January 07, 2014
The Food and Drug Administration (FDA) is establishing a list of U.S. milk product manufacturers and processors (the list) 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 from firms not on the list could be prevented from entering commerce in China.
Applying for inclusion on the list is voluntary. However, to be considered for the list, firms cannot be subject to any pending judicial enforcement action or a pending FDA warning letter, and would need to either have had a FDA inspection within 3 years, or be on the Interstate Milk Shippers List (IMS list) or the U.S. Department of Agriculture list, Dairy Plants Surveyed and Approved for USDA Grading Service (“USDA list”) for the products intended to ship. Also, for the purposes of the manufacturers and processors of milk products FDA would consider for inclusion on the list, the term “milk product*” does not include raw milk.
FDA will update the list quarterly and whenever a firm is removed from the list due to a pending judicial enforcement action, or a pending warning letter. To the extent FDA determines a firm is no longer on the IMS or USDA list, and there is no pending judicial enforcement action or pending warning letter, FDA intends to further investigate to determine whether there are any safety concerns related to the change in the IMS or USDA listing that would necessitate FDA considering removal of the firm from the FDA list. 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.
* Specifically, FDA considers the terms “milk product” and “milk products” to include any “milk product” as defined in 21 CFR 1240.3(j) and to exclude the raw agricultural commodity raw milk, which is not permitted in interstate commerce as per 21 CFR 1240.61.
- Guidance for Industry: Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China