U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era of smarter food safety (the Statement). The Statement reflects on the evolution of our food system from an “around

Last week, the Centers for Disease Control and Prevention (CDC) released a report entitled, “Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food – Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2015-2018” (the Report). The Report summarizes data collected by the Foodborne Diseases Active Surveillance Network (FoodNet), which tracks infections caused

This post summarizes several regulatory developments related to cannabis and cannabisderivatives, including cannabidiol (CBD). The Food and Drug Administration (FDA) recently announced it will hold a public meeting on May 31, 2019 and open a docket for public comments to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale

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The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule.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

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow more time for farmers and state regulators to receive training on the rule. Routine inspections for large farms (i.e., farms with more

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary

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