Brian Sylvester

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Brian P. Sylvester

Covington & Burling, LLP - Washington, D.C.

Washington, DC

(202) 662-5988

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Brian P. Sylvester 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, shaping policy at the federal and state levels, and new product development.

Mr. Sylvester has specific expertise in developing regulatory strategies to commercialize alternative proteins using plant, microbial and animal cell-based technologies. Drawing on his tenure as a regulatory lawyer with USDA, Mr. Sylvester has particular experience counseling clients on strategic considerations around engagement with and advocacy before USDA and FDA on a range of 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 publications such as The Wall Street Journal, Forbes, and Food Navigator-USA, among others.

Mr. Sylvester 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., Mr. Sylvester 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.

Representative Matters

Advise corporations and industry trade associations on strategies to shape federal and state policies and legislation.
Provide strategic regulatory counsel to facilitate new product development for foods, dietary supplements, OTC drugs, and cosmetic products.
Craft and execute carefully tailored regulatory strategies focused on the use of synthetic biology with respect to FDA and USDA oversight, from R&D and premarket clearance through manufacturing, advertising, and labeling.
Advise companies on developing successful regulatory strategies for commercializing alternative proteins using plant, microbial and animal cell-based technologies.
Obtained favorable rulings from the USDA FSIS prior label approval program.
Obtained USDA FSIS Directive 7120.1 listings for substances intended for use in meat, poultry, and egg products production.
Obtained USDA FSIS clearances for On-Line Reprocessing (OLR) and Off-Line Reprocessing (OFLR) Antimicrobial Intervention Systems.
Counseled clients on issues pertaining to the import and export of FDA-regulated products, including products under import alert and products requiring export certification by foreign governments.
Advised on the legal landscape surrounding the development and marketing of CBD products, including synthetic analogs.
Advised on USDA permits and export certifications needed for importation or exportation of products containing USDA-regulated ingredients.
Counseled clients through recalls and market withdrawals to minimize business disruption, cost, and damage to brands.
Assisted clients with navigating and responding to FDA warning letters, FSIS Notices of Intended Enforcement and unanticipated regulatory scrutiny, generally.
Advised USDA-regulated clients on FSIS reinspection requirements for imported foods.
Assisted clients in complying with FDA’s Food Safety Modernization Act (FSMA), Nutrition Facts Label (NFL) requirements, and menu labeling requirements.
Counseled clients regarding California Proposition 65 warnings and supply chain considerations.
Advised clients on bioengineering labeling and claims, including with respect to regulatory compliance and consumer fraud litigation risks.
Provided regulatory strategy and counsel to support premarket submissions to FDA, namely GRAS Notices and Food Contact Notifications.
Provided regulatory advice and due diligence on a range of mergers and acquisitions in the food and dietary supplement sectors.
Provided strategic regulatory support on a range of consumer class action food litigation matters.
Conducted training for new FDA CFSAN personnel and companies on FDA law and regulation.