Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance
FDA issues guidance outlining enforcement discretion for certain areas of the FDA Food Safety Modernization Act rules.
The FDA is committed to ensuring the U.S. food supply remains among the safest in the world. We’ve been working hard to implement the FDA Food Safety Modernization Act (FSMA), the biggest overhaul of our nation’s food safety laws in more than 70 years. The law evolved from widespread concern about outbreaks of foodborne illnesses that kill thousands each year. These were true public health emergencies that compelled Congress to make this sweeping statutory reform. FSMA represents a profound and fundamental change in our approach to food safety, shifting from being reactive to preventive.
While we’ve been setting in place the public health gains envisioned as part of FSMA by issuing new standards for food safety, we recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated. We value the feedback we’ve received on the new rules and understand manufacturers, farmers and other stakeholders have faced certain challenges as they work to implement the new rules. We’re actively working to pursue permanent fixes to some of these remaining issues through rulemaking or other means, but this will take time. That’s why today we released guidance outlining key areas where we intend to exercise enforcement discretion in four of the rules that implement aspects of FSMA; to address certain challenges as we work to find long-term solutions.
Our aim is to work constructively with farmers and other producers to achieve our shared goals around food safety. These steps are part of our ongoing effort to make sure we take the time to get this new framework right, so it can successfully serve the needs of consumers for the long run.
The provisions the agency does not intend to enforce relate to aspects of the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food. These provisions can be found in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Foreign Supplier Verification Programs Rule; and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Rule. This action will help reduce the burdens on both industry and government and provide the agency the ability to consider the most effective and efficient way forward.
We all share the common goal of maintaining the safety and quality of the American food supply. We look forward to continued collaboration with the affected industry, regulatory partners and other stakeholders to make sure that they understand what’s required in a post-FSMA world and to provide the flexibility needed to implement these new standards across a very diverse food supply.
In addition to the steps we’re taking today, the FDA is committed to taking a comprehensive approach to ensuring that industry and regulatory partners have the tools they need to implement FSMA, including training, technical assistance, and guidance documents to make our expectations clear. FSMA holds tremendous promise for preventing foodborne illness outbreaks and we will continue to take steps to fully and effectively implement this law so Americans can realize the public health benefits.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.