profile

Since 2003, Joshua Kim has counseled and advocated for clients on complex legal, regulatory and legislative matters concerning the U.S. Food and Drug Administration (FDA). Mr. Kim advises clients on FDA's regulation of food, biotechnology, and pharmaceutical products, as well as dietary supplement, medical device, and cosmetic companies.

Mr. Kim advises clients on issues concerning food safety, food ingredients, food processing, food packaging, Generally Recognized As Safe (GRAS) ingredients, and the registration of facilities under the Bioterrorism Act of 2002. Mr. Kim has advised clients on the substantiation of labeling and advertising claims. His experience also includes matters arising under the Hatch-Waxman Amendments, such as the approval pathways under sections 505(b)(1), 505(b)(2), and 505(j) of the Federal Food, Drug, and Cosmetic Act, as well as the Biologics Price Competition and Innovation Act.

Mr. Kim has experience with enforcement matters such as assisting clients with FDA recalls and negotiating Consent Decrees. He has conducted internal investigations and corporate due diligence. Mr. Kim has drafted citizen petitions and other legal forms and agreements.

Mr. Kim has counseled clients before the Federal Trade Commission (FTC) regarding the advertising of food and beverages to children and adolescents. He has advocated for clients in National Advertising Division (NAD) proceedings in challenges brought by competitors and by the NAD. Mr. Kim also has experience in Consumer Product Safety Commission (CPSC) matters relating to child-resistant packaging, as well as matters involving the Drug Enforcement Administration (DEA) and the U.S. Department of Agriculture (USDA).

Mr. Kim earned his J.D. from Harvard Law School and his B.A., summa cum laude, from Yale University, where he was one of only fourteen individuals in his class (top 1%) elected into Phi Beta Kappa in the junior year. Prior to joining KKB, Mr. Kim practiced food and drug law as an associate at prominent law firms in Washington, D.C.

matters

• Advised major food company on the regulation of food and beverage advertising directed toward children and adolescents
• Negotiated Consent Decree for clients in the food industry
• Provided advice on health claim labeling issues
• Advised client on FDA's regulation of medical foods
• Advocated on behalf of client in competitor challenge before the National Advertising Division (NAD)
• Counseled client on country of origin issues
• Conducted FDA regulatory due diligence for corporate transactions
• Counseled trade association on domestic and foreign requirements for the documentation of current good manufacturing practices (cGMPs)
• Conducted internal investigations on behalf of FDA-regulated clients
• Advised company on the use of incidental ingredients
• Prepared comments to FDA regarding the agency’s Regulatory Flexibility Analysis for regulation's economic impact on small businesses
• Challenged third-party use of client's coupons
• Counseled trade association on legal, regulatory, and scientific issues regarding the approval of a complex drug product
• Advised pharmaceutical client on 180-day exclusivity issues
• Counseled client on class-wide Risk Evaluation and Mitigation Strategy (REMS)
• Advised pharmaceutical client on FDA's regulation of efficacy claims
• Drafted clinical trial agreements for pharmaceutical, biotechnology, and consumer product companies
• Advised client on the classification of medical devices
• Counseled packaging client on medical device registration and labeling issues
• Advised client on the marketing of an ingredient as a drug, cosmetic, or dietary supplement
• Drafted letter to FDA on behalf of a consumer products client challenging antimicrobial labeling claims on a competitor's product