Covington & Burling LLP operates as a limited liability partnership worldwide, with the practice in England and Wales conducted by an affiliated
limited liability multinational partnership, Covington & Burling LLP, which is formed under the laws of the State of Delaware in the United States
and authorized and regulated by the Solicitors Regulation Authority with registration number 77071..
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.
Crafted and executed carefully tailored regulatory strategies focused on the use of synthetic biology to produce alternative proteins using plant, microbial and animal cell-based technologies.
Provided strategic regulatory counsel to facilitate commercialization of various food tech innovations, such as molecular farming and sugar reduction technologies.
Advised corporations and industry trade associations on strategies to shape FDA and USDA regulatory frameworks for labeling and premarket review oversight.
Led FDA regulatory diligence for private equity firm L Catterton in largest ever investment in a cultivated seafood company to date ($100 million Series B Round for Wildtype)
On behalf of AFCO (a Zep Company), successfully obtained multiple Food Contact Notification (FCN) clearances from FDA for specialty chemical antimicrobial solutions intended for use in food processing.
Advised on FDA FSMA compliance with a focus on hazard analysis and preventive controls drawing on his experience and certification as a Preventive Controls Qualified Individual (PCQI).
Advised multiple clients in navigating administrative enforcement actions brought by USDA's Animal and Plant Health Inspection Service (APHIS), Agricultural Marketing Service (AMS), Food Safety and Inspection Service (FSIS), and the National Organic Program.
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.
Advised multiple food manufacturers and retailers on compliance with USDA's Supplemental Nutrition Assistance Program (SNAP) administered by the Food and Nutrition Service (FNS).
Back
