KKB’s practice is concentrated on the regulation of products subject to the jurisdiction of the U.S. Food and Drug Administration (FDA) -- pharmaceuticals, biologics, food, dietary supplements, medical devices, veterinary products, and cosmetics. Our clients consist principally of manufacturers, importers, and distributors of FDA-regulated products and other related consumer products. We also represent trade associations, academic institutions, and other entities and individuals in matters relating to our areas of expertise.

Our practice involves all aspects of FDA regulation as well as issues involved in the regulation of:

		Controlled substances (by DEA)
		Pesticides (by EPA)
		Meat, poultry and eggs (by USDA)
		Medicare and Medicaid reimbursement (by CMS)
		Consumer product safety (by CPSC)
		Advertising (by FTC and State agencies)
		Alcoholic Beverages (by TTB)
		Labeling and ingredients under State law (such as California’s Proposition 65).

We also handle private actions relating to FDA-regulated products, 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 product 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 USDA, FDA and FTC. 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.

We are located in Washington, DC, and also have an office in Salt Lake City, Utah.

WHY TURN TO A SMALL, SPECIALIZED FIRM 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.