SharePrinter-friendly versionSend by emailA TitleA TitleA Title A A A Marsha C. Wertzberger TabsetOverviewBar & Court Admission Bar & Court Admissions District of Columbia Bar Maryland Bar Education Georgetown University Law Center, JD, Philadelphia College of Pharmacy and Science, BS, University of Kansas, BA, Marsha C. WertzbergerCounselWashington, DC T 202.857.6122 E marsha.wertzberger@arentfox.com Download vCard Marsha practices in the areas of food and drug law and biotechnology, with a focus on regulatory and enforcement matters, advertising and marketing issues, and product development. Client Work Marsha specializes in regulatory and enforcement issues involving foods, dietary supplements, drugs, and cosmetics, including a variety of products derived from bioengineered crops. She also advises on related advertising and marketing issues, including e-commerce matters. In addition, Marsha focuses on product development, including assisting clients with regulatory strategies for positioning products and ensuring that safety and claims substantiation testing will support the safety and efficacy of the product. She also assists companies in preparing regulatory submissions to the FDA, including New Drug Applications, 510(k) Notifications, and food additive petitions, and Generally Recognized as Safe (GRAS) Notifications. Marsha also works with companies to develop safety and claims substantiation testing packages. Finally, she advises companies who are responding to enforcement actions by FDA and FTC. Previous Work Before joining Arent Fox, Marsha was a partner with the law firm of McKenna & Cuneo. Previously, she was vice president-international and associate general counsel for the Cosmetic, Toiletry and Fragrance Association (CTFA), where she won the American Society of Association Executive's Gold Circle Award for developing CTFA's highly successful Anticounterfeiting Program. Prior to working for CTFA, Marsha served seven years in the Office of General Counsel of the US Food and Drug Administration. She was counsel to the Center for Food Safety and Applied Nutrition and, before that, counsel to the Over-the-Counter Drug Division in the Center for Drugs and Biologics. She twice received FDA's Award of Merit for food matters and also received the Commissioner's Special Citation for her work with OTC Drugs. Before attending law school, Marsha worked as an economic and market research analyst and professional education writer for Merck, Sharp and Dohme in West Point, Pennsylvania. Professional Activities Marsha is active in mentoring activities within the firm and is a founding member of the women in food and drug law group of the Food and Drug Law Institute. The group was established to promote mentoring, networking and marketing skills for women in all phases of regulatory activities in FDA-regulated industries. Publications, Presentations and Recognitions Marsha is the author of two notable publications: “Patient Package Inserts: Informed Consent to Drug Therapy?,” Georgetown Law Journal; 1978 (Vol. 66, p. 837) “Completing the OTC Process,” Food and Drug Law Journal; 1980 (Vol. 35, p. 698) Newsroom Date Type Title 8 / 30 / 2007 Alert Food and Drug Administration Proposes New Rule Governing Sunscreens 9 / 1 / 2006 Alert FDA Proposes to Ban OTC Hydroquinone Skin Bleaching Products 12 / 15 / 2004 Alert FDA Issues Final Food Recordkeeping Rule under the Bioterrorism Act 12 / 9 / 2004 Alert FDA Announces New Dietary Supplement Initiatives 11 / 12 / 2004 Alert Pharmaceutical and Medical Device Companies Required to Adopt Corporate Compliance Programs by July 1, 2005 1 / 18 / 2002 Alert New FDA Requirements for Foreign Drug and Device Establishments
