Miriam Guggenheim, co-chair of Covington’s Food, Drug & 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.
As the food industry faces new challenges – including the implementation of the Food Safety Modernization Act (FSMA), numerous new FDA regulations and guidance documents, and increasing consumer fraud litigation – Ms. Guggenheim remains at the forefront of legislative and regulatory changes, and is highly attuned to 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, Ms. Guggenheim 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 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. Ms. Guggenheim 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, Ms. Guggenheim helps clients solve regulatory problems across the globe.