All food facilities that manufacture, process, pack, or store food, beverages, or dietary supplements for consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA). According to a Freedom of Information Act (FOIA) request obtained by Registrar Corp, there were 207,655 food facilities registered with FDA as of January 1, 2016. Of those registered food facilities, 120,822 were located outside of the United States. See the number of registrations by country here.
The ten countries with the largest number of FDA registered food facilities remain the same in 2016 as those reported in 2015:
1. United States (86,773)
2. Japan (13,941)
3. France (10,450)
4. Italy (10,125)
5. China (9,667)
6. Mexico (9,575)
7. Canada (6,690)
8. Spain (4,688)
9. Republic of Korea (3,921)
10. India (3,455)
The 207,655 registered facilities reported in the FOIA request is significantly lower than the 300,539 registered food facilities FDA reported on the agency’s Food Facility Registration Statistics page on February 4, 2016. According to FDA, this is because facilities that engage in more than one activity (manufacturing, labeling, etc.) are recorded multiple times on FDA’s website, thus leading to inflated registration numbers.
Registrar Corp’s 2016 FOIA request shows a 24% increase in registrations since 2015. From 2014 to 2015, however, the firm’s data showed a 14% decrease in registrations. According to FDA, there was also a large drop in the number of registered facilities from 2012 to 2013 due to facilities failing to renew their registration during FDA’s biennial renewal period.
Registrar Corp expects this pattern to continue: an increase in registrations from odd to even years, and a significant decrease from even to odd years. This is because many facilities are unaware of or forget about FDA’s biennial registration renewal requirement, a requirement established under the Food Safety Modernization Act (FSMA) in 2011. Under FSMA, food facilities must renew their FDA registrations each even-numbered year between October 1 and December 31. The first registration renewal period occurred in 2012. The next registration renewal period will begin on October 1, 2016.
Registrar Corp is an FDA consulting firm headquartered in Hampton, Virginia, USA with 19 regional offices around the world. The firm can help you determine whether your facility must be registered with FDA and verify whether your food facility has a valid FDA registration at no cost. Registrar Corp can also register facilities and renew registrations with FDA as well as provide Certificates of Registration that may be used to ensure buyers that your registration is valid. For more information about FDA registration requirements, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
This blog was originally published as a press release.