Wednesday, Oct. 1 marks the beginning of the second U.S. Food and Drug Administration (FDA) registration renewal period.
All domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must renew their FDA registrations by December 31, 2014.
The registration renewal requirement was established by the Food Safety Modernization Act (FSMA) in 2011 and requires that food facilities renew their FDA registrations between October 1 and December 31 of every even-numbered year. FDA considers registrations that are not renewed by the deadline to be expired, and distributing food in the U.S. without a valid registration is a prohibited act that can lead to prosecution in Federal court.
According to FDA, the number of registered food facilities dropped drastically after the first renewal period in 2012 due to facilities failing to renew. Prior to October of 2012 there were approximately 458,946 domestic and foreign food facilities registered with FDA. As of February 19, 2014, the total number of registered facilities dropped to 197,328.
Registration renewals can be completed directly with FDA or through a third party regulatory specialist. Renewing through regulatory specialists can save time and help assure that your renewal is properly submitted. FSMA also mandates that registering or renewing grants FDA the right to inspect the facility and to collect fees for reinspections. An initial FDA facility inspection costs nothing, but if the inspection reveals certain food safety issues FDA may decide to reinspect the facility at a later date to ensure changes have been made.
For fiscal year 2015 (today through September 30, 2015), the cost for reinspection of a domestic facility is $217 per hour, and the cost for a foreign facility is $305 per hour. FDA may bill for preparation for the reinspection and travel to and from the facility being reinspected. With the new financial risks involved with inspections, it’s more important than ever than ever to familiarize yourself with FDA policies and prepare in advance.
David Lennarz is Vice-President of Registrar Corp. He has conducted seminars on U.S. Food and Drug Administration regulations for food and beverages, drugs, medical devices, and cosmetics for foreign governments, trade associations, and trade shows organizers in more than 30 countries around the world. He served as a Technical Expert for the U.S. Food and Drug Administration’s Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations. Mr. Lennarz is based in Registrar Corp’s head office in Hampton, Virginia.