With more than two decades of navigating complex issues for FDA-regulated companies, Heili Kim provides deep knowledge of FDA combined with business pragmatism to solve real world challenges. Heili understands client priorities by identifying short-term gains to reach long term solutions. Her experience as regulatory counsel at FDA provides unique insight into the workings within the Agency as well as its interactions with other state and federal agencies. Heili has guided food, dietary supplement, cosmetic and medical device companies on matters involving regulatory compliance, evaluating new ingredients, product safety, product complaints, recalls, and Agency enforcement actions.
In addition to FDA, companies must also consider the impact of their advertising and marketing claims. The requirements and standards of the Federal Trade Commission and the National Advertising Division of the Better Business Bureau impact the way companies communicate with consumers and other businesses about the benefits of their products. Heili guides companies with a risk-based approach in understanding how marketing claims affect product classification, consumer expectations, claims substantiation, and potential liabilities. With steep competition in today’s marketplace, Heili regularly counsels companies on advertising challenges and develops sophisticated strategies that combine aspects of regulatory and advertising compliance.
As companies look to expand into global markets, Heili offers international insight into regulatory agencies in Asia with her years at the largest law firm in Seoul, Korea. Heili helps companies coordinate local and foreign counsel to address international compliance and standards to allow FDA-regulated companies to assess and develop a comprehensive approach for these markets.