Attorney Tracey Topper Gonzalez helps clients engaged in manufacturing, importing, marketing, and distributing cosmetics, OTC drugs, dietary supplements, medical devices, and other FDA-regulated consumer products navigate strict regulatory requirements, anticipate and manage risk, and defend against challenges.
Tracey reviews packaging, labeling, ingredient lists, nutrition facts, marketing/advertising materials, user manuals, websites, and other materials for FDA and FTC compliance. She also assists clients with claim substantiation, 766 reconditioning requests, FDA detentions/refusals, establishment inspections, and other compliance issues. Clients also rely on Tracey to handle FDA registrations and listings and 510(k) premarket notifications, advise on FDA litigation, review and implement CGMPs, draft FDA compliance modules, and ensure compliance with CPSC, EPA, and other federal agency regulations.
In addition, Tracey assists clients with global compliance and exportation of FDA-regulated products. She drafts sales, settlement, licensing, confidentiality, and vendor agreements, and advises on tariff classification, product valuation, country of origin/marking, penalties, protests, and other importation issues. Before joining Epstein Becker Green, Tracey was Of Counsel to one of the nation's largest law firms devoted exclusively to international trade and customs matters. Previously, she clerked for the Honorable Richard K. Eaton of the U.S. Court of International Trade.
- Benjamin N. Cardozo School of Law (J.D., 2003)
- Editor-in-Chief, Cardozo Arts and Entertainment Law Journal
- Dean’s Merit Scholar
- Pennsylvania State University (B.A., 1993)
- New York
- U.S. District Court, Southern District of New York
Professional & Community Involvement
- American Bar Association