Thomas O. Henteleff
Managing Partner
toh@kkblaw.com

Tom Henteleff has extensive experience in all matters relating to the administration and enforcement of the Federal Food, Drug, and Cosmetic Act and related laws affecting consumer products, including the Comprehensive Controlled Substances Act of 1970, the Federal Trade Commission Act, the Consumer Products Safety Act, and the Federal Insecticide, Fungicide, and Rodenticide Act.

His practice, which focuses on human drugs, medical devices, dietary supplements, foods, and cosmetics, involves providing legal/regulatory advice on how to: a) avoid regulatory problems (“preventive medicine”); b) assure a level playing field; c) use exclusivity and regulatory provisions to a company’s and the public’s benefit; d) interact with government officials, health care providers, and consumers; e) bring new products to the market with minimum regulatory obstacles/burdens; and f) respond to unanticipated regulatory problems. His practice also involves initiating or defending administrative, quasi-judicial, and/or judicial actions designed to define and protect rights and/or prohibit or limit transgressions by others.

A representative list of published articles include the following topics: “Update of the Final Prescription Drug Marketing Act Regulations,” “DEA Issues New Regulations Governing Freight Forwarding Facilities,” “FDA’s New Attitude Toward Company Sponsored Dissemination of Prescription Drug Information,” “Biotechnology Regulation in the European Community,” “Obstacles, Opportunities, and Options,” “Modernizing the Delaney Cause,” “OTC-A Privileged Class,” “The Delaney Myths,” “Individual Rights v. Pro Bono Publico (For the Public Good),” “A Cosmetic Legal Update,” “The Interrelationships of FDA Laws and Regulations with Product Liability Issues,” “ Legal Developments Relating to Controlled Drugs,” “Suntan Products: Drugs or Cosmetics,” “Drug Device Establishment Inspection,” and “Legal Considerations and Regulatory Procedures Governing Cosmetics.”

Education:
J.D., 1968 Boalt Hall School of Law, University of California at Berkeley, California
B.S., 1965 University of Utah, magna cum laude, Phi Beta Kappa, Certificate on International Relations

Professional Affiliations:
Member of the District of Columbia and California Bars.
Admitted to practice before: the United States Supreme Court; the United States Court of Appeals for the District of Columbia 1st, 3rd, 4th, 7th, 9th, 10th and Federal Circuits.

Practice Credentials:
Partner, Kleinfeld, Kaplan and Becker, LLP, 1974 to present.
Associate, Kleinfeld, Kaplan and Becker, 1969 to 1973.
Law Clerk to Honorable David T. Lewis, U.S. Court of Appeals, for the Tenth Circuit, 1968 to 1969.
Recipient FDA Commissioner’s Special Citation and Wiley Bronze Medal 1997
Recognized in Best Lawyers in America® - FDA Law
Advisory Board, Food and Drug Law Institute
Editorial Board, Food and Drug Law Journal
Medical Device Pilot Initiative Group
Member of Advisory Board of World Pharmaceutical Report
Washingtonian Magazine Top Lawyers
International Who's Who of Life Sciences Lawyer