US food facilities have until end of year to renew FDA registrations or risk cancellation

By Mary Ellen Shoup contact

- Last updated on GMT

Photo: U.S. FDA
Photo: U.S. FDA
Any facility that markets food for consumption in the US has between Oct. 1 and Dec. 31, 2018, to renew its U.S. Food and Drug Administration (FDA) registration, a biennial requirement that is distinct from updating registration, said Registrar Corp, an FDA regulatory compliance consulting group.

The action of renewing every other year ensures that FDA registration will remain valid for 2019.

Any facility that markets food for consumption in the U.S. without a valid registration may also be subject to civil or criminal penalties, Registrar Corp​ noted.  

Registration vs. renewal

All food facilities must register with FDA – which can be done at any point during the year – before it begins manufacturing, packing, processing, or storing food that is intended for consumption in the US 

The original requirement for food facilities to register with FDA was established in 2002 under the Bioterrorism Act.  Under the original requirement, food facilities only needed to register once with FDA and update within 60 days of changes to any required data fields in the registration. 

“The problem was that this update requirement was not enforced, and facilities would shut down, move, or change their points of contact without notifying ​[the] FDA,”​ Mary Hancock, food facility registration manager, Registrar Corp, told FoodNavigator-USA. 

This resulted in the agency wasting resources by sending inspectors to facilities that sometimes weren’t marketing food for consumption anymore, Hancock added.

The Food Safety Modernization Act (FSMA) of 2011 amended the original registration requirement to ensure that FDA has access to current information on all US food facilities.

Now, facilities must renew FDA registrations regardless of whether or not any information has changed about the facility and regardless of when they registered. For example, even a facility that registered in this month (September 2018) is required to renew its registration by the end of the year.

What are the consequences of not renewing?

The FDA will cancel any US food facility registrations that are not properly renewed during the Biennial Registration Period, which occurs on every even number year. In 2016, there was a 28% drop in the number of registered facilities that did not renew during the designated timeframe.

“Registrations that are not renewed are removed from FDA’s registration database, and it’s a prohibited act to manufacture, process, pack, or store food that may be consumed in the US without a valid registration,”​ Hancock said.

If a facility does not renew its registration there is no way to reinstate the original registration number, forcing the facility to either file a new registration or be assigned a new registration number, according to Hancock.

“Many facilities don’t realize their registration is cancelled until there is an issue. For example, a facility may find out their registration is cancelled when their shipment is stopped at the border.  Now their shipment is delayed, which can harm their relationship with their US buyers.”

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