Washington, DC

Brian P. Sylvester

  • Associate
  • Direct Dial: +1 202.434.4139
  • Fax: +1 202.434.4646
  • Professional Assistants: Gaynelle Costner, Aileen Vaughn, and Amanda Davis, Ph: +1 202.434.4347

    Washington, DC

    1001 G Street NW
    Suite 500 West
    Washington, DC 20001

Brian Sylvester practices in the areas of food and drug law and biotechnology with an emphasis on both U.S. and foreign regulation of human food, animal feed, dietary supplements, food packaging and various biotechnology products, including genetically engineered microorganisms and plants, biopesticides and biofuels.

In particular, Mr. Sylvester advises clients regarding new product development, advertising and labeling requirements, product safety compliance and recall and crisis management matters. A sample of his recent experience includes:

  • Advising USDA-regulated clients on compliance and enforcement issues arising under federal statutes administered by the following USDA agencies:

o   Agricultural Marketing Service (AMS)

o   Animal and Plant Health Inspection Service (APHIS)

o   Food Safety and Inspection Service (FSIS)

o   Grain Inspection, Packers & Stockyards Program (GIPSA)

o   National Organic Program (NOP)

  • Counseling food and beverage industry clients on regulatory obligations pursuant to the Food Safety Modernization Act (FSMA), namely, Hazard Analysis and Risk-Based Preventive Controls (HARPC), Good Manufacturing Practices (GMP), and Foreign Supplier Verification Program (FSVP) requirements
  • Preparing premarket filings for submission to the U.S. Food and Drug Administration (FDA) and relevant global authorities to support regulatory clearances for novel food ingredients and substances used in food packaging materials and processing equipment
  • Preparing opinion letters on the compliance status of new food ingredients and additives, including “Self GRAS” positions
  • Reviewing product labeling and advertising to determine compliance with FDA, USDA, and Federal Trade Commission (FTC) requirements
  • Providing strategic legislative and policy advice to trade associations and corporations concerning FDA- and USDA-regulated products
  • Obtaining appropriate authorizations from USDA’s Animal Plant & Health Inspection Service (APHIS) to facilitate the import, transit and release of regulated animal products, veterinary biologics, plants, plant products, pests and genetically engineered organisms.
  • Advising on international food regulatory matters (Canada, Australia and the European Union)
  • Conducting regulatory due diligence to support transactions involving acquisitions of companies that market USDA- and FDA-regulated products.

Prior to joining the firm, Mr. Sylvester was a senior regulatory attorney at USDA’s Office of the General Counsel. During his tenure at the USDA from 2009 to 2014, he obtained experience across the breadth of USDA regulation, uniquely positioning him to navigate the complex regulatory challenges that his clients face in the U.S. and in jurisdictions throughout the world.

Mr. Sylvester received his J.D. from Cornell in 2008. While at Cornell, he served as an Editor of the Cornell Journal of Law & Public Policy and studied international and comparative law at the University of Cape Town in South Africa.


 

Practice Areas

Education

  • Dartmouth College
    • A.B., 2005, cum laude
  • Cornell University
    • J.D., 2008

Bar Admissions

  • Connecticut
  • New York
  • District of Columbia

Memberships

  • Member, Food and Drug Law Institute
    American
    Bar Association