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Deepti Kulkarni

Drawing from over a decade of experience working in both FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of complex matters involving FDA and USDA regulatory oversight. She has played a key role in the development and implementation of the regulatory frameworks for alternative proteins as well as bioengineered food and agriculture products.

Deepti advises companies developing and marketing animal products, foods, dietary supplements, and cosmetics at nearly every step of the product lifecycle. She also counsels clients on potential crises, such as product recalls, import refusals, and other regulatory actions.

Deepti previously served as an Associate Chief Counsel in the 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 animal products, foods, dietary supplements, and cosmetics, 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.

On October 13, 2023, the Food and Drug Administration (FDA) announced that the guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry,” originally released as draft guidance on September 13, 2022, has been made final. FDA received no comments on the draft guidance, and as a result

On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the redesign “transformative” and believes the