Overview

Jason Sapsin helps clients develop foods, drugs and medical devices, introduce those products into the marketplace, and then keep them in the marketplace in the face of regulatory and competitor challenges. Jason offers clients direct insight into FDA’s regulatory and investigative processes, having served as an associate chief counsel to the U.S. Food & Drug Administration.

Product Development

Jason works with clients investigating and developing a wide range of FDA-regulated products. Some might be inventors developing their first medical devices while others are multinationals determining what evidence they should gather before launching innovative food additives. Jason helps these clients chart their pathways to market — taking into consideration their marketing objectives, resource constraints and legal requirements — and prepare for critical FDA meetings and submissions.

Due Diligence

Jason advises food, drug and device companies preparing to raise funds (privately or publicly) and companies looking to grow their businesses through acquisitions or mergers. He helps them evaluate compliance history, identify operational considerations, review current product labeling and advertising, and assess critical relationships with suppliers, manufacturing partners and distributors from the standpoint of regulatory risk.

Compliance

Jason has participated firsthand in FDA facility inspections and uses this experience to advise companies in addressing and mitigating areas of compliance risk. This includes evaluating existing practices and procedures as well as assisting clients in developing new materials to respond to shifting regulatory requirements. Jason conducts internal FDA investigations and audits to identify areas of weakness and also to help management respond to and correct known individual and systemic production and marketing lapses.

Investigations, Enforcement and Recalls

Jason provides strategic and practical guidance, on-site or remotely, to clients preparing for and undergoing FDA inspections. He helps clients determine whether and when to submit product reports and how to respond to formal and informal FDA actions. He also assists clients in all phases of product recalls as they face their most challenging business decisions.

Food & Drug Administration

While at FDA, Jason advised the agency on investigations, seizures, injunctions, product recalls and other enforcement actions against drugs, dietary supplements and adulterated foods. He participated in regulatory actions such as FDA’s promulgation of rules and guidance regarding fresh produce, food safety, and nutritional and menu labeling. He also helped to execute FDA’s initiative to expand the scope of federal/state enforcement cooperation.

Public Health

Jason’s diverse legal and public health background includes serving as assistant attorney general for the Maryland Attorney General’s office in the Maryland Department of Health and Mental Hygiene, the Maryland Health Care Commission and the Maryland Community Health Resources Commission. Jason served as faculty at the John Hopkins Bloomberg School of Public Health, working closely with state departments of public health, the CDC, NIH and USAID.

Credentials

Bar Admissions

Colorado

Court Admissions

U.S. Court of Appeals for the Fourth Circuit

Education

Johns Hopkins University
M.P.H. (2003)

University of Michigan Law School
J.D. cum laude (1994)

Williams College
B.A. magna cum laude (1991)

Insights & Events

Other Perspectives
  • Introduction to New Drug Development
    Presenter, The Food and Drug Law Institute, March 2018
  • New Drug Development Under an IND
    Presenter, The Food and Drug Law Institute, November 2017
  • Food Law and Regulation Fundamentals: An Essential Primer
    Seminar co-lead, The Amercian Conference Institute’s Food Law and Regulations Boot Camp, November 2017
  • FDA and USDA Food Safety Regulations 101
    Co-chair and Presenter, The Amercian Conference Institute’s Food Law and Regulations Boot Camp, November 2017
  • Social Media Marketing
    Moderator, Food Advertising, Labeling and Litigation Conference: For the Food and Dietary Supplements Industries, September 2017
  • Cosmetic Labeling: Understanding Regulations to Ensure Your Product is Beautiful Inside and Out
    Presenter, Natural Products EXPO EAST, September 2017
  • FDA's New Supply Chain Food Safety Requirements: Is Your Company in Compliance?
    Co-presenter, International Dairy Foods Association, Webinar, July 2017
  • FSMA: How Sweeping Reform of Food Safety Laws Has Affected Your Business
    Presenter, Natural Products ExpoWest, March 2017
  • The New NDI Guidance: Impact on Industry and Investment
    Nutrition Business Journal, Webinar, November 2016
  • Establishing Protocols for the Next Wave of FSMA Rule Implementation for Animal Feed, Pet Food and Animal Drug Manufacturers
    Presenter, The American Conference Institute’s Second Annual Legal, Regulatory and Compliance Forum on Animal Health, September 2016
  • FSMA Compliance and Enforcement Priorities Across the Global Food System
    Moderator, 2016 Food & Agriculture National Conference, Faegre Baker Daniels, Indianapolis, May 2016
  • FDA Regulation of Dietary Supplements
    Panelist, FDLI Annual Conference, Washington, D.C., May 2016
  • What Is Killing the Supplement Industry, and How to Fix It?
    Moderator, Engredea and Natural Products Expo West, Anaheim, California, March 2015
  • Introduction to Drug Regulation
    Chapter author, The Fundamentals of Life Sciences Law, American Health Lawyers Association, 2nd edition, 2014
  • The “State” of GMO Labeling
    NOW, Natural Products Association, December 2014
  • Current Risk Management Issues in Due Diligence
    Thomson Reuters and Villanova University School of Law, Villanova, Pennsylvania, June 2014
  • Trends in Functional Foods
    NutraIngredients-USA Webinar, June 2014
  • Developing and Marketing ‘Foods That Work’
    Engredea, Anaheim, California, March 2014
  • Medical Foods: The Next Horizon in Health Care
    Panelist, ExpoWest, March 2014
  • FDA’s Unique Device Identification System
    Bloomberg BNA Medical Devices Law & Industry Report, November 27, 2013

Leadership & Community

Professional Associations

  • Food and Drug Law Institute - Food and Dietary Supplements Committee Member, 2016 
  • American Health Lawyers Association
  • Oxford University Law Society

Civic Activities

  • Colorado Department of Public Health and Environment — Vaccine Advisory Committee, 2013-17
  • Summit Charter Middle School, Boulder, Colorado — Board Counsel, 2011-15
  • Colorado State University Regulatory Affairs Industry/Academic Consortium, 2010-11
  • Hickenlooper-Garcia Transition Committee, 2010
  • Northeast Baltimore Charter School, Baltimore, Maryland — Director, 2003-05
  • Burlington Community School District, Burlington, Iowa — Director, 1999-2001

Honors

  • Department of Health and Human Services — Outstanding Service, 2009
  • Delta Omega (national public health honorary society) — Alpha Chapter, 2003
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