Registrar Corp writes to remind the food industry of an important upcoming regulatory deadline. Under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), food facilities that manufacture, process, pack, or store food for distribution in the United States are required to renew their FDA registrations between October 1 and December 31, 2016.
Food facilities have been required to register with FDA since 2003. FSMA updated this requirement in 2011 to include biennial renewals in order to keep FDA’s registration database up-to-date. Food facilities are now required to renew every even numbered year between October 1 and December 31.
FDA’s Registration Renewal requirement applies to both domestic and foreign food facilities registered with FDA. Foreign facilities must also designate a U.S Agent for FDA Communications in Section 7 of their renewal. It’s important to designate a professional knowledgeable on FDA regulations , as this U.S. Agent will have access to information submitted in the facility’s registration and may speak on behalf of the facility to FDA regarding inspections, shipments, and other regulatory matters.
Facilities must renew their FDA registration no matter when they submitted their initial registration. A facility could have registered with FDA one month or even one day before October 1, and the facility would still need to renew. If a facility does not renew its registration by December 31, FDA will consider the registration to be expired. Distributing food in the United States with an expired registration is a prohibited act and may lead to detention of products or other regulatory action by FDA.
There was a 14% decrease in the number of food facilities registered with FDA from January 2014 to January 2015. Registrar Corp believes the drop was due to facilities failing to renew their registration during the 2014 renewal period.
Registration renewals may be completed directly with FDA by mail, fax, or online, or facilities may authorize a third party individual to complete their renewal.
Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, U.S. Agent requirements, food labeling, and new requirements under the Food Safety Modernization Act. Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world. Contact Registrar Corp for assistance.
This article was originally published as a press release.