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Miriam Guggenheim’s practice focuses primarily on the food and dietary supplement industries. Drawing on her food regulatory expertise, Ms. Guggenheim regularly assists a broad range of major food companies in achieving their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food labeling and advertising. For example, on product development issues, Ms. Guggenheim advises clients regarding the use of food and color additives, GRAS substances, compliance with current Good Manufacturing Practices (cGMPs), and arrangements with suppliers to ensure that source ingredients, including imported materials, are compliant with U.S. laws and regulations. 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 labeling and marketing claims are adequately substantiated. Ms. Guggenheim is particularly experienced in issues relating to food marketing directed toward children. 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.
Ms. Guggenheim often works closely with Covington’s Government Affairs experts to help her clients take advantage of legislative opportunities and manage risks at both the Federal and state levels. She also collaborates with the firm’s product liability and U.S. Customs attorneys to help her clients guard against problems before they arise. 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. She has spoken at seminars across the country on legislative and regulatory developments, particularly on issues relating to food safety and security. Ms. Guggenheim also brings to her food industry work additional perspectives from her significant experience in matters pertaining to the regulation of prescription and over-the-counter drugs.
Representative Matters
- Co-counsel in obtaining FDA approval for the first qualified health claim for a conventional food and first health claim of any kind for a single whole food, regarding the claim that walnuts may help reduce the risk of heart disease.
- Co-counsel to canned tuna industry in successful preemption challenge to California consumer warning requirement.
- Co-counsel to sectors of the food packaging industry in obtaining favorable FDA regulatory clarification relating to the application of Bioterrorism Act requirements to this industry.
Memberships and Affiliations
- Food and Drug Law Institute’s Student Writing Competition Review Committee, Member
Publications and Speeches
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