A. Wes Siegner, Jr.
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 controversial products.
Foods and Dietary Supplements
• Helps manufacturers and marketers of conventional foods, medical foods, dietary supplements, and novel food ingredients comply with FDA, FTC, and USDA regulations.
• Identifies and engages independent scientific experts to substantiate product claims.
• Develops strategies for addressing manufacturing problems, including issues related to contamination, bacteria, pesticides, and allergens.
• Provides guidance to manufacturers and marketers of homeopathic drugs.
• Represents clients before the National Organic Program of the USDA.
Animal Drugs and Feeds
• Advises manufacturers of pet food and animal feed on FDA and USDA regulations.
• Advises clients on off-label drug use in veterinary practice.
Advertising and Promotion, FTC
• Provides counsel to clients facing challenges from FTC and competitors, working with the NAD and the ERSP.
Awards & Recognition
• The International Who's Who of Business Lawyers (Life Sciences), 2016
Articles / Publications
• HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent,
see more speaking engagements
• Twelfth Annual Nutrition Law Symposium Plus China Food Law Workshop, October 14, 2016
• CRN/Informa: Fall Regulatory Roundup, Medical Foods, September 14, 2016
• ACC Mountain West Chapter Annual Nutrition Law Symposium, 9/25 Speech: "NY AG Cease & Desist Update & Related Matters", September 25, 2015
• CHPA Market Exchange Conference, 9/16 Presentation at CHPA's Dietary Supplement Committee Meeting, September 16-17, 2014
• Orange County Regulatory Affairs Annual Educational Conference, June 4-5, 2014
see more blog entries
• FDA Rolls Out a New Form—You May Want to Pay Attention to This One,
September 15, 2016j
• FDA Tries New Approach to Removing Marketed Dietary Ingredients; Prepares About-Face on Dietary Ingredient Status of Vinpocetine,
September 7, 2016
• FDA Finalizes Compliance Policy Guide Pet Food Diets Intended for Sick Animals are Drugs but FDA will Exercise Enforcement Discretion under Limited C,
May 5, 2016
• Attorney General Lynch Delivers a Public Service Announcement About DOJ’s Enforcement Actions for Unsafe Dietary Supplements,
March 10, 2016
• Fixing Erroneous FDA Guidance Can Take a Decade – and Persistence,
March 7, 2016