Tag: FDA

  • GAO Issues Report on Seafood Imports

    The U.S. Government Accountability Office (GAO) has issued “Imported Seafood Safety: FDA Should Improve Monitoring of Its Warning Letter Process and Better Assess Its Effectiveness,” finding that the U.S. Food and Drug Administration (FDA) was inconsistent in following key procedures and meeting goals for monitoring the importation of seafood. The report’s recommendation is that FDA…

  • FDA Announces Investigation into Real Water

    The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the filing of several lawsuits alleging harm to consumers of the water, including children. The agency announced that Real Water was not cooperating…

  • A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens

    By Associate Anna El-Zein & Of Counsel John Johnson III Recent actions by the U.S. Food and Drug Administration (FDA) suggest that, in 2021, the Agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare the presence of major food allergens. In a series of high-profile warning letters and press releases,…

  • FDA Announces Actions on Metals in Baby Food

    The U.S. Food and Drug Administration (FDA) has responded to the House report on levels of heavy metals in baby food with the promise of additional action. The FDA statement notes, “First, today we issued a letter to industry reminding manufacturers of these types of foods of their existing responsibilities related to these efforts. Secondly,…

  • USDA, FDA Issue Joint Statement on Transmissibility of COVID-19 on Food Packaging

    The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have issued a joint statement stating that “there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19.” The statement was issued…

  • FDA Responds to Baby Foods Congressional Reports as Class Actions Are Filed

    The U.S. Food and Drug Administration (FDA) has issued a constituent update responding to the Senate’s report on elevated levels of heavy metals in baby foods. “While the report released on February 4, 2021 by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy raises important questions on…

  • Shook Attorneys Detail Honey Litigation for Law360

    Shook Partner Jim Muehlberger and Of Counsel John Johnson III have authored an article for Law360 detailing litigation targeting honey producers. “Honey producers have sometimes been accused of diluting their product with syrup,” they explain. “They have also faced many other accusations, including that their honey contains contaminants, that it lacks some key quality characteristic, or that its country of origin has…

  • Genetically Engineered Pigs Approved for Food Use

    The U.S. Food and Drug Administration (FDA) has announced the approval of GalSafe pigs, which have a “first-of-its-kind intentional genomic alteration (IGA),” for use in food. “This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses,” the announcement states. “The…