DEEPTI KULKARNI is a partner in the Food, Drug and Medical Device Regulatory practice, who counsels clients on a wide range of matters involving FDA regulatory issues. Since joining Sidley from the FDA’s Office of Chief Counsel in 2015, Deepti has focused her practice on assisting clients in launching their products and complying with regulatory requirements for foods and dietary supplements, animal products, medical devices, and prescription and OTC drugs. In addition, she 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 food companies with respect to requirements under the FDA Food Safety Modernization Act (FSMA);
- Advising clients on issues involving FDA issuance of Emergency Use Authorizations (EUAs) for medical products;
- 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;
- Providing strategic advice on matters involving FDA advisory committees, including requirements under the Federal Advisory Committee Act (FACA) and FDA’s implementing regulations;
- Counseling on issues related to the import and export of FDA-regulated products, including products under import alert 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.
Prior to joining Sidley, Deepti served as an Associate Chief Counsel in the FDA’s Office of Chief Counsel from 2009 to 2015. While at FDA, Deepti counseled various components of FDA and HHS on a broad scope of issues related to conventional foods, dietary supplements and animal products, as well as cross-product matters involving advisory committees, imports/exports and constitutional issues. Deepti received several individual and group awards during her time at the FDA, including the FDA Award of Merit (FDA’s highest award), Commissioner’s Special Citation, 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 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.