FDA registration renewal deadline looming for US food and feed facilities

17-Sep-2020 - Last updated on 17-Sep-2020 at 08:47 GMT

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All US food and feed facilities must renew their US Food and Drug Administration (FDA) registration between October 1 and December 31, 2020. Renewal is required every even-numbered year, and failure to renew results in a cancelled registration, says a consultancy.

Facilities located outside of the US must also designate a US agent to communicate with the FDA on their behalf in relation to registration of their factory. The FDA will not finalize a facility’s renewal until the US agent accepts the designation, said Registrar Corp, which assists businesses with regulatory compliance.

Exporting food to the US that was manufactured or processed by a facility that does not renew its registration may result in detention or refusal of the goods, explained the consultancy. Facilities within the US that continue to produce food or feed for use within the US without a valid registration may be subject to civil or criminal penalties, it added.

The FDA cancelled 20% of food facility registrations in 2019 after they failed to renew by the 2018 deadline, said Mary Christine Hancock, senior regulatory specialist, manager food facility registration team, Registrar Corp.

“Details of individual FDA registrations, such as what foods they handle, are not public information, so we do not know the breakdown of how many of these were animal versus human food,” she told us.

Even if a facility registers as late as September 30, 2020, they will still be required to renew that registration, she said.

New identification requirement

While food and feed facilities have been required to biennially renew their FDA registrations since 2012, this year the FDA is requiring US and non-US facilities to input a Unique Facility Identifier (UFI) as part of their renewal for the first time.

Data Universal Numbering System (DUNS) numbers are currently the only UFI recognized by the US regulator, and they can be obtained directly from the private company, Dun & Bradstreet, explained Hancock. “The DUNS number itself is free of charge.”

Obtaining the UFI can be a lengthy process, so it is wise to start that process early, she stressed.

“It is possible that this new requirement will cause a backlog of UFI requests. A delay in receiving your UFI puts you at risk of not being able to renew your facility in time.”

The difficulty of obtaining a DUNS and renewing for non-US facilities will likely depend on whether the staff are fluent in English and comfortable with technology, as FDA's registration system is online and only available in English, said Hancock. “If a facility encounters trouble while trying to obtain a DUNS number or to renew its FDA registration, Registrar Corp can assist.”

An FDA guidance document on registrations can be accessed here.