Jacqueline J. Chan draws on her significant experience in regulatory and advertising law to advise U.S. Food and Drug Administration (FDA)-regulated companies of all sizes from start-ups to global entities. As an active member of her clients’ teams, Jackie’s clients know they can trust her to find practical, creative, and risk-based solutions to meet their legal and business goals. She counsels her clients throughout the product lifecycle, including related to labeling, advertising and promotion, enforcement and litigation risk assessment, post-marketing obligations, agency submissions, and regulatory strategy and compliance. In particular, her work focuses on the laws and regulations implemented and enforced by the FDA, U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), and related federal, state, and local agencies.
Using her knowledge of today’s litigation and regulatory trends, Jackie works closely with her clients as they develop new products, label claims, promotional campaigns, and advertising materials. She provides training sessions to clients on labeling, marketing, and claim substantiation and helps them navigate marketing through digital ads, social media, and influencers. She counsels clients in developing strategies related to evolving regulatory and policy issues, including drafting comments and responses to agency rulemaking and inquiries. In addition, Jackie assists clients in their interactions with FDA and certifying bodies, including related to voluntary recalls, warning letters, 510(k) clearances, food ingredient submissions, and organic certifications. She further handles regulatory due diligence investigations for transactional matters involving FDA-regulated company acquisition and divestment.
Jackie 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 is a frequent speaker and author on various FDA and advertising law topics, including the basics of food law, food labeling and claims substantiation, current trends in food advertising and associated challenges, plant-based foods and standards of identity, “green” claims, and novel medical device technologies including telemedicine, medical apps, and software. She has also served as a co-author of the American Bar Association’s Food, Cosmetics, and Nutraceuticals Committee’s FCN Digest, where she discussed key developments in the food, cosmetics, and nutraceuticals industry.
Before joining KKB, Jackie 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.
Publications & Speaking Engagements
“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 (7th Edition 2021, 6th Edition 2019, 5th Edition 2017).
“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 Insight, June 2020.
“It’s Not Always Easy Being Green – Lawsuit Related to ‘Recyclable’ Claims Highlights Risks Related to Environmental Benefit Claims,” KKB Insight, March 2020.
“U.S. FDA and the Products it Regulates,” Contributing Author, Kirk-Othmer Encyclopedia (2019).
“No Time Like the Present: FDA Issues Numerous Device-Specific Guidance Documents in 2018,” KKB Insight, 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).
Moderator, “What’s in a Name? How Plant-Based Products are Transforming the Market,” FoodBev Exchange (October 8, 2020).
Discussion Leader, “What’s in a Name? Labeling of Plant-Based Food Products,” 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).
Recognition & Professional Activities
- Food and Drug Law Institute (FDLI), Food and Dietary Supplement Safety and Regulation Conference Planning Committee (2021)
- FDLI Austern Writing Awards Committee (2020)
- FDLI Publications Peer Review Committee (2018-2019)
- FDLI Update Magazine Editorial Advisory Board (2015-2017)
- Co-Editor, FCN Digest, American Bar Association, Food, Cosmetics and Nutraceuticals Committee
- Johns Hopkins University Second Decade Society (SDS)
B.A., Johns Hopkins University (with honors)
Law Clerk for the Honorable Patrick L. Woodward, Maryland Court of Special Appeals