The U.S. Food and Drug Administration (FDA) has issued guidance on its intent not to enforce certain provisions of five rules that implement the 2011 Food Safety Modernization Act (FSMA). As FDA began implementation of these rules, it received questions and comments from stakeholders regarding specific provisions. In certain situations, FDA has determined that it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health.
As FDA works on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance. The enforcement discretion policies announced are specific to provisions in the following rules: