About the Firm

Our founders set a high standard with their innovative practice of law and many contributions to the profession through teaching, writing and their generous sharing of their insight and experience. We continue this tradition and experience.  

About the Firm

Kleinfeld, Kaplan & Becker is one of the most distinguished and experienced law firms in the country specializing in FDA law. Our practice concentrates on the regulation of products subject to the jurisdiction of the U.S. Food and Drug Administration (FDA) — including food, drugs, biologics, cosmetics, medical devices, dietary supplements, controlled substances, tobacco products, and animal food and drugs — as well as related areas of advertising law. We also advise on regulatory issues affecting similar products (such as meat and poultry regulated by the United States Department of Agriculture (USDA); and consumer products regulated by the Consumer Products Safety Commission (CSPC)). For more information, see our Practice Areas.

Our firm has a comprehensive administrative law practice, including the submission of petitions and comments relating to rulemaking and the resolution of administrative actions before the FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), USDA, Drug Enforcement Administration (DEA) and other Federal and state agencies. We conduct litigation, primarily in Federal court, and our attorneys are admitted to practice before a number of Federal courts as well as in the District of Columbia and various States. We also practice before the National Advertising Division (the advertising self-regulatory program of BBB National Programs, Inc.) and engage in alternative dispute resolution and settlement negotiations on behalf of clients.

Our clients consist principally of manufacturers, importers, distributors, and retailers of FDA-regulated products, including major multinational corporations as well as mid-sized companies and smaller start-up ventures. We also work closely with healthcare institutions, other law firms, private equity firms, and other specialists in our areas of concentration.

KKB has been consistently recognized as one of the finest law firms in the field; for example, we have been ranked among the Best Law Firms of 2010 – 2020 for FDA Law and Advertising Law by U.S. News and World Report and Best Lawyers.

History

Our firm was founded by Vincent A. Kleinfeld, one of the first private practitioners of food and drug law. Mr. Kleinfeld entered government service in 1935 and eventually became Head of the General Regulations Unit, Criminal Division, in the U.S. Department of Justice, where he was in charge of litigation under the Federal Food, Drug, and Cosmetic Act. From 1950-1951, he served as chief counsel for the House Select Committee to Investigate the Use of Chemicals in Food Products (the “Delaney Committee”). In 1953, Mr. Kleinfeld became a partner in the Washington, DC law firm of Bernstein, Kleinfeld & Alper, where he advised numerous clients in the pharmaceutical, food and cosmetics industries. He was joined by Alan H. Kaplan, who had been a Food Law Institute fellow in 1956-1957 and an attorney in FDA’s Office of the Chief Counsel. In 1967, they created the firm of Kleinfeld & Kaplan. The firm adopted its current name when Robert H. Becker, who was counsel to Norwich Eaton Pharmaceuticals, became a partner in the early 1970s.