Importers that are
required to register with the Food and Drug Administration (FDA) must renew before
the end of the year!
derived from U.S. Customs and
The Food and Drug Administration (FDA) Food
Safety Modernization Act (FSMA), signed into law on January 4, 2011, enables
FDA to better protect public health by strengthening the food safety system.
Among many other changes, FSMA amended Section 415 of the Federal Food, Drug,
and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D], which requires domestic
and foreign facilities that manufacture, process, pack or hold food for human
or animal consumption in the U.S. to register with FDA. Under FSMA, all food
facilities that are required to register with FDA under Section 415 of the
FD&C Act must renew their registrations with FDA, every
other year, during the period of time beginning on October 1 and ending on
December 31 of each even-numbered year.
Beginning on January 1, 2015, if a foreign
food facility is required to register with FDA, but fails to do so, food from
that facility that is being imported or offered for import into the U.S. is
subject to be held under Section 801(l) of the FD&C Act.
Food Facility Registrations (FFR) that are
not renewed by December 31, 2014 will be subject to invalidation of
registration and could result in food shipments manufactured by those
facilities without valid registrations to be held at the port upon arrival in
As a result, FDA
encourages import brokers who file prior notices for food shipments take
proactive action and contact clients with high-volume food shipments, inquire
about the FSMA food facility registration renewal status of foreign
manufacturing facilities associated to their shipment, and confirm any new
registration numbers. Doing so could greatly mitigate any prior notice
shipment delays related to registration on or after January 1, 2015.
For more information
on the FDA food facility registration requirement, see FDA’s website at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm.
For assistance with
registration issues contact FDA Industry Systems Help Desk at 800-216-7331 or
For assistance via
email, utilize the form on FDA’s website http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm.
contained in this newsletter has been compiled from various industry
newsletters and other public sources. While we use reasonable efforts to
furnish accurate and up-to-date information Page & Jones, Inc. is not
liable or responsible for the accuracy or reliability of any information