What’s New with the FDA?
FDA Removed Thousands of Expired Food Facility Registrations from its Database
Food facilities that were previously registered with the Food and Drug Administration were required to re-register with the FDA between October 1, and December 31, 2016. If a food facility did not register between that period, their prior registration has been invalidated by the FDA. Thus, a US Customs clearance rejection may have already occurred or may occur when importing from an invalidated foreign facility. In addition, food facility registrations were also invalidated for failure of confirmation by a US Agent and/or foreign manufacturer (registered by a third party) as required under the FDA Food Safety Modernization Act (FSMA).
What does this mean?
If you are an importer experiencing a rejection or problems importing that you did not experience last year, please ensure your foreign supplier has followed the steps to register their facility. If they have already started the process, the manufacturer may check the status of their registration by logging into their FURLS Food Facility Registration Module account to verify the status of the individual registration. FURL information listed below.
Please note, registrations that have been invalidated cannot be renewed. However, a new registration can be created.
It’s a simple fix. It just needs to get done.
Registrations can be done online, via mail or fax, although FDA encourages online registration. The FDA even allows authorized third parties to register for the foreign facilities. Note, regardless of how the facility is registered, the US Agent or the owner must confirm the receipt of the registration within 30 days for it to be valid in the FDA reference database.
What if the Manufacturer doesn’t Register?
Failure to have a valid registered manufacturer can cause a delay in your shipment, therefore it is not recommended to file a prior notice if the registration is pending or use a facility registration that was invalidated due to failure to renew or confirmed by the US Agent/Owner.
What are some Resolutions for Rejections on Prior Notice?
Filers of Prior Notice receiving rejections due to registration invalidations should consult the following for possible resolution:
Registrations that have had a change in status
- Verify the status of the registration within the manufacturers FURLS Food Facility Registration Module (FFRM) account
- Verify the status of the registration with the third party that filed the food facility registration on the manufacturer’s behalf
- Verify with the manufacturer that they are willing to be registered and inspected by the US Food and Drug Administration
- Verify the owner, operator, or agent in charge listed in the registration is still in that current position and employed by the manufacturer
- To facilitate communication with FDA, verify the owner, operator, or agent in charge has current valid contact information including a valid email address listed in the food facility registration.
- Verify the owner, operator, or agent in charge has confirmed the submission of the registration if filed by a third party or is a US manufacturing facility.§ To confirm the receipt notification, the owner operator, or agent in charge must create an online FURLS account and follow the instructions for the owner operator, or agent in charge at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#confirm.§ Owner, operator, or agent in charge confirmation can only be completed electronically
U.S. Agent Verification Process
- Manufacturer or registrant needs to verify the U.S. agent in charge listed in the registration is still in that current position and agrees to be the U.S. Agent.
- Manufacturer or registrant needs verify the U.S. agent has current valid contact information including a valid email address listed in the food facility registration.
- Manufacturer or registrant needs to verify the U.S. agent has agreed to serve and confirmed the listing on the registration of a foreign facility.§ To confirm the listing, the U.S. agent must create an online FURLS FFRM account and follow the instructions for the U.S. agent at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#confirm.§ US agent confirmation can only be completed electronically.
Invalid Registration Reject
If your entry is in reject status due to invalid registration, perform a CA Correction (PGA correction / update). Filing a duplicate entry for the shipment without resolving the original entry rejection will cause a delay in the release of the shipment. A cancellation of the rejected entry will cause a review of the shipment by CBP and/or FDA to determine if registration requirements are being circumvented.
Support Contact information
Manufacturers should contact the FURLS Help Desk at FURLS@fda.gov or call 1-800-216-7331 to verify the current status of your food facility registration. Due to the high call volume, please expect long wait times for phone calls. You may also access the Food Facility Registration Module (FFRM) to verify the status of your registration.
Trade may contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to verify the rejection reason.
Trade may also contact the Division of Food Defense Targeting at email@example.com or 866-521-2297 for assistance with valid food registrations verified by the FURLS Help Desk that may be rejecting improperly.
Other Upcoming FDA Change Notices
Furthermore, beginning in May 2017, FDA will require new data elements for entries subject to the Food Safety Modernization Act-Foreign Supplier Verification Program Rule (FSVP). Most FDA-regulated food entries are subject to the rule; however, alcoholic beverages, seafood, juice HACCP products are exempt.
These elements will be required for each line:
- Name of FSVP Importer (not necessarily the same as the Importer of Record)
- Unique Facility Identifier for FSVP Importer (currently only a DUNS number will be accepted)
- Contact email address for FSVP Importer
The FSVP Importer is responsible for verifying the food safety practices of the foreign supplier among other things. FDA will maintain a database of FSVP importers and will conduct inspections on that basis.
If you have any US Customs or FDA-related questions, don’t hesitate to email us anytime at firstname.lastname@example.org.