Claudia Lewis, co-chair of Venable’s FDA Group, counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. She has deep knowledge of dietary supplement labeling regulations and represents scientists, physicians, nutritionists, healthcare associations, and citizen groups. She has also assisted international clients in establishing a U.S. market for their products.
Regulatory & Litigation Experience
Claudia has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA). She represents clients in matters involving labeling, import and export of FDA-regulated goods, approval procedures for medical devices, and health claim petitions.
Industry Focus
She has extensive experience representing leading manufacturers and distributors of dietary and nutritional supplements, homeopathic preparations, medical devices, medical foods, OTC drugs, and cosmetics. Claudia also advises clients on FTC regulations governing advertising on the Internet, television, print media, and radio; FTC telemarketing regulations; U.S. Department of Agriculture (USDA) regulations governing the use of the term “organic”; and EPA regulations governing pesticides.
Recognition & Thought Leadership
Claudia has been recognized as one of the premier attorneys advising on dietary supplement label and labeling regulations and has handled complex civil matters from the administrative complaint stage through the Court of Appeals. She has appeared on several radio programs discussing issues such as the impact of Pearson v. Shalala (labeling standards for disease or health-related claims of dietary supplements), FTC advertising regulations, Senate Bill 722 (increased regulatory oversight of dietary supplements), proposed Current Good Manufacturing Practices (cGMPs), and industry-wide labeling and manufacturing standards for dietary supplements. She has also been quoted in Vegetarian Times, Natural Pharmacy, and The Tan Sheets.
Related Practices
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