Food

Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China

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How to Comment

Submit written comments at any time to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-4484.

Contains Nonbinding Recommendations

June 2017

This guidance document revises a guidance document issued in January 2014 entitled “Guidance for Industry: Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China” to add seafood, infant formula, and formula for young children and to clarify the procedures for establishing and maintaining the lists for each type of product. This revised guidance document explains how establishments should apply to be included on FDA’s lists of exporters to China, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information.

 FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance listed on the title page.

 

Page Last Updated: 06/28/2017
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