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    • FDA Law Alert – September 2020September 10th, 2020

      During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and …

    • Lawsuit Challenges USDA’s BE Labeling RuleAugust 24th, 2020

      On July 27, 2020, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (“Plaintiffs”) filed a complaint against USDA challenging the final “BE labeling rule,” i.e., the final rule implementing …

    • FSIS Petition: Don’t Rush Rulemaking for Labeling of Cell-based Meat and Poultry Products; Respect the First AmendmentAugust 17th, 2020

      On July 23, FSIS acknowledged that it had received a Petition from the Harvard Law School’s Animal Law and Policy Clinic (Harvard or Petitioner) regarding the naming of cell-based or cultured meat and poultry products. Petitioner requests that the Food Safety Inspection Service (FSIS) of …

    • FDA Finds Limited Evidence That Daily Consumption of Certain Cranberry Products Reduces The Risk of Recurrent UTIs in Healthy WomenJuly 28th, 2020

      On July 21, 2020, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consumption of certain cranberry products and a reduced risk of recurrent urinary tract …

    • AMS Publishes Final Guidance related to BE LabelingJuly 20th, 2020

      On July 8, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) published in the Federal Register its notice on the issuance of final guidance to assist regulated entities in complying with the National Bioengineered (BE) Food Disclosure Standard (Standard).  AMS previously …

    • FSIS Denies Petition by Physician’s Committee for Responsible Medicine; No Evidence of Transmission of COVID-19 via Meat and PoultryJuly 17th, 2020

      On May 20, the Physician’s Committee for Responsible Medicine (PCRM) submitted a Petition to FSIS requesting that FSIS require all meat and poultry establishments to test and report on a weekly basis the number of workers and the number of their family members with presumptive …

    • FDA Releases Blueprint For “Smarter Food Safety”July 16th, 2020

      After a few months’ delay caused by the COVID-19 pandemic, FDA released its blueprint for adapting to ongoing and anticipated changes in the food system, titled New Era of Smarter Food Safety: FDA’s Blueprint for the Future.  The blueprint is the result of discussions that …

    • DGAC Draft Report: Like Mom Said, “Eat Your Vegetables!”July 1st, 2020

      The U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) work together to update and release the Dietary Guidelines for Americans (Dietary Guidelines) every five years. (See our post about the 2015 Dietary Guidelines here.)  Each edition of the Dietary Guidelines is intended …

    • ACI’s Food Law – Regulation, Compliance, and Litigation – VIRTUAL ConferenceJune 24th, 2020

      The American Conference Institute (“ACI”) is sponsoring its annual Food Law Conference on July 15, 2020. Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Food Law conference is a unique, …

    • No (Added) Sugar and Yet it is Sweet; Sugar Association Petitions FDA to Require Transparency about Industry’s Use of Alternative SweetenersJune 16th, 2020

      On June 3, 2020, the Sugar Association (SA) filed a Petition with FDA.  The Petition calls on FDA to improve the labeling of alternative sweeteners in the ingredients list on food labels, take steps to address the “particular difficulties raised by the unquantified presence of nonnutritive sweeteners …

    • Tuesdays (and Thursdays) With Regulations.gov BETAJune 11th, 2020

      Anyone who has recently (on Tuesdays and Thursdays at least) tried – and we mean tried – to wander on to www.regulations.gov to do a little FDA docket research has likely been redirected to a new URL: https://outage.regulations.gov/beta-redirect/.  And the first thing you see on …

    • ACI’s Dietary Supplements – Legal, Regulatory & Compliance – VIRTUAL ConferenceJune 2nd, 2020

      The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The virtual conference is scheduled to take place on June 23-24, 2020. This “must-attend” event for legal, regulatory, and compliance stakeholders in …

    • FDA Provides Additional Temporary Flexibility Concerning Labeling of Foods for HumansMay 28th, 2020

      Last week, FDA announced availability of a guidance that would temporarily  provide flexibility regarding certain labeling requirements during (and possibly after) the COVID-19 pandemic. This is the fifth time since the start of the pandemic that FDA announced flexibility regarding labeling regulations for foods.  The temporary …

    • GAO report on Safety of Cell-Cultured Meat; Many Questions About Technology RemainMay 20th, 2020

      The U.S. Government Accountability Office (GAO) released a report titled “Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat.”  This report was requested by Rep. Rosa DeLauro (D-Conn.), and concerns the federal oversight of cell-cultured (or cell-based) meat, …

    • Court Vacates USDA Rule Citing APA ViolationsApril 20th, 2020

      Given the broad deference afforded to federal agencies, it is rare when a court overturns an agency action challenged under the Administrative Procedure Act (APA).  In a recent decision, however, a court found that a regulation issued by the U.S. Department of Agriculture (USDA) violated …