January 8, 2014

FDA Establishes List of Approved U.S. Milk Exporters to China 

The Food and Drug Administration (FDA) announced yesterday that it is establishing a list of U.S. milk product manufacturers and processors interested in exporting milk products to China.  FDA is taking this step to help U.S. manufacturers comply with new requirements of the Chinese government for the importation of milk products into China.  China has advised that milk products (a category which, in this case, does not include raw milk) from firms not on the list could be prevented from entering commerce in China.

To be considered for the list, which is voluntary, firms cannot be subject to any pending judicial enforcement action or a pending FDA warning letter, and would need to have had one of the following:

  • FDA inspection within 3 years
  • Inclusion on the Interstate Milk Shippers List (IMS list)
  • Inclusion on the U.S. Department of Agriculture list, Dairy Plants Surveyed and Approved for USDA Grading Service (“USDA list”)

FDA will update the list quarterly andwhenever a firm is removed from the list due to a pending judicial enforcement action, or a pending warning letter. FDA intends to notify the firm of FDA’s findings and, as appropriate, FDA’s intent to remove the firm from the FDA list.   FDA will also post the list to its website and provide the list directly to the Chinese government, which may post some or all of the information contained in the list on its own website.

In December of each even-numbered year, FDA intends to send a letter to manufacturers that are on the list, requesting that they update the information initially provided and indicate whether they wish to continue being listed.

Firms may apply to be on the list beginning January 7, 2014.  The first posting of the list and notification to China will occur on or about April 30, 2014.

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