May 15, 2017, was the “stand up” day for the Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) new organizational structure under its Program Alignment initiative. The Program Alignment initiative began in 2013 as an effort to modernize and strengthen the agency’s workforce and to improve public health response. A key aspect of the Program Alignment initiative is a shift from the current geography-based district offices to program-specific “division” offices where staff are aligned by FDA-regulated product – i.e., there will now be distinct food-based offices, inspectors and labs and distinct medical products-based offices, inspectors and labs. This means that, over time, food companies will be inspected by individuals trained in food inspections, not drug or device inspections. This increase in specialization is intended to create a more proficient workforce and increase the efficiency of FDA operations.
With the change to program-specific division offices, some of the former district offices have been merged together. Practically speaking, this means that for some food companies, the contacts in their respective division offices may have changed. Other key changes under the Program Alignment initiative include a reorganization of the import program, state cooperative programs, and FDA’s field laboratories, and the creation of a Produce Safety Network. We have provided an overview of the key organizational changes at ORA that impact the food industry.