For over 15 years, Josh has focused on U.S. Food and Drug Administration legal and regulatory counseling, effectively providing creative and strategic solutions for his clients.

Overview

As former in-house food lawyer for one of the largest multinational FDA-regulated companies in the world, Josh embraces the challenges that clients face and manages the spectrum of food. drug, cosmetic and veterinary industry legal needs. He frequently advises food industry clients on FDA manufacturing, labeling and safety requirements; represents pharmaceutical and biotechnology companies on drug product approval pathways and life-cycle management; counsels cosmetic companies on cosmetic safety and labeling; advocates for animal/veterinary stakeholders; advises on clinical trials; counsels clients on the FDA's regulation of radiation emitting products; and advises on the full range of proactive and defensive regulatory and legislative actions impacting FDA-regulated industries.

Josh has represented clients before the U.S. Department of Justice, U.S. Department of Agriculture, Federal Trade Commission and Environmental Protection Agency, as well as quasi-governmental bodies like the National Advertising Division of the Council of Better Business Bureaus. His regulatory experience includes matters under the jurisdiction of the U.S. Consumer Product Safety Commission, Korea (Republic of) Ministry of Food and Drug Safety (formerly Korean Food and Drug Administration) and Health Canada, as well as various state and local government agencies. Additionally, Josh conducts internal investigations and provides regulatory insight and perspective in corporate transactions and litigation matters, including class-action lawsuits. He is fluent in Korean.

Experience

Josh regularly counsels food, beverage, dietary supplement and medical food clients on FDA manufacturing requirements, food safety, labeling and advertising, product recalls and enforcement actions.

He helps clients influence proposed regulations, draft guidance and pending legislation.

He advises clients on the implementing regulations of the Food Safety Modernization Act (FSMA) Food Additive Petitions, as well as standard of identity issues.

Josh partners with clients on a variety of USDA issues such as inspections, HACCP, biofuels and organic certification.

He represents pharmaceutical and biotechnology companies on drug product approval pathways such as NDAs, 505(b)(2) applications, ANDAs and BLAs, as well as various marketing exclusivity issues such as new chemical entity, 3-year, pediatric, 180-day orphan drug and biologic exclusivities.

He advises companies on OTC drug monographs, United States Pharmacopeia – National Formulary (USP-NF) monographs and Drug Master File (DMF) submissions.

Josh counsels clients on regulatory enforcement issues and post-marketing requirements, as well as drug/device combination products and medical device substantial equivalence analyses in the context of 510(k) submissions and PMA applications.

Josh counsels Cosmetic companies on the various issues that may subject cosmetic products to drug, medical device or food regulations.

He has experience with Voluntary Cosmetic Registration Program (VCRP) and Cosmetic Ingredient Review issues.

He counsels clients on color additives and the importation of cosmetic products into the U.S.

Josh advises the animal feed industry on medicated feed, food additives, feed contaminants, CGMPs, pet food, recalls and GRAS, as well as issues involving AAFCO.

Josh navigates issues at the intersection of human food and animal feed, such as coproducts and rendering.

He also counsels the animal health industry on NADA, ANADA and MUMS issues such as marketing exclusivity, bioequivalence, suitability petitions, user fees and drug designation.

Other Experience

Serves as a Council Member on the Council of the Food, Drug, and Device Section of the Minnesota State Bar Association (MSBA)

Served as an MSBA Assembly Representative for the Minnesota Asian Pacific American Bar Association.

Selected to participate in the Leadership Cohort of the Eagle Brook Association (part of Eagle Brook Church, whose weekly attendance is 20,000+.)

News & Insights

Speaking Engagements

Moderator, "FDA Forum: Recent Developments in Regulatory and Litigation Topics," Minnesota State Bar Association, Minneapolis, MN, March 2019

"Trends in FDA Enforcement: What We're Seeing Today," Minnesota State Bar Association, Minneapolis, MN, June 2018

"FDA Forum: Developing Trends and Topics for Food, Drug and Device Companies," Minnesota State Bar Association, Minneapolis, MN, February 2017

"Legal and Regulatory Challenges and Opportunities for Ingredient Suppliers to Global Food Companies," Institute of Food Technologists Annual Event and Food Expo, New Orleans, LA, June 2014

"Diversity within Diversity: The Asian American Experience Negotiating Multiple Identities within the Legal Profession," Minnesota Asian Pacific American Bar Association, Minneapolis, MN, May 2014

Admissions

  • Minnesota
  • District of Columbia
  • Maryland (inactive)

Education

Harvard Law School, J.D., 2003

Yale University, B.A., summa cum laude, 2000

  • Phi Beta Kappa Junior Year

Regent College, M.Div. (in progress)

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