Overview

Product safety and compliance are Heili Kim’s priorities. She blends inside knowledge from her role as regulatory counsel for the Food and Drug Administration (FDA) with business pragmatism and international perspective to guide food, dietary supplement, cosmetic and medical device clients on regulatory issues and advertising. She seeks to understand each client’s risk tolerance, objectives and goals to provide client-focused advice that will help the company thrive.

Regulatory Compliance

Heili collaborates with companies whose products are regulated by the FDA to evaluate ingredients and products and assess risk based on FDA policy. As clients launch new food, supplement, cosmetic, medical device and agricultural products, Heili assists with product classification, counsels on feasibility for market entry and advises on best practices for obtaining FDA approval. With knowledge and perspective on the entire product life cycle, she provides valuable insight on compliance with requirements from the FDA, Department of Agriculture (USDA), and Food Safety and Inspection Service (FSIS).

When product complaints and challenges arise, Heili represents clients in responding to agency enforcement actions and assists with litigation related to the Federal Food, Drug and Cosmetic Act.

Heili began her legal career as regulatory counsel with the FDA Center for Food Safety and Applied Nutrition (CFSAN), where she developed, drafted and reviewed food and nutrition regulations. Armed with this insight, she trains company leadership and employees on regulatory best practices and compliance issues.

Marketing & Advertising

Heili offers specialized knowledge on marketing and advertising regulations for food and health care products. When companies take products to market, she helps them navigate Federal Trade Commission (FTC) standards for substantiating marketing claims as well as requirements from the National Advertising Division of the Better Business Bureau and state and local regulators.

Heili defends challenges by private litigants and class action plaintiffs related to product claims and advertising.

International Experience

Beyond the U.S., Heili offers international insight on obtaining product approvals, gaining market access and overcoming compliance challenges. She spent three years in private practice in South Korea, where she counseled multinational pharmaceutical, medical device and food companies on corporate matters, product approval and pricing, compliance, post-marketing requirements, advertising and government relations. She is experienced in handling international recalls and confidently communicates with regulatory authorities around the world.

Health Policy

In addition to her private practice and FDA career, Heili spent time as a health policy analyst in California, where she executed federal, state and local policy objectives for a health care nonprofit funded by the U.S. Centers for Disease Control and Prevention and forged coalitions to impact government policy.

Credentials

Bar Admissions

District of Columbia
Maryland

Education

University of California, Los Angeles (UCLA)
M.P.H. in Public Health (2009)

American University Washington College of Law
J.D. (1999)

University of California-Riverside
B.S. in Biology (1994)

Insights & Events

Other Perspectives
  • Bringing Beauty Across Borders: Master Class on the International Commercialization of Cosmetics and Personal Care Products
    Cosmetics & Personal Care Products – Legal, Regulatory and Compliance, ACI, New York City, March 27, 2019
  • Legal and Regulatory Outlook for the Natural Products Industry
    Natural Products Expo East, 2018
  • A Mock Recall Exercise: How Does a Company Make a Decision on When a Recall Is Required?
    Food Law Conference, American Conference Institute, April 2018
  • Digitally Manufacturing Food to Your Dietary Needs — Are Innovations Advancing Faster Than the FDA Regulations Are Evolving
    Inside 3D Printing Conference and Expo, October 2014
  • Menu and Food Labeling: What Happens Next?
    The Legal Council’s Seminar, Spring 2014

Leadership & Community

Civic Activities

  • Suited for Change — Board of Directors

Honors

  • U.S. Food & Drug Administration — Pearson Implementation Award, 2001
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