Presently, although there is no requirement for submitting individual adverse event human case reports involving food products to the FDA the Agency does have the expectation that manufacturers have a strong quality management system in place to document and investigate adverse events. This will allow the manufacturer to identify unexpected new risks or hazards with their distributed food products and immediately notify the FDA if there is a potential public health risk via the Reportable Food Registry. For food products this requires implementing a post market surveillance program for capturing and documenting individual adverse event reports and, during a quality investigation, evaluating the need to submit a Reportable Food Report to the Registry. A Reportable Food is an article of food (other than dietary supplements or infant formula) where it is concluded following a quality investigation that there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse public health consequences or death to humans or animals.
An example of this may be a scenario where a consumer called a food company regarding their peanut free energy bar to say they are allergic to peanuts and after eating the energy bar their lips began swelling, but they were able to manage at home with a quick dose of Benadryl, but that they believe there might be peanuts in the energy bar. SafetyCall’s primary role would be a surveillance center for the intake of adverse events involving foods whereby our clients may use our reports to initiate a quality investigation to determine if the product meets expected quality standards. If upon investigation the client found that there were peanuts (whether intentionally added or by cross contamination) in the formulation, they would then be required to submit a Reportable Food Report because people with peanut allergies could develop a serious adverse event or death.
Again, while there is a mandatory requirement to submit instances of a Reportable Food to the FDA Reportable Food Registry, the FDA does not mandate reporting of individual adverse event reports involving food products. The FDA does recommend that members of the food industry voluntarily report individual adverse event reports to the FDA, especially if they qualify as serious. SafetyCall is prepared to assist our clients in the preparation of voluntary MedWatch reports for serious individual adverse event reports involving food products.
The FDA Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry may be reviewed here.