IA #99-30, REVISED 2/23/2009, 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"
NOTE: The revision of this Import Alert dated 2/23/2009 updates the FDA
contact information. Changes are bracketed by asterisks (***).
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: 03A[][][] Bread/Rolls
03B[][][] Prep Dry Mix(Bread Etc) W/Milk Or Egg
03D[][][] Bread Heat/Serve
03E[][][] Bread Doughs
03F[][][] Crackers
03G[][][] Filled Crackers
03H[][][] Plain Cookies, Biscuits and Wafers
03J[][][] Filled/Iced Cookies, Biscuits and Wafers
03K[][][] Prep Dry Cookie, Biscuit, Wafer Mix W/Milk Or Eggs
03M[][][] Cookie, Biscuit and Wafer Doughs
03N[][][] Sweet Goods Custard/Cream Filled
03P[][][] Prep Dry Sweet Goods Mix W/Cust-Crm Filled
03Q[][][] Sweet Goods, Dough & Batter, Cust-Crm Filled
03R[][][] Sweet Goods not Custard/Cream Filled
03S[][][] Prep Dry Sweet Goods Mix Wo/Cust-Crm Filled
03T[][][] Sweet Goods, Dough & Batter, Wo/Cust-Crm Filled
03U[][][] Icing and Icing Mixes
03Y[][][] Other Bakery Products, N.E.C.
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
14A[][][] Filled Milk Products
14Y[][][] Filled/Imitation Milk Prod N.E.C.
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,
analysis, preparation, or analytical methodology, contact the
Division of Field Science at (301) 827-7605. ***
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 fromthe 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
ORIGINAL
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
ORIGNAL ISSUE
DATE: 11/12/2008
REVISED BY: John E. Verbeten, DIOP, 1/15/2009
*** John E. Verbeten, DIOP, 2/23/2009 ***
DATE LOADED
INTO FIARS: February 23, 2009
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