DEEPTI KULKARNI provides strategic advice to clients on a wide range of complex matters involving FDA and USDA regulatory oversight. Drawing from over a decade of experience working in both FDA’s Office of Chief Counsel and private practice, Deepti advises companies developing and marketing foods, agricultural products, dietary supplements, cosmetics, and medical products, at every step of the product lifecycle. She also counsels clients on potential crises, such as product recalls, import refusals and other regulatory actions.
Deepti’s recent representations include:
- Providing strategic regulatory counsel to companies developing alternative proteins using plant, microbial and animal cell-based 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 animal drug companies on FDA requirements pertaining to drug development, product classification, and marketing;
- Advising on matters involving the promotion and labeling of conventional foods, dietary supplements, medical foods, pet food and animal feed;
- 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; and
- Assisting clients in responding to inquiries from FDA and state public health departments, and drafting comments in response to FDA regulatory actions.
Before joining Sidley in 2015, Deepti served as an Associate Chief Counsel in the FDA’s Office of Chief Counsel for several years. While at FDA, Deepti counseled various components of FDA and HHS on a broad scope of issues related to foods, dietary supplements and animal products, as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. 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.