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Miriam Guggenheim, co-chair of Covington’s Food, Drug and Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Ms. Guggenheim serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and Congress. In recent years, Ms. Guggenheim has advised clients extensively regarding the federal and state legal landscapes surrounding the development and marketing of products containing cannabidiol (CBD). Chambers USA notes, Ms. Guggenheim is "incredibly sharp and very responsive" and a client reports, "I rely on Miriam tremendously to help me find ways forward in difficult and novel situations, and she never fails to deliver."

  • Counseled numerous clients through recalls and market withdrawals, including on a global scale, to minimize business disruption, cost, and damage to brands.
  • Prepared 50-state surveys regarding the legal landscape surrounding the development and marketing of CBD products.
  • Provided strategic counseling to food and dietary supplement companies receiving warning letters from FDA, and drafted responses to such letters that succeeded in averting further enforcement action.
  • Provided regulatory and public health policy guidance regarding the development of a number of new food and dietary supplement products, from formulation to labeling, marketing, and website design.
  • Counseled clients regarding California Proposition 65 warnings and supply chain considerations.
  • Advised clients on bioengineering labeling and claims, including with respect to regulatory compliance and consumer fraud litigation risks.
  • Provided regulatory advice and due diligence on a multi-billion-dollar acquisition of a major dietary supplement company, and on many other mergers and acquisitions in the food and dietary supplement sectors.
  • Prepared submissions to FDA, the U.S. Congress, and local legislative bodies that documented the safety of caffeine in food and beverages and helped stave off restrictions on caffeinated products.
  • Provided strategic regulatory support in numerous food litigation matters.
  • Drafted influential amicus brief in FTC contempt proceeding against a major dietary supplement marketer.
  • Successfully petitioned FDA for an exemption from the new Food Safety Modernization Act (FSMA) hazard analysis and preventive controls requirements for most warehouses and distribution facilities.
  • Advised clients regarding issues relating to marketing to children and prepared responses to FTC and CARU inquiries regarding such marketing.
  • Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2012-2020)
  • Best Lawyers in America, FDA Law (2016-2020)
  • Washington DC Super Lawyers, FDA (2014-2020)