David R. Joy

David Joy counsels clients in a broad range of food and drug regulatory matters. He has extensive experience in pharmaceutical regulation and in the regulation of food additives, ingredients, and food labeling, including nutrition labeling and health claims, medical devices, and drug/device combination products.

He began his career on Keller and Heckman’s scientific staff, then worked as a law clerk, Associate, and Partner with the firm before taking a position with the U.S. Food and Drug Administration (FDA) in 2008.

David has a deep understanding of the inner workings of FDA, which stems from working for almost 15 years in the Office of Regulatory Policy (ORP) in FDA’s Center for Drug Evaluation and Research, serving as Director of ORP’s Division of Regulatory Policy IV for six years. At FDA, David was involved in a wide variety of regulatory policy matters, including drug approvals and withdrawals of approval, accelerated approval and other expedited programs, drug establishment registration and listing, inactive ingredient review and labeling, drug advertising and promotion, FDA’s post-approval drug safety authorities, the regulation of drug/device combination products, and the drug/device jurisdictional boundary. In 2014, David served as a senior policy analyst in FDA’s Europe office during a 3-month detail and participated in discussions with the European Medicines Agency on the Mutual Reliance Initiative.

In 2023, David re-joined Keller and Heckman, where he advises clients on food additives, dietary supplements, drugs, and medical devices, including premarket clearance requirements and advertising and labeling provisions applicable to these products. Additionally, he helps clients navigate the Generally Recognized as Safe (GRAS) determination process and provides advice on the regulation of antimicrobials used in food and non-food applications.

In addition to FDA issues, David assists clients with matters related to the U.S. Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA).

David’s extensive knowledge of law and science, combined with his understanding of agency dynamics, allows him to thoroughly assist clients with their regulatory needs.

Awards

•Commissioner’s Award of Excellence, Member of Pandemic and All-Hazards Preparedness Act Reauthorization Work Group
•Commissioner’s Special Citation, Member of the Opioids SUPPORT Act Team
•FDA Group Recognition Award, Member of the Expedited Program for Serious Conditions Draft Guidance Working Group
•CDER Team Excellence Award, Gluten in Drug Products Working Group

Insights & In the News

A Quick Take on FDA’s New Draft Accelerated Approval Guidance for Drug Products

12.16.2024
Publication

FDA Issues Revised Guidance on the Control of Nitrosamine Impurities in Human Drugs

09.24.2024
Publication

FDA Issues Final Rule Overhauling Regulation of Medical Gases

06.20.2024
Publication

Best Law Firms Features Keller and Heckman in 2026 Edition

Press Release
11.06.2025