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Friday, December 14, 2012

Food Facility Registration and Biennial Registration Renewal


If you are crunched for time during this end of year holiday season, this may be good news from FDA:
In 2003 food and dietary supplement facilities were required to register with FDA. Re-registration or renewal was only required when information about the facility changed. As part of the Food Safety and Modernization Act enacted on January 4, 2011, a new biennial renewal requirement was established and all facilities were to renew their registration by December 31, 2012.  FDA was slow to establish a system to handle the renewals and this week FDA extended the deadline to January 31, 2013 for all food and dietary supplement facilities to renew their registration. 

All foreign and domestic facilities that manufacture or hold food or dietary supplements for sale in the US market must submit the following information:

  • Facility name, address, phone number, and emergency contact phone number;
  • Parent company name, address, and phone number (if applicable);
  • Name, address, and phone number of the owner, operator, or agent in charge;
  • Email address for the contact person of the facility or, in case of a foreign facility, the U.S. Agent for the facility;
  • All trade names the facility uses;
  • Applicable food product categories, as listed on the registration form;
  • Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent;
  • Certification that the information submitted is true and accurate and that the person submitting the registration is authorized to do so; and
  • Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

There is no fee for registration and it can be done online (at Food Facility Registration or using paper or CD-ROM (see Paper or CD Registration).

A helpful set of questions and answers regarding food facility registration is available at Facility Registration Q&A

All of us at and Bioscience Translation & Application wish you a joyous holiday season and a great year in 2013.
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