CSMS Message: 08-000303

To: All ABI Filers

On 11/12/2008, FDA issued 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".

The alert can be found at the following link: http://www.fda.gov/ora/fiars/ora_import_ia9930.html

Import Alert 99-30 covers a wide variety of human food and animal food products that contain milk. Importers should be aware of the products they import from China and be knowledgeable of the ingredients contained in those products.

Import Alert 99-30 states that to secure release for detained products, importers 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).

Given the large numbers of products covered by this import alert, delays in entry processing can be expected. If you believe your product does not contain milk or milk-derived ingredients, it may speed FDA's review process if you provide the documentation described above at the time of entry. Contact the local FDA office at the port of entry if you have any questions regarding their preferred method of receiving documents

Contact FDA's Division of Import Operations and Policy at (301) 443-6553 with any questions about this message.