FDA Announces Conditional Exercise of Enforcement Discretion With Respect to Reportable Food Registry Requirements

By Ricardo Carvajal –

FDA previously announced that the Reportable Food Registry that the agency is required to establish by section 417 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") would become operational on September 8, 2009, and that responsible parties would be expected to comply with the reporting obligations imposed under section 417 on that date.  However, the agency has just updated its guidance document on the Registry to make clear that, while responsible parties must comply with their reporting obligations as of September 8, “FDA intends to consider exercising enforcement discretion for a period of 90 days, until December 8, 2009, in circumstances where FDA determines that a responsible party has made a reasonable effort to comply with the requirements of section 417 of the FD&C Act and has otherwise acted to protect public health.”  This is a welcome announcement, given the relative complexity of the reporting obligations under section 417, and the many questions that have already arisen about FDA's implementation of the Registry.

The Food and Drug Law Institute is sponsoring a webinar on the Registry on September 10.  For registration and other information, see here.