FSMA: Many people are unfamiliar with the requirements and consequences of failing to renew their US FDA registrations
Under the Food Safety Modernization Act (FSMA), all facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must biennially renew their registrations with the US Food and Drug Administration (FDA).
This includes facilities located outside of the US that export food to the country.
The biennial registration renewal period occurs from October 1 to December 31 of each even-numbered year.
Because the renewal requirement is still fairly new (the first renewal period was in 2012), many people are unfamiliar with the requirements and consequences of failing to renew.
FDA considers registrations that are not renewed to be expired, and conducting business with an expired registration can lead to a number of issues, including:
1) Distributing food in the US with an expired registration is a prohibited act, and the federal government can bring a civil or criminal action in Federal court to prosecute a person who commits a prohibited act.
2) Food shipped to the US by a facility with an expired registration will be held at its port of entry. FDA or Customs and Border Protection may also send the food to a secure facility. The food will not be delivered to the importer, owner, or consignee until the responsible party properly registers its facility.
3) Under FSMA, FDA is required to increase the number of inspections it conducts. In 2011, FSMA mandated that FDA inspect all high-risk domestic facilities by 2016 and then again every three years, and all low-risk domestic facilities by 2018 and then again every five years. FSMA mandated that FDA inspect 600 foreign facilities in 2011 and then double that number each year through 2016. As part of an inspection, FDA will check a facility’s registration status, and an expired registration could cause a violation during the inspection.
You can renew your registration with FDA online or by mail, or you can use a third-party consultant.’
David Lennarz is the vice-president of Registrar Corp. He has conducted seminars on US 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 US Food and Drug Administration’s Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations. Lennarz is based in Registrar Corp’s head office in Hampton, Virginia.
