On Jan. 7, 2014, FDA issued guidance on the creation of a list of facilities intending to ship dairy products to China. While the list is voluntary, any facility not on the list by May 1, 2014, will not be eligible to ship any dairy products to China until the facility is added to the list. The new list is needed because China issued Decree 145 that requires, among other things, all foreign competent authorities to maintain a list of facilities that are eligible to ship to China. Any facility that does not have an impending judicial enforcement action, or a pending administrative action, and has had either an FDA inspection within the last 3 years or is on the IMS or AMS lists will be eligible to be on the list of facilities intending to ship to China. A separate list will be created for infant formula manufacturers in the near future, so infant formula manufacturers can disregard this notice. Companies wishing to be added to this voluntary list can mail or email the following information to Esther Lazar (Esther.Lazar@fda.hhs.gov) at:

Ms. Esther Lazar
Center for Food Safety and Applied Nutrition (HFS-306)
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740

Information required to be added to the list:

• Name, telephone number and email (if available) of contact person;
• List of products presently shipped to China and those intended to be shipped;
• Name and address of the manufacturing plant for each product;
• Name of any federal, state or local governmental agencies that inspect the plant, along with the government assigned plant identifier (e.g., plant number) and date of last inspection; and
• Copy of last inspection notice and, if other than an FDA inspection, copy of last inspection report.

Further information can be found in the FDA notice. If you have any questions, please contact Matt McKnight (mmcknight@usdec.org) or Mitch Bowling (mbowling@usdec.org) at 703-528-3049.