Miriam J Guggenheim

Miriam Guggenheim assists a broad range of major food 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. Ms. Guggenheim counsels clients in all aspects of food development and marketing, from product ingredient, formulation, sourcing and manufacturing considerations to food labeling and advertising. On product development issues, she advises clients regarding the use of food and color additives and GRAS substances, and arrangements with suppliers to ensure that source ingredients, including imported materials, are compliant with US laws and regulations. She is an expert on the new Food Safety Modernization Act (FSMA) and helped her clients successfully influence the implementation of that major legislation. Regarding labeling and advertising, Ms. Guggenheim assists her clients in conveying 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. She also advises clients regarding the most advantageous regulatory categories for the marketing of their products – whether as conventional foods, dietary supplements, or medical foods. In addition to her work for individual clients, Ms. Guggenheim serves as outside counsel to a number of major trade associations to help them achieve broad industry goals. REPRESENTATIVE MATTERS Counseled numerous clients through recalls and market withdrawals, including on a global scale, to minimize business disruption, cost, and damage to brands. 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 and gave a number of presentations regarding FSMA, its potential implications, and its effect on FDA’s current inspection and enforcement activities. Prepared comments to FDA to help shape proposed rules. Provided regulatory advice and due diligence on a multi-billion-dollar acquisition of a major dietary supplement company. Advised a number of clients on whether reports to FDA’s new Reportable Food Registry are required in particular circumstances. Secured the release of imports from FDA holds in a timely manner to preserve the marketability of the food products, including perishable goods. More Representative Matters HONORS AND RANKINGS Chambers USA - America's Leading Business Lawyers, Food & Beverages: Regulatory & Litigation (2012)