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The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise  enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing, and holding almonds, pulse crops, wine grapes, and hops. FDA received feedback from these entities that they should be exempt after it…

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand food safety monitoring. The statement details how FDA would use requested funds, if provided by Congress, to build a “smarter, more technologically advanced…

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must…

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of imported foods. The Strategy sets out four food safety goals: 1) preventing food safety problems in the foreign supply…

As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding…

This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule) to conduct a vulnerability assessment if using the Key Activity Types method. Below,…

The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA).  Together with the release of this Guidance, FDA Commissioner Scott Gottlieb, M.D., released a statement addressing FDA’s goal of expanding use of the mandatory recall authority in…

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first document is for farms covered by the Produce Safety Rule (PSR). The second document is for facilities subject to FDA’s Preventive Controls for…

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish and publish a list of high-risk foods and engage in rulemaking setting forth…

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule under the FDA Food Safety Modernization Act (FSMA). Through a Notice to Industry, FDA is inviting food companies with…