profile

Tom Henteleff joined KK&B in 1969 after spending a year clerking for the Honorable David T. Lewis of the United Court of Appeals for the 10th Circuit. Mr. Henteleff became a partner of the firm 4 ½ years after joining the firm and became the firm's managing partner in the 1990s. Since joining the firm Mr. Henteleff has been engaged in all aspects of "Food & Drug" law. He represents companies, trade associations, investors and individuals that manufacture, market, invest in, or otherwise have a keen interest with respect to the legal and regulatory requirements pertaining to drugs, medical devices, foods, dietary supplements, cosmetics, pesticides and other consumer products. His practice covers the administration and enforcement of the Federal, Food, Drug and Cosmetic, as amended, the Controlled Substances Act, the Federal Trade and Commission Act, the Lanham Act and other related laws. He has been honored by FDA and numerous national and international lawyer rating organizations (see, Recognition)

Mr. Henteleff has successfully assisted clients in developing a legal and regulatory course of action designed to bring new products to the market in a manner which meets applicable legal requirements, company's business objectives, is cost-effective and takes advantage of available opportunities for market exclusivities. This includes determinations as to the regulatory status of a product (e.g. drug, controlled drug, device, biologic, combination product, food, medical food, dietary supplement, cosmetic), potential legal pathways to the market (e.g. NDA, 505(b(2), OTC switch, 510(K), 510(k) exempt PMA, Laboratory Development Tests, De Novo, Notification, GRAS Affirmation, Food Additive ) entitlements to exclusivity (e.g. patent, 5 year, 3 years, pediatric, orphan drug).

Mr. Henteleff also frequently assists clients regarding FDA or competitive issues that arise subsequent to market entry, including labeling, advertising, communication, manufacturing and quality control issues. Ideally, this involves keeping clients abreast on relevant legal and regulatory requirements and providing advice on achieving compliance but also, on occasion, involves defending clients in formal or informal actions initiated by FDA, FTC, DEA, or competitors, including administrative and judicial actions. Mr. Henteleff also has successfully initiated action against regulatory agencies designed to assure that the law is administered and enforced in an appropriate, fair and even-handed manner. Additionally, Mr. Henteleff has been involved in a number of internal investigations and due diligence reviews on behalf of clients. (see, Matters).

Mr. Henteleff has served on FDA's Grassroots Task Force, FDLI's Advisory Board, Editorial Board FDLI and Advisory Board of World Pharmaceutical Report.

matters

• Assisted clients in the successful development and implementation of life cycle management strategies consistent with legal requirements and opportunities
• On behalf of a client brought a successful suit against HHS/FDA that required FDA to pursue its class action enforcement initiative so that all members of the class were treated in a similar manner (level playing field)
• On behalf of a trade association assisted in the proactive development of proposed guidelines that were presented to FDA for its consideration and which culminated in FDA issuing guidelines that to a significant extent adopted the suggestion embodied in the proposed guidelines
• Assisted a client in developing the legal and factual basis for FDA reversing its preliminary determination that the first monoclonal in vitro test could not be cleared through the 510(k) process
• Assisted a client in developing the legal and factual basis why an enzyme used to convert a sugar into a form that could be safely and comfortably consumed by otherwise intolerant individuals was entitled to GRAS status
• Assisted a client in developing a course of action to aggressively address alleged GMP/Quality System deficiencies and thereby provide the basis for FDA concluding that its threaten enforcement action against the company should not be pursued
• Assisted clients in the development and implementation of a course of action that resulted in the successful switch of drugs products from Prescription to OTC status and concomitant 3 years market exclusivity
• Assisted clients in developing procedures and policies designed to achieve and maintain compliance with the requirements imposed under the Controlled Substances and thereby successfully convince DEA that threatened enforcement action was not necessary or justified
• Assisted clients in preparing documents proposing that FDA issue a written request for pediatric studies which culminated in the written request being issued and the concomitant opportunity for pediatric exclusivity
• Assisted clients in the successful defense of trade names against an initial challenge by FDA relating to the trade name involved
• Assisted clients in the preparation and filing of trade complaints with FDA and other regulatory bodies that resulted in enforcement action against the products or practices at issue

recognition

Recipient FDA Commissioner's Special Citation and Wiley Bronze Medal

Best Lawyers in America-FDA Law (2006-2012)

Chambers USA-FDA Law (2009-2012)

International Who's Who of Life Sciences Lawyers-FDA Law (2008-2012)

Washingtonian Best Lawyers-FDA Law (2007, 2009, 2011)

Washington DC Super Lawyers-FDA Law (2010-2012)

AV Preeminent Attorney-Martindale & Hubbell

publications

VINCENT A. KLEINFELD & THOMAS O. HENTELEFF, Legal Considerations and Regulatory Procedures Governing Cosmetics, in 3 COSMETICS, SCIENCE AND TECHNOLOGY 503-538 (M.S. Balsam & Edward Sagarin eds. 2d ed. 1974).

Thomas O. Henteleff, Drug and Device Establishment Inspections, 30 FOOD DRUG COSM. L.J. 613 (1975).

Thomas O. Henteleff, Suntan Products: Drugs or Cosmetics, 91 COSM. & TOILET. 21 (1976).

Thomas O. Henteleff, Legal Developments Relating to Controlled Drugs, 31 FOOD DRUG COSM. L.J. 465 (1976).

Thomas O. Henteleff, The Interrelationships of FDA Laws and Regulations with Product Liability Issues, 32 BUS. LAW. 1029 (1977).

Thomas O. Henteleff, A Cosmetic Legal Update, 33 FOOD DRUG COSM. L.J. 252 (1978).

Thomas O. Henteleff, Individual Rights v. Pro Bono Publico (For the Public Good), 33 BUS. LAW. 2255 (1978).

Thomas O. Henteleff, The Delaney Myths, 33 FOOD DRUG COSM. L.J. 396 (1978).

Thomas O. Henteleff, OTC – A Privileged Class, 36 FOOD DRUG COSM. L.J. 332 (1981).

Thomas O. Henteleff, “Modernizing” the Delaney Clause, 38 FOOD DRUG COSM. L.J. 147 (1983).

FDA’s New Attitude Toward Company Sponsored Dissemination of Prescription Drug Information

Symposium, Consumer Products: New Perspectives in Self-Care – Obstacles, Opportunities, and Options, 3 REG. AFF. 33 (1991).

Thomas O. Henteleff, Biotechnology Regulation in the European Community, WORLD PHARMACEUTICAL REPORT (BNA International, Inc., London)

Thomas O. Henteleff & Stacy L. Ehrlich, Relief for Tired Eyes, 10 REG. AFF. J. 373 (1999).

Thomas O. Henteleff & Scott M. Lassman, Innovating Within the OTC Monograph System, REG. AFF. FOCUS, Mar. 2000, at 23.

Thomas O. Henteleff & Scott M. Lassman, DEA Issues New Regulations Governing Freight Forwarding Facilities UPDATE (Pharmaceutical Distribution and Marketing Audits, Inc., Richmond, Va.) Winter 2000, Vol. 7, Issue 3.

Thomas O. Henteleff & Stacy L. Ehrlich, Illegal Sampling Practices May Result in Huge Settlements, UPDATE (Pharmaceutical Distribution and Marketing Audits, Inc., Richmond, Va.) Spring 2001, Vol 8, Issue 2.

Thomas O. Henteleff & Stacy L. Ehrlich, Update of the Final Prescription Drug Marketing Act Regulations, UPDATE (Pharmaceutical Distribution and Marketing Audits, Inc., Richmond, Va.) Winter 2001, at 5.

Karen M. Becker, Ellen J. Flannery & Thomas O. Henteleff, Scientific Dispute Resolution: First Use of Provision 404 of the Food and Drug Administration Modernization Act of 1997, 58 FOOD DRUG L.J. 211 (2003).

Thomas O. Henteleff & Daniel R. Dwyer, Over-the-Counter Drugs, FOOD AND DRUG LAW AND REGULATION, Adams, Cooper et. al., eds., FDLI. pp 413-432 (2008)

Thomas O. Henteleff, Kinsey S. Reagan, Scott M. Lassman, et al., Medical Devices Law and Regulation Answer Book 2011-2012. Practising Law Institute 2011.