U.S. Tightens Import Restrictions On Foods From China

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Chinese Milk
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The U.S. has expanded its import controls on Chinese foods that is suspects might be contaminated with melamine. The U.S Food and Drug Administration has issued a nationwide import alert that applies to all milk products, all milk derived ingredients and all finished food products containing milk. Previously, its controls applied only to specific products. From the FDA’s November 13 notice:

"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."

The FDA also says that bulk vegetable protein products were found in 2007 to be contaminated with melamine, apparently from deliberate contamination, which has not, as far as this Bystander can recall, been widely reported before.

Chinese products currently being held in U.S. ports include baby food, baked goods, breakfast food, candies, chocolate products, cheese, ice cream, beverages, pet food and lab-animal food. Melamine has been found in candy and crackers but there are no reports of illness in the U.S. yet. Why the FDA has acted now may have more to do with the U.S. presidential interregnum, than changes in food safety concerns. It will certainly give top food safety officials from both countries something to talk about next week when they meeting in Beijing ahead of the FDA opening three offices in China.

Reported by China Bystander. The following is from FDA.

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.

Districts may detain without physical examination all milk products, all milk derived ingredients, and finished food products containing milk from China.

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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:

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

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:

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.

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.

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.

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