FDA Commissioner backs off on enforcing some FSMA rules

January 5, 2018

The U.S. Food and Drug Administration (FDA) has released a guidance document that states the intent of the agency not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities.

“While we’ve been setting in place the public health gains envisioned as part of FSMA [Food Safety Modernization Act] 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,” said FDA Commissioner Scott Gottlieb in a statement on fda.gov. “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.”

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,” explained Gottlieb.

The guidance is immediately effective because the FDA has determined that prior public participation is not feasible or appropriate.

Guidance document

Gottlieb statement