Our law practice at Kleinfeld, Kaplan and Becker, LLP, 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. Our practice also covers many related areas, including: DEA regulation of controlled substances; pesticide regulation (EPA); meat, poultry and egg product regulation (USDA); Medicare and Medicaid reimbursement compliance issues (HHS and CMS); unfair trade practice investigations (FTC); consumer product safety (CPSC); alcoholic beverages (TTB); and related state law (such as state unfair trade practice laws and California’s Proposition 65). We handle competitive trade disputes such as advertising claims challenges at the National Advertising Division (NAD) and under the Lanham Act. We also provide transactional due diligence and contractual advice relating to our area of concentration.
Our clients consist principally of manufacturers, importers, and distributors of FDA-regulated products and other providers of consumer products and services. We also work closely with law firms, private equity firms, and other technical experts on our areas of concentration.
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.