Dietary Supplements and Functional Foods: A Practical Guide to FDA Regulation is a complete guide to the formulation, manufacturing, positioning, labeling and marketing of dietary supplements, conventional foods with functional properties, and medical foods. The Guide helps you navigate and understand the FDA's (and the FTC's) complex regulations. In clear, concise language, it explains the federal requirements, discusses common problem areas, provides case studies and examines current enforcement trends.
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About the Author
Stuart M. Pape is managing partner of the law firm Patton Boggs LLP in Washington, D.C., and a member of the firm's Executive and Management Committees. His primary area of practice is food and drug regulatory issues related to the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture, and similar health and safety regulatory bodies worldwide. Mr. Pape has served in various positions in the Office of the Chief Counsel at the FDA. He is the former Associate Chief Counsel for Food, and from 1978 to 1979, he served as executive assistant to FDA Commissioner Donald Kennedy. He is a frequent speaker on food and drug topics and is the author of numerous articles on food and drug law.
Daniel A. Kracov is a partner in the law firm of Patton Boggs LLP, in Washington, D.C. He concentrates his practice on matters relating to the FDA's regulation of foods, dietary supplements, drugs, biologics and medical devices. His clients include start-up companies, trade associations and large manufacturing companies. He has assisted clients in negotiating the legal requirements relating to the development, approval and marketing of numerous products, from novel dietary supplements to orphan drugs. Mr. Kracov also regularly represents and counsels clients in enforcement and compliance matters, including product-related crises, inspections, investigations, product recalls and litigation. His practice also includes developing regulatory corporate compliance programs and conducting regulatory due diligence investigations for financings, mergers and acquisitions. Mr. Kracov is a frequent speaker and author on topics in food and drug law.
Paul D. Rubin is a partner in the law firm of Patton Boggs LLP in Washington, D.C. His primary area of practice includes food and drug issues subject to regulation by the FDA, U.S. Federal Trade Commission, Consumer Product Safety Commission, U.S. Drug Enforcement Administration, Bureau of Alcohol, Tobacco and Firearms, U.S. Department of Agriculture, and other health and safety regulatory agencies at the federal and state levels. Mr. Rubin is a frequent speaker and author on topics related to food and drug law.
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