Abhishek Gurnani is a Member at Amin Talati & Upadhye. Mr. Gurnani provides regulatory, transactional and litigation services to food, drug, dietary supplement, medical device, and cosmetic companies.
Mr. Gurnani primarily advises companies on legal and regulatory matters relating to the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), United States Customs, United States Department of Agriculture (USDA) and other federal and state regulatory agencies. Mr. Gurnani regularly assists clients with drug and medical device listings, food, drug and medical device facility registrations, 510k medical device submissions, new dietary ingredient notifications, FDA detentions, FDA Import Alerts, FDA warning letters and Form 483 observations, FTC, NAD, and State substantiation inquiries, as well as a variety of other regulatory matters involving FDA, FTC, USDA, U.S. Customs and EPA.
Mr. Gurnani previously clerked for the Illinois State Department of Professional Regulation where he assisted Department attorneys with medical and health related prosecutions.
J.D., The John Marshall Law School
B.S., Biomedical Engineering, University of Illinois at Chicago
A. Talati and A. Gurnani. “Chapter 33: Dietary Supplements and Homeopathic Products.” (Update) Fundamentals of Regulatory Affairs (9th Edition), Regulatory Affairs Professional Society, 2015. 395-418.
A. Gurnani. “Bayer, FTC Clash Over Advertising Claims.” Natural Products Insider. November/December 2014.
A. Gurnani. “The Importance of Quality Control Agreements in the Dietary Supplement Industry.” Natural Products Insider. September/October 2014.
A. Gurnani. “Structure/Function Claims and Other Claim Notifications: An Achilles Heel for Industry.” Natural Products Insider. September/October 2014.
A. Gurnani. “Treading the Clean Label Trend.” Natural Products Insider. July/August 2014.
A. Gurnani. “FSMA Gives FDA Emergency Access to Records.” Natural Products Insider. May/June 2014.
A. Gurnani. “FDA Showcases Mandatory Recall Powers Under FSMA.” Natural Products Insider. January/February 2014.
A. Talati and A. Gurnani. "FDA Issues Controversial Draft Guidance on New Dietary Ingredients. Food Drug Law Institute. Update Magazine. March/April 2012.
A. Talati and A. Gurnani. "Chapter 8: New Dietary Ingredients." The FDA Food Safety Modernization Act: A Comprehensive, Practical Guide to the Landmark Legislation. Washington, D.C.: Food and Drug Law Institute, 2012. 137-57.
A. Talati and A. Gurnani. "Dietary Supplement Adverse Event Reports: Review and Analysis." Food Drug Law J. 2009;64(3):503-13.
A. Talati and A. Gurnani. "The World's Most Trusted Article on Puffery" : Non-Actionable Puffery or Misleading? Food and Drug Law Institute. Update Magazine. Issue 6 (2008).