Wes Siegner provides counsel on FDA and FTC regulation of foods and dietary supplements, OTC drugs and cosmetics, devices, and animal drugs and feeds. Since joining the firm in 1986, Mr. Siegner has worked in all areas of FDA regulatory practice. His work encompasses a wide range of regulatory matters including product labeling, advertising and promotion, and FDA, FTC and USDA enforcement actions. Recently, he has focused on foods, dietary supplements, and OTC drugs, helping to pioneer and defend novel products in the dietary supplement, medical food, and homeopathic drug industries. Mr. Siegner has worked extensively in the rapidly expanding area of organic food regulation, representing clients before the National Organic Program of the USDA.
Mr. Siegner’s background in biology facilitates his work with scientists to substantiate and defend product health claims. He advises clients on responding to challenges from FTC and competitors, working with the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). Mr. Siegner also provides guidance on food hazard analysis and critical control points, as well as dietary supplement GMPs and manufacturing problems, which range from contamination and allergen issues, to equipment malfunctions.
In addition to providing counsel to clients, Mr. Siegner advocates on behalf of the industry on federal and state regulation of dietary supplements. He participated in congressional debates leading up to the 1994 Dietary Supplement Health and Education Act (DSHEA). Mr. Siegner regularly works with lobbyists on FDA, FTC, and USDA-related matters before Congress and state legislature. He has helped companies form trade associations in order to present a unified industry voice on regulatory and public health issues. As part of these efforts, he has testified in legislative hearings and has served as the public relations spokesperson on Nat’l news programs for