Claudia Lewis

Claudia A. Lewis counsels clients on matters involving Food and Drug Administration (FDA) regulation, labeling, and marketing of foods, over-the-counter (OTC) drugs, medical devices, and other products. With deep knowledge of dietary supplement labeling regulations, Claudia represents scientists, physicians, nutritionists, healthcare associations, and citizen groups.

She has also aided international clients in establishing a U.S. market for their products. She has prepared and presented constitutional and administrative law cases before the FDA, Federal Trade Commission (FTC), Department of Justice (DOJ), Bureau of Land Management (BLM), and Environmental Protection Agency (EPA).

Claudia represents clients in labeling, import/export of FDA-regulated goods, approval procedures for medical devices, and health claim petitions. She has extensive experience representing leading makers and distributors of dietary and nutritional supplements, homeopathic preparations, medical devices, medical foods, OTC drugs, and cosmetics.

She also counsels on FTC regulations governing advertising on the Internet, on television, in print media, and on the radio; FTC telemarketing regulations; U.S. Department of Agriculture (USDA) regulations governing the use of the term “organic”; and EPA regulations governing pesticides.

Claudia has been recognized as one of the premier attorneys advising on dietary supplement label and labeling regulations and has handled complex civil matters from the administrative complaint stage to the Court of Appeals. She has appeared on several radio programs, discussing such issues as 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), the proposed Current Good Manufacturing Practices (cGMPs), and industry-wide labeling and manufacturing standards for dietary supplements). She also has been quoted in the Vegetarian Times, Natural Pharmacy, and the Tan Sheets.

Experience :

• As co-counsel, negotiated with the FDA to obtain qualified health claims for several nutrient-disease relationships
• As lead counsel, negotiated the reconditioning and release of FDA regulated products detained upon import into the United States
• Negotiated with the FTC and avoided the issuance of a civil investigative demand, on behalf of a national client that manufactures and distributes homeopathic preparations
• As lead counsel, negotiated resolutions with the National Advertising Division (NAD) of the Better Business Bureaus (BBB)

Education :

• J.D. American University, Washington College of Law 1995
• B.A. magna cum laude Howard University 1992

Bar Admissions : Admitted in Connecticut Only; Practice Limited to Matters Before Federal Agencies.

Court Admissions : U.S. Supreme Court

Clerk Experience : Judicial Joint Committee District of Columbia Superior Court 2003

Professional Memberships :

• Served on various councils and committees at the American University Washington College of Law, her alma mater
• Member, American University Washington College of Law, Multicultural Development Committee, which seeks to strengthen minority alumni relations
• Contributing editor, The Almanac of the Executive Branch, 2001