Education

J.D., Harvard Law School (cum laude)
B.A., Emory University (magna cum laude, phi beta kappa)
Hebrew University, Jerusalem

Clerkships

Law Clerk for the Honorable Alexander B. Denson, United States District Court of the Eastern District of North Carolina

Admissions

Washington, D.C.

Overview

Stacy Ehrlich draws on more than 25 years of experience to counsel her clients in the pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device industries on regulatory and advertising law matters. In particular, Stacy provides practical, creative, and strategic advice to help clients achieve their business goals in compliance with laws and regulations implemented and enforced by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and related federal, state, and local agencies. These matters include rulemaking and guidance development proceedings, premarket submissions, enforcement actions, legal challenges to agency action, advertising and labeling copy and claim substantiation, and expert due diligence.

Stacy serves as outside counsel for the Coalition of Independent Tobacco Manufacturers of America (CITMA), and has been extensively involved  FDA’s regulation of tobacco  and nicotine products since the early legislative process of the Family Smoking Prevention and Tobacco Control Act.

A prolific author and speaker, Stacy is frequently called upon to educate others on topics of food and drug law, including OTC drug and dietary supplement labeling and marketing and nicotine and tobacco product regulation and enforcement. She has also regularly authored chapters in the Food and Drug Law Institute (FDLI) publications, Food and Drug Law & Regulation, How to Work with the FDA, and Top 20 Food and Drug Cases & Cases to Watch.

Stacy has served on the Board of Directors of FDLI and has consistently been recognized for excellence in FDA Law by The Best Lawyers in America© and Super Lawyers©..

Prior to joining KKB, Stacy clerked for the Honorable Alexander B. Denson in the United States District Court of the Eastern District of North Carolina and practiced food and drug law at a large DC-based international law firm.

Experience

Representative experience:

  • Assisted clients with obtaining FDA marketing authorization for tobacco products, medical devices, and drugs.
  • Advised clients regarding labeling and marketing materials for cosmetics, tobacco products, over-the-counter drugs, foods, and dietary supplements.
  • Assisted clients with responses to FDA warning letters and 483 notices of inspectional observations.
  • Submitted comments to FDA rulemaking and guidance document dockets.
  • Submitted citizen petitions to FDA.
  • Conducted FDA expert due diligence review for corporate transactions.
  • Worked on an emergency use authorization (EUA) for a COVID-19-related product.
  • Advised clients regarding the marketing of hand sanitizers and masks during the COVID-19 pandemic.
  • Assisted clients with prescription-to-over-the-counter switch applications.
  • Outside counsel to a tobacco industry trade association.

Publications & Speaking Engagements

Recent Publications

  • “U.S. FDA and the Products it Regulates,” Co-Author, Kirk-Othmer Encyclopedia (2019).
  • “Cigar Association of America et al. v. FDA et al.,” Co-Author, FDLI Top Food and Drug Cases, 2018, & Cases to Watch, 2019 (2019).
  • “JUUL in Schools: Can FDA Close the Youth On-Ramp While Still Maintaining the Off-Ramp for Adult Smokers?,” FDLI Update Magazine, Oct. 2018.

Recent Speaking Engagements

  • Closing panel, Speaker. Global Tobacco & Nicotine Forum (GTNF) 2020, September 24, 2020.
  • “Premarket Tobacco Product Applications (PMTAs) and the Impending Deadline,” Moderator. FDLI webinar, June 24, 2020.
  • “Nicotine: What it Is, What it Does, and How to Effectively Communicate this Information to the Public,” Moderator. FDLI webinar, Feb. 18, 2020.
  • “The Looming Premarket Submission Deadline for Deemed Tobacco Products: The Road Ahead,” Moderator. FDLI Enforcement, Litigation, and Compliance Conference, Dec. 11, 2019 .
  • “Ongoing Litigation – Updates & Debrief,” Panelist. ENDS US 2019 | Exploring the Electronic Nicotine Delivery Systems Industry, Dec. 10, 2019.
  • “Risk Communication to Adults: How Should Relative Risk Be Conveyed?,” Moderator. Tobacco and Nicotine Products Regulation and Policy Conference, Oct. 24, 2019.
  • “The Elephant in the Room: Tobacco-Free Nicotine,” Speaker. Vapor Technology Association Annual Conference, Sept. 16, 2019.
  • “Electronic Nicotine Delivery Systems: Regulation to Prevent Youth Initiation and Use,” Moderator. FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law, May 3, 2019.
  • “FDA’s regulatory approach to addressing youth appeal and access: How should FDA close the on-ramp for youth while maintaining the off-ramp for adult smokers?,” Panelist. The E-Cigarette Summit: Science, Regulation & Public Health, April 29, 2019.
  • “Tobacco Enforcement Challenges and Recent Actions,” Moderator. FDLI Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries, Dec. 12, 2018.
  • “Risk Communications: Educating the Public About Harm Reduction,” Moderator. FDLI Tobacco Products Regulation and Policy Conference, Oct. 26, 2018.

Recognition & Professional Activities

Recognition

  • 2020 Super Lawyers, Food & Drug
  • Martindale-Hubbell AV Preeminent, 2014-Present
  • Best Lawyers in America, FDA Law, 2014-Present

Professional Activities

  • Board of Directors, Food and Drug Law Institute (FDLI), 2014-2019

News

  • Kleinfeld, Kaplan & Becker Attorneys Selected to the 2021 Washington, D.C., Super Lawyers List - November 19, 2020
  • KKB Partner Stacy Ehrlich to Moderate Panel at 2020 FDLI Tobacco and Nicotine Products Regulation and Policy Conference - October 21, 2020
  • KKB Partner Stacy Ehrlich to Speak at Global Tobacco & Nicotine Forum Annual Conference - September 21, 2020
  • Kleinfeld, Kaplan and Becker, LLP, Attorneys Recognized in “Best Lawyers” Rankings - August 20, 2020
  • Kleinfeld, Kaplan & Becker Well Represented on the Washington, DC, 2020 Super Lawyers List for “Food and Drugs” - April 23, 2020
  • KKB Partner Stacy Ehrlich to Moderate FDLI Webinar on Nicotine - February 17, 2020
  • Kleinfeld, Kaplan and Becker, LLP Recognized “Best Law Firms” and “Best Lawyers” Rankings - November 7, 2019
  • Kleinfeld, Kaplan and Becker, LLP Recognized “Best Law Firms” and “Best Lawyers” Rankings - December 12, 2018
  • KKB Attorneys Author Chapters in FDLI “Top Cases” Publication - May 11, 2018
  • With 55% Market Share and the Creation of a New Verb (“JUULing”), JUUL is Now at the Center of a Firestorm (Vaporstorm?) of Attention - April 30, 2018
  • KKB Partner Stacy Ehrlich Featured in Washington Lawyer Article - January 9, 2018
  • Strong Medicine? After Decades of Diluted Enforcement, FDA Issues Draft Guidance Announcing New Enforcement Policy for Homeopathic Drugs That Takes a Risk-Based Approach - December 19, 2017
  • KKB Lawyers Recognized in 2018 Edition of “Best Lawyers in America” - October 2, 2017
  • FDA’s New Plan for Tobacco and Nicotine Regulation - August 3, 2017
  • KKB Partners Present VTA Webinar on E-Liquid Ingredient Listings - February 11, 2017
  • STACY EHRLICH TO PRESENT AT THE 2016 ANA/BAA 38th MARKETING LAW CONFERENCE - October 10, 2016
  • Stacy Ehrlich to Present at Vapor Technology Association Conference - June 7, 2016
  • Stacy Ehrlich to Participate in Two-Part FDLI Webinar Series on FDA Deeming Regulations - June 7, 2016
  • Stacy Ehrlich to Participate in American Enterprise Institute Panel Discussion - May 29, 2016
  • Stacy Ehrlich to Moderate Panel at FDLI Annual Conference - April 11, 2016
  • Stacy Ehrlich Joins FDLI Board - January 1, 2016
  • Stacy Ehrlich to Speak at SFATA - April 30, 2015
  • Education

    J.D., Harvard Law School (cum laude)
    B.A., Emory University (magna cum laude, phi beta kappa)
    Hebrew University, Jerusalem

    Clerkships

    Law Clerk for the Honorable Alexander B. Denson, United States District Court of the Eastern District of North Carolina

    Admissions

    Washington, D.C.