Tag: FDA

  • FDA, USDA Could Improve Cell-Cultured Meat Cooperation, GAO Finds

    The U.S. Government Accountability Office (GAO) has publicly released its April 2020 report on the partnership between the Food and Drug Administration (FDA) and Department of Agriculture (USDA) on the development of cell-cultured meat. GAO indicated that it began the inquiry after some stakeholders “expressed concern about the agencies’ oversight of cell-cultured meat amidst a…

  • What the FDA Requires for Food Safety During the COVID-19 Pandemic

    By Shook Of Counsel John Johnson The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged during the COVID-19 outbreak. However, COVID-19 is disrupting plant operations and supply-chains, which companies must be mindful of as they continue to function within the regulatory requirements: Food safety remains…

  • FDA Warns CBD Sellers for COVID-19 Claims

    The U.S. Food and Drug Administration has urged several sellers of products with cannabidiol (CBD) to stop marketing their products as able to treat or prevent COVID-19. The letters, sent by the Center for Drug Evaluation and Research (CDER), emphasize that “FDA is taking urgent measures to protect consumers from certain products that, without approval…

  • FDA Warning Letters Provide Opportunity for Food-Safety Reminders During Viral and Bacterial Outbreaks

    By Partner Lindsey Heinz and Associate Zac Parker The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John’s Franchise, LLC and its supplier Sprouts Unlimited Inc. regarding food safety practices after the agency traced an outbreak of E. coli to Jimmy John’s produce, which had previously caused outbreaks of foodborne illnesses. In the…

  • FDA Releases Guidance on Intentional Adulteration

    The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional adulteration of food under the Food Safety Modernization Act. The guidance focuses on food defense corrective actions, food defense verification, reanalysis and recordkeeping. The rule applies to domestic and foreign companies required to register with…

  • FDA Closes Production Facility After Violations

    A U.S. federal court entered a consent decree of permanent injunction prohibiting Home Style Foods, Inc., and its owner and quality manager from selling food products until the company complies with federal regulations. U.S. Food and Drug Administration (FDA) inspections reportedly found Listeria monocytogenes in the company’s food preparation area and documented violations of seafood…

  • No Agreement on Definitions of “Meat” and “Dairy”

    The dispute over the meaning of meat- and dairy-related terms continued in 2019, with more states passing bans on the use of terms implying animal-derived products, such as “burger” or “milk,” to describe plant-based products. Nebraska, Arizona and Washington considered bans, and Arkansas’ ban was targeted with a challenge from Tofurky that has resulted in…

  • Senate Confirms FDA Commissioner

    The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in radiation oncology, reportedly promised to prioritize science, data and public health over political interests when directing the agency’s policy.