Kelly L. Lightfoot

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Kelly Lightfoot Feuer is a regulatory attorney with Fuerst Ittleman David & Joseph, PL’s Food, Drug, and Life Sciences practice group. She focuses her practice in the areas of food, device, and drug law, assisting clients regulated by the U.S. Food and Drug Administration, the Federal Trade Commission and other federal, state and local authorities. Learn More

Overview

Ms. Feuer has extensive experience representing clients in various federally regulated industries, including the medical device, food, dietary supplement, cosmetic, veterinary products, over-the-counter (OTC) drug, and human cells, tissues, and cellular and tissue-based products (HCT/Ps) industries. She has assisted clients with product development, formulation, manufacture, advertising, agency clearance or approval, importation and exportation, distribution, and marketing.

As the senior associate in the firm’s Life Sciences practice group, Ms. Feuer frequently works with clients in the medical device, drug, and biologics industries in the development, approval, and marketing of their products in the United States and abroad. She assists clients with 510(k) submissions and assessing whether medical devices require FDA approval or clearance. Ms. Feuer advises clients in the biotechnology industry on clinical trial regulations, including issues related to informed consent, IRB supervision, investigator/sponsor responsibilities, and financial disclosures. For clients wishing to open clinics and facilities outside of the United States, Ms. Feuer has counseled clients on the medical tourism issues that arise when advertising or promoting foreign services or treatments in the United States as well as issues pertaining to transport of FDA-regulated products or materials to and from the United States.

Ms. Feuer regularly advises international and domestic clients on import and export issues. She has effectively assisted clients with the successful release of FDA-regulated products detained upon importation into the United States. Ms. Feuer has efficaciously assisted her clients importing products to the United States in handling FDA Import Alerts and product refusals.

Additionally, Ms. Feuer is experienced in managing FDA enforcement actions. She has represented clients receiving FDA Warning Letters issued for violations of the Federal Food, Drug, and Cosmetic Act. She has drafted responses to Warning Letters, Untitled Letters, and represented clients in dispute resolution hearings with the FDA. She is also well-versed in FDA inspections of manufacturing and distribution facilities and has advised clients in responding to FDA Form 483 observations.

In her food and drug practice, Ms. Feuer has conducted numerous reviews of dietary supplement, cosmetic, and OTC drug product labels, websites, and advertisements to ensure compliance with FDA and FTC regulations. Ms. Feuer provides her clients with legal advice pertaining to branding, market strategy, and social media to aide her clients in promoting FDA-regulated products while maintaining compliance with federal advertising regulations.

Ms. Feuer is from the Columbus, Ohio area and earned her Bachelor of Arts degree from The Ohio State University. Ms. Feuer earned her juris doctorate from Cleveland-Marshall College of Law where she successfully represented clients in unemployment compensation hearings as part of her school’s Employment Law Clinic. She also served as an intern with the Ohio Attorney General’s Office in the Collections Enforcement section. She is an avid runner, animal lover, and health enthusiast.

Credentials

Education 

  • Cleveland-Marshall College of Law, Cleveland State University Cleveland, Ohio J.D.
  • The Ohio State University Columbus, Ohio B.A.

Admitted

  • Florida

Memberships

  • President, Organization of Women in International Trade-South Florida
  • Co-Editor, Food, Cosmetics and Nutraceuticals Committee Newsletter
  • Member, The Ohio State University Alumni Association
  • Member, Aventura Turnberry Jewish Center
  • Member, Kappa Delta Sorority Alumnae Association

Publications

Publications and Events

  • Speaker, “Regenerative Medicine: Understanding the Regulatory Landscape,” Life Science Training Institute, Webinar, July 21, 2016
  • Authored, “Upcoming Compliance Deadline: FDA’s Electronic Requirements for Medical Device Reports,” Pharmaceutical Compliance Monitor, (July 3, 2015).
  • Authored, “FDA’s New HCT/P Draft Guidance Document: What is Minimal Manipulation in 2015?,” Drug Discovery & Development, (June 30, 2015).
  • Authored presentation materials, “Europe vs. U.S. Food, Drug, Device, & Tobacco Regulation & Policy: Emerging Issues and Comparative Analysis,” FDLI Brussels Conference (November, 2014).
  • Moderated, “FDLI’s Emerging Issues and New Frontiers for FDA Regulation – An FDLI Symposium in Partnership with Harvard Law School,” Medical Tourism Panel, (October, 2014)
  • Authored, “Beverage Products: What’s the Difference Between Conventional Foods and Dietary Supplements?,” Food, Cosmetics and Nutraceuticals Committee Newsletter, (Fall 2013).
  • Co-authored, “Chapter XII – FDA Enforcement Actions: Potential Consequences of Non-Compliance” in FDLI Primer FDA’s Regulation of Veterinary Drug Products, (2013).
  • Authored presentation materials, “U.S. Food and Drug Administration Regulatory Guidelines,” American Academy of Cosmetic Surgery (March, 2012).
  • Co-authored, “Medical Device Dispute Resolution: Administrative and Judicial Options,” South Florida Legal Guide, (December, 2011).
  • Co-authored presentation materials, “Applying FDA Laws and Regulations to Autologous Stem Cell Therapies,” International Cellular Medicine Society: 2nd Annual Congress on Regenerative and Cell-Based Medicine (November, 2010).