Brian P. Sylvester

Special Counsel

Overview

Brian P. Sylvester is a special counsel and food and drug lawyer with Foley & Lardner LLP. He advises food, dietary supplement, cosmetic, medical device and prescription and over-the-counter (OTC) drug companies on federal and state regulatory compliance. As part of his practice, he regularly interfaces with the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC) and analogous state bodies.

Drawing on his regulatory background as a former USDA lawyer, Brian is adept at navigating every stage of the production and distribution lifecycle – from premarket clearance through manufacturing, advertising, labeling, recalls and unanticipated regulatory scrutiny. He also regularly advises corporations and industry trade associations on strategies to shape federal and state policies and legislation.

Professional Memberships

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

Community Engagement

Brian sits on the Board of Trustees of the Harmony DC Public Charter School. He also serves as vice president of the Cornell Black Lawyers Alumni Network. In addition, Brian is an active member of the Dartmouth Club of Washington, D.C. and the Dartmouth Lawyers Association. 

Education

  • Cornell Law School (J.D., 2008)
    • General Editor, Cornell Journal of Law and Public Policy
    • Studied abroad at the University of Cape Town in South Africa
  • Dartmouth College (A.B., cum laude, 2005)
    • Presidential Scholar
    • Dean's Plate recipient
  • Trinity School, NYC (2001)

Presentations

Brian frequently speaks at industry conferences and events across the United States.

  • Speaker, “How Cellular Agriculture Technologies Fit into FDA’s Regulatory Agenda,” International Dairy Foods Association (IDFA) Regulatory RoundUP Webinar (July 21, 2020)
  • Speaker, “Examining Incidents that Give Rise to Reporting Obligation and Recalls,” 4th Advanced Summit on Food Law – Regulation, Compliance and Litigation (July 16, 2020)
  • Speaker, “Clean & Cultured Meat: Trends and Regulatory Implications,” 32nd Annual Food Label Conference, Virtual Location (June 1-2, 2020)
  • Panelist, “Producing Food Products from Cultured Animal Tissues,” The Council for Agricultural Science and Technology (CAST), Webinar (April 28, 2020)
  • Panelist, “The Roundtable: Sharing challenges of Cultured Meat development,” Virtual Roundtable (April 7, 2020)
  • Speaker, “Mastering Cannabis, Medical Marijuana and Hemp Regulation,” Virtual CLE (April 1, 2020)
  • Speaker, “FDA + CBD: Navigating an Evolving Regulatory Landscape,” Cannabis Forum, New York, NY (March 7, 2020)
  • Speaker, “Alternative Proteins - Making Whey and Milk Without the Curds and Cows,” International Dairy Foods Association Dairy Forum 2020, Scottsdale, AZ (January 28, 2020)
  • Speaker, “A Regulatory Workshop,” Cultured Meat Symposium 2019 (CMS19), San Francisco, CA (November 14, 2019)
  • Speaker, “Label Compliance for 2020 and Beyond: Uncovering Current and Developing Requirements,” Food & Beverage Exchange, Chicago, IL (October 2, 2019)
  • Speaker, “Cellular Agriculture Regulatory Considerations,” New Harvest 2019, MIT (July 19 & 20, 2019)
  • Speaker, “Exploring Agriculture Regulatory Considerations,” FDLI Annual Conference, Washington D.C. (May 3, 2019)
  • Speaker, “Future of Food,” 2019 Food Label Conference, Washington D.C. (April 15, 2019)
  • Speaker, “U.S. Department of Agriculture,” FDLI Introduction to Food Law, Washington D.C. (March 20, 2019)
  • Speaker, “Regulation of Cell-Based Meat,” Industrializing Cell-Based Meats Summit, San Francisco, CA (February 7, 2019)
  • Speaker, Cultured Meat Symposium (CMS) 2018, San Francisco, CA (November 1, 2018)
  • Speaker, “Mock Scenario – Inside an FDA Inspection,” Food & Beverage Exchange, Chicago, IL (October 16, 2018)
  • Speaker, “Innovative Foods Part I,” FDLI’s Food Advertising, Labeling and Litigation Conference, Washington D.C. (September 26, 2018)
  • Speaker, “Regulating Outside the Box,” CLE International Food Law Conference, Denver, CO (April 19, 2018)

Publications

Brian has authored and co-authored a number of timely articles on trending legal issues and has been quoted by The Wall Street Journal, ForbesFood Navigator-USA, and Inside Health Policy, among other leading publications.

  • Quoted, “FDA says it’s made ‘substantial progress’ on CBD regs; CV Sciences weighs in on food vs pharma path; man sues CBD firm after failing drugs test,” Food Navigator-USA (June 5, 2020)
  • Co-author, “INSIGHT: Biogen Decision Shows Need for Clinical, Legal Collaboration,” Bloomberg Law® (May 27, 2020)
  • Co-author, “Producing Food Products from Cultured Animal Tissues,” The Council for Agricultural Science and Technology (CAST), Commentary (April 27, 2020)
  • Quoted, “3 Alternative Protein Trends to Watch in 2020,” Forbes (March 3, 2020)
  • Quoted, “Senate Bill Takes Aim at Cell-Cultured Food Labeling,” Food Quality & Safety (January 23, 2020)
  • Quoted, “Attorneys weigh in on CBD lawsuits: ‘A wave of class action litigation was almost inevitable,’” Food Navigator-USA (December 10, 2019)
  • Quoted, “The FDA Issues a Stern Warning on CBD... But does it Signal a Change in Approach?,” Food Navigator-USA (November 27, 2019)
  • Co-author, “INSIGHT: New USDA Hemp Rule May Propel Production Around the Country,” Bloomberg Law® (November 22, 2019)
  • Quoted, “Plaintiff's Bar Turns Attention to CBD with Wave of Lawsuits Alleging Products Contain ‘Significantly Lower Levels’ Than Advertised,” Food Navigator-USA (October 07, 2019)
  • Co-author, “Key Takeaways From USDA's Biotech Regulation Proposal,” Law360 (June 26, 2019)
  • Quoted, “What's the Regulatory Path Forward for CBD?,” Food Navigator-USA (June 3, 2019)
  • Quoted, “Manufacturers Push for Legal Clarity at FDA's First Public Hearing on CBD,” Food Dive (June 3, 2019)
  • Quoted, “Edible Insects, CBD and Cell-Cultured Meat: Regulating the Future of Food,” Food Dive (April 16, 2019)
  • Quoted, “Amyris Teams Up With LAVVAN to Bring Fermentation-Derived CBD to Market in 2020: 'There's a significant cost advantage',” Food Navigator-USA (March 20, 2019)
  • Quoted, “FDA-USDA Agreement to Jointly Oversee Cell-Based Meat,” Inside Health Policy (March 12, 2019)
  • Quoted, “FDA and USDA Shed More Light on How Cell-Based Meat Will Be Regulated, But Don’t Weigh Into Naming Debate… Yet,” Food Navigator-USA (March 8, 2019)
  • Quoted, “FDA, USDA Sign MOU to Jointly Oversee Cell-Based Meat,” IEG Policy (March 7, 2019)
  • Quoted, “Advocates Hopeful That Gottlieb’s Departure Won’t Derail Drive Toward New CBD Rules,” Nutra Ingredients-USA (March 8, 2019)
  • Quoted, “Water Likely to Account for Biggest Segment of CBD Beverages Category,” Food Navigator-USA (March 6, 2019)
  • Author, “Adding Cannabidiol to the Menu,” Food Safety Magazine (February 19, 2019)
  • Quoted, “The ‘World is Watching’ the Cell-Based Meat Industry,” Food Navigator-USA (February 11, 2019)
  • Quoted, “LEGAL VOX POP: Top Attorneys Weigh In,” Food Navigator-USA (December 18, 2018)
  • Quoted, “FDA, USDA, to Share Regulatory Oversight of Cell-Cultured Meat, Poultry,” Food Navigator-USA (November 17, 2018)
  • Author, “Building The Regulatory Conversation On Cellular Agriculture,” Law360 (October 30, 2018)
  • Quoted, “Lab-Grown Meat Raises Regulatory Questions,” The Wall Street Journal (October 2, 2018)
  • Quoted, “USDA-FDA Meeting on Oversight for Cell-Based Meats,” Inside Health Policy’s FDA Week (September 14, 2018)
  • Quoted, “USDA and FDA to Host Joint Public Meeting on Cell Cultured Meat,” Food Navigator-USA (September 10, 2018)
  • Quoted, “Impact of New Missouri Labeling Law for Clean Meat Industry,” Inside Health Policy’s FDA Week (September 4, 2018)
  • Quoted, “Proposed Joint USDA-FDA Oversight for Cell-Based Meats,” Inside Health Policy’s FDA Week (August 27, 2018)
  • Quoted, “FDA-USDA Turf Battle for Regulating Cell-Cultured Foods,” Inside Health Policy’s FDA Week (July 23, 2018)
  • Quoted, “How Cultured Meat Could Be Regulated by FDA and/or USDA,” Inside Health Policy’s FDA Week (July 10, 2018)
  • Author, “FDA Tackles Cell-Cultured Foods,” Food and Drug Law Institute (July 2018)
  • Author, “FDA Greenlights Production of GE Salmon at U.S. Facility, But That Is Not the End of the Story,” American Bar Association (July 2018)
  • Author, “Clean Meat Staking its Claim Amid Regulatory Uncertainty,” Food Safety News (July 1, 2018)
  • Author, “Gene-Edited Crops Ripe For Renewed Regulatory Focus,” Law360 (January 29, 2018)
  • Author, “Shopping For Standard Food Date Labels,” Law360 (August 25, 2016)
  • Author, “Organic Rule Change Causes A Synthetics Scuffle,” Law360 (October 12, 2016)
  • Author, “Food Labeling: Is Mandatory Antibiotic Claim Labeling Needed?,” Food and Drug Law Institute (March/April 2015)
  • Co-author, “USDA-FSIS Steps Up Reinspection Enforcement: Do You Have Your Import Paperwork in Order?,” Food Safety Magazine (March 3, 2015)

Admissions

  • District of Columbia
  • New York