ Fruit
33K[][][] Soft Candy w/ Nuts & Fruits
33L[][][] Soft Candy, w/out Nut/Fruit
33S[][][] Candy Specialties
33Y[][][] Candy w/out Chocolate, N.E.C.
34[][][][] Chocolate/Cocoa Products
35C[][][] Custard Pudding mix
35D[][][] Pudding Mix (Not Custard)
40[][][][] Baby Food Products
67A[][]28 Iodinated Casein (Cat. I, Type A med. Article)
67C[][]28 Iodinated Casein (Combo Cat. I& II, type A, med)
69A[][]28 Iodinated Casein (Cat. I med. feed)
69C[][]28 Iodinated Casein (Combo Cat. I & II, med. feed)
71C[][][] Dairy Byproducts for Animals
71E[][][] Animal Waste Feed Products
71Y[][][] Byproducts for Animals, N.E.C.
72A[][][] Pet Cat Foods
72B[][][] Pet Dog Foods
72D[][][] Pet Fish Foods
72E[][][] Other Pet Foods, N.E.C.
72L[][][] Laboratory Animal Feeds
72Y[][][] Pet and Laboratory Animal Foods, N.E.C.
PROBLEM: Unsafe Food Additive
Poisonous or Deleterious Substance
Unfit For Food
PAF: PES
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)]"
OASIS charge
code: UNFIT4FOOD
RECOMMENDING
OFFICE: Division of Import Operations and Policy, HFC-170
Center for Food Safety and Applied Nutrition, HFS-600
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.
GUIDANCE: Districts may detain without physical examination all milk
products, all milk derived ingredients, and finished food
products containing milk from China.
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
detained pursuant to this Import Alert, the importer should
provide either:
1. 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
OR
2. Documentation supplied in English which shows there
are no milk or milk-derived ingredients in the
product, to include product formulation and product
labeling (for example; process or batch records from
the manufacturer, and the actual product labeling or a
facsimile of the product labeling).
If a firm, shipper or importer wishes to request removal
from detention without physical examination, they should
forward information supporting their request to FDA at the
following address:
Food and Drug Administration
Division of Import Operations and Policy (HFC-170)
5600 Fishers Lane, Room 12-36
Rockville, MD 20857
The request should include information for FDA to adequately
assess whether a manufacturer has appropriate controls and
processes, including:
1. Documentation showing a minimum of five (5)
consecutive non-violative shipments have been released
by FDA based upon results of third party laboratory
analyses, using methods found acceptable to FDA of a
representative sample of the lot, that verify the
products do not contain melamine or cyanuric acid.
AND
2. Documentation from a third-party, in whom FDA has
sufficient confidence, which demonstrates controls are
in place such that products will not be contaminated
with melamine and melamine analogs. To gain
sufficient confidence in a third party, FDA may
determine it needs to conduct a paper or on-site
review of the work of the third party.
AND
3. Documentation that the firm is in compliance with all
Chinese government requirements for exporting the
products to the U.S. Documentation should include
copies of any registration that may be required by the
Chinese government.
All requests for removal from detention without physical
examination will be referred by DIOP to CFSAN (HFS-606) or
CVM (HFV-232) for evaluation.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required
KEYWORDS: Human food, pet food, animal feed, melamine, milk, milk-
derived ingredients
PREPARED BY: John E. Verbeten, DIOP, HFC-170, 301-594-3853
Sal Evola, CFSAN, HFS-606, 301-436-2164
Linda Wisniowski, CVM, HFV-232, 240-276-9233
DATE LOADED
INTO FIARS: November 12, 2008
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zzliyh / 2008-11-19 15:41:52
