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Miriam J. Guggenheim

Partner

Washington +1 202 662 5235

  • About
  • Representative Matters
  • Credentials
  • About

    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, Miriam 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, Miriam has advised clients extensively regarding the federal and state legal landscapes surrounding the development and marketing of products containing cannabidiol (CBD). Chambers USA notes, Miriam 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."

    As the food industry faces new challenges – including the implementation of FSMA, new food labeling requirements including bioengineering disclosures and updates to Nutrition Facts, “clean label” and consumer transparency trends, and increasing consumer fraud litigation and Prop 65 demand letters – Miriam remains at the forefront of legislative and regulatory changes and food policy and litigation trends. She draws on this deep knowledge and insight to advise clients on all aspects of food development and marketing, from product ingredient sourcing and manufacturing considerations to food labeling and marketing.

    For example, Miriam helps clients develop policies and procedures to implement new FSMA requirements, and advises clients in determining whether food ingredients are generally recognized as safe (GRAS) or whether dietary ingredients require new dietary ingredient (NDI) notifications to FDA. She helps many clients convey the health benefits of their products, including by successfully petitioning the FDA for approval of a number of health claims, and helps ensure that marketing claims are appropriately phrased and adequately substantiated. Miriam also advises clients regarding the most advantageous regulatory categories for the marketing of their products – whether as conventional foods, dietary supplements, or medical foods. Partnering with Covington colleagues in international offices, Miriam helps clients solve regulatory problems across the globe.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • 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.

    Areas of Expertise

  • Credentials
    Education
    • Columbia Law School, J.D., 1996
        • Harlan Fiske Stone Scholar
    • University of Pennsylvania, B.A., 1992
        • magna cum laude
        • Benjamin Franklin Scholar
        • Phi Beta Kappa
    Bar Admissions
    • District of Columbia
    • New York
    Judicial Clerkship
    • Hon. Clarkson S. Fisher, U.S. District Court, District of New Jersey, 1996 - 1997
    Accolades
    • Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2012-2023)
    • Best Lawyers in America, FDA Law (2016-2021)
    • Washington DC Super Lawyers, FDA (2014-2020)

    Areas of Expertise

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