Government Experience

  • Regulatory Counsel, U.S. Food and Drug Administration

Bar Admissions

  • District of Columbia
  • Maryland

Education

  • M.P.H., UCLA, 2009
  • J.D., American University, Washington College of Law, 1999
  • B.S., University of California, Riverside, 1994
T +1 202.344.4677
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Heili Kim

Partner

Heili Kim is partner in Venable’s Regulatory Group where she advises food, dietary supplement, cosmetic and other companies in areas of regulatory compliance and advertising tied to the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Heili began her career as regulatory counsel at the FDA, Center for Food Safety and Applied Nutrition (CFSAN) and has established herself in public and private practice in that field for nearly 20 years. She counsels clients, especially food companies, with ingredient and product evaluation, claims substantiation and advertising, and risk analysis based on current FDA and FTC policies.

Having previously worked at the largest law firm in Seoul, South Korea, Heili regularly interfaced with business executives and foreign diplomats regarding the business environment in the Asia Pacific region. She advised large multinational companies with interests in Asia on all aspects of the South Korean market – from establishing an entity to overcoming barriers to gaining market access including product approvals and other compliance barriers.  Additionally, Heili has guided companies through competition and anti-corruption laws – which remain critical components of doing business in Asia – by ensuring that proper internal business practices are maintained.

With her understanding of the domestic and international regulatory and business environments, Heili provides experienced, practical legal advice for companies in the U.S. and those considering or maneuvering in the Asia Pacific region. 

Significant Matters

  • As lead counsel, Heili assisted a large multinational food ingredient company during an international recall of product that may have been contaminated with a pathogen and which spanned four continents and triggered review by local and international food safety and health agencies.
  • As lead counsel, Heili advised a large multinational food company on manufacturing issues and assisted bringing the facility into compliance, recalling products at the retail level, and crisis management communications in Korea.