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Brian P. Sylvester

Special Counsel

Washington +1 202 662 5988 bsylvester@cov.com Download V-card

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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.

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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.

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Leadership Council on Legal Diversity, Fellow
Council for Agricultural Science and Technology, Member
Food and Drug Law Institute (FDLI), Member

U.S. Department of Agriculture, Office of the General Counsel – Marketing, Regulatory & Food Safety Programs Division, Attorney Advisor

Biomanufacturing opportunities to cut agricultural GHG emissions

Mr. Sylvester participated in a workshop for The Information Technology and Innovation Foundation (ITIF), the Boston University Institute for Sustainable Energy (BU-ISE) and the Fraunhofer USA Center for Manufacturing Innovation (CMI) on "Biomanufacturing opportunities to cut agricultural GHG emissions." The workshop focused on barriers that limit ...

Food Innovation

Mr. Sylvester participated in a speaking engagement for Berkeley Center for Law & Technology, on "Food Innovation." He discussed a wide range of regulatory issues posed by exciting developments in the production of food (what some are calling the “age of innovation” in protein), including gene-edited and genetically engineered foods, cellular agriculture, ...

Mastering Marijuana, CBD, Cannabis, & Hemp Law

Mr. Sylvester was an instructor in a virtual seminar for the Rossdale CLE Center, on "Mastering Marijuana, CBD, Cannabis, & Hemp Law." His presentation focused on federal and state requirements focused on CBD and related cannabinoids intended for use in foods and dietary supplements, recent enforcement trends and consumer litigation.

FDA Publishes Materials Clarifying Food Traceability Proposed Rule

In September 2020, FDA released its Food Traceability Proposed Rule, which would impose additional traceability recordkeeping requirements on persons who manufacture, process, pack, or hold foods on FDA’s newly-created Food Traceability List (FTL). FDA has since held three public meetings on the proposed rule, during which stakeholders have raised various ...

USDA Announces Proposal to Regulate Agricultural Animal Biotechnology

On December 21, 2020, the United States Department of Agriculture (USDA) released an Advanced Notice of Proposed Rulemaking (ANPR) to seek comment on a contemplated regulatory framework that, if finalized, would transition to USDA portions of the Food and Drug Administration’s (FDA’s) pre-existing animal biotechnology regulatory oversight. In particular, USDA ...

What legal issues should food & beverage companies watch in 2021?

Brian Sylvester spoke with Food Navigator about the legal issues for food and beverage companies to watch in 2021. Mr. Sylvester says, “I expect cell-based meat to take center stage in the evolving food regulatory conversations occurring in the U.S. and around the world. Earlier this month, in a global first, Singapore greenlighted the first ever cell-based meat ...

Singapore just became the first nation to approve cell-cultured meat for human consumption

Brian Sylvester spoke with The Counter about Singapore’s approval of cell-cultured meat for human consumption, the first country to do so. Mr. Sylvester says several major issues remain unresolved for now. For instance, while FDA already regulates cells cultured for biomedical use, it does not yet stipulate how similar practices should be used for food ...

US Regulatory 101 for Alternative Proteins

Mr. Sylvester participated in a speaking engagement for Modern Agriculture Foundation in Modi'in, Israel, on "US Regulatory 101 for Alternative Proteins." He discussed regulatory considerations for food tech entrepreneurs to incorporate into their product development strategies. His presentation provided a high-level overview of key US regulatory considerations ...

FDA Issues a Draft Guidance on Voluntary Disclosure of Sesame as an Allergen

Yesterday, FDA’s Center for Food Safety and Applied Nutrition (“CFSAN”) issued a draft guidance regarding the voluntary labeling of sesame when used in flavoring or spice or in a food declared by another name, such as tahini. The Federal Register notice will officially be published on Thursday. We briefly summarize the draft guidance below to help inform ...

Key Issues for FDA in a Biden Administration

Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...

FDA Holds Public Meeting on Food Traceability Proposed Rule

On November 6, 2020, the Food and Drug Administration (FDA) held the first of three public meetings regarding its Food Traceability Proposed Rule. The proposed rule, which is required by section 204 of the Food Safety Modernization Act (FSMA), would impose additional traceability recordkeeping requirements on entities that manufacture, process, pack, or hold ...

Introduction to US Food, Dietary Supplement, and Cosmetic Law and Regulation

Mr. Sylvester conducted a training for new FDA employees at the Agency’s Center for Food Safety and Applied Nutrition on FDA regulations and policy regarding FDA Inspection, FDA Enforcement Authority and Imports. His training was part of a one-day course hosted by the Food and Drug Law Institute (FDLI) to provide an opportunity for FDA-CFSAN staff to increase ...

FDA Discusses First 100 Days of its “New Era of Smarter Food Safety”

Yesterday, the Food and Drug Administration (FDA) held a webinar to discuss key actions it has taken since releasing its New Era of Smarter Food Safety Blueprint on July 13, 2020. FDA’s New Era of Smarter Food Safety is an initiative that aims to modernize, enhance, and streamline the agency’s approach to food safety through the use of technology and other ...

What’s for Dinner? Achieving Municipal Climate Mitigation Targets through Alternative Proteins

Mr. Sylvester participated as a panelist in the Environmental Law Institute’s webinar “What’s for Dinner? Achieving Municipal Climate Mitigation Targets through Alternative Proteins.” The panel included Impossible Foods’ Chief Legal Officer and ELI’s Director of the Center for State, Tribal, and Local Environmental Programs, among other leading authorities in ...

Protein Wars: Defining, Naming, and Labeling Alternative Proteins

Mr. Sylvester participated in a speaking engagement at Mitchell Hamline School of Law- Health Law Institute on "Protein Wars: Defining, Naming, and Labeling Alternative Proteins." He discussed the evolving regulatory conversation around alternative proteins, as well as best practices for labeling such products in light of recent and proposed legislative actions. ...

FDA Finalizes Allulose Guidance and Requests Information on Other Sugars Metabolized Differently Than Traditional Sugars

FDA has taken two notable actions regarding the sugars declaration in the Nutrition Facts Label (NFL) and Supplement Facts Label (SFL). On Friday, the agency released a final guidance regarding the declaration of allulose, confirming that this monosaccharide need not be included in the declaration of “Total Sugars” or “Added Sugars,” though it must be included ...

Cell-Cultured Meat Startups, NAMI, Urge USDA to Gather More Data Before Issuing a Proposed Rule on Labeling

Brian Sylvester is quoted in Food Navigator regarding the USDA’s labeling of cell-cultured meats. Mr. Sylvester says that he didn't think an Advance Notice of Proposed Rulemaking (ANPR) would extend the timeline in a meaningful way. “Instead, it could actually be an efficient means of collecting needed data sooner rather than later to lay the foundation for a ...

What's in a Name? FDA Requests Info on Labeling of Cell-Cultured Seafood

Brian Sylvester spoke with Food Navigator about the labeling of cell-cultured seafood. Mr. Sylvester says, “USDA has not yet invited public comment on the labelling of cell-cultured meat & poultry but is expected to do so in due course. It is reasonable to expect that USDA will ultimately put out a similar request and will collaborate with FDA on reviewing ...

FDA Proposes FSMA Food Traceability Rule, Including High-Risk Food Categories

Yesterday, FDA released a proposed rule that, if finalized, would impose additional traceability recordkeeping requirements for certain high-risk foods. This rulemaking is required by section 204 of FSMA, and is an additional action in FDA’s ongoing FSMA implementation. FDA proposes to establish a “Food Traceability List” (FTL) that would enumerate certain foods ...

USDA Updates: FSIS Proposes Significant Updates to Generic Label Approval Oversight, and Finalizes Rules on Modernizing Egg Inspection

The first half of September has seen two major regulatory updates from USDA’s Food Safety and Inspection Service (FSIS). First, on September 14, 2020, FSIS published a proposed rule to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products, which specifically proposes that FSIS will cease evaluating ...

3 Alternative Protein Trends To Watch In 2020

Brian Sylvester noted in Forbes that litigation of alternative proteins was a trend to watch in 2020. Mr. Sylvester says these cases “could influence the ongoing regulatory conversation at the federal level around new standards of identity for both plant-based and cell-cultured meat."

Senate Bill Takes Aim at Cell-Cultured Food Labeling

Brian Sylvester spoke with Food Quality and Safety about a bill aimed at safeguarding accurate and transparent labeling of food products created using animal cell-culture technology. Mr. Sylvester says, “When it comes to food tech, both the FDA and USDA have accommodated new innovations into the existing regulatory framework for years: I think this is absolutely ...

Manufacturers push for legal clarity at FDA's first public hearing on CBD

Brian Sylvester spoke with Food Dive about the push from manufacturers for clarity at the FDA’s first public hearing on CBD. Mr. Sylvester says that in the short term, the FDA could issue a policy statement that says if a company is marketing food or dietary supplements with compounds like CBD and it is derived from hemp, which is legal now because of the Farm ...

Advocates hopeful that Gotlieb's won't derail drive toward new CBD rules

Brian Sylvester spoke with NUTRA Ingredients about the abrupt resignation of the FDA Commissioner and what it could be mean for new CBD rules. Mr. Sylvester says while the FDA may “ultimately choose to undertake rulemaking to authorize the use of CBD in foods and dietary supplements. As an interim action—to facilitate the immediate commercialization of CBD-added ...

The 'world is watching' the cell-based meat industry, says Memphis Meats VP: 'Subpar early products can stigmatize an entire category for decades to come

Brian Sylvester is quoted in Food Navigator regarding the potential impact of state-based regulation on the cell-based meat industry. Mr. Sylvester says while there have been a series of bills in individual states attempting to restrict the use of terms such as ‘meat’ or ‘beef’ to the flesh of animals raised and harvested in a traditional manner, these will ...

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Brian P. Sylvester

Representative Matters

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Accolades

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Education

Cornell Law School, J.D., 2008

Dartmouth College, A.B., 2005

Government Service

Bar Admissions