Sarah A. Gaskell

Sarah Gaskell advises food, dietary supplement, cosmetic, drug, and medical device companies on FDA (U.S. Food and Drug Administration) regulatory, transactional, and compliance matters across the product life cycle, with a particular focus on helping food and dietary supplement manufacturers bring products to market and maintain compliance after launch. She counsels clients on FDA requirements for product development, labeling, advertising and promotion, good manufacturing practices, recalls, inspections, and enforcement actions.

Sarah's FDA practice includes advising on regulatory issues affecting conventional foods, dietary supplements, and other consumer products, including product classification, permissible claims, labeling compliance, manufacturing and quality obligations, and responses to agency scrutiny. She helps clients evaluate whether marketing, labeling, and promotional materials raise FDA or related compliance concerns, including issues involving product claims, substantiation, and the line between permitted structure/function claims and disease claims.

Sarah also provides regulatory due diligence and transactional support for life sciences and health care transactions, including matters involving FDA-regulated products and companies. Her experience includes advising clients on compliance risks in M&A and strategic transactions, as well as supporting health care clients in transactions involving physician practices, hospice providers, private equity investments, management services arrangements, and related professional, management, and administrative services structures.

In addition to her FDA and food regulatory work, Sarah counsels clients on clinical research, direct-to-consumer telemedicine, licensure, patient consent, remote supervision, and corporate practice of medicine issues.

Sarah is a member of the Food and Drug Law Institute (FDLI) and the American Health Lawyers Association (AHLA). She serves on the Outside Advisory Board of the Resnick Center for Food Law and Policy and is a member of FDLI's Austern Writing Awards Committee.