FDA opens Reportable Food Registry electronic portal

Washington

-- The U.S. Food and Drug Administration opened the new Reportable Food Registry (RFR), an electronic portal that food-industry officials are now required to use to alert the FDA when they have reason to believe their products might sicken or kill humans or animals.

Facilities that manufacture, process or hold food for consumption must tell the FDA within 24 hours if they find a reasonable probability that a food item will cause severe health problems or death to a person or animal.

The requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory systems. Some reasons a food may be reportable are bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The FDA issued draft guidance on the RFR in June and sought comment, then held three public workshops across the country to explain the system before a Federal Registry notice was issued Sept. 8 announcing the opening of the portal and the availability of final guidance for compliance.

The reporting requirement applies to anyone who has to submit registration information to the FDA for a food facility that manufactures, processes, packs and holds food for human or animal consumption. Responsible parties must investigate the cause of food adulteration, submit initial and follow-up reports and work with the FDA as needed. But responsible parties are not required to report if they found the problem before the food was shipped and corrected the problem or destroyed the food.

More information is available here.