Registered facilities must report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Information is available about how to report these situations to FDA’s Reportable Food Registry.
FDA allows conventional food manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers to forward reports of serious adverse events in connection with their products to FDA by filing Form 3500.
FDA requires reporting of serious adverse events involving dietary supplements. All reportable events can be documented on the FDA’s Safety Reporting Portal.