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The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021. The IA rule requires food facilities covered by the rule to develop and implement a food defense plan that identifies…

The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s work implementing the FDA Food Safety Modernization Act (FSMA) by establishing a new approach to food safety that…

The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug…

Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light of the COVID-19 pandemic. After temporarily suspending inspections in March 2020, FDA is working toward restarting on-site inspections during…

There are numerous regulatory and practical issues borne out of COVID-19 that are facing the food industry, many of which are increasingly playing out at the state level. As states grapple with so-called “re-opening” of retail establishments, including restaurants and foodservice operators (including retailers offering ready-to-eat foods), some noteworthy trends and insight into requirements and…

The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA:

  1. FDA exercise its statutory authority to establish a regulation under which hemp-derived cannabidiol (CBD) may be legally marketed as a dietary ingredient;
  2. Clarify when a hemp-derived substance is subject to the preclusion provisions of 21

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The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recently released several guidelines for various segments of the food industry to address the COVID-19 pandemic. First, CDC issued Interim Guidance from CDC and the U.S. Department of Labor, Agriculture Workers and Employers (“the Interim Guidance”), which provides recommendations related to COVID-19…

The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food Safety Blueprint (Blueprint), which will outline the agency’s strategy to create “a more digital, traceable, and safer food system” over…

On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public health emergency. The agency’s guidance document is entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment…

On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The agency’s guidance document is entitled “Temporary Policy Regarding Certain Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines” …