Jacqueline Chan is a partner who practices primarily in food and drug (FDA) law and advertising law. She advises all sizes of companies from start-ups to global entities regulated by the Food and Drug Administration regarding regulatory compliance, potential liability, and advertising-related issues. She serves as an active member of her clients’ teams, working to find solutions to meet both legal and business goals.
She regularly counsels and advocates for food/food additive, cosmetic/personal care product, dietary supplement, medical device, pharmaceutical, tobacco, and consumer product clients on a broad range of matters including labeling and promotional activities, enforcement risk assessment and defense, FDA submissions, post-marketing obligations, state regulatory compliance, and regulatory strategy development. Ms. Chan’s practice also includes FDA due diligence investigations for transactional matters involving FDA-regulated company acquisition and divestment.
Ms. Chan currently serves on the Food and Drug Law Institute’s (FDLI) Austern Writing Awards Committee and previously served on the FDLI Publications committee and Editorial Advisory Board of FDLI’s Update magazine. She speaks and writes on various FDA law topics, including food labeling and claims substantiation, current trends in food advertising and associated challenges, novel medical device technologies including 3D printing, medical apps, and software, and medical device premarket submission pathways. She also previously served as a co-author of the American Bar Association’s Food, Cosmetics, and Nutraceuticals Committee’s FCN Digest, discussing key developments in the food, cosmetics, and nutraceuticals industry.
Super Lawyers has named Ms. Chan a “Rising Star” of the Washington, DC, metro area’s “Food & Drugs” bar.
Prior to joining the firm, Ms. Chan worked as an FDA associate at a global law firm and as a litigation associate at a D.C.-based law firm. As a litigation associate, she primarily represented FDA-regulated manufacturers in complex products liability litigations in state and federal courts across the country, including multidistrict litigations and consolidated mass tort proceedings. She also served as a law clerk for the Hon. Patrick L. Woodward of the Maryland Court of Special Appeals. Ms. Chan earned her B.A. in International Relations from the Johns Hopkins University (with honors) and her J.D. from the George Washington University Law School.
“FTC’s ‘Made In USA’ Rule Could Apply To Online Marketing,” Law360, July 2020.
“FDA Issues COVID-19 Policy Providing Temporary Labeling Flexibility to Food Manufacturers,” KKB FDA Alert, June 2020.
“It’s Not Always Easy Being Green – Lawsuit Related to ‘Recyclable’ Claims Highlights Risks Related to Environmental Benefit Claims,” KKB FDA Alert, March 2020.
“U.S. FDA and the Products it Regulates,” Contributing Author, Kirk-Othmer Encyclopedia (2019).
“Devices with Unique Issues – Combination Devices, Radiological Devices, Restricted Devices, Custom Devices, and Device Software” and “Continuing Medical Education (CME) and Industry-Supported Scientific Activities,” Chapters, PLI Medical Devices Law and Regulation Answer Book (6th Edition 2019, 5th Edition 2017).
“No Time Like the Present: FDA Issues Numerous Device-Specific Guidance Documents in 2018,” KKB FDA Alert, September 2018.
“Significant Settlements of 2017,” Chapter, Food and Drug Law Institute Top 20 Food and Drug Cases, 2017, & Cases to Watch, 2018.
“21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software, FDLI Update Medical Devices issue, March/April 2017.
“Significant Settlements 2016,” Chapter, Food and Drug Law Institute Top 20 Food and Drug Cases, 2016, & Cases to Watch, 2017.
“President Obama Signs Federal GMO Law, Preempts Vermont Law,” Food, Drugs, Medical Devices, and Cosmetics (FDA) Legal Insight (Aug. 2016).
“The Future of Medical Device Manufacturing is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing,” Food, Drugs, Medical Devices, and Cosmetics (FDA) Alert (July 2016).
“How Americans Eat: Unveiling of the New Nutrition Facts Label,” Food, Drugs, Medical Devices, and Cosmetics (FDA) Alert (June 2016).
“U.S. FDA Finalizes Medical Foods Guidance,” Food, Drugs, Medical Devices, and Cosmetics (FDA) Alert (May 2016).
“Sandoz Inc. v. Amgen Inc.,” Chapter, Food and Drug Law Institute Top 20 Food and Drug Cases, 2014 and Cases to Watch, 2015.
“Continuing Medical Education (CME) and Industry-Supported Scientific Activities,” Chapter, PLI Medical Devices Law and Regulation Answer Book 2015.
“FDA’s Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices,” Food, Drugs, Medical Devices and Cosmetics (FDA) Alert (March 2015).
“Nanomaterials: Invisible to the Human Eye but Potential for Significant Impact – U.S. FDA Issues Four Guidance Documents on Regulation of Nanotechnology in Products,” Global Food, Drug, and Medical Devices Alert (Fall 2014).
“Thirst Quencher or Meal Supplement? U.S. FDA Provides Guidance Distinguishing Conventional Beverages from Liquid Dietary Supplements,” Global Food, Drug, and Medical Devices Alert (Spring 2014).
“Mutual Pharmaceutical Company v. Bartlett,” Chapter, Food and Drug Law Institute Top 20 Food and Drug Cases, 2013 and Cases to Watch, 2014.
“Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies,” Food, Drugs, Medical Devices, and Cosmetics (FDA) Legal Insight (Nov. 2013).
“Caffeinated Energy Drinks – U.S. Perspective,” Global Food, Drug, and Medical Devices Alert (Fall 2013).
Discussion Leader, “What’s in a Name? Labeling of Plant-Based Foods,” FDLI Law Over Lunch (August 2020).
Presenter, “Overview of Food Law and Regulation” and “Food Facility Registration,” FDLI Introduction to Food Law and Regulation Course (March 2020).
Co-Presenter, “Telemedicine and Telehealth: An Ever-Changing Opportunity and Regulatory Landscape,” Sponsored by the DC Bar Health Law Community (April 2019).
Presenter, “Food Labeling: Nutrient Content Claims, Health Claims, and Other Claims,” FDLI Introduction to Food Law and Regulation Course (March 2019).
Presenter, “Overview of Medical Device Law and Regulation” and “Organizational Structures,” FDLI Introduction to Medical Device Law Course (April 2017).
Panelist, “FDA’s 510(k) Premarket Notification Program,” The Center for Professional Advancement (Jan. 2015).
Presenter, “Overview of Medical Device Law and Regulation,” Food and Drug Law Institute’s Introduction to Medical Device Law and Regulation Course (May 2014).