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Deepti A. Kulkarni

Partner

Washington +1 202 662 5376

  • About
  • Representative Matters
  • Credentials
  • About

    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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advised on matters involving the promotion and labeling of conventional foods, dietary supplements, medical foods, infant formula, pet food, and animal feed.
    • Advised animal drug companies on FDA requirements pertaining to drug development, product classification, and marketing.
    • Provided strategic regulatory counsel to companies developing alternative proteins using plant, microbial, and animal cell-based technologies.
    • Counseled 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 as well as product labeling under the Disclosure Standard.
    • Counseled 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.
    • Counseled 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.
    • Assisted clients in responding to inquiries from FDA, USDA, and state public health departments, and drafting comments in response to FDA and USDA regulatory actions.

    Areas of Expertise

  • Credentials
    Education
    • University of Maryland School of Law, J.D., 2008
        • Editor-in-Chief, Journal of Health Care Law & Policy
    • University of Maryland, B.S., 2003
    Bar Admissions
    • District of Columbia
    • Maryland
    Government Experience
    • U.S. Department of Health and Human Services – Food and Drug Administration
    Accolades
    • Food and Drug Administration:
      • Award of Merit (FDA’s highest award)
      • Commissioner’s Special Recognition Award
      • CFSAN Director’s Special Citation Award
    • LMG Life Sciences, “US Rising Star” – Regulatory (2020)
    • National Law Journal, "D.C. Rising Star" (2019)
    • 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.
    Memberships and Affiliations
    • Deepti serves as an Adjunct Professor of Law at Georgetown Law School where she teaches Food and Drug Law.
    • Advisory Board for Future Food Tech
    • Board of Directors, Women’s Law Center of Maryland (2009-2015)
    Previous Experience
    • Associate Chief Counsel in the Food and Drug Administration’s Office of Chief Counsel

    Areas of Expertise

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