Samantha advises clients on wide-ranging issues regarding the laws and regulations enforced by the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), and related federal and state agencies. As a former FDA attorney, Samantha brings valuable insight regarding regulatory compliance matters and FDA enforcement actions. She works collaboratively with clients to help them achieve their goals while evaluating potential risks from both regulatory enforcement and private challenge perspectives.
Samantha counsels clients throughout a product’s life-cycle, including all aspects of developing, manufacturing, labeling, marketing, and advertising foods, dietary supplements, cosmetics, OTC and prescription drug products, and medical devices. She has also advised clients on their interactions with FDA, including in response to inspectional observations and Warning letters, engaging with state and local authorities, navigating consumer demand letters, and drafting trade complaints. In addition, Samantha has extensive experience advising on promotional claims and claim substantiation, and has represented clients in advertising disputes before the National Advertising Division of the Council of Better Business Bureaus, Inc.
Prior to joining Kleinfeld, Kaplan & Becker, Samantha served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA where she handled enforcement matters across all product areas and litigated challenges to agency actions on issues ranging from drug exclusivity and tobacco product policies to emergency use authorizations. In this role, Samantha worked closely with the U.S. Department of Justice and was responsible for advising senior agency officials on case strategy, implications for agency policy development, and settlement negotiations.
Samantha also previously served in the Office of the General Counsel at the U.S. Department of Health & Human Services (HHS) where she advised various HHS components including the Office of Research Integrity and the National Vaccine Program Office. Prior to her government tenure, Samantha worked as a patent litigator at two international law firms.