Does a Puerto Rico food manufacturer need FDA registration to sell on the U.S. mainland?

Yes, if the plant manufactures, processes, packs or holds food for consumption in the United States and is not exempt. The FDA treats a Puerto Rico plant as a "domestic facility," which must register before it starts operating and renew every two years.

Renewal runs from October 1 through December 31 of each even-numbered year, and the FDA considers the registration expired for any facility that does not renew in that period. Registration is done online through FDA Industry Systems, has no fee and requires a unique facility identifier; the FDA accepts the DUNS number. Qualified facilities also submit their attestation during the same period. Farms, retail food establishments, restaurants, nonprofit food establishments that serve food directly to consumers, certain fishing vessels and plants regulated exclusively by the USDA throughout the entire facility do not have to register.