September 20, 2005

Key Regulatory Attorney Claudia Lewis-Eng Joins Venable’s Food and Drug Group

4 min

WASHINGTON, D.C. (September 20, 2005) – Venable LLP adds another key member to its growing food and drug practice.  Claudia Lewis-Eng becomes a partner with Venable’s D.C. office, joining from Emord & Associates, P.C. in Washington, where she was a principal.

Ms. Lewis-Eng has helped clients navigate the complex and evolving regulatory framework imposed by the FDA and the FTC for the last 10 years.  She has extensive experience representing leading makers and distributors of dietary and nutritional supplements, homeopathic preparations, medical devices, medical foods, foods, over-the-counter drugs, and cosmetics in connection with labeling issues, importation/exportation questions, approval procedures for medical devices, and health claim petitions.

“Given the dual nature of my work, Venable is a perfect fit for me – the firm has one of the best advertising practices in the country,” explained Ms. Lewis-Eng.  “Its principal strengths run across both the FTC and FDA practices – no other firm, in my opinion, has the strength and depth of Venable's platform.  Using this platform, I want to help build one of the country’s premier dietary supplement practices.” 

Ms. Lewis-Eng continued, “My clients can also now benefit from additional Venable experience in key areas like corporate, intellectual property, legislative, and employment, in addition to supporting their advertising and direct marketing needs.  A number of my clients are members of the Electronic Retailing Association, which has just named Venable partner Jeffrey D. Knowles as its chair.  Knowing of Venable’s preeminence in the FTC and FDA areas, my clients are simply thrilled about the breadth and depth of the firm.”

Her current clients include Schiff Nutrition International (formerly known as Weider Nutrition International), one of the country’s leading manufacturers of vitamins and nutritional supplements; AdvoCare, a direct marketer of nutritional and skin care products; and BAQ Enterprises, which makes a device to help patients with chronic obstructive pulmonary disease breathe easier.

Ms. Lewis-Eng’s recent achievements include making a historical-use defense to overcome claimed violations of the FTC’s substantiation requirements for a client’s traditional homeopathic product and obtaining FDA approval for a client’s cosmetic medical device without a 510(k) (pre-market notification) by convincing the FDA that the product fit within a category of its already approved devices.  In addition, she has helped many supplement manufacturers avoid agency review of their products as drugs, a key land mine flowing from strong product claims.

In the FTC arena, she has significant experience helping clients comply with the Do-Not-Call Registry, Telemarketing Sales Rule, and the regulations governing deceptive advertising in all forms of media, as well as negotiating with the agency on behalf of clients accused of overstepping its many requirements.

“Claudia’s broad-based knowledge makes her a tremendous asset to Venable’s regulatory practices,” said David G. Adams, the former Associate Chief Counsel and Policy Staff Director at the FDA who now chairs Venable’s Food and Drug Group.  “She is familiar with many of our clients’ industries and their regulatory challenges.  Among other things, she is highly experienced in both FDA and FTC regulation of labeling and promotion.  Her skill set is a natural complement to our advertising/marketing, consumer products and health care practices.”

Mr. Adams further notes that Ms. Lewis-Eng’s substantial litigation experience is invaluable in the strategic counseling that is necessary to help clients avoid the regulatory pitfalls that may lead down a path towards enforcement litigation.

Ms. Lewis-Eng frequently speaks and writes about constitutional and administrative law topics.  She has commented on Senate Bill 722 (seeking increased regulatory oversight of dietary supplements) and cGMPs (industry-wide labeling and manufacturing standards for supplements).  She also has authored numerous articles about the impact of Pearson v. Shalala (labeling standards for disease or health-related claims of supplements), a case on which she worked alongside former colleague Todd A. Harrison, now a Venable food and drug partner.

Ms. Lewis-Eng earned her J.D., cum laude, from The American University, Washington College of Law (1995) and her B.A., magna cum laude, in Political Science from Howard University (1992), where she was inducted into Pi Sigma Alpha and the Golden Key National Honor Society.

One of the American Lawyer’s top 100 law firms, Venable LLP has attorneys practicing in all areas of corporate and business law, complex litigation, intellectual property and government affairs. Venable serves corporate, institutional, governmental, nonprofit and individual clients throughout the U.S. and around the world from its headquarters in Washington, D.C. and offices in California, Maryland, New York and Virginia.