Registrar Corporation, a company that assists businesses with compliance with U.S. Food and Drug Administration (U.S. FDA) regulations recently revealed under a Freedom of Information Act (FOIA) request showing that of the 207,655 food facilities registered in Jan. 1, 2016, more than half or 120,822 food facilities are moving out of the United States.
Registrar Corp although not affiliated with the U.S. FDA, provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Food and Beverage, Medical Device, Drug, and Cosmetics Industries.
So, what the catch here? Why are more and more food facilities get out of the U.S.?
Domestic facilities often fail to renew its registration, or to renew on time, for a fairly simple reason: Unlike foreign facilities, U.S.-based manufacturers do not have to notify FDA prior to making a food shipment, whereas foreign facilities are required to file an FDA Prior Notice (which includes the manufacturer's registration number) prior to arrival of a shipment of food into our ports of entry. Foreign-based facilities usually have agents to do that for them that's why they are able to comply. IT makes it easier to do business with these companies.
In addition, there is many inspections done within the U.S. FDA Food Safety Modernization Act (FSMA) requires that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:
1. Created, caused, or was otherwise responsible for such reasonable probability; or
2. Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
In the end, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. Regardless where the food facility is located, Americans consume these foods whether located outside or in the U.S.
