Ms. Lewis-Eng represents numerous clients in the areas of FDA regulations governing foods, dietary supplements, over-the-counter drugs, homeopathic preparations, medical foods, medical devices and importation/exportation of FDA regulated goods; FTC regulations governing advertising appearing on the Internet, television, print media and radio; FTC telemarketing regulations; USDA regulations governing the use of the term "organic"; and EPA regulations governing pesticides. Ms. Lewis-Eng also represents scientists, physicians, nutritionists, health care associations, and citizens groups. Furthermore, she has a number of international clients who she has assisted in establishing a U.S. market for their products.
Ms. Lewis-Eng has also appeared and prepared constitutional and administrative law cases before the Food and Drug Administration, the Federal Trade Commission, the Department of Justice, the Bureau of Land Management, and the Environmental Protection Agency.
Ms. Lewis-Eng has been recognized as one of the premier attorneys on dietary supplement label and labeling regulations and has handled complex civil matters from the administrative complaint stage to the Court of Appeals. Her experience in these fields has been in various radio talk shows, where Ms. Lewis-Eng was asked to discuss issues ranging from the impact of Pearson v. Shalala (labeling standards for disease or health-related claims of dietary supplements), FTC advertising regulations, and Senate Bill 722 (increased regulatory oversight of dietary supplements) to the proposed cGMPs (industry-wide labeling and manufacturing standards for dietary supplements). She has also been quoted in the Vegetarian Times, Natural Pharmacy and the Tan Sheets.
Significant Matters
Ms. Lewis-Eng's recent significant matters include:
· As co-counsel, Ms. Lewis-Eng successfully negotiated with FDA to obtain qualified health claims for several nutrient-disease relationships.
· As lead counsel, Ms. Lewis-Eng successfully negotiated the reconditioning and release of FDA regulated products detained upon import into the United States. As lead counsel, Ms. Lewis-Eng successfully negotiated settlements with FTC in the area of deceptive advertisement.
· For a national client that manufacturers and distributes homeopathic preparations, she successfully negotiated with FTC and avoided the issuance of Civil Investigative Demand.
· As lead counsel, Ms. Lewis-Eng has successfully negotiated resolutions with the National Advertising Division of the Better Business Bureaus.
Activities
Ms. Lewis-Eng has served on various councils and committees at the Washington College of Law. Most recently, she is a member of Multicultural Development Committee, which seeks to strengthen minority alumni relations. Ms. Lewis-Eng was also a contributing editor on the 2001 edition of The Almanac of the Executive Branch.
Industries
Consumer Products and Services
Drugs, Medical Devices and Biologics
Dietary Supplements, Cosmetics and Functional Foods
Life Sciences
Judicial Clerkships
Judicial Joint Committee, District of Columbia Superior Court, 2003
News
May 16, 2011, Claudia Lewis-Eng quoted in Law360 article on proposed food marketing guidelines
February 22, 2010, Claudia Lewis-Eng quoted extensively in Advertising Age celebrity diets article
September 20, 2005, Key Regulatory Attorney Claudia Lewis-Eng Joins Venable's Food and Drug Group
Honors
Legislative Intern, Office of United States Senator Riegle (D-MI), Fall 1992
Publications
Ms. Lewis-Eng has written numerous articles on medical foods, pharmacy compounding and FDA regulation of structure function claims.
February 2012, Food & Drug Law Update - February 2012
Todd A. Harrison, Claudia A. Lewis-Eng, Ilene Ringel Heller
Client Alerts
August 18, 2011, Advertising News & Analysis - August 18, 2011
Jeffrey D. Knowles, Gary D. Hailey, Meaghan Hemmings Kent, Claudia A. Lewis-Eng, Melissa Landau Steinman
Advertising Alert
August 4, 2011, Advertising News & Analysis - August 4, 2011
Gary D. Hailey, Jeffrey D. Knowles, Roger A. Colaizzi, Todd R. Farnsworth, Claudia A. Lewis-Eng, Elissa Brockbank Reese, Janet F. Satterthwaite
Advertising Alert
July 2011, FDA's NDI Guidance Will Impact About 90% of the Dietary Supplement Industry
Todd A. Harrison, Claudia A. Lewis-Eng, Michelle C. Jackson
Client Alerts
September 13, 2009, Practical Pointers on Advertising Healthcare Products
Claudia A. Lewis-Eng
May 4, 2009, "Consumer Protection Update" to the ABA Antitrust Section, Consumer Protection Committee
Claudia A. Lewis-Eng, Andrew E. Bigart
April 2007, Consumer Products Regulatory Report, Q1 2007
Claudia A. Lewis-Eng, Todd A. Harrison, Michelle C. Jackson
July 2006, Consumer Products Regulatory Report, July 2006
Todd A. Harrison, Claudia A. Lewis-Eng
March 2006, Consumer Products Regulatory Report, March 2006
Todd A. Harrison, Claudia A. Lewis-Eng
1996, Co-author, Comprehensive Legal Guide for Physicians
Claudia A. Lewis-Eng
Events/Speaking Engagements
Past Events
March 28, 2012, "Fundamentals - Consumer Protection," American Bar Association's Antitrust Law 2012 Spring Meeting
Claudia A. Lewis-Eng
March 21, 2012, "A Deep Dive into Food and Beverage Claim Substantiation," American Conference Institute's Food & Beverage Marketing & Advertising Conference
Claudia A. Lewis-Eng
December 12, 2011, "Determining Whether a New Dietary Ingredient Notification is Necessary" at FDLI's New Dietary Ingredient Regulation and Compliance Workshop
Claudia A. Lewis-Eng
December 1, 2011, "Defending Food & Beverage Consumer Fraud Litigation" for the American Conference Institute
Claudia A. Lewis-Eng
November 15, 2011 - November 16, 2011, PMA's 33rd Annual Marketing Law Conference
Roger A. Colaizzi, Claudia A. Lewis-Eng, Melissa Landau Steinman
July 28, 2011, "Drug Manufacturing in a New Era of Safety" for BPSA International Single-Use Summit
Claudia A. Lewis-Eng
May 3, 2011 - May 5, 2011, Response Expo 2011
Jeffrey D. Knowles, Ellen Traupman Berge, Roger A. Colaizzi, Gary D. Hailey, Todd A. Harrison, Claudia A. Lewis-Eng, David C. Meyer, Ari N. Rothman, Joe A. Shull,Bret P. Siciliano
March 31, 2011 - April 1, 2011, ACI's Food & Beverage Marketing & Advertising Conference
Todd A. Harrison, Claudia A. Lewis-Eng
March 12, 2011, Natural Products Expo West 2011
Todd A. Harrison, Claudia A. Lewis-Eng
March 10, 2011, "Product Development: Regulatory Roundtable - Focus on Immunity Claims" at the NutraCon 2011 Conference
Claudia A. Lewis-Eng
February 28, 2011 - March 2, 2011, ERA's Great Ideas Summit
Jeffrey D. Knowles, Gary D. Hailey, Claudia A. Lewis-Eng, Todd A. Harrison, Roger A. Colaizzi, Ellen Traupman Berge, Mikhia E. Hawkins
February 17, 2011, "Beyond Mere Nutrition: Ethical Considerations in the Labeling of Biologically Active Foods" at the ABA Section of Litigation and Food Supplements First Annual Workshop
Claudia A. Lewis-Eng
January 27, 2011, "Dietary Supplements 2011: What to Expect Inside the Beltway and Beyond," Food and Drug Law Institute Food Week
Claudia A. Lewis-Eng
December 13, 2010, "November 2010 Consumer Protection Update," ABA Section of Antitrust Law's Consumer Protection, Private Advertising Litigation, and Corporate Counseling Committees
Todd A. Harrison, Claudia A. Lewis-Eng, Michelle C. Jackson
November 19, 2010, PMA's 32nd Annual Marketing Law Conference
Melissa Landau Steinman, Claudia A. Lewis-Eng
September 13, 2009, "The Ins and Outs of FTC's Policies on Advertising and Promotion of Healthcare Products" at the RAPS APL Conference
Claudia A. Lewis-Eng
May 4, 2009, "Consumer Protection Update" at the ABA Antitrust Section, Consumer Protection Committee Meeting
Claudia A. Lewis-Eng, Andrew E. Bigart
March 11, 2009, Cosmetics Marketing: Counseling and Crisis Management Lunch Briefing and Webinar
Sharon A. Blinkoff, Claudia A. Lewis-Eng
December 16, 2008, Lisa Jose Fales and Claudia Lewis-Eng provided an FTC/FDA seminar to Univision's legal department
Lisa Jose Fales, Claudia A. Lewis-Eng
December 10, 2008, Bringing New Ingredients to Market: FDA Guidance and Developments in the New Dietary Ingredient Notification Process
Claudia A. Lewis-Eng
September 9, 2008 - September 11, 2008, 2008 Health and Beauty America Global Expo and Educational Conference
Claudia A. Lewis-Eng, Sharon A. Blinkoff
October 17, 2007, ABA Section of Litigation Teleconference
Claudia A. Lewis-Eng
September 18, 2006, Monitoring Your Distributors: Practical Advice on Implementing a Compliance Plan
Claudia A. Lewis-Eng