DEEPTI KULKARNI provides strategic advice to clients on a wide range of complex matters involving FDA and USDA regulatory oversight. Drawing from over 17 years of experience working in both FDA’s Office of Chief Counsel and private practice, Deepti advises companies developing and marketing foods, dietary supplements, cosmetics, and animal health products at nearly every step of the product lifecycle. She works closely with clients to develop and execute strategies to satisfy regulatory requirements and mitigate enforcement and litigation risk while also meeting key commercial goals.

Deepti’s recent representations include:

Providing strategic regulatory counsel to companies developing alternative proteins and other food and color ingredients using precision fermentation, biotechnology, and plant, microbial, and animal cell culture technologies.
Counseling clients that are developing food and agricultural products using synthetic biology, gene editing and biotechnology with respect to FDA, USDA and EPA oversight under federal statutes described in the Coordinated Framework.
Advising clients on new product launches, product formulation, labeling and marketing, and distribution of conventional foods, dietary supplements, medical foods, infant formula, pet food, and animal feed.
Advising animal drug companies on FDA requirements pertaining to drug development and approval, product classification, and marketing.
Counseling clients on measures to protect trade secret and confidential commercial information in FDA submissions, in accordance with the Freedom of Information Act (FOIA), Trade Secrets Act and FDA’s implementing regulations.
Counseling on issues related to the import and export of FDA- and USDA-regulated products, including products under import detention and products requiring export certification by foreign governments.

Advising private equity, venture capital, and other investors on regulatory due diligence relating to the manufacture, distribution, and marketing of foods, dietary supplements, and animal feed and health products. Deepti previously served as an Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, she counseled various components of FDA and HHS on a broad scope of issues related to foods, dietary supplements, cosmetics, and animal health products as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. She also played a key role in the development and implementation of regulatory frameworks for foods and other products developed using biotechnology, gene editing, and other new and emerging technologies.

Deepti received several awards during her time at the FDA, including the FDA Award of Merit (FDA’s highest award), Commissioner’s Special Recognition Award, and the CFSAN Director’s Special Citation Award.

In recognition of Deepti’s success in complex regulatory matters, she was named “US Rising Star – Regulatory” by LMG Life Sciences in 2020 and a “D.C. Rising Star” by the National Law Journal in 2019. Deepti also was named to The Daily Record’s list of “Leading Women” in 2015, which honors women 40 years old or younger from the Maryland legal and business community “who are at the pinnacle of their career and making a sustained impact” in their field and community.