Edgar Asebey-Birkholm

Partner, Practice Group Manager, Food & Drug Law

Fort Lauderdale
350 East Las Olas Boulevard
Las Olas Centre II, Suite 1150
Fort Lauderdale, FL 33301
P 954.759.2754
F 954.462.4260
E easebey@ralaw.com
Washington, D.C.
600 14th Street NW, Suite 400
Washington, D.C. 20005
P 202.625.0600
F 202.338.6340



Edgar Asebey-Birkholm

Partner, Practice Group Manager, Food & Drug Law

Phone: 954.759.2754
Fax: 954.462.4260
Email: easebey@ralaw.com

Mr. Asebey's practice focuses on foods, medical devices, OTC drugs, and cosmetics and provides counsel to clients on compliance, registration, importation and enforcement matters related to FDA-regulated products. He assists clients in registration, clearance, and pre-market approval submissions to the FDA and advises clients on compliance issues associated with the development, manufacture, marketing, and sale of FDA-regulated products.

He is a recognized expert in the Food Safety Modernization Act (FSMA) and has lectured in over 20 forums in Latin America, Japan, and the U.S. on FSMA's impact on U.S. importers, non-U.S. food exporters and food companies. He also has represented numerous foreign food companies before the FDA, including rice, seafood, olive, fish oil, and nut exporters as well as fresh and processed food manufacturers.

With respect to medical devices, Mr. Asebey performs FDA regulatory and CMS reimbursement due diligence for venture capital firms and private companies prior to investment or merger and acquisition activities. He also assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, food additive petitions, GRAS self-affirmations and notifications, and product listings/establishment registrations. His experience includes pursuing client interests before the FDA, FTC, USDA, EPA, and state regulatory agencies.

Education

  • 1996, J.D., The Catholic University of America Columbus School of Law, Patent Law
  • 1986, B.A., The University of Chicago, Molecular Biology

Professional Affiliations

  • American Bar Association, Section on Administrative Law & Regulatory Practice
    • Food and Drug Committee, Co-Chair (2009-present)
    • International Committee, Member (2009-present)
  • Food & Drug Law Institute, Member (2005-present)
  • Dade County Bar Association, Member (2009-present)
  • Dharma Biomedical, LLC, Board of Directors (2007-present)
  • Greater Miami Chamber of Commerce
    • BioScience sub-committee, Chair (2007-2010)
  • BioFlorida, Member (2006-2010)

Publications

  • "Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases" - Aspatore Special Report (October 2013)
  • "FDA 2.0 - The Same But Way More: The Impact of the Food Safety Modernization Act on Importers and Others" - North American Free Trade & Investment Report, Vol. 21, No.7 (April 2011)

Presentations

  • "Food Safety" - Food Marketing Institute (FMI) 2014 Legal Conference, New Orleans, LA (March 2014)
  • "Regulatory Framework" - Panel Moderator, BioFlorida Latin America & Caribbean Life Sciences Conference, Miami, FL (March 2014)
  • "Impact of the Food Safety Modernization Act on Food Importers and Exporters" - 17th America's Food and Beverage Show & Conference, Miami, FL (October 2013)
  • "The Reality of FSMA Implementation - Looking Through the Prism of FDA's Current Enforcement Culture" - NLS Food Quality Symposium, Phoenix, AZ (October 2013)
  • "Food Safety Modernization Act (FSMA) & The Changing Regulatory Landscape" - Regulatory Affairs Professionals Society (RAPS) Annual Meeting, Boston, MA (October 2013)
  • "FSMA Foreign Supplier Verification Programs for Importers: FDA and Industry Expert Insights" - Webinar for the Institute of Food Technologists (August 2013)
  • "Food Safety Modernization Act (FSMA): 2013 Implementation Update for Brokers and Importers" - Training Seminar for Crowley and Customized Brokers, Fort Lauderdale, FL (January 2013)
  • "Food Safety Modernization Act (FSMA): 2012 - 2013 Implementation Update" - Training Seminar for Japanese importers sponsored by JETRO, New York, NY (2012)
  • "La Nueva Ley De Inocuidad Alimentaria (FSMA): Lo Que Cada Exportador Debe Saber en el 2012" - Training Seminar for Mexican Exporters, Mexico City (2012)
  • "Food Safety Modernization Act (FSMA): What Every Importer and Broker Needs to Know in 2012" - Training Seminar for Crowley and Customized Brokers, Fort Lauderdale, FL (2012)
  • "Food Safety Modernization Act (FSMA): Impact on Importer, Exporters and Manufacturers" - International Trade Association of Greater Chicago (2012)
  • "Food Safety Modernization Act (FSMA): Implications for Japanese Exporters" - Seminar Training Series for JETRO, Tokyo, Osaka and Nagoya, Japan (2012)
  • "Importation of FDA-Regulated Goods: What Chilean Importers Need to Know" - Seminar for Chilean Exporters, Miami, FL (2011)
  • "FSMA's Impact at the Border: What Regulatory Professionals Need to Know" - Regulatory Affairs Professionals Society (RAPS) Annual Meeting, Indianapolis, IN (2011)
  • "FDA's Shifting 510(k) Paradigm: The 2011 Changes to Medical Device Regulatory Pathway" - BioFlorida Southeast Chapter (2011)
  • "Food and Product Admissibility" - Import/Export Webinar Series, Office of Economic Development & International Trade (OEDIT) (2011)
  • "The Food Safety Modernization Act: The New Law's Impact on You" - Florida Customs Brokers and Forwarders Association (2011)
  • "Substantial Equivalence: FDA's Evolving 510(k) Policy and Potential Changes" - BioFlorida Southeast Chapter (2010)
  • "FDA Imports: Essential Entry Requirements" - Florida Customs Brokers and Forwarders Association (2010)

Languages Spoken

  • Fluent in Spanish