Brian P. Sylvester
- Firmwide Chair, Food Regulatory Practice
- Washington, D.C.
A Chambers-ranked CPG and Food Industry lawyer, Brian provides strategic FDA, USDA, and CPSC regulatory advice to globally leading companies and trade associations.
Brian Sylvester focuses his regulatory practice on consumer products with an emphasis on the food and beverage sector. He is a leading authority on food tech regulation and serves as a trusted advisor to global brands, startups, life science companies, investors, and trade associations. Chambers USA reports that Brian “is widely noted as an expert in regulatory issues relating to novel food technologies, with significant experience advising on USDA and FDA regulations” and that he “is great to work with, super responsive and has great industry knowledge.”
Brian’s regulatory counsel extends to cosmetics, OTC drugs, medical devices. consumer products generally, and a range of APHIS-regulated commodities. Across all these regulated product categories, his work spans enforcement actions, audits and investigations, regulatory compliance, labeling and advertising, import and export, due diligence, consumer litigation, comment preparation, public policy advocacy at the federal and state levels, and new product development.
In the area of food and beverage, Brian develops regulatory strategies to commercialize a range of food tech innovations, including transgenic crops and alternative proteins, such as cultivated meat and fermentation-derived food ingredients, among others. He draws on his tenure as a former regulator at USDA to counsel clients on strategic considerations around engagement with and advocacy before USDA and FDA on numerous complex issues, including those of first impression.
Brian is a prolific author and frequent speaker at industry-leading events in the United States, the European Union, China, Israel, and other parts of the world. He is regularly called upon to offer insights on trending legal issues by preeminent industry and global publications.
Areas of focus
Education & Credentials
Education
- Cornell Law School, J.D., General Editor, Cornell Journal of Law and Public Policy, 2008
- Dartmouth College, A.B., Psychological & Brain Sciences, cum laude, 2005
Bar and Court Admissions
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District of Columbia
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New York
Related Employment
- U.S. Department of Agriculture, Office of the General Counsel, Marketing, Regulatory and Food Safety Programs Division, Washington, D.C., Attorney-Advisor, 2009-2014
Professional Recognition
Chambers USA – Food & Beverages: Regulatory & Litigation, 2024
Bloomberg Law – They’ve Got Next: 40 Under 40, 2024
MCCA – Rising Star, 2024
National Bar Association – 40 Under 40, Nation’s Best Advocates, 2023
Impact
Professional Leadership
- The Future of Protein Production, Advisory Board Member
- Protein Production Technology International, Editorial Advisory Board Member
- Leadership Council on Legal Diversity, Fellow
- Council for Agricultural Science and Technology, Member
- Food and Drug Law Institute (FDLI), Member
- National Bar Association, Member
Insights
News
Professional Experience
Experience
- Provided strategic regulatory counsel to facilitate commercialization of various food tech innovations, such as cultivated meat, precision fermentation, molecular farming, and sugar reduction technologies.
- Advised Fortune 100 and startup companies on U.S. human food regulations governing the transport, holding, processing, and sale of food from farm to fork.
- Advised corporations and industry trade associations on strategies to shape U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) food regulatory frameworks for labeling and premarket review oversight.
- Provided regulatory strategy and counsel to support premarket submissions to FDA, namely GRAS Notices and Food Contact Notifications, and to USDA for New Technology Notifications.
- Advised on FDA’s Food Safety Modernization Act (FSMA) compliance with a focus on hazard analysis and preventive controls, drawing on his experience and certification as a Preventive Controls Qualified Individual.
- Assisted clients with navigating and responding to FDA warning letters, Food Safety and Inspection Service (FSIS) Notices of Intended Enforcement, and unanticipated regulatory scrutiny, generally.
- Provided strategic regulatory support on a range of consumer class-action food litigation matters.
- Counseled clients through recalls and market withdrawals to minimize business disruption, cost, and damage to brands.
- Advised on USDA-Animal and Plant Health Inspection Service (APHIS) permits and export certifications needed for importation or exportation of products containing USDA-regulated ingredients.
- Advised on the development and marketing of CBD products, including synthetic analogs.
- Advised USDA-regulated companies on FSIS reinspection requirements for imported foods.
- Advised clients on bioengineering labeling and claims, including with respect to regulatory compliance and consumer fraud litigation risks.
- Provided regulatory advice and due diligence on a range of mergers and acquisitions in the food and dietary supplement sectors.
- Represented USDA-regulated stakeholders on compliance with the Packers and Stockyards Act and Perishable Agricultural Commodities Act.
- Assisted clients in complying with FDA’s FSMA, Nutrition Facts Label requirements, and menu labeling requirements.
- Advised multiple food manufacturers and retailers on compliance with USDA's Supplemental Nutrition Assistance Program administered by the Food and Nutrition Service.
- 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 clearances from FDA for specialty chemical antimicrobial solutions intended for use in food processing.*
- Advised multiple clients in navigating administrative enforcement actions brought by USDA's APHIS, Agricultural Marketing 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 and Off-Line Reprocessing Antimicrobial Intervention Systems.*
- Counseled clients on issues pertaining to the import and export of USDA and FDA-regulated products, including products under import alert and products requiring export certification by foreign governments.
- Counseled clients regarding California Proposition 65 warnings and supply chain considerations.
- Conducted training for new FDA Center for Food Safety and Applied Nutrition personnel and companies on FDA law and regulation.*
*Prior firm experience