Kelly L. Lightfoot is a food and drug associate with Fuerst Ittleman. She focuses her practice in the areas of food and drug law, assisting clients with regulatory and legal compliance issues involving the U.S. Food and Drug Administration, the Federal Trade Commission and other federal, state and local authorities.
Ms. Lightfoot 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, importation and exportation, distribution, and marketing.
In her practice at Fuerst Ittleman, Ms. Lightfoot has conducted numerous reviews of dietary supplement, cosmetic, and OTC drug product labels and websites to ensure compliance with all FDA and FTC regulations. She has drafted standard operating procedures (SOPs) for a wholesaler of active pharmaceutical ingredients (APIs) in conformity with state and federal statutes and regulations and third-party standards. Ms. Lightfoot has drafted legal opinions on compliance and regulatory issues involving dietary supplements, medical devices, and food products.
Ms. Lightfoot has also effectively assisted clients with the release of FDA-regulated products detained upon importation into the United States. Ms. Lightfoot has successfully petitioned the FDA for removal of a food manufacturer from multiple FDA Import Alerts to prevent the detention of imported products. Additionally, Ms. Lightfoot has helped clients that received FDA Warning Letters issued for violations of the Federal Food, Drug, and Cosmetic Act to successfully respond to the FDA and address the claimed violations. She is also well-versed in FDA inspections of manufacturing and distribution facilities and has advised clients in responding to FDA Form 483 observations.
Ms. Lightfoot is involved in representing clients in litigation and administrative proceedings with the FDA and FTC. In addition, she has represented clients in administrative proceedings in various matters in front of state health departments.
Additionally, Ms. Lightfoot is experienced in representing clients in customs and import matters involving medical devices, food products, and other merchandise. Ms. Lightfoot has done additional work in the areas of corporate law, tax law, health care law, and litigation.
Ms. Lightfoot is from Columbus, Ohio and earned her bachelor's degree in English from The Ohio State University. Ms. Lightfoot graduated 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 and health enthusiast.
Position:
Associate
Office:
Miami
1001 Brickell Bay Drive
32nd Floor
Miami, FL 33131
Phone:
305.350.5690
Email:
klightfoot@fuerstlaw.com
Practice Areas:
Food and Drug Law
Customs, Import, and Trade
Administrative Law
Agricultural Law
Federal Regulatory Law
Education:
Cleveland-Marshall College of Law, Cleveland State University
Cleveland, Ohio
J.D., 2009
The Ohio State University
Columbus, Ohio
B.A., 2006
Admitted:
Florida 2009
