• The constituent update states that FDA has become aware of a number of issues regarding unnecessary registration and potential misuse of FFR information. The Agency has seen an uptick in businesses registering their facilities with FDA when not required. In addition, third-party businesses are requesting FFR information to log into FDA’s online registration system to verify registration status, and third-party seller platforms are asking food companies to provide a copy of their FDA Food Facility Registration or a registration certificate as part of their product-listing process.
  • According to FDA, registering when not required, then sharing FFR information creates opportunities for bad actors to misuse the registration information for fraudulent purposes such as viewing, changing, or even canceling the FFR. In addition, registering when not required can lead to unnecessary inspections, cause confusion about compliance obligations, and divert FDA resources away from monitoring facilities that are required to register.
  • Under 21 CFR 1.225, food facilities that manufacture, process, pack, or hold food must register their facilities unless exempt. 21 CFR 1.226 provides exemptions for, (1) foreign facilities whose food is further processed outside the U.S.; (2) farms; (3) retail food establishments; (4) restaurants; (5) nonprofit food service establishments; (6) certain fishing vessels; and  (7) facilities regulated entirely by the U.S. Department of Agriculture (USDA) under federal meat, poultry, or egg inspection laws.
  • FDA advises registered facilities to never share the business’ FFR information and to create subaccounts if additional personnel are required to help manage registration and submissions. FDA states that if businesses have shared their FFR information in error, they should consider cancelling the FFR and re-registering the facility.
  • Keller and Heckman will continue to monitor food facility registration developments.