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Brian P. Sylvester advises global brands, leading start-ups, and trade associations on complex and novel FDA and USDA regulatory matters, drawing on more than a decade of experience in private practice and at USDA.

Brian advises food, dietary supplement, cosmetic, OTC drug, veterinary pharmaceutical, and animal feed clients on a broad range of regulatory, legislative, and compliance issues before FDA, USDA, and analogous food and drug regulatory bodies. His practice spans enforcement actions, audits and investigations, regulatory compliance, advertising, import/export, due diligence, consumer litigation, comment preparation, public policy advocacy at the federal and state levels, and new product development.

Brian has specific expertise in developing regulatory strategies to commercialize a range of food tech innovations, including transgenic crops and alternative proteins, among others. Leveraging his experience as a regulator at USDA, Brian counsels clients on strategic considerations around engagement with and advocacy before USDA and FDA on numerous complex issues, including those of first impression. He is a prolific author and frequent speaker at industry-leading events in the U.S. and around the world, and is regularly called upon to offer insights on trending legal issues by leading industry publications.

Brian has written and spoken extensively on the evolving regulatory framework for commercializing alternative proteins. Working with a number of the world's leading alternative protein stakeholders -- including start-ups, established food and life science companies, and trade associations -- he applies his deep substantive knowledge and key relationships at the FDA, USDA and on Capitol Hill to shape federal and state policies and legislation on issues such as labeling and manufacturing requirements. Outside the U.S., Brian partners with his Covington colleagues in international offices to assist clients with commercializing alternative proteins, and a range of other highly regulated products, in multiple jurisdictions around the world.

On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the redesign “transformative” and believes the