Abhishek K. Gurnani

Partner

About Abhishek K. Gurnani

Food, beverage, cosmetic, and nutritional supplement companies facing adversarial challenges from regulatory agencies turn to Abhishek Gurnani, the leader of Amin Wasserman Gurnani’s FDA practice. Abhishek represents a wide variety of health and wellness-focused companies addressing issues such as quality control, recalls, government investigations and class actions, as well as dealing with matters before the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), United States Customs, and the United States Department of Agriculture (USDA).

Clients value his counsel based on the high volume of matters he handles in this sphere, his frequent communications within these agencies, and his impressive record of positive results. Clients commend Abhishek’s strong research, analytical, and writing skills, and also appreciate his exceptional strategic, legal and business judgment. Abhishek has been recognized in 2016, 2017, 2018, and 2019 as a Rising Star by Illinois Super Lawyers for exceptional practice in the field of Food & Drug law.

Abhishek focuses primarily on advising companies on legal and regulatory matters and disputes with federal and state regulatory agencies. He is in frequent communication with regulators on client issues such as investigations, facility registrations, 510k medical device submissions, new dietary ingredient notifications (NDIs), FDA detentions, Import Alerts, Warning Letters and FDA Form 483 Observations. He also leads the firm’s U.S. Customs practice and assists companies with detentions and seizure matters.  Abhishek also regularly assists with due diligence reviews and regulatory aspects of Mergers & Acquisitions.

With a background in science and biomedical engineering, Abhishek is comfortable with the highly complex data, analyses and conversations necessary to enable his clients to successfully navigate the regulatory landscape. His in-depth knowledge of new foods like CBD, raw juice, nutraceuticals, and homeopathic products has gained him a reputation in these rapidly evolving markets. He also co-authored a chapter on the subject in the legal treatise Fundamentals of Regulatory Affairs (9th Edition) along with several other publications, and he speaks on these topics at industry conferences and associations.

Prior to joining Amin Wasserman Gurnani, Abhishek clerked for the Illinois State Department of Professional Regulation where he assisted Department attorneys with medical and health-related prosecutions.