Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA. However, facilities that produce food contact substances (FCS) are exempt from registration unless the FCS is also added directly to food, then the facility dealing with those substances must be registered. 

As background, the final rules to implement the Foreign Supplier Verification Programs [FSVP], a major provision of FDA’s Food Safety Modernization Act (FSMA), were announced in 2015. Food-contact substances are included in the definition of “food” for purposes of the FSVP regulation (21 C.F.R.). However, on January 4, 2018, FDA announced that it did not intend to require importers of food-contact substances to comply with the requirements of the FSVP. FDA cited its premarket review and oversight of food-contact substances, and the regulatory framework for these substances as reasons for exercising enforcement discretion with regards to food-contact substances and the FSVP regulation.

For companies that import food into the U.S., information on how to register food facilities can be found on FDA’s website.