Based in Washington D.C., the Law Office of Bayne & Associates specializes in food, drug, medical device, and cosmetic law, with a special focus on matters concerning the regulation of conventional foods, medical foods, dietary supplements, and botanical products by the U.S. Food and Drug Administration, Federal Trade Commission, U.S. Department of Agriculture, U.S. Customs and Border Protection, and other federal and state regulatory agencies.
The firm was founded in 2001 by Holly Bayne, who brings a unique blend of industry and marketing experience to the practice of law. The firm's goal is to offer companies engaged in the development, manufacture, sale, and marketing of FDA-regulated products a seasoned and practical approach to regulatory compliance in a highly-competitive marketplace and rapidly evolving digital age. The firm routinely advises companies on a wide range of issues, including the regulatory status of ingredients, GRAS conclusions, new dietary ingredient (NDI) notifications, labeling, advertising and promotional activities, claim substantiation, cGMP compliance, inspections, food safety, product recalls, FSMA compliance, and related areas. The firm also provides business and strategic planning advice for companies engaged in the sale and marketing of FDA-regulated products, including drafting and negotiating manufacturing, supply, licensing and clinical trial agreements, scientific expert consultation, and litigation support, among other areas.
