Everything You Need To Know About FDA Registration Renewal

By Sam Lewis

October 2016 marks the beginning of the third-ever FDA registration renewal period. Registration renewal was mandated by FSMA in 2011. Being a fairly new requirement, the FDA's registration renewal is often overlooked. To assist facilities with compliance during this year's renewal period, I compiled a list of need-to-know questions for Mary Hancock, senior regulatory specialist at Registrar Corp.

Food Online: Who must comply with the FDA’s registration renewal?  

Hancock: Both foreign and domestic facilities that process, manufacture, store, pack, and label food, beverages, and dietary supplements for human and animal consumption must renew their existing FDA food facility registrations. Retail food establishments, restaurants, and private residences are exempt from FDA registration requirements. This infographic provides additional guidance on who is required to register and renew.

Food Online: What are the important deadlines for it?  

Hancock: Food Facilities are required to renew registrations between October 1 and December 31 of every even numbered year in order to keep the FDA’s databases current. Food facilities must renew regardless of when they initially registered. For example, if a facility registered September 30, it is still required to renew the registration between October and December.

Food Online: Why is the FDA requiring registration renewal?

Hancock: The FDA requires registration renewal in order to keep their records up-to-date. Accurate facility information allows the agency to use its inspection resources efficiently as well as better trace food in the event of an emergency.

Food Online: How do facilities go about renewing registration?

Hancock: There are several ways to renew an FDA registration. A facility may renew directly with the FDA by mail, fax, or online. Facilities may also authorize a third-party individual, such as a Regulatory Specialist, to complete its renewal.

Food Online: Has anything changed since the 2012 renewal period?

Hancock: The FDA recently implemented new verification procedures for the registration and renewal process. These changes will take effect October 1, 2016. For example, foreign facilities are required to designate a U.S. Agent for FDA communications in section 7 of their renewal. The FDA will now e-mail the listed U.S. Agent and will not activate the foreign facility's registration until the U.S. Agent agrees. The FDA also made various changes to activity types and food products.

Food Online: What happens if a facility does not renew its registration?

Hancock: The FDA will cancel registrations that are not renewed by the December 31 deadline. Without a valid registration, distributing food or beverages in the U.S. is a prohibited act and may result in the detention of products. For food exported to the U.S., the FDA will hold the food at the port of entry and it will not be released to the importer, owner, or co-signee until the facility is registered properly. There was a 14 percent drop in the number of food facilities registered with the FDA from January 2014 to January 2015. We believe this decrease was due to facilities failing to renew.

About Mary Hancock
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. Mary can be reached via email at mhancock@registrarcorp.com