This presentation was provided at the 2015 Regulatory Workshop in October. The presenter, Maile Gradison Hermida, presented on legal framework, FDA Enforcement powers, park doctrine, recent enforcement actions, and FSMA considerations.

The microbial safety of “ready-to-eat” (RTE) foods is a hot topic that ASTA is hearing a lot about when it comes to implementation of the Food Safety Modernization Act (FSMA). The U.S. Food and Drug Administration (FDA) has not yet published guidance regarding classifying and processing RTE foods. In these “frequently asked questions” (FAQs), ASTA is sharing information on positions FDA could take on RTE based on the preambles to the FSMA final rules, talks that FDA officials have given, information published in the update to the spice draft risk profile, informal conversations with FDA officials, and other published FDA draft guidance. ASTA has produced these FAQs in order to help members understand FDA’s current thinking on RTE foods, but we note that we have not received input on this document from FDA.