The Who, What, When, Where and Why of FDA Registration RenewalThe Who, What, When, Where and Why of FDA Registration Renewal
Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their registrations with FDA between Oct. 1 and Dec. 31, 2016; to help facilities prepare, we provide the who, what, when, where and why of FDA registration renewal.
October 14, 2016
Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their registrations with FDA between Oct. 1 and Dec. 31, 2016.
Who: Domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register and renew. If FDA determines a registered facility is not required to register, FDA may cancel the registration.
What: Food facilities have been required to register with FDA since 2003. While 21 CFR requires facilities to update their registrations within 60 days of a change to any required data elements in a registration, this requirement was not actively enforced by FDA. In 2011, FSMA updated the Federal Food, Drug and Cosmetic Act to require biennial registration renewals as an assurance that the information in FDA’s Food Facility Registration database would remain accurate and current.
When: FDA registrations must be renewed between Oct. 1 and Dec. 31 of every even-numbered year. It does not matter when a food facility completes its initial registration. Even if a facility registers the day before a renewal period begins, the facility will need to renew its registration.
Where: Facilities can renew their registrations directly with FDA by mail, fax or online, or they can authorize a third party individual, such as a regulatory specialist at Registrar Corp to renew their registration. FDA will require renewals to be submitted electronically beginning in 2020.
Why: Facility registrations that are not renewed on time are considered by FDA to be invalid, and the agency will remove the registration from its database. Distributing food within the United States without a valid FDA food facility registration is a prohibited act. Foreign facilities that do not renew may find their shipments to the United States held by FDA at the port of entry until the facility is compliant.
Mary Hancock is a senior regulatory specialist at Registrar Corp,, an FDA consulting firm that helps companies comply with FDA regulation. She has been assisting companies with FDA regulations since 2009 and has assisted more than 20,000 food facilities to navigate FDA registration requirements.
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