In the News

FDA Updates Guidance on Reportable Food Registry

Jun 22, 2010

The U.S. Food and Drug Administration (FDA) announced the availability of an updated draft guidance on the reportable food registry (RFR), titled, "Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)." The RFR was incorporated into a new website, called the Safety Reporting Portal (SRP), which was launched jointly by FDA and the National Institutes of Health on May 24, 2010. FDA's updated draft guidance provides information on the SRP, in addition to addressing inquiries that the agency has received since the Reportable Food Registry was implemented on September 8, 2009.

In addition to food safety problems, the SRP can currently be used to report problems with pet foods and pet treats, safety problems related to animal drugs, and adverse events occurring on human gene transfer trials. In the future, the SRP is expected to provide a mechanism for the reporting of pre- and post-market safety data to the a broad array of federal agencies once it is fully developed. "The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," said FDA Commissioner Margaret A. Hamburg in a news release about the SRP.

The requirements for the establishment and operation of the RFR can be found in section 417 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the act, if a responsible party—such as a food manufacturer—determines that a reportable food has originated at one of its facilities then that party must submit a report to FDA and investigate the cause of the adulteration. The reporting requirement does not apply to food packaging manufacturers unless food is also packaged in their facilities, since the act defines "responsible party" as a "person that submits the registration under section 415(a) [of the FD&C Act] for a food facility...at which such article of food is manufactured, processed, packed, or held." However, when a responsible party's investigation determines that a packaging component is the cause of adulteration, such information may likely be reported to FDA.

Comments on the RFR draft guidance should be submitted by July 26, 2010 for FDA to consider them before it begins work on the final version of the guidance.