FDA announced that it will exercise enforcement discretion for certain provisions of the Food Safety Modernization Act, effective January 4th, 2018, until FDA decides on further action for each of the issues. This guidance only applies to specific provisions in the Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal food rules (PC Human Food and PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety).
Specifically, the guidance focuses on how these provisions apply to:
- Certain facilities conducting farm-related activities that are subject to human food or animal food PC rules.
- Written assurance provisions in the rules related to the control of identified hazards.
- Importation of food contact substances under FSVP.
- Certain manufacturing/processing activities for human food by-products for use as animal food.
More details can be found here, FDA Announces Enforcement Discretion Policy. Companies with questions about FSMA provisions and FDA’s enforcement of those provisions may contact our team of regulatory experts and affiliated attorneys for further information.
