KKB's practice is concentrated on the regulation of products subject to the jurisdiction of the U.S. Food and Drug Administration (FDA) — food, drugs & biologics, cosmetics, medical devices, dietary supplements, controlled substances, and tobacco products — as well as advertising law and other regulatory law governing consumer products and services.
KKB was recognized as one of the Best Law Firms of 2010
for FDA Law by U.S. News and World Report.
Our practice also covers many related areas, including: Controlled substances (DEA); pesticides (EPA); meat, poultry and egg regulation (USDA); Medicare and Medicaid reimbursement compliance issues (HHS and CMS); consumer product safety (CPSC); alcoholic beverages (TTB); and related State law (such as California's Proposition 65).
Our clients consist principally of manufacturers, importers, and distributors of FDA-regulated products and other providers of consumer products and services.We also handle private actions relating to FDA-regulated products and consumer products and services, such as claims for false and misleading advertising under the Lanham Act, and contractual disputes. We provide defensive counseling to our clients with respect to products liability.
KKB 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, FTC, USDA, DEA and other 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, California, and several other States. We also engage in alternative dispute resolution (e.g., arbitration) and conduct settlement negotiations on behalf of clients.
Why turn to KKB for FDA-related expertise?
- For fifty years, we have focused our practice on food-and-drug law, and our knowledge and experience in this field are both broad and deep. As a result, we can address even your most complex regulatory problems effectively and efficiently.
- We are focused on the needs of clients in FDA-regulated industries. We understand your business, including how FDA-regulated products are developed, manufactured, and marketed. We have worked extensively with companies in all areas of FDA regulation. We know your needs, and we meet them by providing practical legal advice tailored to your specific circumstances.
- We work as a team. All of our attorneys are experienced in food-and-drug law. We are always available to assist you with a diverse array of regulatory issues. We are committed to you. All of us at KKB are committed to, and passionate about, our clients' success. We strive to build enduring, trust-based relationships that help our clients succeed and prosper over the long term.
History
KKB's history dates from 1953, when Vincent A. Kleinfeld became one of the first lawyers in private practice to specialize in food and drug law. Mr. Kleinfeld began his career during the New Deal in the Department of Justice enforcing the Federal Food, Drug, and Cosmetic Act of 1938. Alan H. Kaplan came to work with Mr. Kleinfeld in 1960 from the FDA Chief Counsel's office. In 1969, Robert H. Becker joined the firm after working for Norwich Eaton Pharmaceuticals and the FDA Chief Counsel's office.
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.
Messrs. Kleinfeld, Kaplan and Becker were widely recognized pioneers and leaders in the food and drug bar throughout their careers. They were known for their inspired and tenacious advocacy - a legacy our firm continues to maintain